His Patients Inspired His Songwriting In and Out of the… : Neurology Today – LWW Journals

Article In Brief

Working with neurology patients has inspired William Baek, MD, to write and produce songs for two albums. This lifelong musician discusses the added value music brings to his life and how that passion prevents him from feeling burnout.

William Baek, MD, is a clinical associate professor at University of California Riverside; a Fellow of the American Association of Neuromuscular and Electrodiagnostic Medicine; and diplomate of the American Board of Disability Analysts. But when he's not working as a general neurologist in private practice in Upland, CA, you can find him in a music studio, writing and recording songs.

A passionate musician since childhood, he has found inspiration for his songwriting from his patients' experiences. His first album, released in 2018, can be found on YouTube and Spotify. His second album is due out in 2020.

Dr. Baek spoke to Neurology Today about the role music-writing has played in his practice and life. His comments are edited and excerpted below.

I started playing the piano at age 10. Initially the lessons were my mom's ideashe plays the piano wellbut I loved music and really took to it. I was born in the United States, but my family moved to Seoul, Korea, when I was nine and then returned to the States when I was 26, and it was in Korea where I learned to play the piano.

As a pre-medical student, I also took up the trombone. I had always wanted to play a brass instrument, and initially I thought about the trumpet, but I found the trombone interesting because it's almost like singing. You have to have a good sense of pitch because you can play multiple notes in the same position.

I loved music so much that while I was in college, I thought that I wanted to become a singer and a rock star, but back where I come from in Korea, if you want to go into the entertainment business, you say goodbye to college. I was already a pre-med student, so I thought I should finish that. But I played lead trombone in our medical school orchestra, and while I was taking the bus home at midnight after studying in the medical school library, I would write songs.

There wasn't a lot of time for that, but I did do one fun project. My uncle was a producer with a record label, and he had a song that they wanted to be sung in many different languages. Since I'm bilingual in Korean and English, I translated the song into Korean. Translating lyrics isn't as easy as it soundsyou can't just do a direct translation. You have to make the translation work as a song. I had listened to enough Korean music that I could do that. Then one of my co-residents and I recorded the song in Korean for my uncle's label. It was a typical love song, but my uncle put a good pop-catchy spin on the arrangement that was totally amazing. I still have that CD at home.

But other than that, during my residency and fellowship my musical interests went on the back burner. I got married and we had children, and while I took a couple of voice lessons, there wasn't much time.

In 2012, I had gone into private practice and had a little more room to breathe. Recording an album of my own was my dream, but I wanted to learn how to sing more professionally first. So every Thursday at lunchtime I'd rush out of clinic, grab a sandwich, and drive to a 30-minute voice lesson. After I had been doing that for several years, all the time writing songs, one of the ICU nurses at a hospital where I work, who sings semi-professionally, introduced me to Stephan de Reine, a producer with GRA music group. Once I met him I realized that my dream could come true. I began working with himI write the melody and the lyrics, and he does all the arranging. In January 2018 I released my first album on his label.

During my rotations, I often hear very poignant stories that aren't really something I could put into scientific papers. I want other people to hear our patients' stories about their life experiences, so that maybe I can raise awareness and also maybe reach out to people who are experiencing these conditions so that they can be comforted.

Nowadays I listen to a lot of music that is a bit superficial, and I want to talk about more serious topics. The songs on my first album are about Alzheimer's and Parkinson's, there's a song about myasthenia, and a song about multiple sclerosis, Walk Again. Another song, Chained to a Dream, is about stroke. My father experienced a stroke back in 1996 and I wanted to write about what that was like. The songs don't have medical terminology or lingo, I've kept them abstract so that people who don't have these medical conditions can relate to them as well. I can't compete with Ariana Grande or Taylor Swift, but I could find my own niche, and I think this is a good niche for me.

I clearly remember when this first occurred to me. It was 2005, and I was a neuromuscular fellow at the University of California, San Diego. My mentor and I were treating patients with amyotrophic lateral sclerosis (ALS), and I thought, Maybe I could write a song that could express musically some of what they are experiencing. That song is also on my album, and it was my first song inspired by a patient.

They're always very interestedthey want to follow my YouTube channel and find out where they can get the album. Naturally, the patients gravitate toward the songs that describe their illness in particular. I recently heard from one patient and it was particularly heartwarming. She is a full-time pharmacist who has MS. She's a wonderful patient advocate and an example of how people can overcome illness. She told me, When I have a bad day, I listen to your song and it makes me feel so much better. That made me feel that I've already achieved what I wanted to do.

He's a man of few words, so it was hard for me to try to get into his brain and describe the illness. But when my mom heard it, she was like Aha! She thought it really described the struggle of the person, and their relationship to their caregiver. Some people might find it depressing, but for others, it's cathartic. I wrote the album to help heal my patients, but I think it's healed me.

The second album was completed at the end of December 2019, but there have been problems with releasing it. I went to record in France with my producer last June, but then there were strikes and some delays. It should be coming out this year, and it will include some more songs inspired by medical conditions. I see a significant pediatric population, and I wrote a song about life with ADHD called Free Wheeling. Although I don't have ADHD, I did feel a lot of stress under the school system in Korea to conform. I had to fit the norm and the social structure, but I had my ideas and my own person. The school wouldn't budge, and they wanted to treat each child uniformly in a mechanical way, which is something like the way society seems to want to control people with ADHD.

Back in 2018, I sang Walk Again at the MS Walk in Fontana, CA. That was just an amazing experience. I also sang it at a family practice conference held at Disneyland. I'm hoping to sing at another MS Walk this year, and someday I would love to share my songs at the AAN conference.

If you're always invested 100 percent of your waking time in patient care, it's exhausting and monochromatic. We need this variety and variability in our lives, in order to appreciate different things. So many of my friends who are doctors have other talents too, and they should take time for them. We see a lot of burnout, and I tell my colleagues: You were somebody before you became a doctor, and I'm sure you still have other non-medical aspects to your life. People need to explore these other sides of themselves and cultivate them in order to avoid burnout. The more involved I am in music, the happier I am.

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His Patients Inspired His Songwriting In and Out of the... : Neurology Today - LWW Journals

Biomarkers of Senescence and Inflammation Linked to Risk of… : Neurology Today – LWW Journals

Article In Brief

Scores on a set of five markers of inflammation predicted the cognitive scores of patients with Parkinson's disease at 36 months. Two measures of cellular senescence likewise predicted cognitive outcomes.

Blood-derived biomarkers of senescence and inflammation look promising as predictors of cognitive decline in Parkinson's disease (PD), according to a January 13 study in the Journal of Parkinson's Disease.

At diagnosis, patients' summary scores on a set of five markers of inflammation predicted their cognitive scores at 36 months. Two measures of cellular senescence likewise predicted cognitive outcomes.

While significant, the results from the Incidence of Cognitive Impairments in Cohorts with Longitudinal Evaluation-Parkinson's Disease (ICICLE-PD) study were not strong enough to be of immediate clinical utility. They add, however, to the existing literature on risk factors observable at diagnosis that should one day enable neurologists to offer patients a reliable prognosis of cognitive outcomes, said the study's senior author and independent commentators.

The findings look robust, commented David K. Simon, MD, PhD, professor of neurology at Harvard Medical School and director of the Parkinson's Disease and Movement Disorders Center at Beth Israel Deaconess Medical Center, who was not involved with the study.

This is a very well organized, well conducted study. But we see a lot of studies about biomarkers like this, and we're not using them in the clinic yet. I'd want to see the results validated in a larger cohort before I use these biomarkers to tell a patient that they're likely to develop dementia.

The ongoing ICICLE-PD study, based in Newcastle upon Tyne and Gateshead, United Kingdom, includes154 newly diagnosed PD patients and 99 healthy, age-matched controls from the Newcastle area.

The inflammatory markers used in the study were C-reactive protein, TNF alpha, IL-6, IL-10, and IFN-gamma. For markers of senescence, the investigators used p21 and p16cell-cycle regulators known to suppress tumorsas well as telomere length in blood cells. Found at the end of every chromosome, telomeres serve as protective caps. Because their length has previously been shown to shorten with age, stress and illness, the study sought to determine if a shorter length at baseline would distinguish patients from controls and predict worse cognitive outcomes at 18 and 36 months.

As expected, the study found that PD patients as a group had shorter average telomeres in blood cells at baseline and 18 months compared to age-matched healthy controls. Shorter telomere length among the PD patients was also correlated with an increased risk of PD dementia (PDD) at 36 months.

Results from measurements of p21 and p16 were not as clear. Overall, the best predictor of cognitive score over the 36 months of the study was a summary score of the five markers of inflammation, while the development of dementia best correlated with short telomeres.

We think these different components might be related, said the senior author of the paper, Gabriele Saretzki, PhD, a lecturer in aging research at the Biosciences Institute of Newcastle University.

As more patients in the ICICLE-PD cohort progress to dementia, she said, results should strengthen.

For now we could only go to 36 months, Dr. Saretzki said. At 72 months, we should have three to four times more dementia cases, and that will allow us to make much better statistical associations.

A spate of recent studies has sought to tease out which clinical and biological markers might be predictive of PDD. Last November, another paper in the journal Movement Disorders based on the ICICLE-PD cohort reported that pro-saccades appear to be a useful non-invasive biomarker for long-term PD cognitive decline.

For the new study, Dr. Saretzki and colleagues sought to use ICICLE-PD blood and serum samples in hopes of bringing clarity to contradictory data regarding telomeres. Some prior studies had found no evidence that their length in leukocytes or other cellular chromosomes held any value for predicting PDD. Other studies had found significant effects, although one, published in PLoS One in 2014, found the opposite of the expected direction: longer, rather than shorter, telomeres were associated with increased risk of dementia progression.

The whole telomere field is very difficult, said Dr. Saretzki. I tell students, be very careful when you read papers in this area. Results can depend on not just genetics but on lifestyle factors, psychological or physical stress and inflammation. It's really complex.

After correcting for multiple comparisons, Dr. Saretzki's group found that PD subjects had significantly shorter telomere length at baseline compared with controls (p< 0.001) as well as significantly faster shortening of their telomeres over the first 18 month period (p=0.002).Even so, the telomere lengths of some PD patients overlapped with those of controls. Importantly, however, they also found shorter telomeres at baseline in those PD patients who went on to develop an early dementia.

Even so, because only 11 of the PD patients developed dementia within 36 months, as measured by the Mini-Mental State Examination and Montreal Cognitive Assessment (MoCA), the small numbers precluded a meaningful regression analysis of the predictive power of telomere length for PDD, the paper concluded.

