EMERYVILLE, Calif., June 4, 2012 /PRNewswire/ –Adamas Pharmaceuticals, Inc., a privately held company, announced today that it will present an update on its Nurelin (amantadine HCl extended release capsules) program at the Cambridge Healthtech Institute’s (CHI) Targeting Parkinson’s Disease Symposium being held today in Philadelphia. Nurelin, a once-daily extended release formulation of amantadine intended for night-time administration, is being developed for the treatment of levodopa-induced dyskinesia (LID) in Parkinson’s disease (PD) patients. Results from the Company’s prior Phase 1 studies, its preclinical program in Parkinson’s and other indications, along with a status report on the ongoing Phase 3 study, Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED), will be presented by Gregory T. Went, Ph.D., Co-Founder and Chief Executive Officer of Adamas. The talk is entitled, “Exploring the Potential of Modified Release Aminoadamantanes in Parkinson’s Disease and Related Indications.”

“We are excited to introduce the Nurelin program at the conference today, and to provide an update on the previous preclinical and clinical studies that have led to our first Phase 2/3 study of Nurelin in Parkinson’s patients who experience levodopa-induced dyskinesia,” said Dr. Went. “Amantadine is a remarkable drug that has received little attention from the pharmaceutical industry for the past 30 years, and we hope the EASED study of Nurelin, combined with recently presented academic studies in Parkinson’s disease, will help establish new treatment indications for Nurelin. We look forward to presenting the results from this study and assessing the potential of Nurelin as our second NDA candidate to Arimenda.”

There are no medications currently approved for the treatment of levodopa-induced dyskinesia, thus there is a significant unmet medical need. Pending the outcome of the EASED study and regulatory review, Nurelin may become the first drug indicated for the treatment of levodopa-induced dyskinesia in Parkinson’s disease. Nurelin also is being investigated as a therapeutic agent to address the non-motor symptoms of Parkinson’s disease, including fatigue.

About Nurelin (ADS-5102)

Nurelin (ADS-5102) is a proprietary formulation of amantadine in development for the treatment of central nervous system (CNS) disorders including LID in PD patients. Nurelin is designed for once daily administration at night and is being investigated at plasma concentrations up to 2.5 fold higher than those achievable with the commercially available immediate release amantadine tablets. Nurelin capsules can be opened and the contents sprinkled on food for ease of administration in patients who have difficulty swallowing capsules.

Nurelin has a pharmacokinetic profile designed to overcome the CNS side effects associated with immediate release forms of amantadine, while offering potential for enhanced efficacy. This novel pharmacokinetic profile of Nurelin is characterized by: i) higher plasma concentrations during the daytime hours when the motor and non-motor symptoms of Parkinson’s disease are at their peak; ii) low plasma concentrations overnight, which may reduce sleep disturbance and vivid dreams occasionally associated with amantadine; and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall CNS tolerability of amantadine.

The efficacy and tolerability of multiple doses of Nurelin in the treatment of LID in Parkinson’s disease patients is currently being studied in a Phase 2/3 study. This study, entitled EASED (Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia), is designed to evaluate the efficacy of three dose strengths of Nurelin for the treatment of LID, and to confirm the tolerability of the new formulation (www.easedPD.com).

About LID in Parkinson Disease

Parkinson’s disease is a chronic, progressive disorder with prominent motor signs including tremors, rigidity, bradykinesia and postural instability. Levodopa, the most commonly prescribed and effective drug treatment for symptomatic relief in PD is associated with dose limiting motor side effects, including abnormal involuntary, dance-like movements known as dyskinesia. With continued levodopa treatment, and as PD progresses, dyskinesia can become severely disabling and has been associated with a decrease in the quality of life.

About Adamas

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Newswise Because there is currently no laboratory test that can diagnose Parkinsons disease, it is practically impossible to detect those individuals who are in the earliest stages of the disease. As a result, Parkinsons disease can only be diagnosed by a clinical neurological examination based on findings suggestive of the disease.

