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Peregrine Pharmaceuticals Doses First Patient in Phase II Clinical Trial of Bavituximab in Patients With Advanced Breast Cancer
Date:2/12/2008

demonstrated encouraging potential in initial clinical studies," said David Tabagari, M.D., Ph.D., the head of Medulla Immunotherapy and Chemotherapy Clinic and principal investigator of the bavituximab breast cancer trial being conducted in the Republic of Georgia. "We are pleased to have the opportunity to conduct the first Phase II trial of this potentially valuable new approach to treating cancer."

Tumor response in this study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.

The National Cancer Institute estimates that approximately 178,480 U.S. women were diagnosed with cancer of the breast in 2007 and about 40,460 women died of the disease. According to the World Health Organization, breast cancer is the most commonly diagnosed cancer in women, and is second only to lung cancer as a leading cause of female cancer deaths.

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 tumors, 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 tumor growth and spread. In a Phase lb 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% of the evaluable patients. Peregrine has recently received regulatory approval to conduct three Phase II trials to study the anti-tumor effects of bavituximab in combination with chemotherapy. These include two breast cancer protocols and a non-small cell lung cancer protocol testing
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SOURCE Peregrine Pharmaceuticals, Inc.
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