Background:
Historically, acid pretreatment technology for the production of bio-ethanol from corn stover has required severe conditions to overcome biomass recalcitrance. However, the high usage of acid and steam at severe pretreatment conditions hinders the economic feasibility of the ethanol production from biomass. In addition, the amount of acetate and furfural produced during harsh pretreatment is in the range that strongly inhibits cell growth and impedes ethanol fermentation. The current work addresses these issues through pretreatment with lower acid concentrations and temperatures incorporated with deacetylation and mechanical refining.
Results:
The results showed that deacetylation with 0.1 M NaOH before acid pretreatment improved the monomeric xylose yield in pretreatment by up to 20 % while keeping the furfural yield under 2 %. Deacetylation also improved the glucose yield by 10 % and the xylose yield by 20 % during low solids enzymatic hydrolysis. Mechanical refining using a PFI mill further improved sugar yields during both low- and high-solids enzymatic hydrolysis. Mechanical refining also allowed enzyme loadings to be reduced while maintaining high yields. Deacetylation and mechanical refining are shown to assist in achieving 90 % cellulose yield in high-solids (20 %) enzymatic hydrolysis. When fermentations were performed under pH control to evaluate the effect of deacetylation and mechanical refining on the ethanol yields, glucose and xylose utilizations over 90 % and ethanol yields over 90 % were achieved. Overall ethanol yields were calculated based on experimental results for the base case and modified cases. One modified case that integrated deacetylation, mechanical refining, and washing was estimated to produce 88 gallons of ethanol per ton of biomass.
Conclusion:
The current work developed a novel bio-ethanol process that features pretreatment with lower acid concentrations and temperatures incorporated with deacetylation and mechanical refining. The new process shows improved overall ethanol yields compared to traditional dilute acid pretreatment. The experimental results from this work support the techno-economic analysis and calculation of Minimum Ethanol Selling Price (MESP) detailed in our companion paper.Source:
http://www.biotechnologyforbiofuels.com/rss/
Monthly Archives: August 2012
Epigallocatechin gallate incorporation into lignin enhances the alkaline delignification and enzymatic saccharification of cell walls
Background:
Lignin is an integral component of the plant cell wall matrix but impedes the conversion of biomass into biofuels. The plasticity of lignin biosynthesis should permit the inclusion of new compatible phenolic monomers such as flavonoids into cell wall lignins that are consequently less recalcitrant to biomass processing. In the present study, epigallocatechin gallate (EGCG) was evaluated as a potential lignin bioengineering target for rendering biomass more amenable to processing for biofuel production.
Results:
In vitro peroxidase-catalyzed polymerization experiments revealed that both gallate and pyrogallyl (B-ring) moieties in EGCG underwent radical cross-coupling with monolignols mainly by beta--O--4-type cross-coupling, producing benzodioxane units following rearomatization reactions. Biomimetic lignification of maize cell walls with a 3:1 molar ratio of monolignols and EGCG permitted extensive alkaline delignification of cell walls (72 to 92 %) that far exceeded that for lignified controls (44 to 62 %). Alkali-insoluble residues from EGCG-lignified walls yielded up to 34 % more glucose and total sugars following enzymatic saccharification than lignified controls.
Conclusions:
It was found that EGCG readily copolymerized with monolignols to become integrally cross-coupled into cell wall lignins, where it greatly enhanced alkaline delignification and subsequent enzymatic saccharification. Improved delignification may be attributed to internal trapping of quinone-methide intermediates to prevent benzyl ether cross-linking of lignin to structural polysaccharides during lignification, and to the cleavage of ester intra-unit linkages within EGCG during pretreatment. Overall, our results suggest that apoplastic deposition of EGCG for incorporation into lignin would be a promising plant genetic engineering target for improving the delignification and saccharification of biomass crops.Source:
http://www.biotechnologyforbiofuels.com/rss/
Rejected drug may protect against toxic substance common to Alzheimer’s and Parkinson’s diseases
Public release date: 13-Aug-2012 [ | E-mail | Share ]
Contact: Mount Sinai Press Office newsmedia@mssm.edu 212-241-9200 The Mount Sinai Hospital / Mount Sinai School of Medicine
The second of two studies on latrepirdine, recently published in Molecular Psychiatry, demonstrates new potential for the compound in the treatment of Alzheimer’s disease, Parkinson’s disease, sleep disorders, and other neurodegenerative conditions. An international team led by Mount Sinai School of Medicine scientists found that latrepiridine, known commercially as Dimebon, reduced the level of at least two neurodegeneration-related proteins in mice.
Latrepirdine was initially sold as an antihistamine in Russia, following its approval for use there in 1983. In the 1990s, the compound appeared effective in treating some of the earliest animal models of Alzheimer’s disease. In a high profile Phase II clinical trial in Russia, overseen by a panel of top U.S. clinical trial experts, including Mount Sinai’s Mary Sano, PhD, Professor of Psychiatry and Director of the Mount Sinai Alzheimer’s Disease Research Center, latrepirdine showed significant and sustained improvement in cognitive behavior in Alzheimer’s patients with minimal side effects. However, when the drug was tested in the U.S. in a Phase III trial, it did not demonstrate any improvement in people with the disease, causing the sponsors to halt further clinical study of the drug in Alzheimer’s disease.
Before the failed trials however, Mount Sinai researchers led by Sam Gandy, MD, PhD, Professor of Neurology, and Psychiatry, and Director of the Mount Sinai Center for Cognitive Health, began studying how latrepirdine worked.
