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News Breaks | | | | January 7, 2013 | | 08:46 EDT |  | PPHM | Peregrine provides update on the internal review of its Phase II NSCLC trial
Peregrine Pharmaceuticals provided an update from its internal review of discrepancies from its Phase II randomized, double-blind placebo-controlled trial of bavituximab in second-line non-small cell lung cancer, or NSCLC, in 121 patients. The review was prompted by the discovery of vial coding discrepancies while preparing for an end of Phase II meeting with the FDA. The internal review included a thorough operational review of multiple third-party vendor operations at sites worldwide, testing of investigational product used in the trial, additional patient sample testing to determine drug levels and a review of immunogenicity testing results from the trial. The results of the extensive internal review indicate that discrepancies are isolated to the placebo and 1 mg/kg treatment arms of the trial and that there was no evidence of discrepancies in the 3 mg/kg treatment arm of the trial. | |
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News For PPHM From The Last 14 Days Check below for free stories on PPHM the last two weeks. |
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| May 20, 2013 | | 08:50 EDT | | PPHM | Peregrine reaches agreement with FDA on Phase 3 trial design for Bavituximab
Peregrine Pharmaceuticals announced that it has reached agreement with the FDA on a Phase III registration trial design of the company's lead clinical immunotherapeutic candidate bavituximab in second-line non-small cell lung cancer. The trial design was supported by promising data from a Phase IIb trial in patients treated with bavituximab plus docetaxel. The Phase III clinical trial will be a randomized, double-blind, placebo-controlled trial evaluating bavituximab plus docetaxel versus docetaxel alone enrolling approximately 600 patients at sites worldwide. The trial will enroll Stage IIIB/IV non-squamous, NSCLC patients who have progressed after standard front-line treatment. The primary endpoint of the trial will be overall survival. | | | 08:40 EDT | | PPHM | Peregrine trading halted, pending news
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