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Peregrine Pharmaceuticals Reports Positive Results From Phase II Bavituximab Lung Cancer Trial
Date:10/5/2009

17 of these patients were deemed evaluable. In this initial cohort, 11 of the 17 evaluable patients achieved an objective tumor response by the time that treatment with the combination of bavituximab, carboplatin and paclitaxel was completed. These initial results exceeded the pre-specified endpoint needed to expand the trial, which then enrolled an additional 28 patients to reach the planned study total of 49 patients.

Secondary objectives of the study include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients in the study are evaluated regularly for tumor response according to RECIST criteria. Patients may continue to receive bavituximab as a monotherapy after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable. The trial is being conducted in India according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.

Lung cancer is a major cause of cancer deaths worldwide. According to the American Cancer Society, lung cancer is the second most commonly diagnosed cancer in men and women in the U.S. and is the leading cause of cancer deaths. It estimates that in 2009, there will be approximately 219,440 new cases of lung cancer in the U.S. and an estimated 159,000 lung cancer deaths. NSCLC is the most common type of lung cancer, accounting for approximately 85-90% of lung cancer cases.

Bavituximab is a monoclonal antibody that targets 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 masking PS, bavituximab is believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels. Bavituximab is being tested in combination with chemotherapy in three Phase
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SOURCE Peregrine Pharmaceuticals, Inc.
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