Peregrine Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, announced the initiation of an Investigator-Sponsored Trial (IST) for patients with HER2-negative metastatic breast cancer, which accounts for 75% of metastatic breast cancers. This open-label phase I trial will treat patients with Peregrine's investigational monoclonal antibody bavituximab in combination with the chemotherapy agent paclitaxel.

“Bavituximab combined with chemotherapeutic agents has shown promising anti-tumour activity in two phase II breast cancer clinical trials and has repeatedly demonstrated synergistic anti-tumour activity in preclinical models,” said Alison Stopeck, MD, lead investigator of this trial and director of the clinical breast cancer program at the Arizona Cancer Centre at UMC North. “This safety study will also examine the role of cell-specific micro-particles, potentially providing novel insights into biomarkers that may correlate with a patient's response to therapy and ultimate prognosis.”

Currently, Peregrine's bavituximab is being evaluated in randomized phase II trials in front-line Non-Small Cell Lung Cancer (NSCLC), second-line NSCLC, pancreatic cancer, and HCV. Peregrine's first IST, a phase I/II trial in hepatocellular carcinoma, was initiated last month and additional studies are being planned.

“Our two signal-seeking phase II breast cancer trials combining bavituximab with taxane-based chemotherapy regimens showed promising tumour response and progression-free survival,” said Joseph S. Shan, vice president, clinical and regulatory affairs at Peregrine Pharmaceuticals. “We are delighted to support Dr Stopeck and her team as they elucidate the potential mechanisms behind the enhanced anti-tumour activity.”

In this phase I single-arm, open-label trial, up to 14 patients with HER2-negative metastatic breast cancer will be treated with paclitaxel (80 mg/m(2)) weekly for three weeks out of each four-week cycle and bavituximab (3 mg/kg) weekly. Patients will be treated until disease progression or intolerable toxicity. The primary endpoint is to determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy. Secondary endpoints include pharmacodynamics and coagulation marker changes. Patients will also be assessed for objective overall response rate and median Progression Free Survival (PFS) according to RECIST criteria.

Peregrine's IST programme offers oncologists the opportunity to conduct clinical trials with bavituximab.

The World Health Organization reports that breast cancer is the most commonly diagnosed cancer in women and is second only to lung cancer as a leading cause of female cancer deaths. The National Cancer Institute estimates that approximately 192,370 US women will be diagnosed with breast cancer in 2009 and 40,170 women will die of the disease in the US alone. HER2-negative accounts for approximately 75% of metastatic breast cancers.

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.