Contrary to expectations, PD participants displayed significantly lower levels of p21 gene expression than controls at baseline (p< 0.001), but there was no difference in change with time. For p16 expression, the differences between PD and controls at baseline or the rate of change per month of p16 expression levels did not reach statistical significance. Dr. Saretzki speculated that perhaps the gene expression measures her group conducted on p16 and p21 are less informative than the measures of protein levels previously published.

The baseline composite inflammatory score was only predictive of MoCA score (p=0.037) at 36 months, independently of age, gender, body mass index, and levodopa equivalent doses. Thus, the composite inflammatory score at baseline was best associated with cognitive score, but not with rate of change for any other clinical indicators over the follow-up period. What's more, none of the baseline biomarkers of senescence or inflammation significantly predicted motor function at 36 months or their rate of change.

Connie Marras, MD, PhD, associate professor of neurology at the University of Toronto and a neurologist at the Toronto Western Hospital Movement Disorders Centre, said that the study provides the basis for further investigations. But, she said, Because they only had 11 people who developed dementia at 36 months, we have to consider these findings quite preliminary.

Even so, she applauded the effort, given the importance to patients of a reasonably accurate prognosis of their cognitive status.

Cognitive slowing is a big deal for patients, she said. My patients ask what they can expect. It affects their planning for their lives and their careers. We need better ways to predict who will progress faster in terms of cognitive decline.

Elizabeth Bradshaw, PhD, the Adler assistant professor in neurological sciences at Columbia University's department of neurology, said she was excited to see the results on senescence. In particular, the findings regarding telomeres look straightforward and quite exciting.

But, she said, the findings for p16 and p21, as well as for the inflammatory markers, puzzled her.

The p16 and p21 didn't go in the direction you might expect based on the telomere results, Dr. Bradshaw said. But they examined total blood. If they had been able to break it out into specific cell types, like monocytes or memory T cells, perhaps that would explain what was driving the reduction of p21. If it turned out to be in a memory T population, that would be consistent with data suggesting that there is a potentially pathogenic role for memory T cells.

Dr. Simon agreed that the study's finding that increased risk of dementia was linked to lower, rather than higher, levels of p16 and p21 was the opposite of what was expected.

The authors acknowledge in the paper that some of the results were paradoxical, he said. The bottom line is I wouldn't discount their findings, but I would like to see the results replicated in other studies.

Dr. Marras has received fees for consulting for Acorda Therapeutics, serving on the advisory board of Denali Therapeutics, an honorarium for teaching from EMD Serono, and research contracts from Grey Matter Technologies.

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Woman with COVID-19 developed a rare brain condition. Doctors suspect a link. – Live Science

Coronavirus science and news

A woman who tested positive for COVID-19 developed a rare brain disease known as acute necrotizing encephalopathy, a condition that can be triggered by viral infections like influenza and herpes.

At this point, the brain damage "has yet to be demonstrated as a result of COVID-19 infection," according to a case report published March 31 in the journal Radiology. However, as the novel coronavirus continues to spread, "clinicians and radiologists should be watching for this presentation among patients presenting with COVID-19 and altered mental status," the authors wrote.

"We need to be thinking of how were going to incorporate patients with severe neurological disease into our treatment paradigm," Dr. Elissa Fory, a Henry Ford neurologist who was part of the team of medical experts involved in making the diagnosis, said in a statement. "This complication is as devastating as severe lung disease."

The woman, a 58-year-old airline worker, checked into the Henry Ford Health System in Detroit, after having a fever, cough (known coronavirus symptoms) and "altered mental status" for three days, the report noted. At the hospital, the woman appeared confused, lethargic and disoriented, the statement noted. She tested negative for influenza, herpes, Varicella zoster virus (which causes chickenpox) and West Nile virus; and her cerebrospinal fluid, which saturates the brain and spinal cord, contained no trace of bacterial infection.

Noting her symptoms, the doctors also tested the patient for COVID-19 using a diagnostic test provided by the U.S. Centers for Disease Control and Prevention (CDC), and found that she tested positive for the disease.

Related: 10 deadly diseases that hopped across species

CT scans of the woman's brain revealed symmetrical tissue damage in the thalamus a structure buried in the center of the brain that helps relay sensory information from the body to the rest of the organ, according to BrainFacts.org. These damaged areas appeared darker on the woman's CT scan than they did in a scan of a healthy brain, meaning they were less dense than usual, according to an explanation of radiological terms from St. Vincent's University Hospital. Brain regions can become less dense when due to edema, when excess fluid floods the tissue after injury, or necrosis, when cells making up the tissue die off in large quantities, the case study authors noted.

The doctors gathered additional scans of the woman's brain using MRIs (magnetic resonance imaging) and examined them to find evidence that the patient had suffered a hemorrhage, or bleeding from a ruptured blood vessel. They again found damage in the thalamus, as well as in portions of the wrinkled cerebral cortex and in brain regions that lie just below its folds. The doctors diagnosed the woman with acute necrotizing encephalopathy, which, if left untreated, can progress to cause "coma, liver problems and neurological deficits," according to The National Institutes of Health's Genetic and Rare Disease Information Center (GARD).

"The team had suspected encephalitis at the outset, but then back-to-back CT and MRI scans made the diagnosis," Fory said.

The rare condition develops most commonly after a viral infection, such as those caused by influenza A, influenza B and the human herpes virus 6, according to GARD. These infections can trigger a so-called cytokine storm in the brain, when inflammatory substances that normally help the body fight off disease instead go haywire and damage the infected tissue, the case report authors noted. Cytokine storms break down the tissue that surrounds blood vessels in the brain, known as the blood-brain barrier, and can thus lead to hemorrhage, they wrote.

Although the doctors could not directly demonstrate that COVID-19 triggered the woman's unusual brain disease, a recent report in the journal the Lancet suggests that a subset of infected patients appear vulnerable to brain-bound cytokine storms. In addition, a case report published in the Cureus Journal of Medical Science described a 74-year-old patient with both COVID-19 and signs of encephalopathy.

It should be noted that "elderly patients with chronic conditions are at an increased risk of altered mental status in the setting of acute infections," the authors of the Cureus paper wrote. At this point, the potential neurological symptoms of COVID-19 are not well understood, but they should be further investigated in infected patients, they added. Altered mental status might even serve as an early symptom of COVID-19 in some people, they said.

"If patients with neurological conditions are not considered to have COVID-19, this may present a nationwide issue to health care team members treating patients and in turn the general public if they are discharged and further exposed to other people," the Cureus authors noted.

Originally published on Live Science.

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First Case of Encephalitis Linked to COVID-19 Reported – Medscape

Clinicians from Henry Ford Health System in Detroit, Michigan, have reported the first presumptive case of acute necrotizing hemorrhagic encephalopathy associated with COVID-19.

"As the number of patients with COVID-19 increases worldwide, clinicians and radiologists should be watching for this presentation among patients presenting with COVID-19 and altered mental status," the clinicians advise in a report published online March 31 in Radiology.

"This is significant for all providers to be aware of and looking out for in [COVID-19] patients who present with an altered level of consciousness. This complication is as devastating as severe lung disease," Elissa Fory, MD, a neurologist with Henry Ford who was part of the team of medical experts that made the diagnosis, said in a statement.

"We need to be thinking of how we're going to incorporate patients with severe neurological disease into our treatment paradigm," Fory added.

Brent Griffith, MD, radiologist with Henry Ford and senior author of the case report, said the case shows "the important role that imaging can play in COVID-19 cases."

The 58-year-old woman presented with a 3-day history of fever, cough, and muscle aches symptoms consistent with COVID-19. She was transported by ambulance to the emergency department and showed signs of confusion, lethargy, and disorientation.

The woman tested negative for influenza, but a rapid COVID-19 test confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) infection. She was later diagnosed with acute hemorrhagic necrotizing encephalopathy.

"The team had suspected encephalitis at the outset, but then back-to-back CT and MRI scans made the diagnosis," Fory said in the statement.

Noncontrast head CT revealed "symmetric hypoattenuation within the bilateral medial thalami with a normal CT angiogram and CT venogram," the team reports in their article. Brain MRI showed "hemorrhagic rim enhancing lesions within the bilateral thalami, medial temporal lobes, and subinsular regions."

The patient was started on intravenous immunoglobulin but not high-dose steroids, because of concern for respiratory compromise. As of April 1, the patient was hospitalized in serious condition. Henry Ford Hospital has not provided an update.

Acute necrotizing encephalopathy (ANE) is a rare complication of viral infections, but until now, it has not been known to have occurred as a result of COVID-19 infection. ANE has been associated with intracranial "cytokine storms," and a recent report in the Lancet suggested that a subgroup of patients with severe COVID-19 might develop a cytokine storm syndrome.

Commenting for Medscape Medical News, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University in St. Louis, Missoui, said, "Since this is just one report of one patient, the findings are the most preliminary we can conceive, and more research is needed to determine the extent to which COVID-19 may affect the central nervous system."

Fory, Griffith, and Raji have disclosed no relevant financial relationships.

Radiology. Published online March 31, 2020. Full text

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Cannabidiol as an Adjunctive Therapy for Patients With Treatment-Resistant Dravet Syndrome – Neurology Advisor

Cannabidiol daily doses of 10 or 20 mg/kg can be a safe and effective adjunct treatment to reduce seizure in patients with highly resistant Dravet syndrome, according to study results published in JAMA Neurology.

Previous studies have supported the safety and efficacy of cannabidiol at a daily dose of 20 mg/kg as an add-on antiepileptic treatment in patients with Dravet syndrome. The goal of the current study was to assess the efficacy and safety of 2 daily doses of cannabidiol, 10 mg/kg or 20 mg/kg, in children with Dravet syndrome.

The double-blind, placebo-controlled, randomized clinical trial included children aged 2 to 18 years from 38 centers in the United States, Spain, Poland, the Netherlands, Australia, and Israel with a confirmed diagnosis of Dravet syndrome and at least 4 convulsive seizures during a 4-week baseline period while receiving antiepileptic therapy.

The patients were randomly assigned to receive cannabidiol oral solution at a daily dose of 10 (CBD10) or 20 (CBD20) mg/kg, or matched placebo in 2 equally divided doses for 14 weeks. The primary outcome was the change in the frequency of convulsive seizure frequency from baseline.

A total of 198 patients (mean age, 9.3 years; 52.5% girls) were enrolled in the study; of these, 65 received placebo, 66 received CBD10, and 67 received CBD20. A total of 190 patients completed the treatment period, and 186 (97.9%) entered the open-label extension trial.

