Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
September 10, 2007 at 12:00 AM EDT
Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast CancerTUSTIN, Calif., Sept. 10 /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 it has submitted a clinical protocol with the Drug Controller General of India (DCGI) for an open label Phase II safety and efficacy trial of bavituximab in combination with the chemotherapy drugs paclitaxel and carboplatin in patients with metastatic breast cancer. The multi-center trial is expected to begin enrolling patients pending regulatory and ethics committee approvals.
The trial has a two-stage design. Up to 15 patients with metastatic breast cancer will be enrolled initially and the study will be expanded up to a total of 46 patients if promising results are observed in the first cohort. The primary objective is to assess the overall response rate to the combination of bavituximab with doses of paclitaxel and carboplatin. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive weekly administration of bavituximab with weekly doses of paclitaxel and carboplatin as long as their cancer does not progress, unless side effects require earlier cessation of therapy.
"The filing of this second cancer clinical protocol reflects our strategy of fielding a number of targeted Phase II combination studies in specific cancer indications," said Steven W. King, president and CEO of Peregrine. "Despite advances in treatment, breast cancer remains a major source of mortality among women. We designed this study using data generated from our recently completed Phase Ib cancer study, which showed that the combination of bavituximab with paclitaxel and carboplatin might be especially promising in breast cancer patients. We look forward to assessing bavituximab's potential in this larger trial in women battling metastatic breast cancer."
Tumor response will be evaluated every other month 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) guidelines.
According to the World Health Organization, metastatic breast cancer is the most commonly diagnosed cancer in women, and is second only to lung cancer as a leading cause of female cancer deaths. The National Cancer Institute estimates that 178,480 U.S. women will be diagnosed with cancer of the breast in 2007 and 40,460 women will die of the disease.
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is normally 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 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 protocol for a Phase ll trial of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) is currently undergoing regulatory review in India. Bavituximab is also in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.
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 protocol will not be approved, 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 pre-clinical 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 annual report on Form 10-K for the year ended April 30, 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.
SOURCE Peregrine Pharmaceuticals, Inc.
CONTACT: Investors, GendeLLindheim BioCom Partners, 1-800-987-8256; or Media, Barbara Lindheim, +1-212-918-4650, for Peregrine Pharmaceuticals, Inc.
Web site: http://www.peregrineinc.com
The trial has a two-stage design. Up to 15 patients with metastatic breast cancer will be enrolled initially and the study will be expanded up to a total of 46 patients if promising results are observed in the first cohort. The primary objective is to assess the overall response rate to the combination of bavituximab with doses of paclitaxel and carboplatin. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive weekly administration of bavituximab with weekly doses of paclitaxel and carboplatin as long as their cancer does not progress, unless side effects require earlier cessation of therapy.
"The filing of this second cancer clinical protocol reflects our strategy of fielding a number of targeted Phase II combination studies in specific cancer indications," said Steven W. King, president and CEO of Peregrine. "Despite advances in treatment, breast cancer remains a major source of mortality among women. We designed this study using data generated from our recently completed Phase Ib cancer study, which showed that the combination of bavituximab with paclitaxel and carboplatin might be especially promising in breast cancer patients. We look forward to assessing bavituximab's potential in this larger trial in women battling metastatic breast cancer."
Tumor response will be evaluated every other month 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) guidelines.
According to the World Health Organization, metastatic breast cancer is the most commonly diagnosed cancer in women, and is second only to lung cancer as a leading cause of female cancer deaths. The National Cancer Institute estimates that 178,480 U.S. women will be diagnosed with cancer of the breast in 2007 and 40,460 women will die of the disease.
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is normally 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 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 protocol for a Phase ll trial of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) is currently undergoing regulatory review in India. Bavituximab is also in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.
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 protocol will not be approved, 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 pre-clinical 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 annual report on Form 10-K for the year ended April 30, 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.
SOURCE Peregrine Pharmaceuticals, Inc.
CONTACT: Investors, GendeLLindheim BioCom Partners, 1-800-987-8256; or Media, Barbara Lindheim, +1-212-918-4650, for Peregrine Pharmaceuticals, Inc.
Web site: http://www.peregrineinc.com