GlobalData Expert Insight: Fall from grace of Peregrine Pharma

Last month, Peregrine Pharmaceuticals (Nasdaq: PPHM) announced the discovery of “major data discrepancies” between reported results and patient treatment code assignments for its randomized, double-blind, Phase IIb clinical trial investigating bavituximab as second-line treatment in stage IIIb and IV non-small cell lung cancer (NSCLC) patients (The Pharma Letter September 25). Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is believed to trigger vascular disruption, and enhance antitumor and antiviral immune responses.

The company had revealed exciting interim data suggesting patients in the treatment arm of the study receiving bavituximab and docetaxel had a median Overall Survival (OS) of 12.1 months compared with 5.6 months in patients treated with docetaxel alone, comment analysts at industry expert GlobalData - written by Irfaan Dawood, GlobalData's analyst covering oncology, Elizabeth DelGiacco, GlobalData's senior analyst covering neurology, and Dr Toli Koutsokeras, Globaldata's analyst covering clinical trials.

Given the magnitude of the apparent success of this drug in terms of median OS, the trial raised a few eyebrows as to its legitimacy. Half of the patients enrolled were from Eastern Europe and India with no clear geographic breakdown, so racial disparities as well as regional clinical trial standards cannot be accounted for.