Convulsive seizure frequency compared with baseline was reduced by 48.7% in the CBD10 group and by 45.7% in the CBD20 group compared with 26.9% in the placebo group. The percentage reduction from placebo was 29.8% (95% CI, 8.4%-46.2%; P =.01) for the CBD10 group and 25.7% (95%CI, 2.9%-43.2%; P =.03) for the CBD20 group.

The most common adverse events occurring in 10% of patients in any group included decreased appetite, diarrhea, somnolence, pyrexia, and fatigue. Serious adverse events occurred in 40 patients (10 in the placebo group, 13 in the CBD10 group, and 17 in the CBD20 group). Elevated liver transaminase levels occurred more frequently in the CBD20 (n=13) than the CBD10 (n=3) group, with all affected patients receiving concomitant valproate sodium.

The study had several limitations, according to the researchers, including the short-term follow-up period, limited option to assess the effects of specific drug combinations as cannabidiol was added to various antiepileptic regimens, and lack of data on the safety and efficacy of cannabidiol in daily doses <10 mg/kg.

Our key finding is the significant and clinically meaningful reduction of seizures with an acceptable safety profile for both cannabidiol doses in patients with highly treatment-resistant Dravet syndrome, concluded the researchers.

Disclosure: This clinical trial was supported by GW Research, Ltd. Please see the original reference for a full list of authors disclosures

Reference

Miller I, Scheffer IE, Gunning B, et al. Dose-ranging effect of adjunctive oral cannabidiol vs placebo on convulsive seizure frequency in Dravet syndrome: a randomized clinical trial [published online March 2, 2020]. JAMA Neurol. doi:10.1001/jamaneurol.2020.0073

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Discontinuation of Dolutegravir Due to Neurologic Side Effects Linked to Pre-Existing Mental Illness – Neurology Advisor

Dolutegravir (DTG) discontinuation due toneuropsychologic side effects (NPS) may be associated with preexistingpsychiatric conditions of depression and anxiety, according to results of astudy presented at the virtual Conference on Retroviruses and OpportunisticInfections, held from March 8 to 11, 2020.

DTG treatment has been associated with a higherrate for discontinuation as a result of NPS. Several associated factors forthis association have been described, including older age, female sex, abacavircoadministration, higher DTG exposure, and pharmacokinetic- and pharmacodynamic-mediatedvariants. In addition, there has been an observed increase in the rates ofmoderate depression among patients who have switched to DTG. However,pre-existing psychiatric disorders have not previously been associated with ahigher risk for NPS. Therefore, this prospective, observational study describedthe clinical features and outcomes of patients stopping DTG for NPS.

In total, 1455 participants starting DTG (naive and treated) were included from 2 Italian outpatient clinics. Clinical, therapeutic pharmacokinetics variables with the risk for DTG discontinuation due to NPS were analyzed. This analysis focused on patients who stopped DTG for NPS in terms of pre-existing psychiatric comorbidities and outcomes after drug withdrawal (resolution of symptoms was recorded at the first available follow-up after discontinuation).

Of all included participants, after a median of5.1 months, 526 participants discontinued DTG, with the most common reasonbeing treatment switches with no efficacy or tolerability issues (n=274); 66(4.5%) of participants discontinued DTG due to NPS. Of the 66 participants whodiscontinued DTG due to NPS, 21 (31.8%) participants had pre-existingpsychiatric conditions, with the 2 most common being depression (12 [18.2%]patients) and anxiety (4 [6.1%] patients).

The most common symptoms according to the preexisting psychiatric comorbidities of depression and anxiety were sleep disorders (35.6%), anxiety (28.9%), and headache (24.4%). Both headache (P =.039) and sleep disorders (P =.083) were associated with complete resolution of symptoms. After discontinuation, DTG was replaced with raltegravir (n=20), elvitegravir/c (n=19), darunavir/c (n=17), or rilpivirine (n=8), with the most complete resolution of symptoms observed with the elvitegravir/c replacement and the converse observed among patients who received rilpivirine.

Overall, the study concluded that NPS wereheterogeneous, with sleep disorders, headache, and anxiety being the moreincident among such effects, and no signal for a better switching strategyemerged.

Reference

Andrea C, Borghetti A, Milesi M, et al. Clinical features and outcomes of patients stopping STG for neuropsychiatric symptoms. Poster presented at: CROI 2020; March 8-11, 2020; Boston, MA. http://www.croiconference.org/sites/default/files/uploads/croi2020-boston-abstract-ebook.pdf. Accessed March 27, 2020.

This article originally appeared on Infectious Disease Advisor

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Sonnet BioTherapeutics Announces Formation of Scientific Advisory Board – Yahoo Finance

PRINCETON, NJ / ACCESSWIRE / April 6, 2020 / Sonnet BioTherapeutics Holdings, Inc. (SONN), a biopharmaceutical company developing innovative, targeted biologic drugs with enhanced single or bispecific mechanisms of action, announced today the formation of its Scientific Advisory Board. The Board comprises experts from leading institutions across the United States, including MD Anderson, Memorial Sloan-Kettering, Fox Chase and Robert Wood Johnson. The members bring decades of experience in oncology, neurology, drug discovery and clinical development.

"Sonnet is privileged to have this distinguished group of scientific advisors from leading institutions to help guide our clinical development and discovery programs," commented Sonnet Founder and CEO, Pankaj Mohan, Ph.D. "The advisors come to the company after reviewing its assets and are excited to be a part of the team. They share deep experience in oncology drug development from initial discovery to late-stage clinical studies, which will enhance our strategic efforts through the next phase of growth."

Sonnet Scientific Advisory Board members include:

Jason Bock, Ph.D., - Dr. Bock is the Vice President and Head of Biologics Product Development at MD Anderson Cancer Center. In this role, Dr. Bock works with MD Anderson's Therapeutic Discovery team, including world-class oncology researchers and clinicians, to create life-saving transformational medicines quickly, safely and effectively. Before joining MD Anderson, Dr. Bock spent 20 years in small, medium and large biotech and biopharma companies (including Human Genome Sciences, CoGenesys and TEVA) developing biologic therapeutics. He has brought 15 novel drugs through preclinical development into clinical studies and has guided the process to bring three biologics through the clinic and to commercialization globally. He received his Ph.D. from Stanford University in Molecular & Cellular Physiology.

Joseph R. Bertino, M.D., - Dr. Bertino is University Professor of medicine and pharmacology, UMDNJ-Robert Wood Johnson Medical School and is the interim director of the school's Cancer Institute of New Jersey. Dr. Bertino joined The Cancer Institute of New Jersey in 2002 as associate director and was appointed chief scientific officer in 2004. Previously, Dr. Bertino served as chair of the Molecular Pharmacology and Therapeutics Program, and member and co-head of the Program in Developmental Therapy and Clinical Investigation at Memorial Sloan-Kettering Institute for Cancer Research. Dr. Bertino has been internationally recognized for his role in finding curative treatments for leukemia and lymphoma. He is the author or co-author of more than 400 scientific publications and the associate medical editor of the journal Hem/Onc Today. After earning his medical degree, Dr. Bertino did a USPHS fellowship in hematology and oncology at the University of Washington School of Medicine.

Hossein Borghaei, D.O., M.S., - Dr. Borghaei is Chief of Thoracic Medical Oncology at Fox Chase Cancer Center, where he is also a Professor in the Department of Oncology/Hematology, Co-Director of the Immune Monitoring Facility and the Gloria and Edmund M. Dunn Chair in Thoracic Malignancies. In his clinical practice, Dr. Borghaei has participated in numerous immunotherapy-based clinical trials. He is also the principal investigator (PI) of a laboratory that develops new monoclonal antibodies and novel immune-modulating drugs. He served as the PI of a phase III randomized study that proved the effectiveness of nivolumab in the treatment of patients with advanced non-squamous non-small cell lung cancer after progression on prior chemotherapy. This work led to the approval of nivolumab, one of the first immunotherapy-based drugs to be approved for lung cancer in this setting. Dr. Borghaei earned his D.O. degree at Philadelphia College of Osteopathic Medicine, did his residency at Graduate Hospital (Philadelphia) and was Chief Fellow, Hematology-Oncology, at Fox Chase Cancer Center.

Guido Cavaletti, M.D., - Dr. Cavaletti is Dean of Research and Professor at the University of Milan-Bicocco, and Senior consultant neurologist and head of the Neuroimmunology Center, S. Gerardo Hospital, Monza (Italy). At the University of Milan-Bicocco, he is Head of the Experimental Neurology Unit at the School of Medicine and Surgery and Director of the Ph.D. program in Neuroscience. He is also Deputy Scientific Director of the Milan Center for Neuroscience (NeuroMI). Dr. Cavaletti is coordinator of the steering committee of the international CI-PeriNoms group on the investigation of chemotherapy-induced peripheral neurotoxicity. He has authored more than 250 peer-reviewed papers. He received his medical degree from the University of Milan and is Board-certified in Neurology.

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About Sonnet BioTherapeutics Holdings, Inc.

Founded in 2011, Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bispecific action. Known as FHAB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. FHAB is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies and vaccines.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Sonnet Biotherapeutics Investor Contact

Alan LadaSolebury Trout617-221-8006alada@soleburytrout.com

SOURCE: Sonnet BioTherapeutics Holdings, Inc.

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Sonnet BioTherapeutics Announces Formation of Scientific Advisory Board - Yahoo Finance

Coronavirus: Ministry will monitor any reports of test price cheats – Cyprus Mail

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Coronavirus: Ministry will monitor any reports of test price cheats - Cyprus Mail

Dr. James T. Goodrich, Who Operated on Conjoined Twins, Dies at 73 – The New York Times

This obituary is part of a series about people who have died in the coronavirus pandemic.

Dr. James T. Goodrich, a pediatric neurosurgeon known for successfully separating conjoined twins in a complicated and rare procedure, died on Monday at Albert Einstein College of Medicine and Montefiore Medical Center in the Bronx. He was 73.

The cause was complications of the coronavirus, according to Montefiore, where he was the director of pediatric neurosurgery and had spent more than 30 years of his career.

Dr. Goodrich was thrust into public view when he conducted a series of four operations over nearly a year on Clarence and Carl Aguirre, twins from the Philippines who were joined at the tops of their heads and shared major veins in their brains. Dr. Goodrich led a team of surgeons at Montefiores Childrens Hospital, and the twins story generated headlines, including in The New York Times, and was the subject of television specials.

During the final surgery, in August 2004, the team discovered that the twins brains were connected by more brain tissue than they had initially thought, a potentially serious complication.

We got to this point and we were stuck, Dr. Goodrich told The Times after the operation, but we did a lot of soul-searching and decided to continue.

