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Thursday, November 8, 2012

Company initiates trial to evaluate clinical performance of molecular diagnostic to identify patients that have, or are at risk of developing, multiple sclerosis


GAITHERSBURG, Md., Nov. 8, 2012 /PRNewswire/ -- DioGenix, Inc., a company developing molecular diagnostics for the early diagnosis and monitoring of immune-mediated neurological diseases, today announced its lead product MSPrecise™ outperformed the specificity of the current standard of care for cerebral spinal fluid (CSF) analysis in patients suspected of having multiple sclerosis (MS) by almost two to one with no loss of sensitivity. MSPrecise is a proprietary next-generation sequencing assay that analyzes changes in key genes involved in the adaptive immune system of patients being evaluated for MS. The results of this clinical study are consistent with two prior DioGenix studies, all of which compared MSPrecise results both to published performance data for the oligoclonal banding test and experimental controls.
Patients that present with clinical symptoms and evidence of inflammation and damage to the myelin sheath that surrounds and protects nerve fibers in the CNS undergo a battery of tests in a diagnostic process that can take months to years to complete. The diagnostic standard of care for MS includes CSF analysis using the oligoclonal banding test, which detects immunoglobin G proteins that indicate an immune response within the CNS. Because the oligoclonal banding test yields a high rate of false positive results, confident diagnosis also requires a comprehensive set of clinical tests including magnetic resonance imaging and, in certain cases, visual evoked potentials. Due to the variability of symptoms between patients and the lack of a definitive test, it has been estimated that the misdiagnosis rate for MS is higher than any other immune-mediated neurological disease.
"The results of our most recent study continue to support our belief that MSPrecise will be an important new tool in the management of patients suffering with MS. We have clearly demonstrated, in a series of clinical studies, the power of MSPrecise to accurately identify patients in the early stages of neurodegenerative disease," said Larry Tiffany, Chief Executive Officer, DioGenix, Inc. "We believe our deep sequencing approach has the potential to not only diagnose and classify patients with MS but eventually other immune-mediated neurological diseases as well."
In the recently completed study, DioGenix analyzed CSF samples that were retrospectively and prospectively collected from patients with MS and other neurological diseases, as well as healthy controls. CSF from two cohorts of approximately 40-45 patients each were compared; the first cohort included patients with a confirmed diagnosis of relapsing remitting MS, and the other cohort consisted of patients with other neurological diseases that mimic the presentation of MS and healthy controls. Subjects with MS had MSPrecise scores that were statistically significantly higher (p-value < 0.05) compared to both healthy controls and patients with other neurological diseases. The MSPrecise interpretive scoring system demonstrated a clear improvement in the ability to classify early-stage MS patients from those with other neurological diseases in comparison to published performance of oligoclonal banding tests.
"MSPrecise quantifies specific molecular changes in CSF-derived B cells and results generated to date indicate that it is more accurate than oligoclonal banding. The DioGenix assay bridges the divide between immunology research and bedside care using cutting-edge technology," said Dr. Michael Racke, Professor and Chairman of Neurology at The Ohio State University. "This represents an exciting advance in our efforts to more accurately diagnosis patients with multiple sclerosis and it is based on clinically relevant biomarkers of immune system response."
DioGenix has begun to validate these results in a prospective, multi-site clinical trial that has started enrolling approximately 150 subjects. This trial is designed to analyze subjects as they typically present to a neurologist and are being evaluated for a diagnosis of MS or other neurological disease. All subjects enrolled in this study will receive the current diagnostic standard of care in addition to analysis using MSPrecise


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Wednesday, November 7, 2012

Ginko Biloba Ineffective in Treating MS-Related Cognition Impairment


The herbal supplement ginkgo biloba did not improve cognitive function in people with MS in a recent research study involving 120 people at the LSU Health Sciences Center in New Orleans. This study followed up on a promising earlier small study by Dr. Jesus Lovera, assistant professor of neurology, and his colleagues that had shown improvement in cognitive function with ginkgo biloba in people with MS. Some studies have also shown improvement after treatment with ginkgo biloba in people with Alzheimer's disease.
"Ginkgo biloba supplements are frequently used by people with MS. Ginkgo appeared beneficial in a prior small pilot study we had done," says Dr. Lovera.

The researchers wanted to conduct a larger, more robust study to determine the validity of the preliminary results. One hundred twenty people with MS were randomized to either the group treated with 120 mg of ginkgo biloba twice a day, or to the group taking matching placebo tablets. Participants were treated for 12 weeks and then underwent a battery of cognitive tests. Participants and their families also answered standardized questionnaires about their cognitive function and social integration. The tests found that there were no statistically significant improvements in cognitive function between the two groups.

