Peregrine Pharmaceuticals, Inc, a clinical stage biopharmaceutical company, has received approval from the Drug Controller General of India (DCGI) to its phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).
The primary objective of the multi-centre clinical trial is to assess the overall tumour 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 tumour 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, 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."
Tumour response in this study will be evaluated using Response Evaluation Criteria in Solid Tumours (RECIST) parameters. The trial is being conducted according to International Conference on Harmonisation (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 US 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 US 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 tumours, 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 tumour growth and spread. In a phase Ib 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 per cent 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 US in patients with advanced solid tumours and in patients co-infected with HCV and HIV.