Biologics manufacturer Peregrine Pharmaceuticals' has informed its investors that its second-line lung cancer drug bavituximab, for which the company just released phase IIb data showing evidence of efficacy, is plagued by faulty data it says is the result of poor work by a third-party clinical trials contractor.
In its 24 September release, Peregrine said it discovered the deficient data when preparing for an end-of-phase II meeting with the US Food and Drug Administration (FDA). The company, it said, "Discovered major discrepancies between some patient sample test results and patient treatment code assignments."
The study, started in June 2012, was a placebo-controlled study comparing a control group with two treatments groups receiving Docataxel plus either bavituximab 1mg/kg or 3mg/kg. The trial was being conducted at 53 study locations throughout the US, India, Russia and the Ukraine. At the time of the study's release, the company's chief of regulatory affairs, Robert Garnick, called the data "robust," and said they were looking to work with FDA to, "Identify the most efficient path toward commercialization."
No information was provided in Peregrine's press release or the www.ClinicalTrials.gov posting regarding the identity of the contractor or contractors.
Unnamed Contractor Blamed for Problems
Peregrine places blame on the as-yet-unnamed contractor or contractors, which it claims was responsible for the trial and subsequent data coding deficiencies.
"Due to the double-blind nature of the trial, Peregrine was not permitted to have access to either patient group assignments or related product coding information," it said. "As part of the trial's execution, Peregrine contracted with independent third-party contractors to execute treatment group assignments and oversee clinical trial material coding and distribution according to established procedures. A subsequent review of information has determined that the source of these discrepancies appear to have been associated with the independent third-party contracted to code and distribute investigational drug product."
Peregrine's stock has since plunged more than 80% after the release of the company's statement, reports Reuters.
The data reporting error is the second major one to plague a drug manufacturer in the last five months. In May, Cambridge, Massachusetts-based Vertex Pharamceuticals was similarly forced to report having overstated the effectiveness of a new cystic fibrosis therapy, also causing its shares to take a hit. Vertex, however, released corrected data that the therapy was still effective when compared to a placebo.