Peregrine Pharmaceuticals To Begin Trial Of Bavituximab In Patients With Metastatic Breast Cancer
Peregrine Pharmaceuticals's Phase II clinical protocol to study bavituximab in combination with the chemotherapy drug docetaxel in patients with metastatic breast cancer has been approved by the Drug Agency of the Ministry of Labour, Health and Social Affairs of Georgia. The open label, multi-center safety and efficacy trial is expected to begin enrolling patients by early 2008.
The primary objective of the trial is to assess the overall response rate to the combination of bavituximab with docetaxel, a chemotherapy drug commonly used in the treatment of metastatic breast cancer. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. In the trial's two-stage design, up to 15 patients with metastatic breast cancer will be enrolled initially. The study will then be expanded up to a total of 46 patients if promising results are observed. The trial is expected to enroll patients at a minimum of three clinical trial sites.
"We are eager to assess bavituximab's potential in Phase II combination studies in a number of cancer indications, and we are very pleased to have received prompt regulatory approval to proceed with this breast cancer trial," said Steven W. King, president and CEO of Peregrine. "The clinical sites in the Republic of Georgia that will be participating in assessing bavituximab have extensive experience in conducting mid and late stage cancer studies that adhere to FDA and international standards, and we look forward to working with them to ensure the timely conduct of this important Phase II trial."
Tumor response in this new 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.
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 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 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 II trial of bavituximab in combination with the chemotherapy drugs paclitaxel and carboplatin in patients with metastatic breast cancer is currently undergoing regulatory review in India. A protocol for a Phase II trial of bavituximab in combination with the chemotherapy drugs paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) is also under regulatory review in India. Bavituximab is in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.