Peregrine Shares Higher as Co. Reports Significant Progress in Advancing Cotara Program Into Pivotal Phase III Trial
Peregrine Pharmaceuticals (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced that it has made significant progress in advancing its Cotara program into late-stage development through its agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM). The FDA has agreed with the company'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). Cotara is a targeted loco-regional therapy that delivers a high dose of radiation directly into the brain tumor while sparing radiation exposure to healthy brain tissue. Cotara is being studied as a one-time treatment that in previous clinical trials has shown promising overall survival in patients with recurrent GBM.
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