“Despite the failure to replicate the positive Russian trial results in U.S. patients, we found unexpected evidence that latrepirdine had potential as a treatment for a number of neurodegenerative disorders,” said Dr. Gandy. “Our study shows that the compound prevents neurodegeneration in multiple ways and should remain a contender for battling these devastating diseases. The anti-amyloid approach most recently exemplified by reports that a second bapineuzumab trial has failed might only help patients if begun before the brain pathology begins to build up.”
In the new study, the researchers administered the drug to three different systems: yeast, mice and mammal cells all showing build-up of alpha-synuclein, a protein known to cause neurodegeneration. In all three systems, they determined that latrepiridine activated autophagy, the so-called “self-eating” process of cells that protects the brain from neurodegeneration, which targeted synuclein and protected against its toxicity. In mice, the drug reduced the amount of synuclein accumulated in the brain through autophagy.
John Steele, PhD, a Mount Sinai neuroscience graduate student, devoted his PhD thesis to these studies. Lenard Lachenmayer, MD, a postdoctoral fellow working under the supervision of Zhenyu Yue, PhD, Associate Professor of Neurology at Mount Sinai, shares first authorship of the new paper with Steele and with Shulin Ju, PhD, a postdoctoral fellow at Brandeis University working under the direction of Greg Petsko, PhD, and Dagmar Ringe, PhD, both professors of biochemistry, chemistry and neuroscience at Brandeis.
This study is the second of two published by Dr. Gandy’s team in Molecular Psychiatry. The first, published July 31, 2012, determined that latrepiridine stopped the toxicity of amyloid-beta protein accumulation in mice present with Alzheimer’s disease by inducing autophagy. In that study, they randomly administered either latrepirdine or placebo to mice engineered to have the early stages of Alzheimer’s disease and found that, through autophagy, the drug improved memory.
Dr. Petsko, an expert in protein structure who is now Professor of Neurology and Neuroscience at Weill Cornell Medical College, noted that, surprisingly, latrepirdine protects yeast cells from the toxicity of alpha-synuclein while leaving the cells vulnerable to killing by either the Huntington’s disease protein or by either of the two key proteins responsible for ALS-FTD, a spectrum of diseases that includes both Lou Gehrig’s disease and frontotemporal dementia.
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Rejected drug may protect against toxic substance common to Alzheimer's and Parkinson's diseases
Rejected Drug Could Protect Against Parkinson’s And Alzheimer’s
Editor’s Choice Main Category: Alzheimer’s / Dementia Also Included In: Parkinson’s Disease;Sleep / Sleep Disorders / Insomnia Article Date: 13 Aug 2012 – 14:00 PDT
Current ratings for: Rejected Drug Could Protect Against Parkinson’s And Alzheimer’s
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Over 5 million people worldwide suffer from Alzheimer’s disease, an incurable, progressive neurodegenerative disease that is the leading cause of dementia in the elderly, whilst around 1 million people in the U.S. suffer from Parkinson’s disease, a progressive disorder that leads to muscle stiffness, tremors and slowed movements and gait.
Latrepirdine was approved in Russia in 1983 as an antihistamine. However, in the 90s, researchers discovered that the drug seemed to be effective in the earliest animal models of Alzheimer’s disease. A high- profile Phase II clinical trial in Russia demonstrated that latrepirdine showed a considerable and sustained improvement in cognitive behavior in Alzheimer’s patients with minimal side effects. A panel of U.S. clinical experts oversaw the trial. The panel included Mary Sano, PhD, Professor of Psychiatry and Director of the Mount Sinai Alzheimer’s Disease Research Center. However, later tests of latripirdine in a U.S. Phase III trial failed to show any improvement in those affected by Alzheimer’s, which prompted the sponsors to stop further clinical trials of the drug for Alzheimer’s disease.
Prior to the failed trials Sam Gandy, MD, PhD, Professor of Neurology, and Psychiatry, and Director of the Mount Sinai Center for Cognitive Health and his team started investigating the way in which latrepirdine functions. Dr. Gandy declares:
Their new study entailed administering the drug to three different systems, including yeast, mice and mammal cells that all showed a build-up of alpha-synuclein, i.e. a protein that is known to cause neurodegeneration.
They discovered determined that latrepiridine activated autophagy in all three systems, the “self-eating” process of cells that protects the brain from neurodegeneration, which targeted synuclein and protected against its toxicity. They discovered that the drug decreased the amount of synuclein accumulated in the brain of mice through autophagy.
This is the second study published in Molecular Psychiatry by Dr. Gandy’s team. Their first study, which appeared in the July 31 issue, revealed that a mice study showed that latrepiridine stopped the toxicity of amyloid-beta protein accumulation by inducing autophagy in animals with Alzheimer’s disease. The study entailed randomly administrating latrepirdine or placebo to mice with early stages of Alzheimer’s disease, revealed that the drug improved memory through autophagy.
To his surprise, Dr. Petsko, an expert in protein structure, Professor of Neurology and Neuroscience at Weill Cornell Medical College, observed that latrepirdine protects yeast cells from the toxicity of alpha-synuclein and leaves the cells vulnerable so that they can be killed by either the Huntington’s disease protein or by either of the two key proteins responsible for ALS-FTD. ALS-FTD is a range of diseases, including Lou Gehrig’s disease and frontotemporal dementia.
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Rejected Drug Could Protect Against Parkinson's And Alzheimer's
Does Your Dog have What it Takes to Be Parkinson’s Top Dog?