Hours later, Clarence and Carl lay next to each other, alive and well. They had no major complications after the surgery, and their mother, Arlene Aguirre, said, My dream has come true.

Carl and Clarence, who turn 18 later this month, live with their mother in Scarsdale, N.Y.

James Tait Goodrich was born in Portland, Ore., on April 16, 1946, to Richard and Gail (Josselyn) Goodrich. His mother was an artist and a designer, and his father worked in advertising. Dr. Goodrich served in the Marines during the Vietnam War, then studied neurosurgery and psychobiology at the University of California, Irvine; Columbia University; and the Neurological Institute of New York before starting at Montefiore.

He married Judy Laudin in 1970. In addition to his wife, he is survived by three sisters, Kristine Goodrich, Jan Rentenaar and Carol Montecucco.

In another celebrated case, Dr. Goodrich led a team of 40 surgeons in a 27-hour procedure in 2016 to separate another set of twin boys, the seventh separation procedure of his long career.

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Dr. James T. Goodrich, Who Operated on Conjoined Twins, Dies at 73 - The New York Times

High Levels of Air Pollution Linked to Increased MS Risk – Medscape

Air pollution may be another environmental risk factor for developing multiple sclerosis (MS), new research suggests.

A large cohort study of almost 550,000 individuals living in Italy showed that participants living in areas with high levels of pollutants had a significantly greater risk of developing MS than those who lived in areas with low levels of pollutants.

Dr Roberto Bergamaschi

The findings further confirm a relationship between exposure to air pollutants and risk for MS that has been shown in previous research, Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy, told Medscape Medical News.

"Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS," Bergamaschi said.

The findings were presented at the Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.

Several environmental factors may trigger an abnormal immune response that manifests in MS. The most studied of these are low vitamin D level, cigarette smoking, and an unhealthy diet, Bergamaschi said.

However, "other environmental factors deserve to be studied pollution included," he added.

Among the most toxic air pollutants are particulate matter (PM), which is a mixture of fine solid and liquid particles suspended in the earth's atmosphere. PM may range from 2.5 microns (PM2.5) to 10 microns (PM10) in diameter.

The main sources of such pollutants are household and commercial heating (53%) and industrial activities (17%), followed by road vehicle and nonroad vehicle use, agriculture, and electricity production.

The World Health Organization estimates that more than 3.2 million individuals worldwide die prematurely every year because of lung cancer, cardiovascular disease, and other diseases related to air pollutants, said Bergamaschi.

Epidemiologic research has uncovered a relationship between air pollution and MS. A large American study published in 2008 in Science of the Total Environment showed a significant association between MS prevalence and PM10 levels (P < .001).

Other studies have shown an increase in the number of clinical relapses of MS that were linked to air pollution.

The current investigators assessed the association between PM2.5 levels and MS prevalence in the northern province of Pavis, which has a population of 547,251 individuals in 188 municipalities.

Pavia is situated in a flat territory that encompasses the highly industrialized regions of Piedmont, Lombardy, Emilia-Romagna, and Veneto. It has a high level of anthropogenic emissions, or environmental pollutants originating from human activity, Bergamaschi reported.

The region also has "peculiar" geographical features that "favor the accumulation of pollutants," such as the natural barrier of the Alps in the north and low wind speed, he said.

The researchers identified 927 individuals with MS (315 male and 612 female) in the province. The overall MS prevalence rate was 169.4 per 100,000 population (95% confidence interval [CI], 158.8 180.6), which is 10-fold higher than 50 years ago, Bergamaschi said. In addition, this MS prevalence is higher than that in the United States, which is about 150 per 100,000 population.

Using sophisticated Bayesian disease mapping, the investigators looked for clusters of MS. They also gathered emission data for PM2.5 from 2010 to 2017 from the European Monitoring and Evaluation Programme database. They then divided the region on the basis of average winter concentrations of PM2.5.

Three distinct lateral areas of air pollution were identified. The more northern region, which includes the large urban center of Milan, had the highest level of air pollution. Concentrations decreased the further south the investigators looked.

After adjusting for age, urbanization (population density), and deprivation index, results showed that living in areas with high levels of pollutants was associated with increased MS risk.

When controlling for PM2.5 pollution, participants in urban areas had an increased risk for MS compared with rural dwellers (relative risk [RR], 1.16; 95% CI, 1.04 1.30; P = .003)

Bergamaschi said it is unclear whether this risk is higher for certain types of MS. "To my knowledge, no study has analyzed possible relationships between MS phenotypes and air pollution," he noted.

Several mechanisms might help explain the relationship between air pollution and MS risk, he added. These include oxidative stress, which results in cell damage, inflammation, and proinflammatory cytokine release.

Vitamin D also likely plays some role, Bergamaschi said. Upon penetrating the lower strata of the earth's atmosphere, ultraviolet B radiation is absorbed and scattered by suspended pollutants.

Several studies have highlighted the correlation between living in a polluted area and vitamin D hypovitaminosis; "so air pollution can contribute to increasing the risk of MS by reducing vitamin D synthesis," he said.

Recent research has also shown that air pollution is associated with a higher risk for other autoimmune disorders, including systemic lupus erythematosus, rheumatoid arthritis, and type 1 diabetes mellitus.

However, pollution alone is only part of the picture. MS prevalence in highly populated and polluted countries such as China and India is low, with no more than 30 to 40 cases per 100,000 population, Bergamaschi noted.

"This discrepancy is explained by different genetic backgrounds. While Caucasians are particularly susceptible to MS, Asians are not," he said.

Study limitations cited included a possible bias because the analysis did not include other possible contributing risk factors, particularly other pollutants, Bergamaschi said.

Commenting for Medscape Medical News, Lily Jung Henson, MD, chief of neurology at Piedmont Healthcare in Stockbridge, Georgia, said the findings provide "a fascinating glimpse" into possible causative factors for MS and warrant further investigation.

"This research also suggests other opportunities to look at, such as progression of the degree of air pollution and the incidence of MS over time," said Henson, who was not involved with the study.

Bergamaschi and Jung Henson have reported no relevant financial relationships.

Congress of the European Academy of Neurology (EAN) 2020: Abstract 1957. Presented May 23, 2020.

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High Levels of Air Pollution Linked to Increased MS Risk - Medscape

It’s Stroke Month, and this advice from a Birmingham expert can save lives – Bham Now

Photo via Brookwood Baptist Health

May is American Stroke Awareness Month. We sat down (virtually, of course) with one of the top stroke experts in the state to share what Birmingham residents need to know when it comes to stroke symptoms, treatment and care. Learn all about it here!

I grew up learning to share the worst parts first when youre telling a story. The fact is, most of us probably know someone whos been affected by a stroke. Theyre hugely common in the United States. In fact, its the fifth leading cause of death for Americans.

Here are a few statistics about stroke in the US from the CDC, updated in January 2020:

Sure, the numbers can be a bit frightening. However, its good to be aware of the risk and how serious strokes are. When you know whats at stake, youre much less likely to attempt waiting it out or driving yourself to the hospitalneither of which are great ideas when it comes to a stroke.

Jitendra Sharma, M.D., is an interventional neurologist at Brookwood Baptist Medical Center. He earned his medical degree at M.G.M. Medical College in India and completed fellowships in Serono Research, Vascular Neurology and Neurointervention.

Dr. Sharma specializes in Interventional Neurology, and hes one of only five physicians in the state of Alabama to do so.

Interventional neurology is an emerging field. What we do is we go inside the blood vessel and we try to help patients who have blood clots in the brain

As interventional neurologists, we can take care of stroke intervention, which means pulling the blood clot out. We also take care of brain aneurysms and close them off

Even carotid artery disease, we can insert a stent. So thats what the umbrella of interventional neurology covers.

These procedures are very new to the field, and patients have shown significant improvements immediately after surgery. The methods are also much less invasive than traditional brain surgeries.

Dr. Sharma currently practices within the Brookwood Baptist Health Primary & Specialty Care Network.

Brookwood Baptist Medical Center is a Certified Primary Stroke Center. This essentially means youre getting the best of the best when it comes to stroke care. Theyre prepared 24 hours a day + seven days a week to treat these urgent medical emergencies.

For the past 3 years, the American Heart Association and American Stroke Association have also granted Brookwood Baptist Medical Center the highest level of recognition for stroke care it awards. This establishes both their quality and speed of care as the true gold standard in Alabama and beyond.

When it comes to strokes, the key is to BE FAST. Strokes are considered one of the most urgent medical emergencies, which means seconds matter. The faster a patient gets to the hospital and receives treatment, the better their chance of recovery.

Knowing and recognizing the symptoms of a stroke can be the difference in survival and/or lasting damage in you or someone you love. BE FAST isnt just important to remember in your reaction timeits also important when you see symptoms.

We cant say it enough: time + treatment are CRITICAL in stroke situations. So lets talk about emergencies during a pandemic. Apprehension about going to a hospital right now is understandable, and you should always take precautions.

However, the risk of an untreated stroke statistically outweighs the risk of a virus. If youre experiencing symptoms or are around someone who is, call 911 immediately. Dont wait it out home, dont hop in your car and mosey on down to your local urgent care.

Once the blood flow to the brain is stopped, every minute, millions of brain cells die We see sometimes in the community that people want to stay homethey think it will go away.

Instead, it just gets worse and worse, and then they come to the hospital, and then its too late for us to help them.

After learning from Dr. Sharma, I realized some of my ideas about strokes were incorrect. I always believed that as a twenty-something, I was basically immune. Turns out, people as young as 24 years old can fall victim.

What we are seeing nowadays is patients who are young are having more strokes. Risk factors such as diabetes, cholesterol, high blood pressure, obesityall these risk factors play a role in having a stroke.

We are seeing more and more patients who are 40 or 50 coming to us with stroke-like symptoms.

So, now that you know the symptoms + how to respond, weve reached the most important question (at least in my opinion). How can you prevent a stroke? Of course, theres no foolproof method, but there are ways you can be proactive. Heres what Dr. Sharma recommends:

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It's Stroke Month, and this advice from a Birmingham expert can save lives - Bham Now

SOC Telemed Partners with Beauregard Health System – Leesville Daily Leader

SOC Telemed (SOC), the leader in acute care telemedicine and Beauregard Health System, a rural acute hospital in DeRidder, Louisiana today announced a partnership to deliver scalable, flexible telemedicine services across five key specialties including the first SOC deployment of teleCardiology services.

With a blend of regional and national specialists, Telemed IQ provides vital support to rural Louisiana

By partnering with SOC, Beauregard gains access to specialists and care that might otherwise be unavailable to the rural Louisiana community.

