Mom's Story, A Child Learns About MS

Mom's Story, A Child Learns About MS
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Tuesday, December 20, 2011

Fast Forward and Lineagen to Collaborate to Develop Gene and Biomarker-Based Clinical Assays for Multiple Sclerosis

Fast Forward, LLC, a nonprofit subsidiary of the National Multiple Sclerosis Society, and Lineagen, Inc., an innovative molecular diagnostics company focused on complex, genetically linked disorders, today announced an alliance to fund the clinical development and validation of a blood-based assay for multiple sclerosis (MS). The goal of the program is to develop a test that can aid clinicians in diagnosing MS, distinguishing it from other neurological disorders, and providing the prognostic information needed to help guide treatment decisions and response to therapies.

Under the terms of the Sponsored Research Agreement, Fast Forward is committing $622,000 to establish and validate a broad array of biomarkers for MS, including genes associated with predisposition to the disease and blood based markers that have diagnostic and prognostic potential. The funding will support an ongoing clinical program that is being conducted under the teams of John W. Rose, M.D., Professor of Neurology at the University of Utah and Mark Leppert, Ph.D., Professor of Human Genetics at the University of Utah.

"We are pleased to partner with Lineagen in the advancement of its innovative technology for MS.” said Timothy Coetzee, Ph.D., Chief Research Officer of the National MS Society. "Fast Forward's partnership with Lineagen reflects our commitment to create new tools and technology to assist physicians in making diagnostic and treatment decisions that will improve the quality of life for people living with this disease."

Michael S. Paul, Ph.D., Lineagen’s President and Chief Executive Officer, stated, “It is a great opportunity for Lineagen to collaborate with Fast Forward and the National MS Society. This collaboration will enhance the development and validation of our proprietary gene and biomarker-based assay in MS. The funding from Fast Forward will accelerate this clinical program, allowing the collaborative team to evaluate and affirm a broad number of biomarkers simultaneously, with the collective goal of delivering our best testing services to physicians and patients.”

Dr. Rose commented, “One of the most critical challenges is to find answers to key questions such as How do we identify those patients who are more likely to experience disease progression and How do we determine patients’ potential responsiveness to therapy? With this important funding provided by Fast Forward, we will rapidly gain key insights that we believe can have a profound impact on the lives of people living with MS.”

Sunday, December 11, 2011

Researchers confirm link between MS and a gene linked to vitamin D

Investigators in the United Kingdom and Canada report an association between a rare variation of a gene that controls vitamin D levels and the development of MS in rare families with multiple members who have the disease. This gene variation causes dysfunction that leads to vitamin D deficiency, and the same variant was previously reported in two Norwegian families. Drs. George Ebers, Sreeram Ramagopalan (University of Oxford) and colleagues report their findings in the Annals of Neurology, Accepted manuscript online, November 25). Read a summary of the study on the web site of the MS Society of the United Kingdom, which funded the study along with the Wellcome Trust.

This gene was previously suspected to play a role in MS susceptibility based on a large-scale Australian genome study, along with many other gene variations that contribute to MS susceptibility. (Read about the largest genome-wide study yet, reported earlier this year.) Research is increasingly pointing to reduced levels of vitamin D in the blood as one factor that can increase the risk of developing MS. The National MS Society (USA) is funding several projects in this area, including a new clinical trial getting underway to test whether vitamin D can reduce disease activity in people who have MS. Read more about what we know about causes of MS.

Next week, the Society is convening an international summit in Chicago discussing whether it is possible to prevent MS using vitamin D. Register for a webcast to be held December 13, 2011 in conjunction with this meeting, featuring internationally prominent MS investigators discussing key MS research to follow in 2012.

Thursday, December 1, 2011

Positive Results Announced from Second Phase III Study of Alemtuzumab in MS

Genzyme has announced that the experimental intravenous therapy alemtuzumab (with a proposed brand name Lemtrada™) met two primary endpoints by significantly reducing relapse rates and the worsening of disability in a two-year study comparing alemtuzumab to standard subcutaneous dosing of Rebif® (interferon beta-1a, EMD Serono Inc. and Pfizer). The study, called CARE-MS II, involved 840 people with relapsing-remitting MS. The results were announced in a November 14, 2011 press release, which also indicated that the company plans to apply in early 2012 to the U.S. Food and Drug Administration for marketing approval. Data analysis is ongoing and the company expects to provide a full report at an upcoming medical meeting. Alemtuzumab has been designated by the FDA as a “Fast Track Product,” which should expedite its future review.