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news.Also completes enrollment of 49 NSCLC patients for this study
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Peregrine Pharmaceuticals has reported additional positive results from its phase II trial. The study evaluated bavituximab in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC).
The company had earlier reported an initial cohort of 21 patients in the study, which indicated that 11 of 17 evaluable patients with locally advanced or metastatic NSCLC achieved an objective tumor response according to RECIST criteria.
Recent analysis from the 21 patient cohort now shows the median progression free survival (PFS) for these patients was 6.5 months. This compares favorably with the PFS range of 4.2 to 4.5 months reported in a similar patient population receiving carboplatin and paclitaxel as a single agent in NSCLC trials, that were the basis for the design of the ongoing bavituximab study.
The company said that the primary objective of the multi-center, open-label phase II NSCLC study is to assess the overall response rate to bavituximab, with carboplatin and paclitaxel.
According to the company, the secondary objective of the study includes measuring time to tumor progression, duration of response, overall patient survival and safety parameters.
Steven King, president and CEO of Peregrine, said: “The PFS data we reported today along with the objective tumor response data previously reported for the first set of patients in this study are very encouraging. Based on these results we have already begun designing our next studies in NSCLC, where we believe bavituximab has considerable promise. We will continue to assess patients enrolled in the now-completed expansion cohort over the coming months and look forward to reporting results from the full 49-patient study population.”
Bavituximab is a monoclonal antibody that targets the cellular membrane component phosphatidylserine (PS) 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.