Peregrine Pharmaceuticals To Conduct Trial Of Bavituximab
Peregrine Pharmaceuticals's 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.
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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.