A new study spotlights the use of an experimental drug, Ocrelizumab, as a potential treatment for multiple sclerosis (MS). The clinical trial, in Phase 2, included 220 MS patients. Researchers at the University of California, San Francisco (UCSF) Medical Center, Calif, worked in collaboration with hospitals in the United States, Canada, and Europe.
Participants involved in the clinical trial had relapsing-remitting MS. The patients were randomly placed into four groups, two groups received injections of the monoclonal antibody Ocrelizumab at two different doses. The third group received the standard MS drug interferon-beta and a placebo was given to the fourth “control” group.
The study reports that doctors gauged the effectiveness of the treatments by performing month magnetic resonance imaging (MRI) brain scans of the patients and counting the number of inflamed lesions. The severity and frequency of neurological “attacks” resulting in loss of vision, in coordination, weakness, and numbness, were also compared.
The trial’s results indicated that patients treated with Ocrelizumab fared better and exhibited fewer signs of the disease than those who received the standard treatment or the placebo. The study says that Ocrelizumab led to an 89% reduction in the formation of brain lesions and reduced the number of new MS attacks over 24 weeks. Results also suggest that during the short-tem study, the drug interferon performed no better than the placebo.
Stephen Hauser, MD, the Robert A. Fishman Distinguished professor and chair of the department of neurology at UCSF, led the study and says of the trial results, “The prospect of an extremely effective therapy for MS that can be safely administered at 6-month intervals could represent a major step forward, if the safety profile and benefits are sustained over longer periods of use.”
Serious adverse effects were reported at 24 weeks in 4% of the placebo patients and interferon patients, and 6% of the patients taking 600 mg and 2000 mg of Ocrelizumab.
Hauser reiterates that the next step in the Phase 3 of the trial will be to determine if the drug’s effect and positive safety profile can be sustained over time.
Hauser adds that B cells in the immune system appear to induce T cells, the cells deemed in the past as the “smoking gun” of the disease. Hauser explains that while the mechanism is unclear, the Phase 2 trial exhibited a reaction in which if B cells are blocked, there may be the possibility of stopping the T cells as well. Hauser says the trial has validated this concept and “Transformed our understanding of what we needed to do to develop more selective and effective therapy for MS.”
The study was recently published in the journal Lancet.
Source: UC San Francisco