TORONTO, ONTARIO–(Marketwire -08/14/12)- This year more furry friends will join the 14,000 Canadians who champion Parkinson SuperWalk. Pets are demonstrating their support for Parkinson SuperWalk through a new online contest, Pets for Parkinson’s, launched this week by Parkinson Society Canada.
A first for Parkinson SuperWalk, Pets for Parkinson’s challenges Canadians to show support for the walk by submitting photos of their pets demonstrating their enthusiasm for the cause to help raise awareness of Parkinson’s disease. Winners will be selected weekly between now and September 10th and awarded a $100.00 PetSmart gift card. Friends and family will also have the chance to participate and vote online for their favourite Parkinson’s Pet who will be awarded the grand prize of a $250.00 gift card to PetSmart.
“For many people, pets are an integral member of the family, and every year we have a large number of canine companions who attend Parkinson SuperWalk to show their support. We think this is a great way to have some fun and get more pets (and their families) involved in the cause,” says Joyce Gordon, Parkinson Society Canada President and CEO.
Visit http://bit.ly/NvtDnM to see some of Canada’s pets with personality gearing up for Parkinson’s SuperWalk and to enter the weekly prize draw online. Please see contest terms and conditions for more information.
About Parkinson SuperWalk
Parkinson Society Canada’s 22nd annual Parkinson SuperWalk is less than a month away! On September 8th-9th, 14,000 volunteers and participants in 95 communities across Canada will walk together with a goal to raise $3 million nation-wide. Parkinson SuperWalk is Parkinson Society Canada’s largest fundraising event and since its inaugural walk in 1990 led by a small group of committed volunteers, the nation-wide event has raised more than $25 million for education, support services, research, and advocacy on behalf of Canadians living with Parkinson’s. Register online at http://www.parkinsonsuperwalk.ca.
About Parkinson’s Disease
Parkinson’s is a neurodegenerative disease for which there is no cure. It is estimated that there are more than 100,000 people living with Parkinson’s disease across the country(i). Canadians are encouraged to get involved in their community.
To register, donate, or find a walk, visit http://www.parkinsonsuperwalk.ca. Follow Parkinson SuperWalk on Facebook or on Twitter.
For more about Parkinson’s disease and Parkinson Society Canada, and where to find support in your community, visit http://www.parkinson.ca or call 1-800-565-3000.
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Does Your Dog have What it Takes to Be Parkinson's Top Dog?
Parkinson’s Disease treatment options topic of Wednesday lecture
MOBILE, Alabama — A community lecture on treatments for Parkinsons Disease, tremors and other movement disorders is planned for 11:30 a.m. Wednesday at Via! Health, Fitness & Enrichment Center in Mobile.
Dr. Daniel Dees, who specializes in movement disorders, will talk about Parkinsons Disease, a disorder of the brain that leads to shaking and difficulty with walking, movement, eating and coordination. He is expected to discuss the causes and symptoms and offer up-to-date treatment options, organizers said.
The Via! Health, Fitness & Enrichment Center is located at 1717 Dauphin St. in Mobile.
Lunch will be served at 11:30 a.m. The presentation begins at noon.
The Med School Caf lecture and lunch are provided free of charge, though reservations are required. To make reservations, call Kim Partridge at 251-460-7770 or e-mail kepartridge@usouthal.edu.
For more details about the event, check out the USA Med School Water cooler.
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Parkinson's Disease treatment options topic of Wednesday lecture
Dementia information roadshow on the Isle of Wight
THE Alzheimers Society Dementia Community Roadshow will visit the Isle of Wight this week, offering advice and information about the condition.
It will be at the Tesco store, Ryde, today (Tuesday) and tomorrow, from 10am to 4pm.
People living with dementia and those worried about a friend or relative are encouraged to drop by with any questions.
Carol Elliott, services manager at the Alzheimers Society, said: “The roadshow is pioneering as it helps us reach out to communities, tackle stigma by raising awareness of the condition and encourage people who are worried about their memory to visit their GP.”
MP Andrew Turner, who will be visiting the roadshow today morning, said: “It is estimated there are more than 2,500 Islanders suffering from dementia but less than 40 per cent of them have received a formal diagnosis.
“The onset of dementia can be confusing and frightening, both for the person affected and for those around them so I welcome this free drop-in service coming to the Island so people can easily find out information about the condition.
“They can also get information about what help and support is available, such as the excellent Alzheimers Cafes, which are now held regularly in four Island towns.”
Reporter: emilyp@iwcpmail.co.uk
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Dementia information roadshow on the Isle of Wight
Research and Markets: Spinocerebellar Ataxias – Pipeline Review, H1 2012
DUBLIN–(BUSINESS WIRE)–
Research and Markets (http://www.researchandmarkets.com/research/pgsg7h/spinocerebellar_at) has announced the addition of Global Markets Direct’s new report “Spinocerebellar Ataxias – Pipeline Review, H1 2012″ to their offering.
Global Markets Direct’s, ‘Spinocerebellar Ataxias – Pipeline Review, H1 2012′, provides an overview of the Spinocerebellar Ataxias therapeutic pipeline. This report provides information on the therapeutic development for Spinocerebellar Ataxias, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Spinocerebellar Ataxias. ‘Spinocerebellar Ataxias – Pipeline Review, H1 2012′ is built using data and information sourced from Global Markets Direct’s proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team.
Scope
– A snapshot of the global therapeutic scenario for Spinocerebellar Ataxias.
– A review of the Spinocerebellar Ataxias products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.
– Coverage of products based on various stages of development ranging from discovery till registration stages.
