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Peregrine Initiates Second Randomized Phase IIb Lung Cancer Trial Using PS-Targeting Monoclonal Antibody Bavituximab

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Peregrine Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, announced that it has initiated a second randomized Phase IIb non-small cell lung cancer (NSCLC) trial, this one in front-line patients.

The clinical trial will compare bavituximab plus carboplatin and paclitaxel versus treatment with carboplatin and paclitaxel alone. A first-in-class phosphatidylserine (PS)-targeting monoclonal antibody, bavituximab is now being evaluated in combination with standard chemotherapy in two Phase IIb trials, the first in refractory patients and the second in front-line NSCLC patients.

Positive data from a previous Phase II signal-seeking trial which preceded this new Phase IIb trial were recently presented at the ASCO 2010 Annual Meeting. Data from this previous study showed an objective response rate (ORR) of 43% (21 of 49 patients) and median progression-free survival (PFS) of 6.1 months for front-line NSCLC patients treated with bavituximab in combination with carboplatin and paclitaxel. These results exceeded the ORR of 15% and median PFS of 4.5 months following treatment with carboplatin and paclitaxel alone in a separate front-line NSCLC trial.

"Bavituximab represents an entirely new targeted approach to cancer therapy," said David E. Gerber, M.D., assistant professor, Division of Hematology/Oncology at the University of Texas Southwestern Medical Center. "Earlier lung cancer studies combining bavituximab with conventional chemotherapy have shown encouraging response rate and progression-free survival data compared to historical outcomes using chemotherapy alone. Chemotherapy has been shown to increase the exposure of phosphatidylserine on tumor blood vessels, thereby enhancing bavituximab's cancer targeting. Bavituximab has been shown to fight tumors by reactivating the immune system and causing vascular changes. This mechanism of action could provide a new treatment option against this deadly form of cancer."

"Building on the promising data reported at ASCO from our earlier Phase II trial, we are launching this new Phase IIb study to advance the development of bavituximab as a potential new, broad-spectrum therapeutic option for cancer patients," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. "Our goal is to complete patient enrollment in this trial by mid-year 2011. As this trial is unblinded, we plan to report interim data as this trial progresses while we continue to monitor median overall survival from our earlier Phase II NSCLC trial."