Policy & Regulation
Blaze Bioscience Initiates Pivotal Clinical Trial for Tumor Paint: BLZ-100 and the Canvas Imaging System
5 December 2018 - - US-based biotechnology company Blaze Bioscience, Inc has enrolled the first patient at Seattle Children's Hospital in their Phase 2/3 pivotal study entitled "A randomized, blinded study of fluorescence detection of pediatric primary central nervous system tumors in subjects receiving tozuleristide and imaged with the Canvas System," the company said.

The randomiSed, blinded, multi-center, single dose Phase 2/3 study in pediatric patients with central nervous system tumors will assess the safety and efficacy of BLZ-100 as well as the performance of the Canvas System.

This trial is expected to enroll 114 patients at fifteen leading US pediatric cancer surgery centers throughout the US that are participants in the Pacific Pediatric Neuro-Oncology Consortium.

BLZ-100 (tozuleristide) is the first product candidate from Blaze's Tumor Paint platform and consists of a targeting peptide and a fluorescent dye, which emits light in the near-infrared range.

Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells, potentially enabling more precise, complete resection of cancer and sparing of normal adjacent tissue throughout surgery.

BLZ-100 has been tested in four Phase 1 clinical trials and has demonstrated clinical proof of concept in brain, breast and skin cancers.

Additional potential applications of BLZ-100 include prostate, lung, colorectal and other solid tumor cancers. BLZ-100, an investigational agent, is being evaluated in a Phase 2/3 clinical study in pediatric CNS tumors.

The Canvas Imaging System developed and manufactured by Teal Light Surgical, Inc. (a wholly-owned subsidiary of Blaze Bioscience Inc.) is designed to provide high-sensitivity detection of NIR light in the operating theater under ambient light conditions.

The first Canvas Imaging System under development is adapted for use with surgical microscopes and detects both BLZ-100 and indocyanine green.

Blaze Bioscience is a privately held biotechnology company dedicated to improving the lives of cancer patients. Blaze was founded in 2010 by Dr. Jim Olson, a pediatric neuro-oncologist at the Fred Hutchinson Cancer Research Center and Seattle Children's Hospital, and Heather Franklin, a former senior executive at ZymoGenetics.

The company is working to develop Tumor Paint products and related therapeutics. Surgery is first-line therapy for most solid tumor cancers and Tumor Paint products have the potential to improve cancer surgery by providing real-time, high-resolution visualization of cancer cells throughout surgery.

The ability to see cancer cells in real time and high resolution throughout surgery should enable better detection and more complete and precise surgical removal of cancer--while sparing surrounding normal tissue.

Gateway for Cancer Research is a nonprofit 501(c) (3) organization committed to funding innovative cancer research.
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