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February 2009 Off the Wire . . .

 Date

Title

02-02-09
Encouraging Stem Cell Research Published
Researchers in America have reported encouraging results from a trial treating people with MS with stem cells derived from their bone marrow.

The study, reported in the Lancet Neurology, involved 21 people with relapsing/remitting MS who had had two relapses in the previous year despite treatment with beta interferon. The injections of stem cells followed courses of treatment with immune suppressing drugs.
[read article]
02-02-09
Turning Down Gene Expression Promotes Nerve Cell Maintenance
Anyone with a sweet tooth knows that too much of a good thing can lead to negative consequences. The same can be said about the signals that help maintain nerve cells, as demonstrated in a new study of myelin, a protein key to efficient neuronal transmission.
[read article]
02-03-09
Improvement Of Walking Ability In People With Multiple Sclerosis: Acorda Therapeutics Submits New Drug Application For Fampridine-SR
Acorda Therapeutics, Inc. (Nasdaq: ACOR) has announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) on January 30, 2009 for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). The Company expects that the NDA filing, if accepted, will be subject to standard review, which would provide a target for the FDA to complete its review within ten months from receipt of the submission. 
[read article]
02-04-09 Promise: 2010 Nervous System Repair Teams Meet, Plan Next Steps Toward Restoring Nerve Function in People with MS
Acorda Therapeutics, Inc. (Nasdaq: ACOR) has announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) on January 30, 2009 for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). The Company expects that the NDA filing, if accepted, will be subject to standard review, which would provide a target for the FDA to complete its review within ten months from receipt of the submission. 
[read article]
02-04-09
Acorda Therapeutics Submits New Drug Application For Fampridine-SR For Improvement Of Walking Ability In People With Multiple Sclerosis
Over 70 members of the four international teams funded through the National MS Society’s Promise: 2010 Campaign met in New York City in January to share progress, forge new collaborations, and plan future steps to speed efforts toward clinical trials of therapies to protect and reverse neurological damage in people with multiple sclerosis.
[read article]
02-04-09
15-Year-Old Theory About The Nervous System Disproved By Researchers
A delay in traffic may cause a headache, but a delay in the nervous system can cause much more. University of Missouri researchers have uncovered clues identifying which proteins are involved in the development of the nervous system and found that the proteins previously thought to play a significant role, in fact, do not. Understanding how the nervous system develops will give researchers a better understanding of neurological diseases, such as multiple sclerosis and Charcot-Marie-Tooth disorders.
[read article]
02-05-09
An Oral Disease Modifying Drug For Relapsing Remitting Multiple Sclerosis Would Earn High Patient Shares In Both Europe And The United States
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that an oral disease-modifying therapy for relapsing-remitting multiple sclerosis would earn a 50 percent patient share in Europe and a 40 percent patient share in the United States, according to surveyed U.S. and European neurologists. [read article]
02-05-09
A Constitution For Social Care Needed, Says Demos, UK
Equality think tank Demos has today warned that millions of people in the UK who rely on social care risk becoming "second class citizens" unless their rights are protected by an NHS-style Constitution. [read article]
02-05-09 Vitamin D And Gene Variant Affect MS Risk
Researchers in the UK and Canada have discovered that vitamin D and a particular gene variant interact to increase the risk of developing multiple sclerosis (MS), and suggested that vitamin D deficiency during fetal growth and early childhood may increase the risk of developing MS in later life.
[read article]
02-06-09
COPAXONE(R) Is Approved For Treatment Of Patients With A First Clinical Event Suggestive Of Multiple Sclerosis
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved an expanded label for COPAXONE® (glatiramer acetate injection) to include the treatment of patients with clinical isolated syndrome (CIS) suggestive of multiple sclerosis (MS). This approval includes 24 EU member countries that take part in the MHRA "mutual recognition procedure". A similar application for the expanded COPAXONE® label is currently under review by the U.S. Food and Drug Administration (FDA).
[read article]
02-06-09
Genetic Study Shows Direct Link Between Vitamin D And MS Susceptibility 'Gene'
Scientists have found evidence that a direct interaction between vitamin D and a common genetic variant alters the risk of developing multiple sclerosis (MS).

The research, published on 6 February in the journal PLoS Genetics and funded by the MS Society, suggests that vitamin D deficiency during pregnancy and the early years may increase the risk of the offspring developing MS later in life.
[read article]
02-06-09 Study Sheds New Light On Role Of Vitamin D In MS
A team of researchers have demonstrated a direct link between a particular genetic variant and vitamin D which can determine an individual's risk of developing MS.

The new evidence emerged from a study published in the journal PLoS Genetics which found that the most important gene implicated in susceptibility to MS, the variant gene DRB1 can be switched on by vitamin D in laboratory experiments.
[read article]
02-06-09 Update: Cell Therapy for MS and Stem Cell Clinics
The National MS Society has determined that research involving all types of stem cells holds great promise, potential, and hope for people affected by MS, and that this will improve our understanding of the MS disease process and lead to new pathways for therapeutic intervention.

There are many types of stem cells, and varying degrees of research and knowledge about different types of stem cells and their potential usefulness for treating MS. At present, there has been no proven therapy for MS that uses stem cells.
[read article]

02-09-09 MS Patients Treated With TYSABRI(R) Remain Free Of Disease Activity For Two Years, According To Data Published In The Lancet Neurology
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced five-times as many multiple sclerosis (MS) patients taking TYSABRI® (natalizumab) were free from disease activity versus placebo in the overall patient population. Results from this retrospective analysis showed that two years after beginning treatment with TYSABRI, 37 percent of patients remained free of disease activity, compared to seven percent of placebo-treated patients. Sixty-four percent of patients showed no sign of relapse or sustained disability progression and 58 percent were free of radiological disease activity. Both of these measures were used to define freedom from disease activity in this analysis of the AFFIRM clinical trial. These data were published online today and in the March 2009 issue of The Lancet Neurology. 
[read article]
02-11-09 Award-winning Documentary Screens Next Week, MS Society UK
On 17 February the award-winning documentary Here's Johnny, which highlights the battle against multiple sclerosis (MS) of artist Johnny Hicklenton, will be screened on More4.