But researchers from the Technion-Israel Institute of Technology Faculty of Medicine have now identified a biomarker comprised of five genes shown to predict Parkinson’s disease with high accuracy. The findings are reported in a research article now published online by the scientific journal Molecular Neurodegeneration.

A predictive biomarker for Parkinson’s disease could also help to identify high-risk individuals before symptoms develop a stage where prevention treatment efforts might be expected to have their greatest impact to slow disease progression, says lead researcher Dr. Silvia Mandel. It could allow diagnosis of carriers of the genetic risk factors, or those who may exhibit pre-symptomatic stages of the disease [depression, sleep disturbances or hyposmia (reduced ability to smell)] and are good candidates for neuroprotective treatment.

All five genes that comprise the biomarker play a role in the ubiquitin-proteasome system of protein degradation, whose involvement in the pathology of Parkinson’s disease has previously been demonstrated.

The study was conducted on blood samples from 62 early stage Parkinson’s disease patients and 64 healthy age-matched control subjects. The selection of the genes and determination of their expression in the blood was based on previous research conducted by Dr. Mandel and Prof. Moussa Youdim on the brains of deceased Parkinson’s disease patients.

More strikingly, in 30 patients at advanced stages of Parkinson’s disease, the model was 100 percent accurate. It was also able to fully discriminate between Parkinson’s disease and Alzheimer’s disease.

The researchers believe the blood test could one day be combined with brain imaging and/or biomarkers in the spinal fluid or other peripheral tissues, as a gold standard not only for early diagnosis, but also for the differential diagnosis of Parkinson’s disease and motor disorders that often mimick the disease symptoms.

Dr. Mandel, who is Vice Director of the Eve Topf Center of Excellence for Neurodegenerative Diseases Research and Teaching at the Technion, conducted the research together with her PhD student Leonid Molochnikov, Professor Youdim; Prof. Judith Aharon of Rambam Medical Center; and Prof. Martin Rabey of Assaf HaRofeh Medical Center. Scientists from the Universities of Wrzburg and Pisa also contributed to the research.

The Technion-Israel Institute of Technology is consistently ranked among the world’s leading science and technology universities. Home to three of Israel’s five winners of the Nobel Prize in science, the Technion commands a worldwide reputation for its pioneering work in computer science, nanotechnology, biotechnology, energy, water-resource management, medicine, drug development, and aerospace. Headquartered in New York City, the American Technion Society (ATS) promotes scientific and technological research and education at the Technion.

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Public release date: 4-Jun-2012 [ | E-mail | Share ]

Contact: Kagan Kerman kkerman@utsc.utoronto.ca 416-287-7249 University of Toronto Scarborough

Researchers at the University of Toronto Scarborough (UTSC) used an innovative technique to examine chemical interactions that are implicated in Parkinson’s Disease.

The work details how a protein called alpha-synuclein interacting with the brain chemical dopamine can lead to protein misfolding and neuronal death.

Parkinson’s Disease is a neurodegenerative disease which results in loss of motor control and cognitive function. Although the cause isn’t known precisely, the disease involves the death of brain cells that produce dopamine, a chemical important in neuronal signaling. The disease also involves a protein called alpha-synuclein which aggregates in the neurons of people with the disease.

Kagan Kerman, a chemist in the Department of Physical and Environmental Sciences, and Ian R. Brown, a neuroscientist who founded UTSC’s Centre for the Neurobiology of Stress in the Department of Biological Sciences, looked at the way dopamine interacts with alpha-synuclein to form aggregates that may be toxic to neurons.

“This is very fundamental,” says Kagan Kerman. “It gives us a new point of view of the misfolding proteins and how they are affected by dopamine.”

These sorts of interactions are often studied using microscopy. But the UTSC researchers decided to use an electroanalytic technique called voltammetry. By studying tiny changes in electric current as dopamine and alpha-synuclein interacted they were able to determine details about the early phases of the interaction.

