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Peregrine Pharmaceuticals Doses First Patient in Phase II Trial of Bavituximab in Patients With Non-Small Cell Lung Cancer
Date:6/30/2008

safety parameters. Tumor response in the study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. Patients may continue to receive bavituximab as long as the cancer does not progress and side effects are acceptable.

The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.

Lung cancer is a major cause of cancer deaths worldwide. According to the American Cancer Society, in the U.S. lung cancer is the second most commonly diagnosed cancer in men and women and is the leading cause of cancer deaths. It estimates that in the U.S. in 2008, there will be approximately 215,400 new cases of lung cancer and an estimated 161,800 lung cancer deaths. Non-small cell lung cancer, or NSCLC, is the most common type of lung cancer, accounting for approximately 85-90% of lung cancer cases.

Bavituximab is a monoclonal antibody that binds to the cellular membrane component phosphatidylserine (PS) that is usually located inside 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. By binding to PS, bavituximab is believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels. Bavituximab currently is in Phase II combination therapy trials for the treatment of advanced breast cancer and non-small cell lung cancer and a second Phase II trial in breast cancer is expected to begin soon. In a Phase Ib 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. A Phase I bavituximab monotherapy trial in advanced solid cancers is continuing.

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc.
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