The film enters the surreal world of the acclaimed graphic novel artist and follows his journey living with MS - escaping the confines of his condition through his artwork. 
[read article]
02-16-09 Oral Laquinimod For Multiple Sclerosis Granted Fast Track Status By FDA
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced that oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS), has received a Fast Track designation from the U.S. Food and Drug Administration (FDA). Teva completed enrollment for the first of its two Phase III clinical trials for laquinimod (ALLEGRO) in November 2008 and is currently enrolling RRMS patients globally for the second Phase III study (BRAVO). 
[read article]
02-17-09 FDA Agrees To Fast Review For Oral Drug Being Tested For MS
It was announced by the drug makers Teva Pharmaceutical Industries (Petach Tikvah, Israel) and Active Biotech (Lund, Sweden) that oral laquinimod has been designated by the U.S. Food and Drug Administration as a "Fast Track Product." This designation should expedite its future review by the FDA after the sponsor submits results of current trials now underway. 
[read article]
02-18-09 ArGentis Receives Orphan Drug Designation For European Union
arGentis Pharmaceuticals, LLC announced today that the European Medicines Agency (EMEA) accepted the company's product candidate ARG201 (native type 1 bovine collagen) for the treatment of diffuse systemic sclerosis, also known as systemic scleroderma (SSc) for designation as an orphan medicinal product in the European Union. 
[read article]
02-19-09 Research Brings New Hope To Multiple Sclerosis Patients
Researchers at Aurora St. Luke's Medical Center have developed a technique that counteracts an unusual, but serious, side effect from natalizumab (Tysabri(R)), a drug that fights multiple sclerosis (MS).

The side effect is a brain virus called progressive multifocal leukoencephalopathy (PML). 
[read article]
02-19-09 Cyclists Pedal To Create A World Free Of MS In 25th Anniversary BP MS 150 Bike Ride
On the weekend of April 18 - 19, 13,000 cyclists will make their mark against multiple sclerosis (MS) in the 25th Anniversary BP MS 150 Bike Ride from Houston to Austin. A record-setting $17 million fundraising goal has set the handlebar high for the two-day, 180-mile ride. Funds raised through the National Multiple Sclerosis Society, Lone Star Chapter will support MS research and programs for an estimated 20,000 Texans affected by MS in 174 counties. 
[read article]
02-20-09 Can Breastfeeding Reduce Multiple Sclerosis Relapses?
Women who have multiple sclerosis may reduce their risk of relapses after pregnancy if they breastfeed their babies, according to a study released today that will be presented at the American Academy of Neurology's 61st Annual Meeting in Seattle, April 25 to May 2, 2009.
[read article]
02-21-09 Young Smokers Increase Risk For Multiple Sclerosis
People who start smoking before age 17 may increase their risk for developing multiple sclerosis (MS), according to a study released that will be presented at the American Academy of Neurology's 61st Annual Meeting in Seattle, April 25 to May 2, 2009.
[read article]
02-22-09 Biopartners To Appeal The CHMP's Negative Opinion On Its Novel Interferon Beta-1a
Biopartners GmbH has announced that it will request a re-assessment from the EMEA in support of its novel interferon beta-1a, Biferonex®, after receiving a negative opinion from the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP).
[read article]
02-24-09
Motor Neurons Derived From Embryonic Stem Cells Mimic The Progress Of Familial ALS
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a devastating condition in which motor neuron degeneration causes progressive loss of movement and muscle tone, leading to death.
[read article]
02-25-09
Positive Results In Randomized Withdrawal Sativex(R) Study Confirm Long Term Efficacy In MS Spasticity
GW Pharmaceuticals plc (GWP:AIM) announces positive results from a placebo-controlled randomized withdrawal study of Sativex® in patients with spasticity due to Multiple Sclerosis (MS). This study was performed following regulatory guidance from the UK regulatory authority (MHRA) and provides evidence of long term efficacy to be included as part of the forthcoming European regulatory submission planned for Q2 09.
[read article]
02-25-09
Sativex Satisfies Regulatory Hurdle, UK
The makers of cannabis-based treatment Sativex have today reported the results of a trial held to establish how effective the therapy is in people with multiple sclerosis (MS). GW Pharmaceuticals were asked by the Medicines and Healthcare Regulatory Authority (MHRA) to hold the withdrawal study, which evaluated 36 people with spasticity and who had previously been taking Sativex on prescription.
[read article]
02-27-09
Walking Ability Of Some Multiple Sclerosis Patients Improved By Fampridine
In an article published in this week´s edition of The Lancet, the findings of a Phase III study, indicate that the drug called fampridine improves walking ability in some multiple sclerosis (MS) patients and seems well accepted by patients with all disease course types of MS.
[read article]
02-28-09
Rapid Research Progress Signified By Discovery Of A Second MND Gene Mutation In One Year
A collaborative research project involving Professor Christopher Shaw of the Institute of Psychiatry, King's College London (KCL), Dr Tom Kwiatkowski at Massachusetts General Hospital (MGH) and Professor Robert H Brown at University of Massachusetts, has revealed that mutations in a gene called FUS (fused in sarcoma) cause familial Motor Neuron Disease (also known as Amyotrophic Lateral Sclerosis).
[read article]











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