Using the technique, they were able to detail how changes in pH levels and ionic strength of the solution affected the interaction. They found that at higher pH levels and higher ionic strengths, dopamine interacted much more strongly with alpha-synuclein, forming aggregates more quickly.

The results could have implications for understanding and treating the disease. Normally dopamine is contained in structures called vesicles, in which pH levels are low and dopamine is unlikely to interact with alpha-synuclein. Outside of the vesicles dopamine encounters higher pH levels and, according to the new research, is much more likely to interact to create aggregates.

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I’ve always loved horses. I’ve been riding since I was five, I come from a horse family, says Patricia Labau of Gunnison, CO. Her life revolved around horses. She was competing, showing and jumping… Until one day when her life suddenly changed.

I woke up one morning and couldn’t walk, she says.

She learned some news she never expected.

They diagnosed me with multiple sclerosis, she explains.

Multiple sclerosis is a debilitating disease. But Labau didnt let it keep her from the stables.

Sometimes you can get sick and go, ugh, and I’m not one of those people. I went ok, how can we fix this?

She used a form of riding called dressage as her therapy.

Dressage is to riding as ballet is to dance. Its a classical, very logical systematic approach, says Alice West, announcer and trainer for Grand Valley Dressage Show.

Dressage is a slower form of riding that takes incredible muscle control from the rider.

It also involves very intense training on the part of the rider. The rider has to have a very supple and elastic seat so they don’t interfere with the horses motion and yet still be able to influence the horse, West says.

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Horses as a Treatment for Multiple Sclerosis

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June 04–Many institutionalized dementia patients are known to lash out as part of their condition — to strike the aides trying to feed or clean them, to yell at other patients, to aggressively resist intrusive but necessary medical care such as IVs and catheters.

They are also known to be heavily medicated to control such behavior, a practice that government officials, nursing home industry leaders and patient care advocates say needs to be curbed.

The federal Centers for Medicare & Medicaid Services, or CMS, and the others announced an initiative last week designed to reduce use of antipsychotic drugs on nursing home patients with dementia by 15 percent by year’s end. Too often, they say, the staffs of long-term care facilities have relied on the medications to control behavior of patients with Alzheimer’s or a similar disease instead of trying other methods, even though the health of those residents can be damaged.

“It’s often related to care activities in which the [patient] becomes frightened, bewildered, apprehensive, very anxious — they don’t know what’s happening and may resist care or may actually strike out,” said Jules Rosen, chief of geriatric psychiatry at UPMC. “What has happened culturally is the knee-jerk reaction of many staff and many doctors is to prescribe these drugs, that it will calm them down. It serves that purpose for some people, and doesn’t for others.”

The two leading trade groups representing nursing homes, the American Health Care Association and LeadingAge, endorsed the CMS initiative and said they would work with the government to help steer facilities toward other methods with difficult patients. By July, the federal agency plans to list on its website devoted to nursing home comparisons the statistics describing each facility’s use of antipsychotic medications on dementia patients.

“We’re seeing a number of facilities steer away from these medications, but it’s still way too high,” said David Gifford, the AHCA’s senior vice president of quality and regulatory affairs. “One of the biggest challenges is many clinicians, physicians, nurses and family members think these medications are necessary and effective, but data suggest otherwise.”

A CMS report on the issue found that nearly 40 percent of nursing patients with signs of dementia in 2010 received antipsychotic drugs when they did not have any of the conditions for which the medications were government-approved, such as schizophrenia or bipolar disorder. It also stated more than 17 percent of nursing home residents had daily doses of the drugs exceeding recommended levels.

The new initiative calls upon nursing homes to assign consistent staff that gets to know the patients better and can more reliably understand their needs, considering the difficulty many dementia patients have in expressing themselves. Facilities are also being urged to devote more time to alternative behavioral solutions such as music therapy, exercise and other social activities.

