National Cancer Institute Approves Trial Design for Collaborative Study

Peregrine Pharmaceuticals and the New Approaches to Brain Tumor Therapy (NABTT) Consortium have received approval from the National Cancer Institute (NCI) for their clinical protocol to treat Glioblastoma Multiforme, a deadly form of brain cancer, using Cotara.

The protocol was approved by the Protocol Review Committee of the NCI Cancer Therapy Evaluation Program. Peregrine and NABTT are currently in the process of initiating the multicenter study at participating institutions.

The NCI-approved protocol, titled "An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B (Cotara) for the Treatment of Glioblastoma Multiforme at First or Second Relapse," will evaluate safety, radiation exposure and efficacy of a single dose of Cotara.

Prior Phase I and Phase II brain cancer studies examined safety and efficacy of Cotara administered through single or multiple infusions. Data from these two studies indicated that safety and efficacy were related to total radioactive dose delivered rather than the number of infusions used to deliver the drug.

Based on this information, Peregrine designed the current protocol using a single dose, which enhances patient convenience and simultaneously lowers the overall cost of manufacturing and related expenses. The approved protocol represents the first part of Peregrine's FDA-approved product registration clinical trial for Cotara.