-- Peregrine's Second Phase II Bavituximab Cancer Trial Is Evaluating the Anti-Tumor Activity of Bavituximab in Combination with Carboplatin and
TUSTIN, Calif., June 30 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that patient screening and dosing has begun in a Phase II trial designed to evaluate the safety and efficacy of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC). The primary objective of the study is to assess the overall response rate to the combination of bavituximab with a standard regimen of carboplatin and paclitaxel in NSCLC patients. The multi-center clinical trial is being conducted in India.
"The initiation of patient enrollment and dosing in our trial of bavituximab in combination with chemotherapy in lung cancer patients marks an important milestone in our Phase II bavituximab clinical program," said Steven W. King, president and CEO of Peregrine. "We are eager to test the combination of bavituximab with carboplatin and paclitaxel in these patients, since 50% of advanced cancer patients treated with this combination in our Phase Ib trial achieved an objective tumor response. We look forward to learning more about bavituximab's potential in NSCLC, an important new indication that is a leading cause of cancer deaths for both men and women."
In the trial's two-stage design, up to 21 patients with NSCLC will be enrolled initially. The study will then be expanded up to a total of 49 patients if promising results are observed in the initial cohort. Secondary objectives of the study include time to tumor progression, duration of response, overall patient survival and safety parameters. Tumor response in the study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. Patients may continue to receive bavituximab as long as the cancer does not progress and side effects are acceptable.
The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.
Lung cancer is a major cause of cancer deaths worldwide. According to the American Cancer Society, in the U.S. lung cancer is the second most commonly diagnosed cancer in men and women and is the leading cause of cancer deaths. It estimates that in the U.S. in 2008, there will be approximately 215,400 new cases of lung cancer and an estimated 161,800 lung cancer deaths. Non-small cell lung cancer, or NSCLC, is the most common type of lung cancer, accounting for approximately 85-90% of lung cancer cases.
Bavituximab is a monoclonal antibody that binds to the cellular membrane component phosphatidylserine (PS) that is usually located inside cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. By binding to PS, bavituximab is believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels. Bavituximab currently is in Phase II combination therapy trials for the treatment of advanced breast cancer and non-small cell lung cancer and a second Phase II trial in breast cancer is expected to begin soon. In a Phase Ib trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the evaluable patients. A Phase I bavituximab monotherapy trial in advanced solid cancers is continuing.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://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 the company will experience
delays or difficulties in enrolling patients in the study, the risk that
the standard carboplatin and paclitaxel response rates will not be improved
as a result of the combination therapy, and the risk that the results from
this trial will not be consistent with the results of prior trials or
preclinical studies. It is important to note that the company's actual
results could differ materially from those in any such forward-looking
statements. Factors that could cause actual results to differ materially
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, 2007 and the quarterly
report on Form 10-Q for the quarter ended January 31, 2008. 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.
GendeLLindheim BioCom Partners
firstname.lastname@example.org Jennifer Anderson
(800) 987-8256 (212) 918-4642
|SOURCE Peregrine Pharmaceuticals, Inc.|
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