Last Update: 05-Dec-12 08:17 ET
Peregrine shares surge 24% following progress in Phase 3 Trial
Peregrine Pharma (PPHM $1.60 +0.32) announced that it has made significant progress in advancing its Cotara program into late-stage development through its agreement with the FDA on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM). The FDA has agreed with the co's proposed randomized trial design comparing two dose levels of Cotara in up to 300 patients. The trial design allows for multiple interim data analyses with the potential to stop patient accrual early based on predicted success or futility. Cotara has been granted orphan drug status and Fast Track designation for the treatment of GBM and anaplastic astrocytoma by the U.S. Food and Drug Administration (FDA) and orphan drug designation by the European Medicines Agency (EMA).
Peregrine Pharma (PPHM $1.60 +0.32) announced that it has made significant progress in advancing its Cotara program into late-stage development