Shares of Peregrine Pharmaceuticals Inc. (PPHM: Quote) are losing about 76.0 percent on Monday after it revealed discrepancies in data from a phase II study of its lead drug candidate bavituximab in non-small cell lung cancer.
Peregrine, while preparing for an end-of-phase II meeting with regulatory authorities and following recent data 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.
According to the company, a review of information has found that the source of the discrepancies appear to have been associated with the independent third-party contracted to code and distribute investigational drug product.
Earlier this month, Peregrine reported positive results for bavituximab in a Phase IIb trial in non-small cell lung cancer, as the drug showed a statistically significant improvement in overall survival and a doubling of median overall survival. The company now says investors should not rely on clinical data it earlier provided with regard to Phase II bavituximab trial for second-line non-small cell lung cancer.
The company in March too had revealed data discrepancies, after an independent review showed unexpectedly high progression-free survival rates in lung cancer patients receiving standard chemotherapy.
Bavituximab is a genetically engineered antibody, designed to target a lipid molecule found on tumor blood vessels, and works by suppressing the immune system. It is being studied as a treatment for a range of cancers, including pancreatic and breast cancer.
Peregrine said the discrepancy will have no impact on other ongoing bavituximab trials.
Shares of Peregrine are trading at $1.26, down $4.12 or 76.57%, on a volume of over 56.0 million shares on the Nasdaq.
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by RTT Staff Writer
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