SOURCE: Peregrine Pharmaceuticals

Peregrine Pharmaceuticals

January 19, 2011 08:00 ET

Peregrine Announces Initiation of Investigator-Sponsored Trial in HER2-Negative Metastatic Breast Cancer

Targeted Antibody Bavituximab to Be Evaluated in Combination With Paclitaxel

TUSTIN, CA, and TUCSON, AZ--(Marketwire - January 19, 2011) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today 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-tumor activity in two Phase II breast cancer clinical trials and has repeatedly demonstrated synergistic anti-tumor activity in preclinical models," said Alison Stopeck, M.D., lead investigator of this trial and director of the clinical breast cancer program at the Arizona Cancer Center at UMC North. "This safety study will also examine the role of cell-specific microparticles, 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 tumor 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-tumor activity."

About the Phase I Breast Cancer Trial
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/m2) 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.

For further information about this trial, please visit http://www.peregrinetrials.com/ or http://www.clinicaltrials.gov/ct2/results?term=bavituximab.

About Peregrine's Investigator-Sponsored Trials (IST) Program
Peregrine's IST program offers oncologists the opportunity to conduct clinical trials with bavituximab. To apply for Peregrine's IST program, please visit http://www.peregrineinc.com/pipeline/investigator-sponsored-trials.html.

About Breast Cancer
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 U.S. women will be diagnosed with breast cancer in 2009 and 40,170 women will die of the disease in the U.S. alone. HER2-negative accounts for approximately 75% of metastatic breast cancers.

About Peregrine Pharmaceuticals
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 programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.

Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that results from investigator-sponsored trials will not be consistent with results experienced in earlier clinical trials and preclinical studies, the risk that investigators may experience delays in patient enrollment, risk that results may not support registration filings with the U.S. Food and Drug Administration, and the risk that Peregrine may not have or raise adequate financial resources to complete the planned clinical programs. Factors that could cause actual results to differ materially or otherwise adversely impact the company's ability to obtain regulatory approval for its product candidates include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2010 and the quarterly report on Form 10-Q for the quarter ended October 31, 2010. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

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