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Peregrine president and CEO Steven W. King noted, "The rapid completion ofenrollment in the first stage of this study adds to the positive momentum wehave built in our bavituximab clinical program. We look forward to reportinginitial data from this trial as patient treatment and follow-up continue andto learning more about bavituximab's potential as a novel targeted therapy forthis devastating disease."
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In the trial's Simon two-stage design, 21 patients with NSCLC have beenenrolled in Stage A of the study. The trial may be expanded to include up toa total of 49 patients if promising results are observed in the initialcohort. Secondary objectives of the study include assessing time to tumorprogression, duration of response, overall patient survival and safetyparameters. Patients are receiving bavituximab and up to six cycles ofcarboplatin and paclitaxel, and they may continue to receive bavituximab aslong as the cancer does not progress and side effects are acceptable. Thetrial is being conducted in India according to International Conference onHarmonization (ICH) and Good Clinical Practices (GCP) standards.
Lung cancer is a major cause of cancer deaths worldwide. According to theAmerican Cancer Society, lung cancer is the second most commonly diagnosedcancer in U.S. men and women and is the leading cause of cancer deaths. Itestimates that in the U.S. in 2008, there will be approximately 215,400 newcases of lung cancer and an estimated 161,800 lung cancer deaths. Non-smallcell lung cancer is the most common type of lung cancer, accounting forapproximately 85-90% of lung cancer cases.
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, as well as the Phase II combination therapy trial for thetreatment of NSCLC. A Phase I bavituximab monotherapy trial in advanced solidcancers 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-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 results from the first stage of the Phase Il trial will notjustify expansion to the second stage of the Phase II trial, that the companywill experience delays or difficulties in enrolling patients in the study, therisk that the standard carboplatin and paclitaxel response rate will not beimproved as a result of the combination therapy, and the risk that the resultsfrom this trial will not be consistent with the results of prior trials orpreclinical studies. It is important to note that the company's actual resultscould differ materially from those in any such forward-looking statements.Factors that could cause actual results to differ materially include, but arenot limited to, uncertainties associated with completing preclinical andclinical trials for our technologies; the early stage of product development;the significant costs to develop our products as all of our products arecurrently in development, preclinical studies or clinical trials; obtainingadditional financing to support our operations and the development of ourproducts; obtaining regulatory approval for our technologies; anticipatedtiming of regulatory filings and the potential success in gaining regulatoryapproval and complying with governmental regulations applicable to ourbusiness. Our business could be affected by a number of other factors,including the risk factors listed from time to time in the company's SECreports including, but not limited to, the annual report on Form 10-K for theyear ended April 30, 2008 and the quarterly report on Form 10-Q for thequarter ended July 31, 2008. The company cautions investors not to place unduereliance on the forward-looking statements contained in this press release.Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does notundertake to update or revise any forward-looking statements in this pressrelease.Contacts: GendeLLindheim BioCom Partners Investors Media [email protected] Barbara Lindheim (800) 987-8256 (212) 918-4650
SOURCE Peregrine Pharmaceuticals, Inc.