Claire Curry, a legal director for the Legal Aid Justice Center, which advocates for patients, said the nursing homes need to learn “to not reach for a magic pill that’s going to tranquilize someone, but use these other tools I’m so happy to see CMS pushing. The drug should always be a very last resort.”

Government and medical officials note that while commonly used antipsychotic medications such as risperidone and olanzapine can be beneficial, they have not been proved to have the same value for dementia patients as for their intended use and there can be more harmful side effects for patients with Alzheimer’s or similar conditions.

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Despite pouring rain Monday morning, throngs of Princeton University graduates gathered on Cannon Green for their Class Day ceremonies, where a local teen was made an honorary class member and actor Steve Carell addressed the students.

Derek DiGregorio, 14, of Princeton, received the loud cheers as he was inducted as an honorary member of the class.

Derek has touched the hearts of many throughout the Princeton community and the Class of 2012, said John Monagle, class treasurer, as he introduced the boy during the ceremony. Hes had a deep impact on many of our classmates Princeton experiences.

Derek, an eighth grader at John Witherspoon Middle School, was born 14 years ago with a disease called ataxia telagiectasia (A-T) that will eventually rob him of movement, compromise his immune system and may cause cancer.

Derek has worked to raise awareness of A-T and to support families who are also facing the disease, said Mr. Monagle, who noted to loud cheers, that the boy is a five-time world champion in tae kwon do and a gold medalist in bowling at the New Jersey Special Olympics. Dereks story is one of courage, passion and determination. He lives the values Princetonians hope to embody and Im honored to present Derek as an honorary class member of the Class of 2012.

According to Derek, the honor was awesome, and he plans to wear his class jacket to school on June 5.

It felt really, really good and it was very special to be a part of something like that, said Derek after returning home from the ceremony and lunch party on campus.

Dereks father, Steve DiGregorio, is a former Princeton University football coach from 1987 to 1999 who left the team to spend more time with his son.

I dont have words; this is so overwhelming for all of us, said Mr. DiGregorio. We got word two and a half, three weeks ago that this was going on, and we are so overwhelmed. My wife and I are very grateful for all of this and very grateful to the senior class for doing this for Derek and making it such a special day for our family.

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Frank Shorter, left, autographs White Plains runner Alicia Sokolofsky’s bib on Sunday.JEFF GOULDING/Times Herald-Record

Published: 2:00 AM – 06/04/12

MIDDLETOWN Brian Baker doesn’t seem to age, from his youthful appearance to his spectacularly consistent road running times.

Baker, of Walden, turned 50 this year, but continues to clock times that would make a 20-year-old proud. He won the 50- to 54-year-old age group in 39:54 on Sunday at The Classic 10K.

Baker is within only 90 seconds or so of times he ran as a 19-year-old. He has missed only four of the 32 Classics (2006-present) and Orange Classics (1981-2005).

“I’m psyched that I’m maintaining that consistency,” he said.

A vegetarian most of his life, Baker chalks up his remarkable consistency to “good genes and a healthy lifestyle.” He’s also durable, having run for 36 years without being slowed by any chronic injuries. Baker finished his 37th marathon at Boston in April.

Liberty High graduate Mike Belfiore raised more than $5,000 on Sunday for Juvenile Diabetes, honoring a friend’s daughter recently diagnosed with the disease at 18 months old.

“It broke my heart to see them go through what they went through,” said Belfiore, a father of children ages 5 and 1. He said his friend’s daughter is doing well. Belfiore set a goal of $5,000 and had raised about $5,400 through Sunday. Donations to the cause in Belfiore’s name can be made at jdrf.org.

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The Classic notebook: Veteran runner Baker still cooking at 50

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EXTON, Pa., June 4, 2012 /PRNewswire/ — ViroPharma Incorporated (VPHM) today announced the initiation of a Phase 2 program to evaluate maribavir for the treatment of cytomegalovirus infections in transplant recipients. The planned program will consist of two independent Phase 2 clinical studies that will include subjects at different ends of the spectrum of CMV infection or disease, namely those who have asymptomatic CMV, and those who have failed therapy with other anti-CMV agents. Maribavir was granted U.S. Orphan Drug Designation in May of 2011 for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.

