UPDATE 1-Bayer, Genzyme start Alemtuzumab late trial for MS

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Wed Sep 26, 2007 1:59pm BST

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FRANKFURT, Sept 26 (Reuters) - Bayer BAYG.DE and Genzyme GENZ.O said on Wednesday they had started a late trial with alemtuzumab for multiple sclerosis treatment, with filing for marketing approval expected in 2011.

The companies said in a statement the two-stage trial would compare alemtuzumab to rival Merck KGaA's (MRCG.DE) Rebif in patients with relapsing-remitting multiple-sclerosis (MS).

MS is a chronic disease of the central nervous system in which the immune system can attack the brain and spinal cord.

The disease causes a wide range of symptoms including fatigue, difficulty walking, numbness and vision problems. It can progress to cause severe disability. Relapsing-remitting multiple-sclerosis is the most common form of this disease.

The Phase III alemtuzumab trial to test its safety and efficacy followed a mid-stage trial that showed a statistically significant reduction in the risk for sustained accumulation of disability and the risk for relapse for 24 months compared with Rebif-treated patients.

The companies said details of this trial would be presented on Oct. 14 at the European Committee for Treatment and Research in Multiple Sclerosis, ECTRIMS, meeting in Prague.

The CARE-MS I study will enrol up to 525 patients at about 60 medical centres in North America, Australia, Latin America, and Europe, with time to sustained accumulation of disability and the annualised relapse rate as primary endpoints, they said.

Alemtuzumab is also known as Campath for cancer treatment.

Bayer shares were up 0.3 percent at 56.21 euros at 1240 GMT, broadly in line with the German blue-chip DAX .GDAXI index.

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