Beauregard implemented SOC's Telemed IQ telemedicine platform to provide psychiatry, critical care, inpatient neurology, emergency neurology and most recently, cardiology via telemedicine.

The teleNeurology program is staffed by SOC neurologists while their telePsychiatry, teleICU, and teleCardiology programs are staffed by existing members of Beauregard's Medical Staff who live and operate locally or in regional city centers like Alexandriaand Lake Charles.

The 49-bed not-for-profit hospital system at Beauregard is the first to utilize SOC Telemed's platform for teleCardiology services.

After the departure of the community's sole full-time cardiologist in April 2019, Beauregard was forced to transfer an average of 30 monthly cardiology cases to other hospital systems.

"Our community was vulnerable without a full-time local cardiologist," said Traci Thibodeaux, chief operating officer for Beauregard Health System.

"We wanted to partner with a cardiology group in Lake Charles, but knew they couldn't meet our needs for an onsite full-time physician.

Luckily, we'd already deployed SOC's platform in other hospital departments.

By pairing the Telemed IQ platform with a regional cardiology group out of Lake Charles, we were able to close the care gap and improve access to cardiac care for our community."

Dr. Raman Saharan, an internist and hospitalist at Beauregard, noted an additional benefit of acute telemedicine in their ICU during the COVID-19 pandemic, "Unlike some rural hospitals which had to close their doors due to this pandemic, we not only kept our hospital running but also were able to provide a higher level of care including transfusion of Convalescent plasma."

With SOC Telemed in place, the hospital already reports a higher case mix index, fewer transfers and broad patient satisfaction thanks to improved access to cardiologists as well as the specialists in the other four telemedicine-enabled departments.

"Across the nation, rural hospitals struggle to staff specialists in key areas like neurology and stroke care, psychiatry and even cardiology. However Beauregard, although rural, is ahead of many other hospitals by not allowing clinical care to be constrained due to its location or the artificial walls of the hospital that existed before telemedicine," said Jason Hallock, MD, chief medical officer for SOC Telemed. "Whether the doctors who ultimately provide the care are based in Lake Charles, New Orleans or anywhere else in the country, the SOC Telemed platform stands ready to deliver flexible solutions that connect communities in need with specialized medicine, on demand."

About SOC Telemed

SOC Telemed (SOC) is the largest national provider of telemedicine technology and solutions to hospitals, health systems, post-acute providers, physician networks, and value-based care organizations. Built on proven and scalable infrastructure as an enterprise-wide solution, SOC's technology platform, Telemed IQ, rapidly deploys and seamlessly optimizes telemedicine programs across the continuum of care. SOC virtually delivers clinicians to patients through teleNeurology, telePsychiatry and teleICU, as well as enables healthcare organizations to build sustainable telemedicine programs in any clinical specialty. SOC helps organizations to enrich their care models and touch more lives by supplying healthcare teams with industry-leading solutions that drive improved clinical care, patient outcomes, and organizational health.

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SOC Telemed Partners with Beauregard Health System - Leesville Daily Leader

Impact of Baseline Dyskinesia on Safety and Efficacy of NOURIANZ (istradefylline) in Patients with Parkinson’s Disease Presented During…

BEDMINSTER, N.J., May 26, 2020 /PRNewswire/ --Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) a global specialty pharmaceutical company, today announces the presentation of results from a post hoc pooled analysis assessing the impact of baseline dyskinesia (pre-existing dyskinesia before istradefylline treatment) on the safety and efficacy of NOURIANZ (istradefylline) in patients with Parkinson's disease (PD) experiencing "OFF" episodes or "OFF" time. Dyskinesia is recognized as the most frequent adverse reaction in istradefylline treatment.1The findings showed patients had reductions in "OFF" time and increases in "ON" time without troublesome dyskinesia regardless of the presence of dyskinesia at baseline. Patients with baseline dyskinesia before starting NOURIANZ were more likely to experience dyskinesia as an adverse event (AE) during treatment than those who did not have dyskinesia at baseline, but both groups on NOURIANZ experienced a reduction in "OFF" time and an increase in "ON" time without troublesome dyskinesia. These findings were presented during the 6th Congress of the European Academy of Neurology (EAN).

The pooled analysis examined subgroup data from 2,719 patients with PD taking levodopa-containing products with or without other anti-PD medications who experienced "OFF" episodes, either with baseline dyskinesia (+BL-dyskinesia) or without baseline dyskinesia (BL-dyskinesia) prior to the addition of istradefylline or placebo to their treatment regimen. Data were pooled from eight randomized, placebo-controlled, double-blind clinical studies. In the studies, patients received a daily 20mg or 40mg dose of istradefylline or a placebo for 12 or 16 weeks. The primary endpoint for these trials was change in "OFF" time as reported in patient-completed diaries, with AEs recorded throughout.2 Primary analyses from these studies showed that the use of istradefylline as an adjunctive treatment to levodopa/carbidopa in adult patients with PD experiencing "OFF" episodes was associated with a decrease in "OFF" time and an increase in "ON" time without troublesome dyskinesia.1

Results from the post hoc subanalysis of the eight pooled studies demonstrated that dyskinesia was reported by more patients as an AE during the trials by patients with baseline dyskinesia versus patients without baseline dyskinesia, regardless of whether they received istradefylline or placebo. Dyskinesia as an AE during the studies was reported by 14.1%, 24.7% and 25.9% of patients with baseline dyskinesia (+BL-dyskinesia) receiving a placebo or 20 mg/day or 40 mg/day of istradefylline, respectively, versus 3.5%, 4.4% and 8.4% of patients without baseline dyskinesia, respectively. Reduction in "OFF" time and increase in "ON" time without troublesome dyskinesia were greater with istradefylline than with placebo, which was consistent with previous studies.2

"Uncontrolled, involuntary movementscommonly known as dyskinesiacan be very troublesome in patients with PD, especially those patients who experience 'OFF' episodes," said Dr. Stuart Isaacson, MD, Parkinson's Disease and Movement Disorders Center of Boca Raton, Florida."The results being presented at EAN suggest that dyskinesia is observed more often in patients with baseline dyskinesia before istradefylline was added to the treatment regimen and that the overall efficacy of istradefylline was not affected by patients' baseline status. We believe these data can be helpful to physicians as they make treatment decisionsand may provide insight into the appropriate use of NOURIANZ in the treatment of 'OFF' time in patients with PD."

While these data provide further information, physicians should continue to monitor patients for dyskinesia or exacerbation of existing dyskinesia during NOURIANZ treatment. The most common adverse reactions with an incidence 5% and occurring more frequently than with placebo were dyskinesia (15%, 17%, and 8%), dizziness (3%, 6%, and 4%), constipation (5%, 6%, and 3%), nausea (4%, 6%, and 5%), hallucination (2%, 6%, and 3%), and insomnia (1%, 6%, and 4%) for NOURIANZ 20 mg, 40 mg, and placebo, respectively.

NOURIANZis the first and only adenosine A2A receptor antagonist approved in the U.S. as an adjunctive or "add on" treatment to levodopa/carbidopa in adult patients with PD experiencing "OFF" episodes.3

Parkinson's disease is a progressive nervous system disorder that affects movement and occurs when cells in the brain, which produce the chemical dopamine, become damaged or die. Dopamine signaling is an important component of the pathways in the brain that control movement.4 In patients with PD, dopamine loss is often treated with levodopa/carbidopa or other medicines that help regulate dopamine.5 Over time and as the disease progresses, these treatments may become less effective, and symptoms return before it's time for the next dose of medicine. These periods when symptoms return are known as "OFF" episodes or "OFF" time.6

Please see NOURIANZ indication and Important Safety Information below.

IndicationNOURIANZ(istradefylline) is an adenosine receptor antagonist indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "OFF" episodes.

Important Safety Information

Warnings and Precautions

Dyskinesia:NOURIANZ in combination with levodopa may cause dyskinesia or exacerbate pre-existing dyskinesia. In controlled clinical trials (Studies 1, 2, 3, and 4), the incidence of dyskinesia was 15% for NOURIANZ 20 mg, 17% for NOURIANZ 40 mg, and 8% for placebo, in combination with levodopa. One percentof patients treated with either NOURIANZ 20 mg or 40 mg discontinued treatment because of dyskinesia, compared to 0% for placebo.

Hallucinations / Psychotic Behavior:Because of the potential risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with NOURIANZ. Consider dosage reduction or discontinuation if a patient develops hallucinations or psychotic behaviors while taking NOURIANZ. In controlled trials (Studies 1, 2, 3, and 4), the incidence of hallucinations was 2% for NOURIANZ 20 mg, 6% for NOURIANZ 40 mg, and 3% for placebo. In patients treated with NOURIANZ 40 mg, 1% discontinued because of hallucinations, compared to 0% for placebo and 0% for patients treated with NOURIANZ 20 mg.

Impulse Control / Compulsive Behaviors:Patients treated with NOURIANZ and one or more medication(s) for the treatment of Parkinson's disease (including levodopa) may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges. In clinical trials, 1 patient treated with NOURIANZ 40 mg was reported to have impulse control disorder, compared to no patient on NOURIANZ 20 mg or placebo.

Drug Interactions

The maximum recommended dosage in patients taking strong CYP3A4 inhibitors is 20 mg once daily. Avoid use of NOURIANZ with strong CYP3A4 inducers.

Specific Populations

Pregnancy:Based on animal data, may cause fetal harm.

Hepatic impairment:The maximum recommended dosage of NOURIANZ in patients with moderate hepatic impairment is 20 mg once daily. Avoid use in patients with severe hepatic impairment.

Adverse Reactions

The most common adverse reactions with an incidence 5% and occurring more frequently than with placebo were dyskinesia (15%, 17%, and 8%), dizziness (3%, 6%, and 4%), constipation (5%, 6%, and 3%), nausea (4%, 6%, and 5%), hallucination (2%, 6%, and 3%), and insomnia (1%, 6%, and 4%) for NOURIANZ 20 mg, 40 mg, and placebo, respectively.

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Please see Nourianz Full Prescribing Information, here.

About Kyowa KirinKyowa Kirin commits to innovative drug discovery driven by state-of-the-art technologies. Kyowa Kirin focuses on creating new value in four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa Kirin brand, the employees from 36 group companies across North America, Europe and Asia/Oceania unite to champion the interests of patients and their caregivers in discovering solutions wherever there are unmet medical needs. Since 2018, the company has received approval from the U.S. Food and Drug Administration for three first-in-class medicines. You can learn more about the business of Kyowa Kirin at https://www.kyowakirin.com.

