Peregrine Pharmaceuticals
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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