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Peregrine president and CEO, Steven W. King noted, "We are very pleasedthat the sites were able to rapidly complete enrollment in the first part ofthis important Phase ll study. We look forward to generating clinical datafrom both of our ongoing Phase ll studies in advanced breast cancer patientsover the coming months that will enable us to better assess bavituximab'searly potential as a novel targeted therapy for breast cancer."
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As part of this trial's Simon two-stage design, 15 patients with advancedbreast cancer have been enrolled in Stage A of the study. The trial may beexpanded to include up to an additional 31 subjects if promising results areseen in the Stage A cohort. The primary objective of the study is to assessthe overall tumor response rate to the combination of bavituximab withcarboplatin and paclitaxel. Secondary objectives include measuring time totumor progression, duration of response, overall patient survival and safetyparameters. Patients enrolled in the trial are receiving up to six cycles ofbavituximab in combination with carboplatin and paclitaxel. Patients maycontinue to receive bavituximab alone after completion of the combinationregimen cycles as long as the cancer does not progress and side effects areacceptable. The trial is being conducted in India according to InternationalConference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.
The World Health Organization reports that breast cancer is the mostcommonly diagnosed cancer in women, and is second only to lung cancer as aleading cause of female cancer deaths. The National Cancer Instituteestimates that approximately 182,460 U.S. women will be diagnosed with breastcancer in 2008 and 40,480 women will die of the disease.
Bavituximab is a monoclonal antibody that binds to the cellular membranecomponent phosphatidylserine (PS) that is usually located inside cells, butwhich becomes exposed on the outside of the cells that line the blood vesselsof tumors, creating a specific target for anti-cancer treatments. By bindingto PS, bavituximab is believed to help mobilize the body's immune system todestroy the tumor and the tumor blood vessels. Bavituximab currently is intwo separate Phase II combination therapy trials for the treatment of advancedbreast cancer and a Phase II combination therapy trial for the treatment ofNSCLC. A Phase I bavituximab monotherapy trial in advanced solid cancers isalso continuing.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with aportfolio of innovative product candidates in clinical trials for thetreatment of cancer and hepatitis C virus (HCV) infection. The company ispursuing three separate clinical programs in cancer and HCV infection with itslead product candidates bavituximab and Cotara(R). Peregrine also hasin-house manufacturing capabilities through its wholly owned subsidiary AvidBioservices, Inc. (http://www.avidbio.com), which provides development andbio-manufacturing services for both Peregrine and outside customers.Additional information about Peregrine can be found athttp://www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are notpurely historical, including statements regarding Peregrine Pharmaceuticals'intentions, hopes, beliefs, expectations, representations, projections, plansor predictions of the future are forward-looking statements within the meaningof the Private Securities Litigation Reform Act of 1995. The forward-lookingstatements involve risks and uncertainties including, but not limited to, therisk that the company will experience delays or difficulties in enrollingpatients in the study, the risk that the standard carboplatin and paclitaxelresponse rate will not be improved as a result of the combination therapy, andthe risk that the results from this trial will not be consistent with theresults of prior trials or preclinical studies. It is important to note thatthe company's actual results could differ materially from those in any suchforward-looking statements. Factors that could cause actual results to differmaterially include, but are not limited to, uncertainties associated withcompleting preclinical and clinical trials for our technologies; the earlystage of product development; the significant costs to develop our products asall of our products are currently in development, preclinical studies orclinical trials; obtaining additional financing to support our operations andthe development of our products; obtaining regulatory approval for ourtechnologies; anticipated timing of regulatory filings and the potentialsuccess in gaining regulatory approval and complying with governmentalregulations applicable to our business. Our business could be affected by anumber of other factors, including the risk factors listed from time to timein the company's SEC reports including, but not limited to, the annual reporton Form 10-K for the year ended April 30, 2008 and the quarterly report onForm 10-Q for the quarter ended July 31, 2008. The company cautions investorsnot to place undue reliance on the forward-looking statements contained inthis press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation,and does not undertake to update or revise any forward-looking statements inthis press release.Contacts: GendeLLindheim BioCom Partners Investors Media [email protected] Barbara Lindheim (800) 987-8256 (212) 918-4650
SOURCE Peregrine Pharmaceuticals, Inc.
