April 09, 2020
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FDA grants fast track designation to BLZ-100 for pediatric central nervous system tumors

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The FDA granted fast track designation to tozuleristide for treatment of pediatric central nervous system tumors.

Tozuleristide (BLZ-100, Blaze Bioscience Inc.) is a tumor-targeting optical imaging agent. It consists of a targeting peptide and a fluorescent dye that emits light in the near-infrared range.

It is designed to provide high-resolution visualization of cancer cells in real time during surgery, allowing for more effective removal of cancerous tissue while sparing healthy tissue.

A phase 2/phase 3 trial is underway to evaluate tozuleristide and the Canvas Imaging System — manufactured by Teal Light Surgical Inc., a subsidiary of Blaze Bioscience Inc. — for patients undergoing surgery for pediatric CNS tumors. Eligible trial participants can be aged up to 30 years.

“Receiving fast track designation is an important recognition of the importance of our pediatric brain cancer surgery program and the promise of tozuleristide in this patient population,” Dennis Miller, PhD, executive vice president of development at Blaze Bioscience, said in a company-issued press release. “Pediatric brain tumors remain the leading cause of cancer-related death among children and adolescents. We look forward to our continued collaborative relationship with FDA as we work to complete the clinical and other product development work needed to speed the product to approval.”