Peregrine gains on update of bavituximab trial 'discrepancies'

Peregrine Pharmaceuticals Inc. (NASDAQ:PPHM) jumped $1.08 (80%) to $2.43 on Monday after the company said an internal review determined that previously-announced issues in a Phase IIb trial of bavituximab plus docetaxel for second-line non-small cell lung cancer (NSCLC) did not affect the high-dose bavituximab arm. In September, shares of Peregrine plummeted 78% to $1.16 after the company said it discovered "major discrepancies between some patient sample test results and patient treatment code assignments." Peregrine said the internal review determined that the discrepancies were isolated to the placebo and low-dose bavituximab arms (see BioCentury, Oct. 1, 2012).

Additionally, Peregrine said the review showed that patients in the high-dose arm still had "favorable" tumor response rates, progression-free survival (PFS) and overall survival (OS) as compared to combined placebo and low-dose arms. In September, Peregrine reported that bavituximab plus docetaxel significantly improved median OS compared to docetaxel alone before announcing that investors should not rely on the data because of the trial discrepancies. ...