In addition, an abstract of data collected through the use of maribavir at six French transplant centers as part of a named patient program (NPP) has been accepted for the 24th International Congress of the Transplantation Society to be held on July 15th through 19th in Berlin, Germany.

“Physicians continue to see potential value in the novel mechanism of action of maribavir when used at higher doses in critically ill patients, particularly when other options have failed,” stated Marc E. Uknis, MD, medical director, ViroPharma Incorporated. “The outcomes seen in a small number of the NPP patients and the previously published experience in emergency-use IND patients suggests the possibility that maribavir may provide meaningful antiviral effects in treating active CMV infection and merits further careful evaluation because of the serious unmet need in immunocompromised transplant patients.”

“Asymptomatic” CMV Study ViroPharma has initiated a randomized, dose blinded multicenter Phase 2 study intended to enroll up to 160 subjects (recipients of either hematopoietic stem cell or solid organ transplant) who have demonstrated CMV viremia but do not have CMV organ disease. Further, these subjects cannot have CMV infection that is resistant to other anti-CMV agents. Subjects will be randomized to receive oral maribavir at one of three doses (400mg, 800mg or 1200mg BID) or valganciclovir for up to 12 weeks. Blood levels of CMV DNA will be monitored throughout the study, and minimum virologic responses will be required after 3 and 6 weeks of treatment to continue study drug. The study will be conducted at multiple transplant centers in 3-4 countries in Europe.

Resistant/Refractory CMV Study ViroPharma is planning to initiate a second study, a randomized, dose blinded multicenter Phase 2 study intended to enroll up to 120 subjects (recipients of either hematopoietic stem cell or solid organ transplant) who have demonstrated CMV viremia with or without CMV organ disease. All subjects will have failed to have an adequate virologic response to prior treatment with ganciclovir, valganciclovir, or foscarnet, and may have documented viral genetic resistance to any of these anti-CMV agents. Subjects will be randomized to receive oral maribavir at one of three doses (400mg, 800mg or 1200mg BID) for up to 24 weeks. Blood levels of CMV DNA will be monitored throughout the study, and minimum virologic responses will be required after 3 and 6 weeks of treatment to continue study drug. The study is planned to be conducted at multiple transplant centers in the United States.

About Maribavir Maribavir, a member of a new class of drugs called benzimidazole ribosides, is a potent and selective, orally bioavailable antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable clinical safety profile. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, maribavir inhibits viral DNA assembly and inhibits egress of viral capsids from the nucleus of infected cells. Maribavir is active in vitro against strains of CMV that are resistant to commonly used anti-CMV drugs. The previous focus of clinical development of maribavir as an anti-CMV agent was on the prevention of CMV disease in transplant patients. Results from Phase 3 studies indicated that maribavir at a dose of 100mg BID failed to meet its efficacy endpoints; however, maribavir has demonstrated a favorable safety and tolerability profile in all clinical studies to date. While Phase 3 studies of CMV prophylaxis at the 100mg BID dose did not show sufficient activity to prevent CMV disease, the overall safety profile of maribavir and limited data from cases in which open-label maribavir was used as CMV treatment suggest that higher doses may provide clinical activity. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to maribavir in May of 2011 for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.

About Cytomegalovirus CMV is a memberof the herpesvirus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50 percent and 85 percent of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals including cancer patients, HIV patients, and transplant patients, and in children born with primary CMV infection, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.

