Thursday, January 24, 2008

Peregrine receives DCGI approval for phase II trial of Bavituximab

Peregrine Pharmaceuticals, Inc, a clinical stage biopharmaceutical company, has received approval from the Drug Controller General of India (DCGI) to its phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).

Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumours, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumour growth and spread. In a phase Ib pilot trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50 per cent of the evaluable patients.

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