– A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
– Coverage of the Spinocerebellar Ataxias pipeline on the basis of route of administration and molecule type.
– Profiles of late-stage pipeline products featuring sections on product description, mechanism of action and research & development progress.
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Research and Markets: Spinocerebellar Ataxias – Pipeline Review, H1 2012
Harmons Donates nearly $245,000 to National MS Society
Harmons Grocery Stores has given $244,287 to the Utah-Southern Idaho Chapter of the National Multiple Sclerosis (MS) Society as part of the food chains 80th anniversary celebration.
The West Valley City-based chain raised money in May and June for the local non-profit by collecting donations at check stands, selling bratwursts and hot dogs on the weekends, hosting a charity golf tournament and sponsoring a bike team. All proceeds will go directly to the local National MS Society chapter.
“We are incredibly grateful to Harmons for getting behind Bike MS and going over the top every year in raising funds for our programs,” said Royle-Mitchell, MS chapter president “Utah has one of the highest incidence rates of multiple sclerosis in the nation and the funds raised by Harmons will support critical research, information and referral programs, professional and community education, financial assistance, scholarships, wellness programs, advocacy, support groups and a lending library.”
The National MS Society seeks a world free of multiple sclerosis. Every hour someone is newly diagnosed with MS, a chronic, unpredictable often disabling disease of the central nervous system. It is estimated that one in 300 Utahns has MS.
Harmons is one of Utahs few remaining locally-owned and operated grocery chains. It supports local charities throughout the year and is one of the largest contributors in the state to Special Olympics Utah, the National MS Society and the Utah Food Bank.
Copyright 2012 The Salt Lake Tribune. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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Harmons Donates nearly $245,000 to National MS Society
Three Continents, One Gene: DNA Detectives Track Down Nerve Disorder Cause
Gene mutation responsible of inherited ataxia found through sophisticated genetic analysis of Asian, European & American families
Newswise ANN ARBOR, Mich. A global hunt for the cause of a crippling inherited nerve disorder has found its target. The discovery opens the door for better diagnosis and treatment of this particular disease but also for better understanding of why nerves in the brains movement-controlling center die, and how new DNA-mapping techniques can find the causes of other diseases that run in families.
In a new paper in the Annals of Neurology, a team from Taiwan, France and the University of Michigan Health System report that mutations in the gene KCND3 were found in six families in Asia, Europe and the United States that have been haunted by the same form of a disease called spinocerebellar ataxia or SCA. The disease causes progressive loss of balance, muscle control and ability to walk.
The new paper finds the disease gene in a region of chromosome 1 where a Dutch group had previously shown linkage with a form of SCA called SCA19, and the Taiwanese group on the new paper had shown similar linkage in a family for a form of the disease that was then called SCA22.
The Dutch group has just published results in the same issue of the journal, zeroing in on the same gene as the U-M/Taiwanese/French groups.
The gene governs the production of a protein that allows nerve cells to talk to one another through the flow of potassium. Pinpointing its role as a cause of ataxia will now allow more people with ataxia to learn the exact cause of their disease, give a very specific target for new treatments, and perhaps allow the families to stop the disease from affecting future generations.
But the findings also have significance beyond ataxia. The researchers also show that when KCND3 is mutated, it causes not only poor communication between nerve cells in the cerebellum but also the death of those cells. Its information that could aid research on other neurological disorders involving balance and movement.
Margit Burmeister, Ph.D., the U-M geneticist who helped lead the work, notes that the gene could not have been found without a great deal of DNA detective work and the cooperation of the families who volunteered to let researchers map all the DNA of multiple members of their family tree.
We combined traditional genetic linkage analysis in families with inherited diseases with whole exome sequencing of an individuals DNA, allowing us to narrow down and ultimately identify the mutation, she says. This new type of approach has already resulted in many new gene identifications, and will bring in many more.
U-M neurologist Vikram Shakkottai, M.D., Ph.D., an ataxia specialist and co-author on the paper, notes that the new genetic information will help patients find out the specific cause of their disease a reassuring thing in itself.
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Three Continents, One Gene: DNA Detectives Track Down Nerve Disorder Cause
The dizzy spells that mean you need to see the doctor
By Jill Foster
PUBLISHED: 21:29 EST, 13 August 2012 | UPDATED: 21:29 EST, 13 August 2012
Nigel Kilvington was on holiday in Lanzarote with his wife Hazel when he realised something was not quite right with his balance.
I noticed I was wobbling while going up and down stairs, he says.
My balance felt off and then my speech was slurring a little.
Ataxia is Greek for ‘lack of balance or order’. There are at least 50 types – many of which are rare
It was worrying, but as Hazel is a nurse we knew it wasnt an emergency because the symptoms had not happened suddenly.
‘We wondered if it was the heat.
I felt fine in other respects, so I didnt seek medical attention in Lanzarote I waited until I got home a few days later, says the 44-year-old, who works for U.S. bank Citigroup in London.
At home in Brentwood, Essex, Nigel visited his GP.
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The dizzy spells that mean you need to see the doctor
Autism advocate Temple Grandin in Arkansas
(ROBYN BECK/AFP/Getty Images)
LITTLE ROCK, Ark. (KTHV) – A national autism advocate is speaking in Little Rock about autism, what it is, and how to address it in your family.
Temple Grandin, is a source of inspiration for those with autism and their families. Grandin is an autism activist who was diagnosed with the disorder at age 2. She’s also one of the nation’s foremost experts on the treatment of livestock and says she remembers what it was like to grow up autistic.
