MS Research Roundup: January 22, 2015
More Stem Cell Transplant Results; Less MS in Women With Ulcer-Causing Bacteria; Supreme Court Extends Wait for Generic Glatiramir Acetate; Research Drives Biotech Boom
MS Research Roundup collects items of interest to multiple sclerosis researchers from around the Web. Send us your tips: tips@msdiscovery.org.
More Evidence for Stem Cell Transplants
Last week, we published a story on the interim results of a phase 2 trial testing the efficacy of hematopoietic stem cell transplants in 24 patients with aggressive relapsing-remitting MS (RRMS). In that story, we explored the difficulty in balancing the risks and benefits of the conditioning regimen, which usually aims to obliterate the patient’s immune system before transplantation. Conventional conditioning regimens are essentially identical to chemotherapy used in cancer patients and leave patients vulnerable to infection. But one researcher, Richard Burt, M.D., of Northwestern University, told MSDF there are safer alternatives for conditioning regimens than the typical high-dose chemotherapy. Burt’s method doesn’t destroy the patient’s immune system but rather “turns it down,” which he believes keeps the patient better protected from infection. This week, Burt published his findings in the Journal of the American Medical Association (JAMA). In the uncontrolled phase 1 study, some of the 151 treated patients experienced a decrease in disability. At 4 years, 80% of patients with RRMS were relapse-free, and 87% of patients with secondary progressive MS showed no worsening, as measured by MRI, relapses, and disability. A commentary penned by Stephen Hauser, M.D., of the University of California, San Francisco, tempers many of the study’s merits against its limitations. Most of the limitations were related to the lack of blinding and follow-up with the study participants. Stay tuned: We’re working on more in-depth coverage of this report. (JAMA, U.S. News & World Report)
Don’t Get an Ulcer … or Do
Stomach ulcers may come with a silver—or, should we say, bacterial—lining. A recent study in the Journal of Neurology, Neurosurgery, and Psychiatry found that women infected with Helicobacter pylori, the microbe responsible for stomach ulcers, may enjoy a protective benefit from MS. Between 2007 and 2011, researchers tested 550 people with all types of MS and 299 healthy controls for evidence of current or previous H. pylori infection. Approximately 14% of the women with MS showed previous infection with H. pylori, but 22% of healthy women harbored the bug sometime in their lives. Women with MS who tested positive for antibodies to the bacterium also had lower rates of disability. Interestingly, infected men with MS had higher rates of disability. H. pylori is a common bacterial infection that is often benign but can lead to stomach ulcers and cancer. It’s usually acquired early in life, is prevalent in developing countries where standards of hygiene are lower, and can last a lifetime if left untreated. In an accompanying commentary, Jun-ichi Kira, M.D., Ph.D. of Kyushu University in Japan argued that this research may cinch the deal on the hygiene hypothesis as a contributing factor to MS. The hypothesis suggests that infections early in life help train the immune system. Without those infections, the immune system may be more likely to attack the body. This may explain why MS and other autoimmune diseases are more common in the developed world, where children are often kept in cleaner environments. (ABC News Australia; Genetic Engineering & Biotechnology News; Journal of Neurology, Neurosurgery, and Psychiatry; MedicalResearch.com; U.S. News & World Report)
Teva Wins Patent Reprieve on Daily Copaxone
It may not be a “winner take all” outcome for Teva Pharmaceutical Industries, but MS patients and payers will likely have to wait a little longer for cheaper glatiramer acetate (Copaxone). A 7-2 ruling from the U.S. Supreme Court effectively forestalls generic competition until the September 1, 2015, expiration of a key patent, while the case returns to the appeals court. The ruling gives Teva more time to shift as many as 80% of its daily Copaxone patients to a newer, longer-acting version, given three times a week, which won’t face generic competition until 2030. In the original claim, Teva brought suit for patent infringement against two companies seeking to market generic versions of Copaxone: the Sandoz unit of Novartis with Momenta Pharmaceuticals and the generic drug makers Mylan and Natco Pharma. The defendants, led by Sandoz, had convinced the appeals judge that the phrase “a molecular weight of 5 to 9 kilodaltons,” with three different meanings, rendered the patent description vague enough to be meaningless. That’s the wrong way to decide, wrote Justice Stephen Breyer, opining that the appeals court should only second-guess facts from the trial judge if the interpretation was “clearly erroneous.” Teva’s rivals are free to pursue approval for their generics, but they may wait to launch their copycat versions. For patent wonks, Houston lawyer Keith Jaasma summed up the decision in a tweet at @SupremeHaiku: Patent construction/District court's findings of fact/Clear error review. (Bloomberg Business Week, CNNMoney, FiercePharma, Forbes, Jurist, New York Times, SCOTUSblog, Wall Street Journal Pharmalot)
Booming Biotech
“The biotech business is experiencing an almost unprecedented boom of its own. Money is flowing into the industry as never before. Stock prices are high, and drug approvals are up.” So wrote Andrew Pollack, summing up a “mix of exuberance and anxiety [that] characterized the J. P. Morgan Healthcare Conference, the industry’s most closely watched investor event,” in San Francisco last week. “Some of the industry’s seemingly sudden successes stem from years of research behind the scenes,” wrote Pollack, citing gene therapy studies as exhibit A. (New York Times)
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