Peregrine Pharmaceuticals has discovered significant discrepancies while preparing for an end-of-Phase II meeting with regulatory authorities related to data from its Phase II trial of bavituximab in second-line non-small cell lung cancer. The inconsistencies were related to some patient sample test results and patient treatment code assignments, therefore Peregrine was not permitted access to either patient group assignments or related product coding information.
Peregrine had contracted an independent third-party to code and distribute the investigational drug product and a subsequent review of information has determined that the third-party was the source of these discrepancies. This discrepancy is specific to this trial and not associated with other ongoing bavituximab trials.
Peregrine plans to provide further information once it has determined the impact of this issue.