Peregrine Pharmaceuticals' Bavituximab Achieves Primary Endpoint in First Stage of Phase II Lung Cancer Study
TUSTIN, Calif., February 04, 2009 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. today reported that its lead product candidate bavituximab achieved the primary efficacy endpoint in the first stage of its ongoing Phase II clinical trial in patients with non-small cell lung cancer (NSCLC). The open-label, Simon two-stage study is designed to evaluate the safety and efficacy of the combination of bavituximab with the chemotherapy drugs carboplatin and paclitaxel in NSCLC patients. Seventeen of the 21 patients enrolled in Stage A were deemed evaluable for tumor response by the end of four treatment cycles, with six patients achieving partial tumor responses and one patient achieving a complete tumor response, according to RECIST criteria. These preliminary results exceed the pre-specified benchmark criteria established for enrolling an additional 28 patients in Stage B of this trial, up to a total of 49 patients.
"We are very pleased with the promising early results from this pilot Phase II lung cancer trial and will now move forward to initiate the second stage of the study," said Steven W. King, president and CEO of Peregrine. "We are encouraged by the number of tumor responses seen at this early time point of approximately 12 weeks in patients with NSCLC, a leading cause of cancer deaths that responds poorly to current treatments. As these patients continue on treatment, we will be assessing them for further signs of anti-tumor activity, and we look forward to sharing more data from this study as patient treatment and follow-up progress."
The primary objective of the multi-center Phase II clinical trial in patients with previously untreated locally advanced or metastatic NSCLC is to assess the overall tumor response rate. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. All tumor responses in the trial are being evaluated using RECIST criteria. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable. The trial is being conducted in India according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.
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 were approximately 215,020 new cases of lung cancer and an estimated 161,840 lung cancer deaths. 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 two separate Phase II combination therapy trials for the treatment of advanced breast cancer and a Phase II combination therapy trial for the treatment of non-small cell lung cancer. A Phase I bavituximab monotherapy trial in advanced solid cancers is also continuing.
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. (www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
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Posted: February 2009