-Clinical Trial to Evaluate Anti-Tumor Activity of Bavituximab in
Combination with Carboplatin and Paclitaxel-
TUSTIN, Calif., Jan. 22 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that its Phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) has been approved by the Drug Controller General of India (DCGI). The primary objective of the multi-center clinical trial is to assess the overall tumor response rate in NSCLC patients treated with the combination of bavituximab and carboplatin plus paclitaxel.
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. Patients may continue to receive bavituximab as long as the cancer does not progress and side effects are acceptable.
"This phase II trial represents an excellent opportunity for us to evaluate the potential activity of adding bavituximab to a standard regimen of carboplatin plus paclitaxel in NSCLC, a common and deadly cancer that still lacks effective treatment options," said Steven W. King, president and CEO of Peregrine. "With this approval in hand, we can now proceed with final preparations for the trial and look forward to study initiation in the near future."
Tumor response in this study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.
Lung cancer kills more Americans than any other type of cancer. 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 there were approximately 213,400 new cases of lung cancer and an estimated 160,400 lung cancer deaths in the U.S. in 2007. Non-small cell lung cancer, or NSCLC, is the most common type of lung cancer.
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal 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. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. In a Phase lb pilot 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. Peregrine has filed three Phase II cancer protocols to study bavituximab in combination with chemotherapy. In addition to the NSCLC protocol approval announced today, a protocol to study bavituximab in combination with docetaxel in patients with advanced breast cancer has been approved in the Republic of Georgia and is expected to begin shortly, and a second breast cancer protocol to study bavituximab in combination with carboplatin plus paclitaxel is expected to be approved soon in India. Bavituximab is also in Phase I clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.
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 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
quarterly report on Form 10-Q for the quarter ended October 31, 2007. 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 Barbara Lindheim
(800) 987-8256 (212) 918-4650
|SOURCE Peregrine Pharmaceuticals, Inc.|
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