MS News that Caught My Eye Last Week: Bafiertam, Stem Cell Transplant Damage, Gilenya Study, NurOwn Benefits

FDA Approves Bafiertam, Tecfidera Bioequivalent, for Relapsing MS

This is the second disease-modifying therapy (DMT) OK’d by the FDA in the past few months. Bafiertam is a delayed-release pill that’s similar to Tecfidera, but it’s said that it has fewer side effects. Unfortunately, its manufacturer hasn’t yet made it available to the U.S. market and hasn’t said when it will. The same is the case for the other newly approved DMT, Zeposia (ozanimod). The U.S. Food and Drug Administration (FDA) has given final approval to Banner Life Sciences’ Bafiertam (monomethyl fumarate), a bioequivalent alternative to Biogen’s Tecfidera (dimethyl fumarate) to treat people with relapsing multiple sclerosis (MS). Relapsing forms of MS are clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive MS (SPMS). Click here to read the rest of the story.

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‘Transcient’ Damage to CNS Seen with Chemotherapy Used in Stem Cell Transplants for MS

People with MS and their neurologists are always weighing the risks against the benefits when deciding which treatment to use. I’ve always felt that stem cell transplants carry the highest risk, due to the need to use high-dose chemotherapy to wipe out the immune system before trying to rebuild it. A number of different chemo protocols can be used. In this case, it’s a protocol followed in Canada that follows a very intense chemo regime. But, the researchers say its benefits outweigh its risks. A high-dose chemotherapy combination given to wipe out the immune system before its rescue with autologous hematopoietic stem cell transplant (aHSCT) can cause “transient” damage to neurons and supporting cells of the central nervous system in people with aggressive multiple sclerosis (MS), a Canadian study reports. Nonetheless, its researchers believe that the risk of such neuronal toxicity is offset by the benefits of the aHSCT procedure in aggressive MS cases. Click here to read the full story.

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Long-term Gilenya Use Helps Delay Disability in Relapsing MS, 10-year Study Reports

This is encouraging news. According to this study, the longer you use Gilenya, the less disability you should have. Though all of the people studied had their disability level increase, those receiving Gilenya for longer periods had it increase only about 0.58 points compared with patients in the low-exposure group, whose level rose about 1.17 points. Please note that this study was funded by Novartis, the manufacturer of Gilenya. People with relapsing multiple sclerosis (MS) being treated with Gilenya (fingolimod) for eight or more years show smaller increases in disability over 10 years than those using this treatment for a shorter time, a long-term follow-up study reports. Longer use of Gilenya also resulted in lesser disability progression, a reduced reliance on walking aids or wheelchairs, and fewer people transitioning to secondary progressive multiple sclerosis (SPMS) over the 10 years of follow-up. Click here to read the full story.

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NurOwn May Curb Damaging Neuroinflammation in MS, Study Finds

The NurOwn treatment involves extracting a patient’s mesenchymal stem cells (MSC), expanding them, and maturing them into cells that produce high levels of compounds that promote nerve-tissue growth and survival. The cells are then injected back into the spinal canal. Researchers think this process can help repair nerve cells and prevent further damage. It may also have an effect on B- and T-cells, both of which are believed to have a role in the MS disease process. A small Phase 2 trial is under way at the Cleveland Clinic. NurOwn, believed to have neuroprotective and repairing effects, may also be able to curb the damaging immune responses that contribute to multiple sclerosis (MS) progression, a recent study found. This newly identified potential may extend the benefits of this cell-based therapy, its researchers believe. Click here to read the full story.

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