"Unfortunately we did not see any improvement with ginkgo in this new study," notes Dr. Lovera. "Several drugs such as Namenda and Aricept that work for people with Alzheimer's have been tested without success in people with MS. Unfortunately now ginkgo is added to the list of therapies thought to be effective in Alzheimer's disease that failed to improve cognitive performance in MS."

While the study provides solid evidence, the researchers noted several limitations. 

Participants were treated for only 12 weeks and perhaps that was not long enough to modify the disease. The median duration of MS was 20 years, and it is possible that ginkgo may improve cognitive function earlier in the MS disease process. It is also possible that there could have been a positive effect in participants with more severe impairments than those in this study. Additional functional assessments that measure performance in real-life situations may also have detected an effect that was missed by limiting the outcome measures to cognitive tests and questionnaires.

Cognitive impairment affects 40-60% of people with MS, most commonly affecting their processing speed, memory, and executive skills. The research findings were published online ahead of print in Neurology.


Source: MSF
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Relaxation Exercises May Benefit Multiple Sclerosis Patients


A new study suggests that Progressive Muscle Relaxation Technique (PMRT) may reduce fatigue and improve the quality of sleep in patients with multiple sclerosis (MS).

MS is a long-term, progressive, disorder that affects nerve fibers in the brain and spinal cord. Sleep disorders and fatigue are among the many complications of MS.

PMRT is used to treat muscular tension, a common symptom of stress. In PMRT, a group of muscles is tensed up so they are contracted as tightly as possible. The patient inhales with the muscles contracted and holds for 5-10 seconds. Next, the patient exhales as the muscles are relaxed to their previous state.

The recent study included 32 individuals with MS. Before the study, participants answered questionnaires regarding their fatigue and quality of sleep. All participants then practiced PMRT daily for six weeks.

After the six weeks, the participants showed a significant increase in sleep quality and a significant decrease in fatigue.

Researchers concluded that PMRT was an appropriate therapy for improved sleep and fatigue reduction for MS patients. Further research is warranted.



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Alleged conman promised cure for multiple sclerosis sufferer


An alleged conman told a multiple sclerosis sufferer that he would be cured if he handed over thousands of dollars in "goodwill'' money to travel to a clinic in Cyprus, a court has been told.
Australian man Philip Oates made his way into the witness box with the help of crutches and told Auckland District Court today how Loizos Michaels spoke of the possibility of a cure.
"He kept telling me that he had a friend in Cyprus, a doctor who was leading research in MS.''
Michaels has denied 31 Serious Fraud Office charges of deception connected to an alleged $3 million fraud.
Mr Oates told the court he had already paid Michaels a total of $131,000 for shares in a film studio on Australia's east Coast he headed in 2004.
He said Michaels asked him to hand over $11,000 to show "goodwill'' to the doctors in Cyprus who would cure him. But Mr Oates was already heavily in debt and was told by his bank that he could only have $8000.
"He was going to fly me to Cyprus, they were going to put me through a clinic ... they were going to cure me.''
At one point, Michaels told Mr Oates to go home and pack his bags because they were leaving for Cyprus in the next couple of days.
"We sat at home for a week and didn't hear anything.''
The trip never happened and despite repeated promises that the doctors were coming to Australia, Mr Oates was left with his debilitating central nervous system disorder and a massive debt.
Mr Oates said he was diagnosed with multiple sclerosis in 2001 and had to sell his business a short time later.
He had invested about $16,000 in a small stunt training facility with friends who later met Michaels.



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The New England Journal of Medicine Publishes Pivotal Data Demonstrating Efficacy and Safety of Oral


The New England Journal of Medicine Publishes Pivotal Data Demonstrating Efficacy and Safety of Oral BG-12 (Dimethyl Fumarate) in Multiple Sclerosis
Results of Phase 3 DEFINE and CONFIRM Studies Support Dimethyl Fumarate's Potential as a Strong Option for MS Treatment
WESTON, Mass.--(BUSINESS WIRE)-- Today Biogen Idec  announced that detailed results from its two pivotal clinical trials evaluating oral BG-12 (dimethyl fumarate) for the treatment of multiple sclerosis (MS) were published in the Sept. 20, 2012 issue of The New England Journal of Medicine (NEJM).

