Our goal in undertaking such a comprehensive review was to understand every aspect of this clinical trial. Due to the complex nature of this trial, this was an enormous effort involving multiple third-party vendors and thousands of product and patient samples obtained from three different continents. Specifically, we sought to determine the cause and the impact of any discrepancies within the trial and to verify every step within the drug product distribution process. We believe we have accomplished our goals in obtaining a more thorough understanding of the trial and we are very pleased with the outcome.
Jeffrey L. Masten, vice president, quality of Peregrine.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. Company is pursuing multiple clinical programs in cancer with our lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc., which provides development and biomanufacturing services for both Peregrine and outside customers.
PPHM today 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 (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.
Based on the results of the internal review, Peregrine is taking a very conservative approach toward analyzing the results from the trial which included combining the placebo and 1mg/kg arms into one treatment arm (control arm), and comparing those results to the 3mg/kg arm. This analysis indicates that the 3 mg/kg arm continues to show favorable tumor response rates, progression-free survival and overall survival (OS) over the new combined control arm. Peregrine expects to announce more detailed results from the analysis in the near term when it is completed.