Company Says Erroneous Data Reported for Bavituximab in NSCLC
Vendor’s mistake nullifies presentations and documents related to phase II study (Sept. 24)
Peregrine Pharmaceuticals, based in Tustin, Calif., announced on September 24 that during the course of preparing for an “end of phase II” meeting with the FDA and following recent data announcements from its randomized, double-blind, placebo-controlled phase II trial of bavituximab in second-line non–small-cell lung cancer (NSCLC), the company discovered major discrepancies between some patient-sample test results and patient treatment-code assignments.
Because of the double-blind nature of the trial, Peregrine was not permitted to have access to either patient-group assignments or related product coding information. As part of the trial's execution, Peregrine hired independent third-party contractors to execute treatment-group assignments and to oversee the coding and distribution of clinical trial materials according to established procedures. A subsequent review of information has determined that the source of these discrepancies appears to have been associated with the independent third party contracted to code and distribute the investigational drug product.
This discrepancy is specific to this trial and will have no effect on other ongoing bavituximab trials, the company says.
Peregrine intends to communicate further as soon as it is able to determine the effect of this issue. In the meantime, clinicians and investors should not rely on clinical data that the company disclosed on or before September 7, 2012, from its phase II bavituximab trial in patients with second-line NSCLC or any presentations or other documents related to this phase II trial.
For more information, visit the Peregrine Pharmaceuticals Web site.