Data from the Phase 3 DEFINE and CONFIRM studies show that dimethyl fumarate (240 mg), administered twice daily (BID) or three times daily (TID), demonstrated significant and clinically meaningful reductions in MS relapses and brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS) compared to placebo, as well as showed benefit in slowing the progression of the disease. Dimethyl fumarate is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.
"The publication of both dimethyl fumarate pivotal studies in NEJM is another achievement for this important investigational therapy," said Katherine Dawson, M.D., senior medical director, Biogen Idec Neurology Research and Development and Biogen Idec lead author on both dimethyl fumarate manuscripts in NEJM. "The data from its clinical development program consistently indicate that dimethyl fumarate may provide tangible benefits and address existing treatment needs of people living with MS. We are working closely with regulatory authorities across the globe with the aim of making the review of dimethyl fumarate as quick as possible."
DEFINE and CONFIRM Efficacy Results
Together, the DEFINE and CONFIRM manuscripts in NEJM summarize the positive Phase 3 clinical data set for dimethyl fumarate, which formed the foundation for its regulatory filings around the world.
DEFINE was a two-year global study that evaluated dimethyl fumarate (240 mg, BID or TID) compared to placebo in people with RRMS. Results showed that both dimethyl fumarate BID and TID met the study's primary endpoint by significantly reducing the proportion of patients who relapsed by 49 percent and 50 percent (p<0.0001 for both; reported in NEJM as <0.001 due to journal requirement that p-values smaller than 0.001 be reported as p<0.001), respectively, at two years compared to placebo. Both dosing regimens also met all secondary endpoints in the study.

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Monday, November 5, 2012

MRI Research Sheds New Light On Nerve Fibres in the Brain

ScienceDaily (Nov. 2, 2012) — Experts in magnetic resonance imaging from The University of Nottingham's Sir Peter Mansfield Magnetic Resonance Centre have made a key discovery which could give the medical world a new tool for the improved diagnosis and monitoring of brain diseases like multiple sclerosis.


The new study, published in theProceedings of the National Academy of Sciences, reveals why images of the brain produced using the latest MRI techniques are so sensitive to the direction in which nerve fibres run.
The white matter of the brain is made up of billions of microscopic nerve fibres that pass information in the form of tiny electrical signals. To increase the speed at which these signals travel, each nerve fibre is encased by a sheath formed from a fatty substance, called myelin. Previous studies have shown that the appearance of white matter in magnetic resonance images depends on the angle between the nerve fibres and the direction of the very strong magnetic field used in an MRI scanner.
Based on knowledge of the molecular structure of myelin, the Nottingham physicists devised a new model in which the nerve fibres are represented as long thin hollow tubes with special (anisotropic) magnetic properties. This model explains the dependence of image contrast on fibre orientation in white matter and potentially allows information about the nerve fibres (such as their size and direction) to be inferred from magnetic resonance images.
Research Fellow Dr Samuel Wharton said: "While most MRI-based research focuses on tissue measurements at the millimetre length scale, our experimental scans on healthy human volunteers and modelling of the myelin sheath shows that much more detailed microscopic information relating to the size and direction of nerve fibres can be generated using fairly simple imaging techniques. The results will give clinicians more context in which to recognise and identify lesions or abnormalities in the brain and will also help them to tailor different types of scan to a particular patient."


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Blocking hyaluronidase activity can help repair brain damage associated with MS


Researchers at Oregon Health & Science University have discovered that blocking a certain enzyme in the brain can help repair the brain damage associated with multiple sclerosis and a range of other neurological disorders.

The discovery could have major implications for multiple sclerosis, complications from premature birth and other disorders and diseases caused by demyelination - a process where the insulation-like sheath surrounding nerve cells in the brain becomes damaged or destroyed. Demyelination disrupts the ability of nerve cells to communicate with each other, and produces a range of motor, sensory and cognitive problems in MS and other disorders.

The study was published this week in the online edition of the Annals of Neurology. The study was conducted by a team of researchers led by Larry Sherman, Ph.D., who is a professor of cell and development biology at OHSU and a senior scientist in the Division of Neuroscience at the Oregon National Primate Research Center.

"What this means is that we have identified a whole new target for drugs that might promote repair of the damaged brain in any disorder in which demyelination occurs," Sherman said. "Any kind of therapy that can promote remyelination could be an absolute life-changer for the millions of people suffering from MS and other related disorders."

Sherman's lab has been studying MS and other conditions where myelin is damaged for more than 14 years. In 2005, he and his research team discovered that a sugar molecule, called hyaluronic acid, accumulates in areas of damage in the brains of humans and animals with demyelinating brain and spinal cord lesions. Their findings at the time, published in Nature Medicine, suggested that hyaluronic acid itself prevented remyelination by preventing cells that form myelin from differentiating in areas of braindamage.

