MS Research Roundup: February 5, 2014

MS Research Roundup collects items of interest to multiple sclerosis researchers from around the Web. Send us your tips: tips@msdiscovery.org.

May the Force Be With Them

More than half of U.S. clinical trials are not published within 2 years after they end, and many are never published. Even when they are published, the data is not available for further analysis of comparative risks and benefits and disease mechanisms. So Johnson & Johnson and its Janssen Pharmaceutical Companies are basking in headlines about the “stunning” and “unprecedented” decision to open clinical trials data to researchers via the independent oversight of the Yale University Open Data Access Project (YODA). "Everything in the company’s clinical research vaults, including unpublished raw data, will be available for independent review," wrote YODA director Harlan Krumholz, M.D. The drug data is waiting for researchers to request through www.clinicaltrialstudytransparency.com. Data from devices and consumer products are coming soon. A quick search of MSDF’s Drug-Development Pipeline shows only one potential J&J-related MS drug. Ustekinumab did not work in phase 2 tests but may have potential in those with early stage disease, some investigators speculated. And, yes, "data from discontinued programs are included in the scope of the agreement," wrote J&J spokesperson Seema Kumar in an email to MSDF. "We have a long standing commitment to transparency of clinical trial data," she added. "What is new is that through our agreement with YODA, we will now be able to share data from our clinical trials in the form of Clinical Study Reports (CSRs) and participant level data in a systematic and objective way that protects patient privacy and confidentiality." (Xconomy, Forbes, New York Times, Johnson & Johnson, Yale University)

Resetting Innate Immunity in Progressive MS

Bacterial infections linked to the onset and exacerbation of MS, as well as other evidence, has piqued interest in molecules called pattern recognition receptors (PRR) on the surface of innate immune cells. An experimental drug for secondary progressive MS (SPMS) that activates two PRRs (TLR9 and NOD2) seems to help in people, and a new study tells how it may work. The drug, a microparticle called MIS416, appeared to reshape autoimmune T cell responses and lead to a significant reduction in CNS inflammation and disease in a mouse model and phase 2a clinical safety study, reported Anne La Flamme, Ph.D., and her colleagues at Victoria University of Wellington in a paper published January 31 in PLOS ONE. Protection seems to come from interferon-γ and from an expansion in splenic CD4 regulatory T cells and regulatory myeloid cells. The study was funded in part by Innate Immunotherapeutics, based in Auckland, New Zealand. Anecdotal results of compassionate use of the drug led to formal testing. The company plans to begin a randomized placebo-controlled phase 2b trial of 90 people with SPMS in Australia later this year. (Victoria University of Wellington, Innate Immunotherapeutics)

In Limbo Over Drug Cost-Sharing

Many pharmaceutical manufacturers support programs intended to help some patients obtain expensive drugs at reduced prices. But federal rules remain unclear about whether people who buy health insurance on the marketplaces established by the federal health law will be allowed to participate in these programs. And no one knows whether such programs violate the federal antikickback statute, to induce beneficiaries to use their products. For multiple sclerosis, at least 10 disease-modifying therapies cost between $40,000 and $60,000 annually, Nancy Law, executive vice president of programs and services at the National Multiple Sclerosis Society, told Kaiser Health News. If drug companies aren’t permitted to provide direct assistance to people in marketplace plans, presumably the nonprofits could step into the breach as they do with Medicare patients. (Washington Post)

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