The results of two recent studies may provide multiple sclerosis patients with new options for symptom relief.
1. Newly Approved Ampyra Improves Walking in MS Patients
The Food and Drug Administration recently approved the marketing of Ampyra (dalfampridine), which was formerly known as fampridine SR from Acorda Therapeutics, for the drug’s ability to improve walking in patients with all forms of multiple sclerosis (MS).
In a randomized, multi-center, double blind, controlled phase III trial, researchers found that timed walking speeds improved more “in the fampridine group (78/224 or 35%) than in the placebo group (6/72 or 8%; p<0·0001),” according to study results published in The Lancet. In addition, timed walked responders treated with Ampyra “showed greater improvement in 12-item multiple sclerosis walking scale scores (-6·84, 95% CI -9·65 to -4·02) than timed walk non-responders (0·05, -1·48 to 1·57; p=0·0002).”
“The FDA’s approval of Ampyra is wonderful news for many people with MS who experience problems with walking,” said John R. Richert, MD, Executive Vice President for Research & Clinical Programs at the National MS Society. “This brings a welcome symptomatic therapy that may restore some function and make a real difference in quality of life for a large number of people with different types of MS.”
2. Positive Study Results for Longer-acting Version of Interferon
In a study evaluating the potential increase in half-life, overall drug exposure (AUC), and biological potency of Prolor’s long-acting CTP-modified human interferon beta, researchers have found that the drug has 13 times prolonged half-life and 55 times AUC than commercially available recombinant IFN-beta. The CTP-modified human interferon beta also “demonstrated strong biological potency, as measured by several well-validated biomarkers including anti-viral activity and changes in neopterin, and 2’-5’ oligo A synthesase.”
According to the researchers, the results of this new study are consistent with the results of an earlier study that tested the efficacy of Prolor’s IFN-beta to treat cancer. In that study, the IFN-beta showed “100% inhibition of human melanoma tumors implanted in nude mice after eight days and 87.5% inhibition after 10 days, versus 50% inhibition with commercially available IFN-beta after eight days and just 12.5% inhibition after 10 days.”
“The results of this new primate study, together with the strong biological activity seen in our melanoma tumor growth model, further confirm the clinical potential for IFN-beta-CTP as a long-acting version for the treatment of multiple sclerosis, with the potential to provide important benefits to MS patients,” said Dr. Abraham Havron, CEO of PROLOR Biotech. “Many MS patients currently rely on IFN-beta to keep their disease in check, but to do so they must inject the drug frequently, with the attendant risk of adverse reactions that often accompany these injections. By potentially allowing these patients to dramatically reduce the required injection frequency, we believe our IFN-beta-CTP could significantly enhance their quality of life.”