Peregrine Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, announced the completion of enrollment and randomization of 86 patients with previously untreated non-small cell lung cancer (NSCLC) in a phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel. Bavituximab is a phosphatidylserine (PS)-targeting monoclonal antibody with broad therapeutic potential and also is being evaluated in randomized phase II trials for second-line NSCLC, pancreatic cancer, and hepatitis C virus (HCV) infection, as well as in four investigator-sponsored trials (ISTs) in additional oncology indications.

In a prior single-arm phase II study in 49 patients, bavituximab in combination with carboplatin and paclitaxel demonstrated encouraging survival and tumour response data. Median overall survival (OS) of 12.4 months, median progression-free survival (PFS) of 6.1 months, and objective response rate (ORR) of 43% were promising compared to 10.3 months median OS, 4.5 months median PFS, and 15% ORR from a separate historic control trial using carboplatin and paclitaxel alone in a similar patient population.

"Completion of patient enrollment and randomization in this trial is an important milestone for our bavituximab oncology program, and paves the way for reporting interim data by the end of this year in this deadliest form of cancer," said Steven W. King, president and chief executive officer of Peregrine. "I would like to thank the patients and families who chose to participate, our clinical investigators who share our dedication to advancing the development of new therapeutic options for their patients, and our hard-working team at Peregrine driving our multiple phase II trials forward. We are eager to analyze the early tumor response data from this trial as well as to follow the longer-term survival of these patients, as we continue to evaluate bavituximab's broad therapeutic potential in additional ongoing clinical trials."

A manuscript titled "Development of bavituximab, a vascular targeting agent with immune-modulating properties, for lung cancer treatment" was recently published in the August 2011 edition of Immunotherapy. Highlighting bavituximab's unique mechanism of action and promising prior clinical and preclinical data, authors conclude bavituximab has immune modulatory as well as vessel disrupting properties that may be beneficial for the treatment of lung cancer and other malignancies.

This research was supported in part by an American Society of Clinical Oncology (ASCO) Career Development Award and the North and Central Texas Clinical and Translational Science Initiative (NIH KL2RR024983), both awarded to Dr. David E. Gerber, UT Southwestern Medical Center.

Peregrine's randomized phase II front-line NSCLC trial is designed to compare the ORR of carboplatin and paclitaxel with or without bavituximab in up to 86 patients with previously untreated locally advanced or metastatic NSCLC. Secondary objectives of the study include median PFS, duration of response, median OS, and safety parameters.

Patient recruitment is ongoing in Peregrine's second-line NSCLC trial evaluating docetaxel with bavituximab or placebo in up to 120 patients with previously treated locally advanced or metastatic NSCLC. Patient enrollment is expected to be completed early in the fourth quarter of this year.

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumour.

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programmes in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara.