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February 19, 2013
08:43 EDTPPHMPeregrine updates top-line data from Phase 2 clinical trial of Bavituximab
Peregrine Pharmaceuticals reported data from its randomized, double-blind placebo-controlled Phase II trial of bavituximab in patients with second-line non-small cell lung cancer, or NSCLC. Data from the trial has been updated based on completion of an earlier review of discrepancies in the trial and the most current survival data from the trial. Updated results from this Phase II trial indicate a meaningful improvement in median overall survival of 11.7 months in the 3mg/kg bavituximab + docetaxel arm compared to 7.3 months in the control arm. Persistent separation in the survival curves was observed with response rates and progression free survival also favoring the 3mg/kg bavituximab + docetaxel arm in this difficult to treat second-line NSCLC. The results also demonstrated that bavituximab was well-tolerated with no significant differences in adverse events between the trial arms. Peregrine plans to report additional data from the trial, including updated subgroup analysis and safety data, at an upcoming scientific meeting.
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April 23, 2014
07:37 EDTPPHMPeregrine announces investigator-sponsored combination trial with Bristol-Myers
Peregrine Pharmaceuticals (PPHM) announced the opening of an investigator-sponsored trial, or IST, of its investigational immunotherapy bavituximab in combination with Bristol-Myers Squibb's (BMY) ipilimumab, for the treatment of advanced melanoma. Bavituximab is an upstream immune checkpoint inhibitor that targets phosphatidylserine, or PS, a highly immunosuppressive molecule exposed on cells that line tumor blood vessels and tumor cells. Preclinical data in a model of melanoma demonstrate that the combination of a bavituximab equivalent and ipilimumab yield enhanced anti-tumor activity compared to ipilimumab alone. The trial is being conducted at the University of Texas Southwestern Medical Center, Dallas, and led by Arthur E. Frankel, M.D., Associate Professor of Internal Medicine at the Simmons Comprehensive Cancer Center. Bavituximab, Peregrine's lead immuno-oncology candidate, is being evaluated in second-line non-small cell lung cancer, as part of the SUNRISE pivotal Phase III clinical trial.

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