About ViroPharma Incorporated ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing novel solutions for physician specialists to address unmet medical needs of patients living with diseases that have few if any clinical therapeutic options. ViroPharma is developing a portfolio of therapeutics for rare and Orphan diseases including C1 esterase inhibitor deficiency, Friedreich’s Ataxia, and adrenal insufficiency, cytomegalovirus (CMV); and recurrent C. difficile infection (CDI). Our goal is to provide rewarding careers to employees, to create new standards of care in the way serious diseases are treated, and to build international partnerships with the patients, advocates, and health care professionals we serve. ViroPharma’s commercial products address diseases including hereditary angioedema (HAE), seizures, adrenal insufficiency and C. difficile-associated diarrhea (CDAD); for full U.S. prescribing information on our products, please download the package inserts at http://www.viropharma.com/Products.aspx; the prescribing information for other countries can be found at http://www.viropharma.com.

ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company’s web site, http://www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.

Forward Looking Statements Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events, including the therapeutic indication and use, safety, efficacy, tolerability and potential of maribavir and our focus, goals, strategy, research and development programs, and ability to develop pharmaceutical products, commercialize pharmaceutical products, and execute on our plans including clinical development activities with maribavir related to treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease. In February 2009, based upon preliminary analysis of the data, we announced that our Phase 3 trial evaluating maribavir used as prophylaxis in allogeneic stem cell, or bone marrow, transplant patients did not achieve its primary endpoints. In addition, the study failed to meet its key secondary endpoints. Additionally, we announced that our Phase 3 trial evaluating maribavir in liver transplant patients was discontinued and that all patients on study drug were moved to current standard of care. While the current studies are in different patient populations and utilize different dosing levels, there can be no assurance that our clinical program with maribavir for the treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease will yield positive results or support further development of maribavir for either indication. The preliminary results from a small number of NPP and emergency-use IND patients may not be predictive of the results of the studies described in this press release. The FDA or EMA may view the data regarding maribavir for the treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease as insufficient or inconclusive, request additional data, require additional clinical studies, delay any decision past the time frames anticipated by us, limit any approved indications, or deny the approval of maribavir for the treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease.

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As a certified holistic health counselor and a mother, Ive had my share of experience helping children with disabilities. Over the next three weeks, I will be featuring three disabilities that are increasingly prevalent: Autism spectrum disorder (ASD), Down syndrome and cerebral palsy.

Dr. Manny Alvarez, senior managing health editor at FoxNews.com, has asked that I offer suggestions on diets to support children with these special needs. We will be taking a look at brain physiology, common physical symptoms, nourishing foods and foods to avoid.

First up this week is ASD. The most recent statistics indicate approximately 1 in 88 children in the U.S are on the spectrum.

Autistic manifestations usually begin to appear between the first and second year of life and include delays or abnormalities in language and complex behavior, social interactions, repetitive behavior or unusual interests and preoccupations. According to The Autism Society there is no single cause of autism and most cases involve a combination of genetic risk factors, environmental factors and very early brain development.

Studies published by Autism Speaks show that a set of biochemical pathways (methylation, transsulfration and sulfation) tend to function sub-optimally for those with autism. These pathways are involved in detoxification, heavy metal elimination, digestion, immune function and gut integrity.

Gastrointestinal symptoms and inflammation are very common for those on the spectrum. These include diarrhea, constipation, bloating and GI pain.

Gut inflammation is typically caused by food sensitivities and an overabundance of unhealthy bacteria in the gut. Impaired digestion causes nutrient deficiencies and impaired cellular function, which manifests as poor brain function and immune system deficiencies. When food is not broken down properly, as is the case with food sensitivities, it leads to foggy thinking, insensitivity to pain, withdrawal and irritability.

The most common culprits of food sensitivities are gluten, casein and soy. Other common physical symptoms are frequent infections, trouble sleeping, non-localized pain/inflammation and brain fog. These symptoms are typical of yeast overgrowth and excessive toxins.

There is a clear connection between the brain and the gut. Supporting the physical symptoms through diet will increase overall health and should reduce the severity of symptoms.

In order to heal the gut, it is important to eat a diet rich in foods with anti-inflammatory properties such as omega-3 fatty acids found in fish oil (fatty fish such as salmon and sardines), flax seeds and walnuts to reduce any existing gut inflammation.

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Foods for children with autism

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