An investigational treatment for one type of multiple sclerosis is entering the final stage in a series of clinical trials to test its safety and effectiveness. The medication only has a scientific code for now: MBP8298. The drug is designed for people with secondary progressive MS, which affects just under half of all those with the disease around the world.
Patients Being Recruited Now
Last December, drugmaker BioMS Medical announced that the first round of patients was being recruited for a Phase 2/3 clinical trial of the drug. "Today's announcement signifies a major milestone for both the advancement of our lead drug and for the worldwide MS community," said Kevin Giese at the time. Giese is president of BioMS Medical. "Most current and emerging therapies do not target secondary progressive MS, so for people suffering from this form of the disease, there are really limited treatment options available."
More than 550 patients are expected to be enrolled altogether for the trial, designed as a two-year, randomized, double-blind, placebo-controlled, parallel-group study of secondary-progressive MS patients.
How the Study Will Work
For the trial, patients will be selected at random to receive either MBP8298 or placebo through IV administration. Doses will be given every 6 months throughout the study. The primary objective is to evaluate each patient's MS progression as measured by the Expanded Disability Status Scale, a widely used indicator of MS impairment and disability that includes incremental steps as the illness progresses.1
"This trial has been designed to confirm the efficacy and safety shown by MBP8298 in previous clinical trials, particularly in patients with specific genetic profiles often associated with MS," said Leopold Arfors, MD, medical director of BioMS Medical. "We also anticipate gathering additional data regarding the potential of this treatment in patients with other types of MS."
Patients interested in taking part in the trial, which will be conducted at a half dozen sites around Canada, must be referred by their neurologist or physician, BioMS Medical stated.
The Drug's Function in MS
MBP8298 is a synthetic version of naturally-produced myelin basic protein, a major component of the myelin sheath. Destruction of myelin basic protein is the major pathology of MS, experts contend,2 and one of the most important components that make up myelin. The drug works by lowering the disease-associated production of a group of antibodies that target myelin basic protein.3
In a previous phase II trial, 32 patients with either primary or secondary-progressive MS took part in a randomized, double-blinded, placebo-controlled phase, followed two years later by an open label phase. During the double-blinded phase, patients were given doses of medication or placebo by IV once every 6 months.3
In the Phase 2 trial, which lasted 4 years, five of 16 patients in the group receiving MBP8298 reportedly worsened compared to nine of 16 in the group receiving placebo. Using secondary study outcomes—timed walking distance and foot taps—the investigators found that there was a trend for participants in the treated group to score better than placebo. But neither of these results was considered significant due to the small number of patients.4
However, taking the collective results of these early clinical trials, BioMS Medical reported that 61 percent of the patients experienced disease remission as measured by antibody levels in spinal fluid.
1. Sharrack B, Hughes RA, Soudain S, Dunn G. The psychometric properties of clinical rating scales used in multiple sclerosis. Brain 1999 Jan;122(Pt 1):141-59.
2. Lutton JD, Winston R, Rodman TC. Multiple sclerosis: etiological mechanisms and future directions. Exp boil Med (Maywood). 2004 Jan;229(1):12-20.
3. Multiple Sclerosis Association of America. Pharmaceutical companies latest drug RepoMore Patents and Trials Continue with MBP8298. Available at: http://www.msaa.com/articles/article12.html. Accessed March 18, 2005.
4. Multiple Sclerosis Society of Canada. MS Research. Available at: http://www.mssociety.ca/en/research/medmmo-mbpstudy-update-dec04.htm. Accessed March 18, 2005.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
