Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Peregrine Pharmaceuticals has initiated a randomised, open-label Phase IIb non-small cell lung cancer (NSCLC) trial to compare the objective response rate (ORR) of Bavituximab in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin alone.
Subscribe to our email newsletter
Peregrine Pharma said that the current study is based on the positive Phase II NSCLC study results, which showed an ORR of 43% (21 of 49 patients) and median progression-free survival (PFS) of 6.1 months for front-line NSCLC patients treated with Bavituximab in combination with Carboplatin and Paclitaxel.
David Gerber, assistant professor of division of hematology/oncology at the University of Texas Southwestern Medical Center, said: “Bavituximab represents an entirely new targeted approach to cancer therapy. Earlier lung cancer studies combining Bavituximab with conventional chemotherapy have shown encouraging response rate and progression-free survival data compared to historical outcomes using chemotherapy alone.
“Chemotherapy has been shown to increase the exposure of phosphatidylserine on tumor blood vessels, thereby enhancing Bavituximab’s cancer targeting. Bavituximab has been shown to fight tumors by reactivating the immune system and causing vascular changes. This mechanism of action could provide a new treatment option against this deadly form of cancer.”
Joseph Shan, vice president of clinical and regulatory affairs at Peregrine Pharma, said: “Our goal is to complete patient enrollment in this trial by mid-year 2011. As this trial is unblinded, we plan to report interim data as this trial progresses while we continue to monitor median overall survival from our earlier Phase II NSCLC trial.”