“When I was little kid I couldn’t talk. I can remember the frustrations of not being able to talk. I had extremely good early education and early intervention. I can’t emphasize enough develop the child’s strength,” says Grandin.
Grandin, who designed curved chutes and other systems for cattle handling, worries other autistic children won’t get those opportunities. That’s the message she spoke about Monday in Little Rock.
“If you have a 2 or 3 year old child who’s not talking worst thing you can do is do nothing. Then you got the kids who are quirky and different and I’m very upset that these schools have taken the hands-on classes out. All the art and woodshop and cooking and sewing and welding, because those classes teach practical problem solving,” Grandin says.
Clarke Delp knows all too well how autism can affect families. She says Grandin has offered her help with her own autistic child.
“At the age of 6 he was diagnosed with autism. Part of me was a little relieved because I knew what I was dealing with then. Because for 6 years not knowing what I was dealing with was a struggle,” says Delp.
Now, her autistic son Warren is 10-years old. She says Grandinhelped her cope with his disorder.
“She has made sure that her life has not been defined by autism. She has accomplished such incredible things. Autism certainly comes with great challenges, but it doesn’t necessarily mean that you cannot live a fulfilling life, a successful independent life,” says Delp. “She gives me hope, she gives most of the parents, all the parents I know hope that their child can be successful as she is.”
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Autism advocate Temple Grandin in Arkansas
Rasheda Ali, Daughter of Legendary Muhammad Ali and Advisory Board Member of BrainStorm, Visits Company Laboratories …
NEW YORK & PETACH TIKVAH, Israel–(BUSINESS WIRE)–
BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies and CNS therapeutics, announced that Rasheda Ali Walsh, daughter of the legendary Muhammad Ali, visited the Companys laboratories as well as its cleanrooms at Hadassah Medical Center, where she received a briefing on the companys clinical trial conducted there. Ms. Ali Walsh, an internationally known advocate for promoting research and awareness of neurodegenerative diseases, is a member of the Advisory Board of BrainStorm.
BrainStorms President, Mr. Chaim Lebovits, and CEO Dr. Adrian Harel accompanied Ms. Ali Walsh for a meeting with Prof. Dimitrios Karussis, Principal Investigator of the Companys ongoing Phase I/II clinical trial at Hadassah, and Prof. Tamir Ben-Hur, Head of the Neurology Department. The group discussed the latest innovative treatments for neurodegenerative diseases and BrainStorms leading role in this area.
Having heard so much about the recent positive interim safety report and the outstanding progress being made by BrainStorm at Hadassah, I felt the need to actually meet the team in person, commented Ms. Ali. The amazing work being done here gives a ray of hope to patients and families worldwide that autologous stem cell transplants may be the answer theyve been waiting for to overcome neurodegenerative diseases.
According to Dr. Adrian Harel, BrainStorms CEO, The support and encouragement by world-renowned individuals like Rasheda Ali is important for increasing awareness of the need for a cure for debilitating neurodegenerative diseases. We are hopeful that this awareness will lead to more widespread efforts by governments and health organizations worldwide to fund research in this area and provide assistance to patients and their families.
About BrainStorm Cell Therapeutics, Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of adult stem cell therapeutic products derived from autologous bone marrow cells and intended for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel-Aviv University. For more information, visit the companys website at http://www.brainstorm-cell.com.
Safe Harbor Statement Statements in this announcement other than historical data and information constitute “forward-looking statements” and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.’s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as may, should, would, could, will, expect, likely, believe, plan, estimate, predict, potential, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm’s limited operating history, history of losses; minimal working capital, dependence on its license to Ramot’s technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm’s annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorms forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or managements beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
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Rasheda Ali, Daughter of Legendary Muhammad Ali and Advisory Board Member of BrainStorm, Visits Company Laboratories …
ReNeuron Group plc – Stroke Trial Update
ReNeuron Group (Berlin: RQE.BE – news) plc
(“ReNeuron” or the “Company”)
ReNeuron receives DSMB clearance to progress to higher dose in stem cell clinical trial in stroke patients
First (OTC BB: FSTC.OB – news) patient treated in this higher dose cohort
Guildford, UK, 14 August 2012: ReNeuron Group plc (AIM: RENE) today provides an update on progress with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, taking place in Scotland, ReNeuron’s ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.
The Company is pleased to report that the independent Data Safety Monitoring Board (DSMB) for the clinical trial has recommended that the trial advances to the evaluation of a higher dose of ReN001 in the third of four dose cohorts to be treated in the study. In arriving at this recommendation, the DSMB reviewed safety data from the first two dose cohorts of six patients treated with ReN001. Of these patients, two are through 18 month follow-up, one is through 12 month follow-up, one is through 9 month follow-up, one is through 6 month follow-up and one is through three month follow-up. No cell-related adverse events or adverse immune-related responses have been reported in any of the patients treated to date.
The Company is also pleased to report that the first patient in this third dose cohort of three patients has now been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising.
The primary aim of the PISCES study is to test the safety and tolerability of the treatment in ascending doses of the ReN001 cells, in patients with moderate to severe functional neurological impairments resulting from their stroke. The secondary aim of the study is to evaluate efficacy measures for the design of future clinical trials with ReN001, including imaging measures as well as a number of tests of sensory, motor and cognitive functions.
In June of this year, interim data from the PISCES study from the first five patients treated was presented by the Glasgow clinical team at Glasgow at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan (EUREX: FMJP.EX – news) . Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.
The PISCES study is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world. The trial is being conducted in Scotland at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board.