About NOURIANZ (istradefylline) tabletNOURIANZ is an orally administered, selective adenosine A2Areceptor antagonist approved in the U.S. for adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "OFF" episodes. The product has been marketed in Japan under the brand name NOURIASTsince May 30, 2013. In Japan, NOURIASTis indicated for the improvement of the "wearing-off" phenomenon in patients with Parkinson's disease on levodopa-containing preparations.

About Parkinson's diseaseParkinson's disease is a progressive, neurodegenerative disease characterized by motor symptoms such as tremors, rigidity, slow movement and postural instability. It is thought to be caused by progressive degeneration associated with decreased levels of dopamine in certain parts of the brain, i.e., the substantia nigra and striatum.

NOURIANZ and NOURIASTare trademarks of Kyowa Kirin Co., Ltd.

1NOURIANZ (istradefylline) Prescribing Information [Package Insert]. Kyowa Kirin Co., Ltd.; 2019.2Isaacson SH, Hattori N, Truong D, et al. Impact of Baseline Dyskinesia on the Safety and Efficacy of Istradefylline, an Adenosine A2A Receptor Antagonist, in Patients with Parkinson's Disease: a Pooled Analysis of 8 Clinical Studies. Data presented at: 6th Congress of the European Academy of Neurology: May 23-26, 2020; Virtual.3FDA approves new add-on drug to treat off episodes in adults with Parkinson's disease. U.S. Food and Drug Administration (2019). https://www.fda.gov/news-events/press-announcements/fda-approves-new-add-drug-treat-episodes-adults-parkinsons-disease. Accessed April 2020.4Parkinson's Disease. National Institute on Aging. https://www.nia.nih.gov/health/parkinsons-disease. Accessed April 2020.5Schapira AH, Emre M, Jenner P, Poewe W. Levodopa in the treatment of Parkinson's disease. Eur J Neurol. 2009;16:982989. doi: 10.1111/j.1468-1331.2009.02697.x.6Hickey P, Stacy M. Available and emerging treatments for Parkinson's disease: a review. Drug Des Devel Ther. 2011;5:241-254.doi: 10.2147/DDDT.S11836

Contact: Lauren Walrath, Senior Director, Public Affairs North America, [emailprotected]

SOURCE Kyowa Kirin, Inc.

https://www.kyowakirin.com

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Impact of Baseline Dyskinesia on Safety and Efficacy of NOURIANZ (istradefylline) in Patients with Parkinson's Disease Presented During...

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- Robust Response Sustained through Two Years of Treatment with Zygel in Patients from Phase 2 FAB-C Trial -

- Top Line Results of Pivotal CONNECT-FX Trial Expected Late in the Second Quarter of 2020 -

DEVON, Pa., May 26, 2020 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced the availability of a poster describing 116-week (two-year) data from the Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) trial of Zygel (CBD transdermal gel; ZYN002) in pediatric and adolescent patients with Fragile X syndrome (FXS). The data in the poster show that the statistically significant improvements from baseline that were observed at week 12 were sustained in each subscale score of the Aberrant Behavior Checklist for Fragile X (ABC-CFXS) through two years for patients who participated in the open label extension.

The poster entitled Cannabidiol Transdermal Gel for the Treatment of Fragile X Syndrome: Post Hoc Analysis and Pattern of Efficacy on Domains of the Aberrant Behavior Checklist-Community for FXS (ABC-CFXS) Through 116 Weeks of Treatment is available at the 2020 American Academy of Neurology (AAN) Science Highlights Virtual Session. The Virtual Session is online at http://www.aan.com/2020science. A copy of the poster is also available on the Zynerba corporate website at http://zynerba.com/publications/.

Its very exciting to see that the observed early benefits of Zygel appear to be sustained for over two years in patients who enrolled in the open label extension of FAB-C; these data suggest the potential for a sustained and measurable benefit for those patients who experience an early response, said Zynerbas Chief Medical Officer, Joseph M. Palumbo, MD, FAPA, MACPsych. Its also reassuring to see these responses in the context of a strong tolerability profile. We look forward to the results of our pivotal CONNECT-FX study in children and adolescents with FXS late this quarter.

Open Label Phase 2 FAB-C Trial Background

The 12-week treatment results of the Phase 2 FAB-C trial were initially announced in September 2017. These data were published in the August 2nd, 2019 online edition of Journal of Neurodevelopmental Disorders. (Press release)

Twenty patients aged 6 to 17 years of age with Fragile X as confirmed by molecular documentation of FMR1 full mutation were enrolled in the open label FAB-C study. Zygel was added on to other medications being administered. At the completion of the 12-week study (Period 1), patients could enter an extension study (Period 2).

Thirteen patients who completed the Period 1 rolled into Period 2. One patient who withdrew during Period 2 for reasons unrelated to safety or efficacy had no efficacy data post week 12 and therefore was not included in the analyses. Ten patients exceeded two years of therapy.

Sustained Improvement in Core FXS Behaviors over Two Years of Treatment with Zygel

Statistically significant improvements from baseline were observed at week 12 in all six subscale scores of the ABC-CFXS in Period 1 and these statistically significant improvements were sustained through two years in subjects who entered Period 2. The persistence of effect over the two-year period is as follows.

An infographic accompanying this announcement is available athttps://www.globenewswire.com/NewsRoom/AttachmentNg/b30a11af-12db-4428-9a7d-5b857a5ed25f

In addition, statistically significant improvements from baseline were observed at week 12 in the total score and all five subscale scores of ADAMS and these statistically significant improvements persisted to two years.

Responder Analysis

Zynerba performed responder analyses for patients achieving at least a 25% and 50% improvement from baseline for each subscale of the ABC-CFXS.

Maximal 25% responder rates for each ABC-CFXS domain at any visit in patients who completed Period 1 ranged from 72.2% to 83.3% and emerged by week 8 for all domains. Most patients who entered Period 2 met criteria for response at weeks 12 (66.7%) and 116 (80%).

An infographic accompanying this announcement is available athttps://www.globenewswire.com/NewsRoom/AttachmentNg/1f21f88b-08af-47f8-b7da-af5223a2c0bf

Maximal 50% responder rates for each ABC-CFXS domain at any visit ranged from 50.0% to 77.8% in patients who completed Period 1 and were observed at week 8 for all domains except stereotypy. Among patients who entered Period 2, 50% responder rates ranged from 50% to 83.3% at week 12. At week 116, the range of 50.0% responder rates was observed to be descriptively higher, ranging from 60% to 100% across the six ABC-CFXS domains.

An infographic accompanying this announcement is available athttps://www.globenewswire.com/NewsRoom/AttachmentNg/a90b7fe1-1a26-4a3d-a12e-145546369a66

Evidence of Global, Multi-domain, and Sustained Reduction in Behavioral Symptom Burden

Radar charts were created to visualize the proportional effect of Zygel across the six ABC-CFXS subscales. The boundaries of the polygon at screening and endpoint allow visualization of change across all domains cross-sectionally and over time. These radar charts suggest global and sustained reductions in severity with Zygel treatment in patients who entered Period 2.

Tolerability of Zygel over Two Years of Treatment

Zygel was well tolerated in the FAB-C trial over two years. Treatment-emergent adverse events (TEAEs) any event occurring during a trial period whether unrelated or related to study drug - are common in children and expected over a two-year period. Of the 66 TEAEs reported in 19 patients, all were either mild (85%) or moderate (15%), and 91% were determined to be unrelated to treatment. No treatment-related TEAEs occurred in more than one patient. Only one serious adverse event (constipation) was reported over two years of treatment and was not related to treatment.

The authors of the poster concluded that:

About Fragile X Syndrome (FXS)Fragile X syndrome is a rare genetic developmental disability that is the leading known cause of both inherited intellectual disability and autism spectrum disorder, affecting 1 in 3,600 to 4,000 males and 1 in 4,000 to 6,000 females. It is the most common inherited intellectual disability in males and a significant cause of intellectual disability in females, and the leading genetic cause of autism spectrum disorder (ASD). FXS is caused by a mutation in the Fragile X Mental Retardation gene (FMR1) located on the X chromosome and leads to dysregulation of the endocannabinoid pathway including the reduction in endogenous cannabinoids (2-AG and anandamide). The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities and behavioral symptoms, such as social avoidance and irritability.In the US, there are about 71,000 patients suffering with FXS.

About Zynerba Pharmaceuticals, Inc. Zynerba Pharmaceuticals is the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome, autism spectrum disorder, 22q11.2 deletion syndrome, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies. Learn more at http://www.zynerba.com and follow us on Twitter at @ZynerbaPharma.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as predicts, believes, potential, proposed, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Companys current expectations. Managements expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the Companys cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Companys ability to obtain additional funding to support its clinical development programs; the results, cost and timing of the Companys clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; clinical results for the Companys product candidates may not be replicated or continue to occur in additional trials and may not otherwise support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration and foreign regulatory agencies may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Companys ability to obtain and maintain regulatory approval for its product candidates, and the labeling under any such approval; the Companys reliance on third parties to assist in conducting pre-clinical and clinical trials for its product candidates; delays, interruptions or failures in the manufacture and supply of the Companys product candidates the Companys ability to commercialize its product candidates; the size and growth potential of the markets for the Companys product candidates, and the Companys ability to service those markets; the Companys ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Companys product candidates; the Companys expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates; the timing and outcome of current and future legal proceedings; and the extent to which health epidemics and other outbreaks of communicable diseases, including COVID-19, could disrupt our operations or adversely affect our business and financial conditions. This list is not exhaustive and these and other risks are described in the Companys periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available atwww.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Zynerba ContactWilliam Roberts, Vice President, Investor Relations and Corporate CommunicationsZynerba Pharmaceuticals484.581.7489robertsw@zynerba.com

Media contactMolly DevlinEvoke KYNE215.928.2199Molly.Devlin@evokegroup.com

Mean Percentage of Improvements from Baseline in ABC-CFXS Subscale Scores, Patients Who Entered Period 2

Mean Percentage of Improvements from Baseline in ABC-CFXS Subscale Scores, Patients Who Entered Period 2

Proportion of Patients with a 25% Improvement from Baseline ABC-CFXS Subscales for (A) Patients Who Completed Period 1 and (B) Patients Who Entered Period 2

Proportion of Patients with a 25% Improvement from Baseline ABC-CFXS Subscales for (A) Patients Who Completed Period 1 and (B) Patients Who Entered Period 2

Proportion of Patients with a 50% Improvement from Baseline ABC-CFXS Subscales for (A) Patients Who Completed Period 1 and (B) Patients Who Entered Period 2

Proportion of Patients with a 50% Improvement from Baseline ABC-CFXS Subscales for (A) Patients Who Completed Period 1 and (B) Patients Who Entered Period 2

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Zynerba Pharmaceuticals Announces New Two-Year Data from Open Label Extension of the Phase 2 FAB-C Trial in Patients with Fragile X at 2020 American...

