Glenmark Pharmaceuticals SA (Switzerland) a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd has announced that its monoclonal antibody GBR 500 has completed crucial IND-enabling preclinical studies. Glenmark intends to file an IND application with the US FDA by August 2008 for initiation of phase I trials.
The company expects to complete phase I in this fiscal year immediately followed by a Proof of Concept phase IIa study. Glenmark has already manufactured sufficient antibody for conducting phase I and phase IIa clinical studies.
Glenmark intends to develop GBR 500 for indications such as MS (Multiple Sclerosis), COPD (Chronic Obstructive Pulmonary Disease) and IBD (Inflammatory Bowel Disease).
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, MD and CEO, Glenmark Pharmaceuticals Ltd., said, "We are happy to take our biologics programme 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.
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