FONT-SIZE Plus   Neg

Genzyme Reports Additional Data From Phase III CARE-MS II Trial

Genzyme, a Sanofi company (SNY), on Tuesday reported additional data from the Phase III CARE-MS II trial.

Accumulation of disability was significantly slowed in patients with multiple sclerosis who were treated with alemtuzumab versus Rebif, as measured by the Expanded Disability Status Scale, a standard assessment of physical disability progression.

In addition, significant improvement in disability scores was observed in some patients treated with alemtuzumab from baseline and compared to patients treated with Rebif, suggesting a reversal of disability in these patients.
In the trial, patients with pre-existing disability treated with alemtuzumab were more than twice as likely to experience a sustained reduction in disability than patients given Rebif.

Genzyme is developing alemtuzumab in multiple sclerosis in collaboration with Bayer HealthCare.

CARE-MS II was a randomized Phase III clinical trial comparing the investigational drug alemtuzumab to Rebif in patients with relapsing-remitting multiple sclerosis who had relapsed while on prior therapy. The company announced in November that results for the co-primary endpoints of the trial were highly statistically significant.

Additional new data from the CARE-MS II study suggest that alemtuzumab provided significant improvement over Rebif across a number of imaging endpoints, consistent with the effects observed in the clinical endpoints.

The company said it is on track to file for U.S. and EU approval of alemtuzumab in relapsing multiple sclerosis in the second quarter of 2012.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
AT&T announced a definitive agreement to purchase Time Warner in a stock-and-cash transaction valued at $107.50 per share. This purchase price implies a total equity value of $85.4 billion and a total transaction value of $108.7 billion, including Time Warner's net debt. AT&T expects the deal to close before year-end 2017. Chipmaker Qualcomm is reportedly in talks with NXP Semiconductor NV (NXPI) for a possible acquisition, reports said. According to Bloomberg, negotiations are on with a probable price of $110 t $120 per NXP share. The deal would value NXP at around $34.7 billion. Regulators have confirmed the eleventh U.S. fatality linked to Takata Corp.'s defective air bag inflators. The National Highway Traffic Safety Administration or NHTSA said Thursday that a crash fatality in Riverside County, California, was tied to the rupture of a recalled Takata air bag inflator.
comments powered by Disqus
Follow RTT