Medical Update Memo
May 4, 2001
Researchers Drs. Kenneth Warren and Ingrid Catz, University of Alberta, have developed what may be a potential treatment for people who have progressive forms of multiple sclerosis, according to information issued by the company which will fund the clinical trial of the therapy. The researchers have developed a synthetic segment of myelin basic protein called MBP8298. Myelin basic protein is one of the major proteins that make up myelin, the protective insulating covering of the central nervous system. A large, controlled Phase III study should begin in 2002. The Multiple Sclerosis Society of Canada welcomes the launch of a Phase III study that should provide definitive information about the effectiveness of MBP8298.
Dr. Kenneth Warren, director of the MS Clinic in Edmonton, and Dr. Ingrid Catz, senior scientist at the University of Alberta, have developed a synthetic segment of myelin basic protein called MBP8298. According to information released by EPS Capital Corp. of Edmonton, the substance puts people with progressive MS in remission, as measured by a drop in antibody levels in spinal fluid. Drs. Warren and Catz report their research has found there are increased antibodies to myelin basic protein (MPB) in people with progressive forms of MS. They measure this increase by examining fluid drawn from the base of the spine in a standard procedure called a lumbar puncture or spinal tap. Before the wide-spread use of magnetic resonance imaging (MRI) scanning, examination of the spinal fluid to determine if there were increased levels of antibodies was used to confirm the clinical diagnosis of MS.
The researchers have been involved in the development of MBP8298 for more than 20 years. The investigators have given the product to approximately 100 people over the past 10 years in both Phase I and Phase II clinical studies. They report that of 41 people with progressive MS, 61% went into remission as measured by antibody levels in spinal fluid. Phase II study results are not yet available. The investigators report there are no clinically relevant side effects in those who have been given MBP8298 to date. The product is given by intravenous infusions (into the vein) at intervals of several months.
A large, multi-centre, double-blind placebo-controlled Phase III study is scheduled to begin in 2002 at a number of MS clinics across Canada. More information will be provided when it becomes available.
The Multiple Sclerosis Society welcomes the information about MBP8298 and looks forward to the launch of a Phase III study that should provide more definite information about the potential therapy, commented Dr. William J. McIlroy, national medical advisor.
Stages of clinical studies
Multiple sclerosis is an extremely unpredictable disease with sudden attacks and spontaneous recovery, especially during the early years of the disease. Because of this, it is very difficult to determine whether a person's recovery was because of a treatment they were on or whether it would have happened naturally. To overcome this dilemma, possible treatments for MS and other diseases are tested under carefully controlled conditions. Here are the standard methods:
Controlled trial: A study that compares the outcome of a group of randomly assigned participants who receive the experimental treatment to a group of equally randomly assigned participants who receive a standard treatment or an inactive placebo. Controlled trials are usually double-blind, which means neither the participant nor the examining physician knows if the person is on active treatment or placebo - both are "blinded".
Phase I trial: A short, uncontrolled trial of an experimental therapy which is given to a few people (who may or may not have the disease). The primary outcome is to test for the safety of the therapy.
Phase II trial: A controlled trial in a small number of people who have the disease that tests for safety and starts to gather data on whether the therapy actually works.
Phase III trial: A controlled trial that tests a therapy in a large number of people with the disease, often at many research sites for a number of months. It collects data on safety, the effectiveness of the therapy and side effects. These data are necessary for any submission to Health Canada for evaluation of a therapy for possible approval.
The Multiple Sclerosis Society of Canada is an independent, voluntary health agency and does not approve, endorse or recommend any specific product or therapy but provides information to assist individuals in making their own decisions.