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ReNeuron Group plc – Stroke Trial Update
Couple of reasons to attend Pathology Visions 2012
Just a couple of reasons to attend Pathology Visions 2012:
KENNETH BLOOM
IMPLEMENTING A HIGH VOLUME DIGITAL PATHOLOGY REFERENCE LABORATORYBio Abstract Objectives 2) Describe the pros and cons of available digital pathology solutions. 3) Understand the process of implementing a digital pathology solution in a CLIA laboratory. |
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PRASHANT BAVI
USE OF DIGITAL PATHOLOGY SIGNIFICANTLY IMPROVES THE QUALITY OF TISSUE MICROARRAY CONSTRUCTIONBio Abstract Methods: We constructed two identical TMA blocs of 0.6mm diameter from 50 rare histological events that included R&S cells from Hodgkin’s lymphoma, multifocal microscopic carcinoma in thyroid and lymphovasuclar embol/perineural infiltration in colorectal carcinoma. One array block was done in the traditional way and the other array we did digital mapping of scanned images from slides, printing the life-sized images. Slides were scanned with Aperio ScanscopeCS; mapping done with Imagescope and TMA constructed using Semiautomated Arrayer, CM1 Mirlacher, Neuenburg, Germany. Using a image manipulation program IrfanView, we printed the images in the same aspect ratio as it was scanned on a semi-transparent paper. Results: Preliminary results of 10 microscopic multifocal papillary thyroid carcinoma showed a 100% accuracy in picking up the microscopic lesions as compared to 60% with the traditional approach. Remarkably accuracy was associated with a increase in speed. Conclusions: Modifying the process of TMA construction by embracing digital pathology is beneficial and should be adopted routinely. The tangible benefits are:(i) improved accuracy; (ii) saves time (iii) increases the speed; (iv) potentially reduces errors of misidentification and (v) frees up the lab technician to be utilized for other tasks. Objectives |
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Source:Breaking News: Federal Appeals Court Once Again Upholds Gene Patents, Invalidates Comparison Method Patents
The U.S. Court of Appeals for the Federal Circuit announced that it once again partially reversed a lower court’s ruling in the Myriad gene patent case. In a 2-1 decision, the federal court of appeals ruled that companies can patent genes, but cannot patent methods to compare those gene sequences.
This is the second time the Federal appeals court has considered this lawsuit. The Supreme Court vacated this court’s July 2011 decision following the high court’s unanimous ruling in favor of Mayo Collaborative Services in its medical patent suit against Prometheus Laboratories. The Supreme Court then remanded it back to the Federal appeals court in light of the Mayo decision.
The American Civil Liberties Union (ACLU) is representing plaintiffs (including the CAP) in a suit challenging gene patents on human DNA, specifically Myriad Genetics’ patent claims on BRCA 1 and BRCA 2 genes. CAP and other medical societies and organizations provided amicus briefs in support of Mayo at various points in the litigation.
“It is extremely disappointing that despite the Supreme Court’s ruling, the appeals court has failed to fully re-consider the facts of this case,” said ACLU attorney Chris Hansen. “This ruling prevents doctors and scientists from exchanging their ideas and research freely. Human DNA is a natural entity like air or water. It does not belong to any one company.”
The ACLU declined to comment on what this means for the future of the case, except to say their attorneys are weighing all legal options and will discuss future strategies with the plaintiffs.
Source:Should/Could the FDA Regulate Whole Slide Imaging as a Class II Device?
Frequent readers and those who have heard me speak publicly on the topic of government regulation and oversight of whole slide imaging recognize that I really do not think that manufacturers need a stamp of approval from the FDA to the effect that "FDA Approved for Primary H&E Diagnosis" on their claims and marketing materials. Perhaps manufacturers think they do because their sense is that more and more pathologists will in fact buy the technology if it indeed has that stamp of approval that the agency concerned with regulating food, drugs and devices in the bests interests of patient safety and assuring apprropriate risk:benefit ratios says it is OK to use for primary diagnosis.
With that being said, we now know it is unlikely that these devices will be regarded as Class I devices (see below). As they will not be regarded as Class I, I think the device or instrument in question is then regarded as a Class III device requiring pre-market approcal "for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices" (see below according to The FDA Class Classification).
Why then could whole slide imaging devices/systems not be regarded as Class II?
Don't we actually have this with digital pathology today? Special labeling requirements, i.e. certain stains from certain vendors for purposes of prognostic and therapeutic testing (ER, PR, HER2, Ki-67), mandatory performance standards, i.e. constant review, quality assurance, correlations and peer reviews in surgical pathology, a degree of scrutiny unrivaled in any specialty in medicine in terms of self-auditing ourselves and lastly, postmarket surveillance. Here we have 100s of papers written with 1000s of cases studied in peer-reviewed literature and decades worth of experience as a specialty. In a recent survey on digital pathology conducted, 20% of respondents mentioned using digital pathology for primary clinical diagnosis.
In a more recent follow up post on the survey a couple of weeks ago, there was discussion of the best use cases for digital pathology. They are what this survey affirms, in my opinion, image analysis, i.e. ER/PR/HER2 scoring and second opinions/consultations/expert reviews.
Unless your practice is in New York and you are in Aspen, in which case you probably either need to move your lab or move yourself, I do not understand the need for "Primry H&E Diagnosis" by digital pathology. The instances I can think of include in-office laboratories and the occassional times when you are in Aspen, 1000s of miles from your histology laboratory on a temporary basis. Given the number of times of these occurrences and the number of slides produced and read in these types of practice settings, it is a very small percentage of the estimated tens of millions of slides produced annually in the United States.
