Peregrine Pharma plummets after revealing "discrepancies" in one bavituximab trial

25 September 2012

Shares of US drugmaker Peregrine Pharmaceuticals (Nasdaq: PPHM) went into free-fall in pre-market trading yesterday, dropping 85.7% to $0.82, when the company revealed a problem with one clinical trial of its lead drug candidate bavituximab.

The company announced that, during the course of preparing for an end-of-Phase II meeting with regulatory authorities and following recent data announcements from its randomized, double-blind placebo-controlled Phase II trial of bavituximab in second-line non-small cell lung cancer, it discovered major discrepancies between some patient sample test results and patient treatment code assignments. Due to the double-blind nature of the trial, Peregrine was not permitted to have access to either patient group assignments or related product coding information.

As part of the trial's execution, Peregrine contracted with independent third-party contractors to execute treatment group assignments and oversee clinical trial material coding and distribution according to established procedures. A subsequent review of information has determined that the source of these discrepancies appear to have been associated with the independent third-party contracted to code and distribute investigational drug product.

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