BioCentury
ARTICLE | Clinical News

Cotara regulatory update

December 10, 2012 8:00 AM UTC

Peregrine said it reached an agreement with FDA on the design of a single Phase III trial comparing 2 doses of Cotara in up to 300 patients with recurrent glioblastoma multiforme (GBM). The company said the study, which Peregrine plans to run as a global registration trial, will allow for multiple interim data analyses, with the potential to stop patient accrual early based on predicted success or futility. Peregrine also hopes to partner the compound. The company declined to provide details. ...