Nonetheless, assuming we recognize more risk than the microscope itself in this instance (a Class I exempt device) and we are held to "special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance", it would seem logical that whole slide imaging devices/systems be regarded as Class II and allow the market and practioners to define the nuances of these controls, standards and postmarket surveillance conditions.
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FDA Device Class Classification (as cut and pasted from Wikipedia):
The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860).
Class I: General controls
Class I devices are subject to the least regulatory control. Class I devices are subject to "General Controls" as are Class II and Class III devices. General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices. Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury. Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.
Class II: General controls with special controls
Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. A few Class II devices are exempt from the premarket notification. Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance. Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.
Class III: General controls and premarket approval
A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Examples of Class III devices which currently require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.
Source:GOP VP Candidate calls SGR “Ridiculous”
Courtesy of ModernHealthcare Healthcare Business News
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Exclusive interview: Rep. Paul Ryan discusses need for 'market-based' health reform
Premium support an idea whose time has come, Ryan says
Posted: August 14, 2012 - 12:45 pm ET
Tags: Healthcare Reform, Legislation, Medicare, Mitt Romney, Paul Ryan, Payers, Physicians, Reimbursement
Wisconsin Rep. Paul Ryan's selection as the Republican vice presidential nominee has put Medicare reform back in the national spotlight, as Ryan's plans for transforming Medicare into a "premium support" system gain renewed attention.
Of particular significance is how Ryan's plan to offer beneficiaries federal payments to pick the health plan of their choice goes over with voters in Florida and Pennsylvania—two presidential battleground states with large Medicare-beneficiary populations.
Ryan, who finished first last year on Modern Healthcare's 100 Most Influential People in Healthcare list, was interviewed Aug. 2 by Modern Healthcare for an upcoming story, just nine days before presumptive GOP presidential nominee Mitt Romney announced that the 42-year-old member of the House Ways and Means Committee would be his running mate.
In the interview, Ryan emphasized that premium support wasn't only his idea or a Republican idea. He pointed out that he proposed last year's Medicare-reform plan jointly with Oregon Democrat Sen. Ron Wyden. Premium support's origins, he added, can be traced to President Bill Clinton's 1999 Bipartisan Commission on the Future of Medicare and its Democratic co-chair, Rep. John Breaux of Louisiana.
"This is an idea whose time has come," Ryan said. "And it's a bipartisan idea."
Ryan acknowledged that the idea takes some getting used to and said he knew that Congress would not pass last year's proposal.
"What Ron Wyden and I tried to do was to plant the seeds of a bipartisan consensus," Ryan said. "We knew we weren't going to pass it because of the politics. We did this together to get the consensus-building started."
To that end, Ryan said the plan's chances for approval will greatly improve next year.
"I'm actually pretty optimistic," he said.
Ryan said he heard from "some of his doctor friends" at the Wisconsin Medical Society that his plan was the subject of heated debate at the annual American Medical Association House of Delegates meeting in June and that he has had "years of conversations" about premium support with physicians in his state.
“I think it's a good debate,” he said. Medicare, Ryan said, can go in two directions: toward government-directed price controls as dictated by the Independent Payment Advisory Board or toward premium support, which he said "keeps the patient-doctor relationship intact."
"That to me is the best way to deal with costs and save this program," Ryan said. "Competition does work."
Ryan said he envisions a risk-adjusted program in which beneficiaries who need more support get it and said that risk adjustment is "something CMS knows how to do."
"Physicians are also involved in getting proper incentive alignment focused on quality and cost," Ryan stated.
“This will help everyone: Sick or healthy, wealthy and poor,” he added. “We can put society's assets where they need to go and emerge from that with a system that is in keeping with our goals of innovation, competition and quality improvement.”
Ryan also said the U.S. should undertake healthcare reform on its own and "fix this on our terms" instead of borrowing ideas from Europe.
"We believe there are far superior ways to get back to a patient-centered healthcare system, the nucleus of which is the patient and her doctor—and not the government," Ryan said. "We believe consumer-driven, market-based reforms do more to alter the cost curve of healthcare inflation."
Ryan said price controls won't bend the healthcare inflation cost curve and would lead to rationing of services.
Ryan credited his selection last year as the most influential person in healthcare to his having had a seat on the House Ways and Means Committee since 2001 and used that position to focus on the healthcare system's impact on health outcomes and economic and social issues.
"It's just something I've immersed myself in," Ryan said. "What a lot of policymakers have failed to grasp is how important healthcare is to our economy and to our future."
Ryan also predicted that Congress would approve another temporary postponement of a physician Medicare payment cut in January of around 30% under the sustainable growth-rate formula used to calculate reimbursement.
"I think the SGR is ridiculous and should have been replaced long ago," Ryan said, adding that he hopes to replace the SGR next year with a formula that furnishes doctors with something predictable and accountable so that "we don't have this can-kicking exercise every six months."
While the SGR has not worked, Ryan said something worse lurks ahead.
“I always say to the doctors, 'If you don't like the SGR, just wait until you see what the IPAB has in store,'” Ryan said.
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MedicareMedicaidPayersHealthcare Reform
Source:Leslie F. Greengard, M.D., Ph.D., Appointed to AccelPath Medical Advisory Board
AccelPath, Inc. (ACLP) (“AccelPath” or the “Company”) announced today that Professor Leslie F. Greengard, M.D., Ph.D., has been appointed to the Company’s Medical Advisory Board.
