Glenmark's Swiss arm completes Phase I trials for monoclonal antibody GBR 500

Glenmark's wholly owned Swiss subsidiary Glenmark Pharmaceuticals SA, has completed preclinical development for initiating Phase I trials for GBR 500, monoclonal antibody for inflammation.

With the completion of the IND-enabling preclinical studies, Glenmark now intends to file an application with the US FDA by August 2008 for initiation of Phase I trials, whichit expects to complete in this fiscal year immediately followed by a 'proof of concept' Phase IIa study.

"We are happy to take our biologics programme forward with GBR 500 moving into Phase I trials,'' said Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals Ltd. ''This is Glenmark's first NBE to enter the clinics from our pipeline of 11 NCEs and NBEs, and demonstrates our steady progress in the drug discovery space."

Glenmark ahas already manufactured sufficient antibody for conducting Phase I and Phase IIa clinical studies.

It plans to develop GBR 500 for indications such as multiple sclerosis (MS), chronic obstructive pulmonary Disease (COPD) and inflammatory bowel disease (IBD).

Glenmark will become among the first companies to target VLA-2 GBR 500, a monoclonal antibody, which is an antagonist of the VLA-2 (o2B1) integrin. VLA-2 mediates interactions of cells with the extra cellular matrix integrin-mediated cell migration is required for the recruitment of immune cells to sites of inflammation, and Glenmark intends to develop GBR 500 as a modulator of inflammation.

The broad mechanism of GBR 500, a VLA-2 integrin antagonist is validated by marketed drugs ReoPro (Centocor / Lilly), Raptiva (Genentech / Xoma) and Tysabri (Biogen / Elan) are marketed monoclonal antibodies which target integrins.