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Peregrine Pharmaceuticals,
Inc.
, a biopharmaceutical company developing
first-in-class monoclonal antibodies focused on the treatment and
diagnosis of cancer, 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 a
rm 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.
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