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Peregrine Pharmaceuticals Receives Approval to Conduct a Phase II Trial of Bavituximab in Patients With Non-Small Cell Lung Cancer
Date:1/22/2008

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.

Lung cancer kills more Americans than any other type of cancer. 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 there were approximately 213,400 new cases of lung cancer and an estimated 160,400 lung cancer deaths in the U.S. in 2007. Non-small cell lung cancer, or NSCLC, is the most common type of lung cancer.

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 filed three Phase II cancer protocols to study bavituximab in combination with chemotherapy. In addition to the NSCLC protocol approval announced today, a protocol to study bavituximab in combination with docetaxel in patients with advanced breast cancer has been approved in the Republic of Georgia and is expected to begin shortly, and a second breast cancer protocol to study bavituximab in combination with carboplatin plus paclitaxel is expected to be approved soon in India. Bavituximab is also in Phase I clinical trials in the U.S. in patients with advanced solid tumors and in
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SOURCE Peregrine Pharmaceuticals, Inc.
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