"The prospect of an extremely effective therapy for multiple sclerosis that can be safely administered at six month intervals could represent a major step forward, if the safety profile and benefits are sustained over longer periods of use," he added.
At 24 weeks, serious adverse events were reported in 4 percent of patients in the placebo arm, 4 percent of those taking interferon, and 2 percent and 6 percent of patients taking 600 mg and 2000 mg of Ocrelizumab. One patient taking Ocrelizumab died, but the relationship with the study drug, if any, is as yet unclear.
Hauser said that the next step for the drug will be to see if the drug's effect and positive safety profile will be sustained over time. These questions will be addressed in two parallel Phase 3 trials, now enrolling a larger number of patients who will receive the drug regimens for a longer period of time. This trial is now underway at several hundred sites around the world. Hauser serves as lead investigator for these trials, which are sponsored by Roche, the company that owns Ocrelizumab.
What the Trial Suggests About Multiple Sclerosis
Besides the obvious question of whether the drug would work, also under scrutiny in the clinical trial was whether a drug like Ocrelizumab would work in the first place. Its mechanism of action is fundamentally different than other existing therapies for multiple sclerosis. All multiple sclerosis drugs work by targeting a person's immune system only they target fundamentally different parts.
In multiple sclerosis, a person's im
|Contact: Jason Socrates Bardi|
University of California - San Francisco