Fear of unknown affecting people, says neurologist – The Tribune

Sumit Hakhoo

Tribune News Service

Jammu, May 5

Amid the extended lockdown, eminent neurologist Dr Sushil Razdan has said continued isolation is testing the stress-coping mechanism of people and it could lead to an increase in the psychological disorders in Jammu and Kashmir, already affected by decades of violence.

Razdan, who receives a large number of psychiatric patients, especially from the trouble-torn Kashmir valley, said the fear of unknown and the fear of future was affecting individuals as their normal lives had been disrupted.

Talking to The Tribune, Razdan, one of the leading neurologists in the country, said: I receive many calls from people who express their fears about the present situation and how it is impacting them. The loss of work and income is a major concern as they see no end to the present situation.

The UT was put under the lockdown on March 23 like the rest of the country. Since the lockdown, Razdan is providing medical consultation to patients via telephone daily from 10 am to 5 pm but he said it a difficult situation.

We cannot see our patients face to face. But we have managed to create a good interactive system. I speak to patients on the phone. We do as much work as possible so that they dont suffer, the neurologist said.

Expressing concern over the continued closure of the OPDs, Razdan said, The fight against the coronavirus has led to the neglect of patients suffering from normal diseases and emergencies. The shutdown was important but now regular work should start in hospitals.

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Fear of unknown affecting people, says neurologist - The Tribune

Alector Reports 2020 First Quarter Financial Results and Business Highlights – GlobeNewswire

SOUTH SAN FRANCISCO, Calif., May 13, 2020 (GLOBE NEWSWIRE) -- Alector, Inc.(Nasdaq: ALEC), a clinical- stage biotechnology company pioneering immuno-neurology, today announced business highlights and financial results for the first quarter endedMarch 31, 2020.

At Alector we are committed to developing transformative treatments for neurodegeneration. We believe that our mission could benefit millions of patients and families affected by neurodegenerative diseases, and even with the current COVID-19 health crisis, we remain focused on advancing our portfolio of immuno-neurology programs, said Arnon Rosenthal, Ph.D., Co-founder, and Chief Executive Officer of Alector. Our COVID-19 task force and the entire Alector team continues to focus on initiating a pivotal Phase 3 study of AL001 in FTD-GRN patients and a Phase 2 study of AL002 in Alzheimers disease patients in 2020.

Business Highlights

COVID-19 Response

Alector is actively monitoring the evolving impact of COVID-19 on its operations and clinical trials, with a primary focus on the health and safety of employees, clinical trial participants, and clinical trial site teams. The Company is complying with regulatory, institutional, and governmental guidance for conducting its business worldwide. As the COVID-19 pandemic continues to evolve, it could impact Alectors programs in the future. The Company is also continuing with its efforts to complete enrollment across ongoing clinical trials. Currently, certain clinical trial sites have delayed enrollment of new patients and paused clinical trial visits across clinical development programs. Alector is aware that some participants in ongoing trials have not been able to receive scheduled doses on time due to site closures or various state and local shelter-in-place directives. However, the Company is continuing to collect data from all existing clinical trial participants enrolled to date.

The Company remains on track with previously stated guidance to initiate a pivotal Phase 3 study of AL001 in FTD-GRN patients in 2020. Alector also intends to initiate a Phase 2 study of AL002 in Alzheimers disease patients in 2020. Ongoing activities for AL003, AL101, and AL014 programs are continuing as planned. The Company believes that its cash and investments as of March 31, 2020 will be sufficient to fund its anticipated operations through 2022.

Progranulin Portfolio: AL001, AL101

Alzheimers Disease Portfolio: AL002, AL003, AL014

Immuno-oncology Portfolio

First Quarter 2020 Financial Results

Revenue.Collaboration revenue for the quarter ended March 31, 2020 was$7.2 millioncompared to$5.6 millionfor the same period in 2019. This increase was primarily due to an increase in expenses for the AL002 and AL003 programs compared to the same period last year.

R&D Expenses.Total research and development expenses for the quarter ended March 31, 2020 were$34.6 millioncompared to$20.6 millionfor the same period in 2019. This increase was driven by an increase in personnel-related expenses as headcount grew to support the advancement of the clinical and pre-clinical programs. Additionally, expenses increased due to timing of manufacturing runs and continued progression through clinical trials for several programs. Expenses for AL014 increased as well as for other early stage programs as investment in research and clinical pipeline continues.

G&A Expenses.Total general and administrative expenses for the quarter ended March 31, 2020 were$14.6 millioncompared to$5.8 millionfor the same period in 2019. This increase was primarily due to an increase in personnel-related expenses due to increased headcount to support the advancement of the clinical and pre-clinical programs and an increase in legal costs associated with our ongoing arbitration proceedings for certain intellectual property matters.

Net Loss.For the quarter ended March 31, 2020,Alectorreported a net loss of$40.0 million, compared to a net loss of$18.6 millionfor the same period in 2019.

Cash Position.Cash, cash equivalents, and marketable securities were$548.5 millionas ofMarch 31, 2020.

AboutAlector

Alectoris a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders.Alectoris developing a broad portfolio of programs designed to functionally repair genetic mutations that cause dysfunction of the brains immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. The Companys product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimers disease.Alectoris headquartered inSouthSan Francisco, California. For additional information, please visitwww.alector.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the proposed offering, and other risks and uncertainties related to the offering,Alectorand its business as set forth in Alectors Annual Report on Form 10-K filed with theSecurities and Exchange Commission (the SEC) onMarch 24, 2020, as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results forAlectorto differ materially from those contained in Alectors forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, andAlectorspecifically disclaims any obligation to update any forward-looking statement, except as required by law.

Source: Alector, Inc.

Contacts

Media:1ABDan Budwick, 973-271-6085dan@1abmedia.com

or

Investors:Alector, Inc.ir@alector.com

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Alector Reports 2020 First Quarter Financial Results and Business Highlights - GlobeNewswire

First Case of COVID-19 Presenting as Guillain-Barr Reported – Medscape

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Physicians in China are reporting what they believe is the first case of COVID-19 initially presenting as acute Guillain-Barre syndrome (GBS). The patient was a 61-year-old woman returning home from Wuhan during the pandemic.

"GBS is an autoimmune neuropathy, which could be triggered by various infections," corresponding author Sheng Chen, MD, PhD, Shanghai Jiao Tong University School of Medicine, China, told Medscape Medical News.

However, "Our single case report only suggests a possible association between GBS and SARS-CoV-2 infection. It may or may not have a causal relationship," Chen noted.

The case study was published online April 1 in Lancet Neurology.

The female patient returned from Wuhan on January 19 but denied having any fever, cough, chest pain, or diarrhea. She presented on January 23 with acute weakness in both legs and severe fatigue that progressed.

At presentation, temperature was normal, oxygen saturation was 99% on room air, and the patient's respiratory rate was 16 breaths per minute. She was not tested for SARS-CoV-2 at that point.

A neurologic examination revealed symmetric weakness (Medical Research Council grade 4/5) and areflexia in both legs and feet. The patient's symptoms had progressed 3 days after admission, and testing revealed decreased sensation to light touch and pinprick.

Admission laboratory test results indicated a low lymphocyte count and thrombocytopenia. Results of nerve conduction studies performed on day 5 of hospitalization were consistent with demyelinating neuropathy.

She was diagnosed with GBS and given intravenous immunoglobulin. On day 8, she developed a dry cough and fever, and a chest CT showed ground-glass opacities in both lungs. At this point, she was tested for SARS-CoV-2, and the results were positive.

The patient was immediately transferred to an isolation room and received supportive care and antiviral drugs. Her condition improved gradually, and her lymphocyte and thrombocyte counts were normalon day 20.

At discharge on day 30, she had normal muscle strength in both arms and legs, and tendon reflexes in both legs and feet had returned. Her respiratory symptoms had resolved as well. A second SARS-CoV-2 test was negative.

Two relatives of the patient who had been with her during her hospital stay also tested positive for SARS-CoV-2 and were isolated and treated.

All of the hospital staff that cared for the patient, including two neurologists and six nurses, tested negative for SARS-CoV-2.

Given the temporal association, SARS-CoV-2 infection could be responsible for the development of GBS in this patient, the investigators note. They add that the onset of GBS symptoms overlapped with the period of SARS-CoV-2 infection.

"Hence Guillain-Barre syndrome associated with SARS-CoV-2 might follow the pattern of a parainfectious profile, instead of the classic postinfectious profile, as reported in Guillain-Barre syndrome associated with Zika virus," the researchers write.

"More cases with epidemiological data are necessary to support a causal relationship" between SARS-CoV-2 infection and GBS, said Chen.

"However, we still suggest physicians who encounter an acute GBS patient from a pandemic area protect themselves carefully and test [for the] virus on admission. If the result is positive, the patient needs to be isolated," Chen said.

Lancet Neurol. Published online April 1, 2020. Full text

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Patients With Newly Diagnosed Multiple Sclerosis More Likely to Have Impaired Cognitive Performance – Neurology Advisor

Compared to the general population, patients with newly diagnosed multiple sclerosis (MS)/clinically isolated syndrome (CIS) are more likely to have impaired cognitive function, a study in Neurology suggests. The study also found that being black and Hispanic, not having a university degree, and having a relatively low household income are predictors of cognitive performance.

A total of 1174 adults with MS/CIS (mean age, 40.7 years) who were enrolled in the MS Sunshine Study were included in this analysis. The researchers administered the oral Symbol Digit Modalities Test (SDMT) during a structured in-person assessment to identify cognitive impairment in incident cases of MS/CIS (n=554) and matched controls (n=620). Additionally, verbal fluency was also determined. A multivariable linear regression was used to examine the association between SDMT scores and race/ethnicity and MS. Multivariable analyses were adjusted for age at time of interview, sex, education, and household income.

Across all racial/ethnic groups, patients with MS/CIS had significantly lower mean SDMT scores compared to controls (52.2 vs 58.3, respectively; P <.0001). The multivariable linear regression analyses, independent predictors of lower oral SDMT scores included being black (,5.97; P <0.0001) or Hispanic (,3.06; P <0.0001), having MS (,6.04; P <.0001), lower educational attainment (high school, trade school, or less: ,5.02; P <.0001), and having a household income $65,000 (,5.02; P =.0007). The researchers observed no interaction between MS case status and race/ethnicity on SDMT scores.

