Company Watch

Glenmark completes preclinical development of a monoclonal antibody

Our News Bureau - Mumbai

Glenmark Pharmaceuticals SA (Switzerland), has completed crucial Investigational New Drug-enabling (IND) preclinical studies of its monoclonal antibody GBR 500. Glenmark intends to file an IND application with the US FDA by August 2008, for initiation of phase I trials. The company is also expec-ting to complete phase I in this fiscal year immediately followed by a proof of concept phase IIa study. At the same time Glenmark has already manufactured sufficient antibody for conducting phase I and phase IIa clinical studies. It also intends to develop GBR 500 for indications such as Multiple Sclerosis (MS), Chronic Obstructive Pulmonary Disease (COPD) and Inflammatory Bowel Disease (IBD).

Glenmark would be among the first companies to target VLA-2. GBR 500, a monoclonal antibody, is an antagonist of the VLA-2 (a2ß1) integrin. VLA-2 mediates interactions of cells with the extracellular 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. Speaking on this development, Glenn Saldanha, Managing Director and CEO, Glenmark, said, "We are happy to take our biologics program forward with GBR 500 moving into phase I trials. 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.