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Peregrine and New Approaches to Brain Tumor Therapy (NABTT) Consortium Receive Approval for Cotara(R) Brain Cancer Protocol
Friday January 21, 9:24 am ET

National Cancer Institute (NCI) Approves Trial Design for Collaborative Study
TUSTIN, Calif., Jan. 21 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News) and the New Approaches to Brain Tumor Therapy Consortium announced today that they have received approval from the 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 (CTEP). Peregrine and NABTT are currently in the process of initiating the multi- center 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 1st or 2nd 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®.
About Cotara® and Tumor Necrosis Therapy (TNT)
Cotara® is the registered trademark for a chimeric TNT antibody attached to Iodine 131, a radioactive agent. Cotara® is designed to bind to the dead or dying tissue within the tumor and, once bound, its radioisotope irradiates nearby cells resulting in the death of nearby tumor cells.
Rapidly growing tumors quickly outgrow their blood supply resulting in a region of tumor cells that do not receive adequate oxygen, nutrients and waste removal. The accumulation of dying cells results in the formation of a dead, or necrotic, core present in virtually all solid tumors beyond a very small size. TNT-based products directly target and bind to dead and dying tumor cells found in virtually all solid tumors. By using the necrotic core as a stable anchorage in the heart of a tumor, TNT-based therapeutic agents have the potential to deliver therapeutic agents preferentially targeted to virtually all solid tumors, including brain, lung, colon, breast, liver, prostate and pancreatic cancers.