Genzyme reports positive data from 5-year alemtuzumab Phase 2 study in MS

Genzyme Corp., a subsidiary of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), today reported additional five-year patient data from its completed Phase 2 multiple sclerosis (MS) trial showing that nearly two-thirds of alemtuzumab treated patients remained free of clinically-active disease as much as four years after most patients received their last course of the investigational drug. The data were presented at the American Academy of Neurology's 63rd Annual Meeting.

“Low-contrast letter acuity exams are a sensitive way of measuring visual function in MS clinical trials, and can correlate well with structural markers of the disease”

The CAMMS223 Phase 2 trial, first reported in the New England Journal of Medicine in 2008, compared alemtuzumab to the approved MS therapy Rebif® (high dose 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. The study included an extended phase for collection of long-term efficacy and safety data.

Results of the five-year review showed:

• an estimated 65 percent of alemtuzumab-treated patients were free of clinically-active disease, compared to 27 percent of patients taking Rebif (p<0.0001). To be free of clinically-active disease, MS patients in the trial were both relapse-free and without a sustained increase in disability as measured by the Expanded Disability Status Scale (EDSS) through five years;
• an estimated 72 percent of alemtuzumab-treated patients were relapse-free compared to 41 percent of patients taking Rebif; and
• an estimated 87 percent of alemtuzumab-treated patients were free of sustained accumulation of disability compared to 62 percent of patients taking Rebif (previously reported).

"These data suggest that alemtuzumab may have great potential for MS patients," said abstract author Cary Twyman, MD, principal Investigator, Associates in Neurology, Lexington, KY.

Two pivotal Phase 3 studies investigating alemtuzumab, CARE-MS I and II, are currently ongoing. Top-line results from these trials are expected to be available respectively early in the third quarter of 2011 and in the fourth quarter of 2011. The company expects to file for U.S. and E.U. approval in early 2012, and has been granted fast track status by the FDA for this submission.

Alemtuzumab Seen to Improve Low-Contrast Vision

Visual impairment is a common complication of multiple sclerosis. A second abstract presented at AAN reported that sustained improvement in visual contrast sensitivity, as measured by low-contrast letter testing, was more than twice as likely for those patients in the Phase 2 trial receiving the investigational drug alemtuzumab compared to patients receiving the active comparator Rebif.

"Low-contrast letter acuity exams are a sensitive way of measuring visual function in MS clinical trials, and can correlate well with structural markers of the disease," said abstract author Laura Balcer, MD, Associate Professor of Neurology, University of Pennsylvania School of Medicine. "The improvements seen with alemtuzumab treatment as compared with interferon beta are encouraging."

During the trial, patients were asked to identify letters on low-contrast letter charts, which capture the minimum size at which individuals can perceive letters of a particular contrast level (shade of gray on white background). Low-contrast sensitivity was measured for each eye at baseline and quarterly thereafter by masked raters.

The analysis found that alemtuzumab patients were more than twice as likely to experience sustained improvement in vision as compared to Rebif patients.

These data expand upon disability improvements as measured by the Expanded Disability Status Scale. The EDSS is a 10-point scale in which every 0.5-point step marks a notable deterioration in neurological capabilities. In the Phase 2 trial, as previously reported at month 36 and 60 the mean EDSS disability score of patients receiving alemtuzumab improved, while the mean disability worsened in the comparator group.