The American Academy of Neurology (AAN), established in 1948, is a professional society that represents more than 21,000 neurologists and neuroscientists. The 67th annual AAN Conference was held in Washington, D.C. in April. Neurologists and other providers from the Rocky Mountain MS Center Clinic at Anschutz Medical Campus attended the conference and presented posters on various research topics. This issue of eMS news highlights some of the MS research findings from the conference.
B Vitamin Appears Potentially Effective in Patients with Progressive MS
A Phase III study on a regimen of high doses of biotin was presented by MedDay Pharmaceuticals. Biotin is a water-soluble B vitamin that is a coenzyme for carboxylases–enzymes critical in energy metabolism and production of fatty acids. It is hypothesized that biotin may help slow, stop, or even reverse the progression of disability associated with demyelination.
The study found that the high dose biotin appeared to be effective in patients with progressive MS. Researchers found that patients taking the drug had significant improvement at 9 months and 12 months compared with those taking placebo.
The patients who received the biotin treatment (MD 1003) either had an improvement on the Expanded Disability Status Scale (EDSS) or decreased time in the timed 25-foot walk. Professor Ayman Tourbah, of CHU de Reims, Neurology, France explained, “Overall these results show patients in the MS1003 group not only did not progress but even slightly improved within 12 month.”
Although the initial results are positive, researchers strongly cautioned MS patients against going to the store to buy biotin. It is potentially teratogenic – meaning it can cause birth defects and should not be used by pregnant women or those who are planning to become pregnant, and the over-the-counter biotin may be lower grade or not even biotin.
MedDay will move forward with another phase of the phase 3 biotin study and, after the release of those results later this year, will meet with the FDA to discuss a potential plan for drug approval.
Lower Levels of Key Nutrients May Have Link to MS
A study conducted at Johns Hopkins School of Medicine in Baltimore, Maryland found that women with MS have lower levels of folate, magnesium, Vitamin E and other nutrients. These nutrients may have important anti-inflammatory or antioxidant properties.
This was a small study that involved 27 patients with MS and 30 healthy controls. Participants completed a food frequency questionnaire which asked about diet over the previous year. They took vitamin D3, 5000 I/U per day for 90 days. It was found that MS patients had lower levels of key nutrients compared to healthy controls.
The lead researcher, Sandra D. Cassard, ScD, explains, “It’s unclear if deficiencies in these nutrients cause MS or are a consequence of it. These results may also just be coincidental.” More research is needed to clarify the relationship between such nutrients and MS.
Phenytoin Neuroprotective in MS
Researchers at the National Hospital for Neurology and Neurosurgery in London presented a study using the anti-epileptic drug phenytoin (Dilantin). This study involved 86 patients with acute optical neuritis who were randomly assigned to receive either phenytoin or placebo for 3 months. Results showed that the drug appeared to prevent about one third of the damage (neurodegeneration) caused by an optic neuritis attack. Optic neuritis is inflammation of the optic nerve and is a common MS symptom.
Dr. Timothy Vollmer, co-director of the Rocky Mountain MS Center Clinic at Anschutz Medical Campus, was not involved in the research agreed this study is quite important and explained its significance in a recent MedScape article:
“This study provides the first evidence that neuroprotection with phenytoin may be possible in MS patients. It lays the foundation for combination studies, where phenytoin can be added to currently available disease modifying therapies to see if we can further improve the effect of anti-inflammatory therapies on preservation of brain volume and, consequently, long-term outcomes for our MS patients.”
Dr. Vollmer also added that the study further supports the idea that neuroprotective agents will be most effective if used during the most inflammatory phase of MS which is generally at first onset of MS.
Phase 2 Study of anti-LINGO-1
Results from the Phase II trial of anti-LINGO-1 were presented by researchers from Biogen. Anti-LINGO-1 blocks the LINGO-1 protein, which inhibits the production of myelin, and by so doing, spurs myelin growth. Study subjects showed improvement in recovery time of optic nerve conduction latency –meaning it shortened the time it takes for a signal to travel from the retina to the brain’s visual cortex – and indicates possible remyelination of the optic nerve.
53 percent of anti-LINGO-participants had normal or nearly normal full-field visual evoked potential (FF-VEP), compared with 26 percent of placebo participants. The study did not show any effect on the change in thickness of the retinal layers or the visual function of patients.
While the study is potentially encouraging, more studies are necessary to further research the molecule and how the potential remyelination could impact patients clinically.
Gilenya Phase III study failed to show impact on Progressive MS
Novartis presented findings from a Phase III trial of fingolimod (Gilenya). Gilenya is an approved disease modifying therapy for treating relapsing remitting multiple sclerosis. This study showed little difference between Gilenya and a placebo in the treatment of primary progressive multiple sclerosis.
Novartis said although the failure of the study is very disappointing to primary progressive MS patients, the company remains committed to pursuing treatments for patients which MS and other neurological conditions.