The authors note that these analyses may have been limited by the inclusion of only participants from California and the lack of ethnic diversity among the black and Hispanic participants.

The investigators suggest that in addition to optimizing disease-modifying treatments to slow cognitive decline in patients with MS, interventions aimed at improving cognition may also be beneficial. From a societal perspective, improving opportunities for higher educational attainment and higher incomes for black and Hispanic participants in the United States would likely reduce racial/ethnic disparities in cognitive performance.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors disclosures.

Reference

Amezcua L, Smith JB, Gonzales EG, Haraszti S, Langer-Gould A. Race, ethnicity, and cognition in persons newly diagnosed with multiple sclerosis [published online March 9, 2020]. Neurology. doi: 10.1212/WNL.0000000000009210

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Patients With Newly Diagnosed Multiple Sclerosis More Likely to Have Impaired Cognitive Performance - Neurology Advisor

Frontiers in Neurology Publishes Study Evaluating Remote Electrical Neuromodulation (REN) As Viable Alternative to Drugs for Acute Migraine – P&T…

NETANYA, Israel, April 7, 2020 /PRNewswire/ --Theranica Bioelectronics (Theranica), a bio-medical technology company developing advanced electroceuticals for migraine and other pain conditions, announced today that Frontiers In Neurology Journal published an article demonstrating that incorporating Remote ElectricalNeuromodulation (REN)treatment into usual care of migraine has the potential to reduce reliance on acute pharmacological medications.

"This study signals a potentially significant shift in how we approach the acute treatment of migraine," said lead author Michael Marmura,MD, HeadacheSpecialist at the ThomasJefferson UniversityHospital in Philadelphia. "Adding REN as an alternative to traditional migraine treatments opens the door to new long-term treatment strategies. What is most promising is the fact that so many patients in the study chose REN without being specifically prompted, and experienced treatment outcomes similar or slightly better than their usual care."

In a cohort of 117 patients who were given the option of using REN in addition to or instead of their usual care treatments, such as triptans or over-the-counter (OTC) medications, 89.7% used REN exclusively, without medications. When REN was not available, only 15.4% chose to avoid medications in all their reported migraine attacks. The patients who used REN exclusively reported similar treatment outcomes to their usual (pharmacological) care. The article concludes that "Incorporating REN into usual care may have a positive impact on migraine management by reducing the reliance on acute medications."

"When patients experience debilitating migraine symptoms, they are looking for effective relief," said Dr. Morris Levin, chief of the headache medicine division and director of the Headache Center at UCSF Medical Center in San Francisco, who served as the chairman of the independent Data and Safety Monitoring Committee of the study. "Traditionally we've had only a limited number of useful acute migraine treatments, many of which have side effects. REN is a welcome option, due to its apparent safety and almost nonexistent adverse effects. In addition, the risk of medication overuse, often a limiting factor with acute medications, should not be an issue when using a drug free therapy such as REN."

The device used in the study was Theranica's FDA-authorized prescribed therapeutic wearable, Nerivio. The device deploys REN to activate the body's native Conditioned Pain Modulation (CPM) mechanism to treat pain and accompanying migraine symptoms. Nerivio, which was recently named one of TIME's best inventions of 2019, is available in the US with a valid prescription. It is also accessible via online telemedicine portals Coveor UpScript, which provide physician consultations and home delivery.

About Theranica

Theranica Bio-Electronicsis dedicated to creating effective, safe, affordable, low-side effect electroceuticals for idiopathic pain conditions.The company's award-winning flagship product,Nerivio, is thefirst FDA-authorized smartphone-controlled prescription wearable device for acute migraine treatment.Setting the foundation of an effective first-line therapeutic alternative to pharmacological options within the migraine industry, Theranicais expanding its proprietary technology to offer additional solutions for other pain conditions.

Learn more by visiting our website,www.theranica.comand following us on LinkedIn, Twitter and Facebook.

Media Contact: Ellie Hanson Finn Partners ellie.hanson@finnpartners.com +1-929-222-8006

Theranica Contact: Ronen Jashekronenj@theranica.com+972-72-390-9750

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Five named SUNY Distinguished Professors – UB Now: News and views for UB faculty and staff – University at Buffalo Reporter

Campus News

UBNOW STAFF

Five UB faculty members have been named SUNY Distinguished Professors,the highest faculty rank in the SUNY system.

M. Laura Feltri, Jo Freudenheim, Amit Goyal, Elad Levy and Stephen Tiffany were appointed to the distinguished professor ranks by the SUNY Board of Trustees at its meeting on March 17.

The rank of distinguished professor is an order above full professorship and has three co-equal designations: distinguished professor, distinguished service professor and distinguished teaching professor.

The five were all named distinguished professors in recognition of their international prominence and distinguished reputations within their chosen fields. According to SUNY, this distinction is attained through significant contributions to the research literature or through artistic performance or achievement in the case of the arts. The candidates work must be of such character that the individuals presence will tend to elevate the standards of scholarship of colleagues both within and beyond these persons academic fields.

UB is tremendously proud that five of our most distinguished faculty members have been appointed to SUNYs highest rank, said A. Scott Weber, provost and executive vice president for academic affairs. This distinction recognizes that UB faculty are among the best in the world and have a transformative impact through their sustained research and scholarship contributions.

UBs newest SUNY Distinguished Professors:

M. Laura Feltri, SUNY Distinguished Professor of Biochemistry

Feltri, professor of biochemistry and neurology in the Jacobs School of Medicine and Biomedical Sciences and acting director of the Hunter James Kelly Research Institute, is an internationally renowned expert and pioneer in the study of myelin diseases in the nervous system. She conducts research on Schwann cells and disorders that affect the peripheral or central nervous systems, like Charcot-Marie-Tooth disease, multiple sclerosis or Krabbe leukodystrophy.

With the undergraduate, graduate and postdoctoral students she has mentored, Feltri has made numerous seminal discoveries in her field, including developing the first mutagenesis tool for studying Schwann cell development and the signals that regulate myelination. In collaboration with Lawrence Wrabetz, she pioneered the use of transgenic animal to model neurological diseases and develop new therapies.

An internationally recognized leader in the biology of nervous system myelination, her fundamental research is contributing to the development of novel therapies for neurological disorders.

Feltri serves as chair of the Cellular and Molecular Biology of Glia National Institutes of Health study session, as a board member of scientific organizations and on the editorial board of various journals.

Jo Freudenheim, SUNY Distinguished Professor of Epidemiology and Environmental Health

Freudenheim, UB Distinguished Professor and chair of the Department of Epidemiology and Environmental Health in the School of Public Health and Health Professions, is an internationally renowned expert in cancer epidemiology. She has conducted seminal research to understand factors that influence risk for cancer, particularly breast cancer, including the role of diet, alcohol and the physical environment. She uses a variety of methodologically rigorous approaches (e.g., molecular epidemiology) to examine carcinogenesis, from the molecular level to the individual and population levels.

Her research has been funded for more than 25 years by the NIH and other federal funding agencies. She has authored more than 275 peer-reviewed publications in national and international high-impact journals, where they have helped shape the field of chronic disease epidemiology.

A frequent reviewer for such entities as the National Cancer Institute, the American Cancer Society and the Canadian Foundation for Innovation, she also has contributed to the field by serving as a mentor to graduate students and postdoctoral fellows, and in her role as director of a cancer epidemiology training program.

Amit Goyal, SUNY Distinguished Professor of Materials Science

An internationally recognized materials scientist, Goyal is a SUNY Empire Innovation Professor and founding director of UBs RENEW Institute. In 2018, he was elected to the National Academy of Engineering for groundbreaking scientific advances and technological innovations enabling the worldwide commercialization of high-temperature superconductors. He is also a fellow of the National Academy of Inventors, with 87 issued patents and additional patents pending.

Goyal joined UB in 2015 to direct RENEW, an institute that harnesses the expertise of more than 100 faculty in seven UB schools and colleges to explore solutions to globally pressing energy and environmental problems, as well as the social and economic issues connecting them. His leadership has placed UB at the forefront of efforts to reduce water and air pollution, and find innovative, clean ways to produce, transmit and store energy.

In 2019, he was awarded the UB Presidents Medal that recognizes outstanding scholarly or artistic achievements, humanitarian acts, contributions of time or treasure, exemplary leadership or any other major contribution to the development of the University at Buffalo and the quality of life in the UB community.

The author or co-author of more than 350 technical publications and co-editor of six books, Goyal was ranked by Thompson-Reuters Essential Science Indicators as the most cited author worldwide in the field of high-temperature superconductivity from 1999-2009. He is a fellow of eight professional societies: the American Association for Advancement of Science, the Materials Research Society, the American Physical Society, the World Innovation Foundation, the American Society of Metals, the Institute of Physics, the American Ceramic Society and the World Technology Network. He serves on several scientific advisory boards and on several National Academy review panels.

Elad I. Levy, SUNY Distinguished Professor of Neurosurgery

Levy, professor and chair of the Department of Neurosurgery in the Jacobs School, is an internationally renowned expert in stroke and cerebrovascular neurosurgery, and a major contributor to the service of organized neurosurgery. Widely regarded as one of the pioneers in this field, Levy has published extensively and developed new technology and approaches that have been instrumental in helping treat people around the world with previously incurable cerebrovascular disorders.

A member and fellow of the American Association of Neurological Surgeons, the American College of Surgeons and the American Heart Association/American Stroke Association, Levy has achieved additional national and international prominence as one of 100 members of the American Academy of Neurosurgery and one of 12 members of the American Board of Neurosurgery.

He serves as secretary of the Congress of Neurological Surgeons and director of the American Board of Neurological Surgery.

Stephen Tiffany, SUNY Distinguished Professor of Psychology

The Empire Innovation Professor in the Department of Psychology, Tiffany is world-renowned expert on the study of addictions, developing theoretical models that have shaped the way experts in the field conceptualize the relationship between craving and addictive behavior.

Actively involved in numerous clinical studies many of which focus on nicotine Tiffany conducts empirical research with people and animal models using a combination of controlled experimentation and more translational work. He provided a dominant theoretical perspective on craving and its relationship to drug use with his 1990 Psychological Review paper that outlined a cognitive model of craving now referred to as the Tiffany model.

An extraordinarily productive and prolific researcher, Tiffany has more than 100 publications in highly prestigious journals and has received multiple grants from the National Science Foundation and the NIH.

He has served as a standing member of three different NIH review panels and on the editorial boards of multiple journals.

A UB faculty member since 2007, Tiffany served as chair of the Department of Psychology from 2011-18.

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Five named SUNY Distinguished Professors - UB Now: News and views for UB faculty and staff - University at Buffalo Reporter