Genzyme presents 4-year follow-up data from Phase 2 MS trial at neurology meeting

Apr 15 2010

Genzyme Corporation (Nasdaq: GENZ) today reported four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial showing an estimated 71 percent of alemtuzumab treated patients remain free of clinically-active disease as much as three years after most patients received their last course of the investigational compound. The data were presented at the American Academy of Neurology annual meeting.

“In this study, alemtuzumab treated patients who experienced an ITP event and achieved remission have had no recurring episodes of ITP. The remissions were complete and durable”

The CAMMS223 Phase 2 trial, first reported in the New England Journal of Medicine in 2008, compared alemtuzumab to the approved MS therapy Rebif^® (interferon beta-1a) in early, active, relapsing-remitting multiple sclerosis (RRMS) patients who had received no prior therapy. In the trial, alemtuzumab was given to patients in two or three annual cycles of not more than five days per cycle, while Rebif was given to patients three times per week, every week for three years.

Results of the four-year review found:

• an estimated 71 percent of alemtuzumab-treated patients were free of clinically-active disease, compared to 35 percent of patients taking Rebif (p<0.001). To be free of clinically-active disease, MS patients in the trial were both relapse-free and without progression of disability as measured by the Expanded Disability Status Scale (EDSS) throughout the course of the study;
• an estimated 91 percent of alemtuzumab-treated patients were free of sustained accumulation of disability compared to 68 percent of patients taking Rebif; and
• an estimated 77 percent of alemtuzumab-treated patients were relapse-free compared to 49 percent of patients taking Rebif.

"These early data may set a new bar for clinical outcomes in multiple sclerosis," said Omar Khan, MD, Professor of Neurology, Wayne State University School of Medicine, site principal investigator in the CAMMS223 Phase 2 trial.

Post-hoc analyses of the patients free from clinically-active disease were performed using data obtained from patients participating in CAMMS223. The dataset analyzed consists of the originally-planned three years of patient follow-up, additional continuous post-three-year follow-up, and prospective follow-up of patients who initially discontinued but returned to the study to participate in the risk management program. Roughly 15 percent of patients participating in the post-three-year follow-up used non-study MS disease modifying therapies. A sensitivity analysis that censored these patients found that the risk of relapse, sustained accumulation of disability, and free from clinically-active disease status favored alemtuzumab.