Professor Greengard is a Professor of Mathematics and Computer Science at the Courant Institute of Mathematical Sciences at New York University. He received his B.A. degree in Mathematics from Wesleyan University in 1979, his M.D., and Ph.D. degree in Computer Science, from Yale University in 1987. He has been at the Courant Institute since 1989, and served as the director of the Institute from 2006-2011.
Research in Professor Greengard's group is largely focused on developing fast and adaptive algorithms for computational problems in biology, chemistry, materials science, medicine, and physics. He is best-known for having developed the fast multipole method (FMM) during the 1980s with Professor V. Rokhlin, which is now widely used in electromagnetics, astrophysics, molecular simulations, and fluid dynamics. He currently works on protein design, the analysis of "metamaterials," electromagnetic theory, diffusion in complex geometry, and magnetic resonance imaging.
Professor Greengard has been an NSF Presidential Young Investigator and a Packard Foundation Fellow. He received the Leroy P. Steele Prize from the American Mathematical Society in 2001 and the Sokol Faculty Award in the Sciences from NYU in 2004. In 2006, he was elected to both the National Academy of Sciences and the National Academy of Engineering.
“After numerous discussions with AccelPath’s management and board members, I am pleased to join the Company’s Medical Advisory Board,” stated Professor Greengard. “The Company is on an exciting road of implementing digital telepathology networks in the US and abroad. The Company also has powerful 3D imaging technology with multiple applications in medicine. I look forward to contributing to the Company’s ongoing successes.”
“We are very pleased to have formalized a collaborative relationship with Professor Greengard,” stated Shekhar Wadekar, AccelPath’s Chairman and Chief Executive Officer. “Professor Greengard’s expertise in developing fast and adaptive algorithms is a key component to enhancing efficiencies in digital whole slide imaging and 3D imaging. Professor Greengard will help enhance the Company’s proprietary 3D digital imaging technology, which has several medical applications. This 3D imaging technology was acquired as part of the Company’s acquisition of Technest Holdings in 2011. We will continue to exploit the value of this technology, as it relates to non-core applications, while pursuing our core business of digital telepathology and the applications for this technology in medicine.”
Source: AccelPath
Source:For Most Older Women with Early Stage Breast Cancer, Radiation after Lumpectomy Helps Prevent Need for Subsequent Mastectomy
Contrary to clinical recommendations, older women with early stage breast cancer may want to undergo radiation after lumpectomy to help ensure that they will not need a mastectomy in the future. That is the conclusion of a new study published early online in CANCER, a peer-reviewed journal of the American Cancer Society. The findings indicate that current thinking on the risks and benefits of radiation for early stage breast cancer in older women may be inaccurate.
National treatment guidelines state that older women with early stage breast cancer that has not spread to the lymph nodes and that is driven by estrogen in the body can be treated with lumpectomy and estrogen blockers without the need for radiation. Benjamin Smith, MD, of The University of Texas MD Anderson Cancer Center in Houston, and his colleagues evaluated information on 7,403 women aged 70 to 79 years who were treated with lumpectomy for such breast cancers between 1992 and 2002 and whose data were contained in the Surveillance, Epidemiology, and End Results-Medicare database, which links cancer registry information to a master file of Medicare enrollment. Approximately 88 percent of these women received radiation after their lumpectomy.
When the investigators looked to see what happened to these women after their breast cancer was treated, they found that within 10 years after treatment, 6.3 percent of women who did not get radiation eventually had their breast removed by mastectomy, compared with only 3.2 percent of women who received radiation. The reasons for mastectomy are not reported by this dataset, but the most likely reason for mastectomy in this patient group is recurrence of cancer in the breast. The researchers were also able to identify which women were more and less likely to benefit from radiation. Specifically, radiation did not seem to benefit women ages 75 to 79 years with non-high grade tumors (which contain cells that look only moderately abnormal under a microscope), suggesting that this group can probably skip radiation. Patients with high grade tumors (which contain very abnormal-looking cells), regardless of age, seemed to derive the most benefit from radiation.
“These data are important because they suggest that radiation is likely of some benefit to certain women where national guidelines say that radiation is not needed,” said Dr. Smith. “Our data could be helpful to women when they decide whether or not to undergo radiation,” he added.
Article: “Effectiveness of radiation for prevention of mastectomy in older breast cancer patients treated with conservative surgery.” Jeffrey M. Albert, I-Wen Pan, Ya-Chen Tina Shih, Jing Jiang, Thomas A. Buchholz, Sharon H. Giordano, and Benjamin D. Smith. CANCER; Published Online: August 13, 2012 (DOI: 10.1002/cncr.27457).
Author Contact: Laura Sussman of The University of Texas MD Anderson Cancer Center’s media relations office at lsussman@mdanderson.org, or +1 (713) 745-2457.
CANCER is a peer-reviewed publication of the American Cancer Society integrating scientific information from worldwide sources for all oncologic specialties. The objective of CANCER is to provide an interdisciplinary forum for the exchange of information among oncologic disciplines concerned with the etiology and course of human cancer. CANCER is published by Wiley and can be accessed online at http://wileyonlinelibrary.com/journal/cancer.
CANCER News Alert
NOTE: The information contained in this release is protected by copyright. Please include journal attribution in all coverage. A free abstract of this article will be available via the CANCER News Room upon online publication. For more information or to obtain a PDF of any study, please contact:
Jennifer Beal (UK) +44 (0) 1243 770633
Ashley Fontillas (US) 201-748-6035
sciencenewsroom@wiley.com
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