The protocol was approved by the protocol review committee of the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP). Peregrine and the New Approaches to Brain Tumor Therapy Consortium (NABTT) are currently in the process of initiating the multi-center study at participating institutions.
The NCI-approved protocol will evaluate safety, radiation exposure and efficacy of a single dose of Cotara in glioblastoma multiforme.
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 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.
Cotara is 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.
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.