The new study shows that the hyaluronic acid itself does not prevent the differentiation of myelin-forming cells. Rather, breakdown products generated by a specific enzyme that chews up hyaluronic acid - called a hyaluronidase - contribute to the remyelination failure.




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New Multiple Sclerosis Drug Proves Effective Where Others Have Failed

ScienceDaily (Oct. 31, 2012) — Alemtuzumab, a drug previously used to treat a type of leukemia, shown to help people with early multiple sclerosis who relapsed on previous drugs as well as patients who had not yet been treated.


A drug which 'reboots' a person's immune system has been shown to be an effective treatment for multiple sclerosis (MS) patients who have already failed to respond to the first drug with which they were treated (a 'first-line' therapy), as well as affected individuals who were previously untreated. The results of these two phase III clinical trials were published November 1 in the journal TheLancet.
The new studies, sponsored by Genzyme (a Sanofi company) and Bayer Schering Pharma, showed that alemtuzumab significantly reduces the number of attacks (or relapses) experienced by people with MS compared to interferon beta-1a (known commercially as Rebif). This was seen both in patients who had not previously received any treatment (drug-naïve) and those who have continued to show disease activity whilst taking an existing treatment for MS.


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Repair Of Multiple Sclerosis Brain Damage May Be Possible

In what they describe to the press as a "life-changer" for millions of people with the disease, researchers in the US report this week a study where they discovered blocking an enzyme in the brain may help repair the damage associated with multiple sclerosis (MS), and other brain diseases.

The findings are due to be published online this week in the Annals of Neurology.

Myelin Damage

In MS, the protective sheath or myelin around nerve fibers is damaged or destroyed, disrupting the ability of nerve cells to communicate with each other. This process, called demyelination, is what causes the range of sensory, movement and cognitive problems typical of the disease.

Lead researcher of the new study, Larry Sherman, a professor at Oregon Health & Science University, heads a lab that had been studying MS and other disorders where myelin gets damaged for nearly 15 years. 


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Robo-Gloves aid Stroke Victims and MS Patients

Every year nearly 800,000 Americans suffer a stroke. Eighty-five percent of the survivors end up having some degree of hand disability as a result. 

After leaving the hospital, the majority of a stroke patient’s rehabilitation consists of repetitive at-home exercises, says Nizan Friedman, a biomedical engineering student at the University of California, Irvine. "The therapist basically will give the person a booklet of exercises and say ‘Move your fingers like this 100 times, stretch your hand out 100 times.’ And in reality that’s not motivating. Most people don’t complete the therapy and they don’t recover." 

Friedman is part of a research group that's trying to make therapy a little more fun. The scientists invented a game, based on Guitar Hero, meant to make rehabilitation therapy more interesting for people recovering from stroke or who have hand impairments due to cerebral palsy, spinal cord injury, or multiple sclerosis. "Guitar Hero is the third largest video game created in the history of video games," Friedman says. "This is something that people get addicted to, and we want people to get addicted to our therapy." 

To play, the patients match their hand movements to notes falling on the screen. And as in ordinary Guitar Hero, the notes are timed rhythmically with music. But rather than mashing buttons on a fake plastic guitar, the patient touches the thumb to one of their four fingers—each finger corresponds to a different color, or "note". 

The MusicGlove uses conductive fingertip sensors to detect whether the player has achieved the correct finger position. By playing six or seven songs, the patients complete between two and three thousand repetitions of their therapeutic exercises, with real-time feedback about whether they’ve performed the right gestures at the right times. They get a score at the end of each song and can work to beat their previous scores. 

Read more: Robo-Gloves to Aid Stroke Victims - Popular Mechanics 


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Sunday, November 4, 2012

AN Invitation to attend our 2012 MS Symposium in Miami

Register to attend our annual MS Symposium in Miami
(7) Speakers plus (3) Q&A Sessions

EMAIL YOUR RSVP by Wednesday, November 7th, to: info@msviewsandnews.org

Hotel Space is available

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ESPN' reporter, John Clayton's wife loses elections job due to using a wheelchair


ESPN reporter John Clayton is on the other side of the news after his wife claims she lost her job at King County Elections in Washington because she uses a wheelchair.
According to media reports, Patricia Clayton—who has multiple sclerosis—was a temporary worker at the election headquarters in Renton, Wash. She claims she was fired Monday.


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