Advertisement
"Early data from the first stage of this bavituximab Phase II cancer studyhad already exceeded our expectations, so the positive updated resultsreported today are especially encouraging as we proceed with patientenrollment in the second stage of the trial," said Steven W. King, presidentand CEO of Peregrine. "We look forward to reporting more results from thisstudy and a second ongoing Phase II breast cancer trial as we continue tolearn more about bavituximab's potential in this important, hard-to-treatdisease."
Advertisement
The main objective of the multi-center, open label Phase II study is toassess patients' overall response rate to bavituximab and docetaxel. In thetrial's Simon two-stage design, 15 patients with advanced breast cancer wereenrolled in Stage A. With 10 Stage A patients demonstrating objective tumorresponses, the results have exceeded the pre-specified primary efficacyendpoint of six patients with objective tumor responses needed to proceed toStage B. In Stage B, the trial is being expanded to include an additional 31patients, for a total of 46 patients overall. Secondary objectives of thestudy include assessing time to tumor progression, duration of response,overall patient survival and safety parameters. Patients in the study areevaluated regularly for tumor response according to RECIST criteria.
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 Institute estimatesthat approximately 182,460 U.S. women will be diagnosed with breast cancer in2008 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 in twoseparate Phase II combination therapy trials for the treatment of advancedbreast cancer and a Phase II combination therapy trial for the treatment ofnon-small cell lung cancer. A Phase I bavituximab monotherapy trial inadvanced solid cancers is also 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 has in-housemanufacturing 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 docetaxel response rate willnot be improved as a result of the combination therapy, and the risk that theresults from this trial will not be consistent with the results of priortrials or preclinical studies. It is important to note that the company'sactual results could differ materially from those in any such forward-lookingstatements. Factors that could cause actual results to differ materiallyinclude, but are not limited to, uncertainties associated with completingpreclinical and clinical trials for our technologies; the early stage ofproduct development; the significant costs to develop our products as all ofour products are currently in development, preclinical studies or clinicaltrials; obtaining additional financing to support our operations and thedevelopment 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.
