Just this morning, Peregrine Pharmaceuticals (NASDAQ:PPHM) put out a press release and 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.
A little over two months ago, on September 24th, the stock price plummeted as the company announced that there were major discrepancies in the study on the bavituximab drug which it only recently announced the results for. Investors saw shares fall $4.23 (78.48%) and closed at $1.16/share on volume of 68.4 million shares. For weeks after the stock feel even further to a low of $0.65. Analysts came out and adjusted their price targets to significantly lower prices.
Today the review diminishes the news from the previous damaging report. The recent 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.
Jeffrey L. Masten, Vice President, stated this morning in the press release,
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.
Peregrine Pharmaceuticals said the preliminary analysis supports advancing bavituximab into Phase III development. This press release is a significant catalyst for the company, giving the company further potential value in its pipeline. Since my last article, Peregrine Pharmaceuticals Beats Earnings Estimates, I have increased my position in the stock by 25%, and I am still bullish and have adjusted my price target to $2.70.