SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, Inc., the Tumor Paint Company®, a biotechnology company dedicated to improving the lives of cancer patients through development and commercialization of products for fluorescence guided surgery, today announced the publication of Phase 1 results in the peer-reviewed journal Neurosurgery. The publication entitled “Phase 1 Safety, Pharmacokinetics, and Fluorescence Imaging Study of Tozuleristide (BLZ-100) in Adults with Newly Diagnosed or Recurrent Gliomas” by Patil et al is available online in Neurosurgery Now!.
The publication reports data from 17 subjects in a single dose, dose-escalation, open-label clinical trial conducted at Cedars-Sinai Medical Center in Los Angeles and the NEWRO Foundation in Brisbane, Australia. The primary objective of the study was to evaluate the safety and tolerability of tozuleristide in adult subjects with glioma undergoing surgery. Tozuleristide was found to be well tolerated at all tested doses with no dose limiting toxicities observed. A maximum tolerated dose was not reached. Exploratory imaging studies were conducted with the FLUOBEAM®800 (Fluoptics), Odyssey CLx (LI-COR Biosciences) and SIRIS (Teal Light Surgical) imaging devices. Fluorescence signal was detected in both high- and low-grade tumors and was visible from 3 hours to 27 hours post dosing.
“Tozuleristide fluorescence visualized with a high-resolution imaging system shows great promise as a tool to increase extent of resection for both high- and low-grade gliomas while preserving critical normal brain tissue. Improved resection is the single most important factor for improving survival and quality of life in brain tumor patients. Based on these encouraging results, further clinical trials are definitely warranted,” said Dr. Adam Mamelak, MD, neurosurgeon at Cedars-Sinai and senior author on the publication.
“The positive data in adult glioma subjects has paved the way for our broader pediatric brain cancer clinical trials,” said Dr. Dennis Miller, Blaze Bioscience SVP of Development. “The study also pointed out the need for improved imaging devices for brain cancer surgery applications which led to the development of the Canvas Imaging System being used in our ongoing pivotal study.”
About BLZ-100 (tozuleristide)
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 (NIR) range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells throughout surgery, potentially enabling more precise, complete resection of cancer while sparing normal adjacent tissue. 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 pivotal Phase 2/3 clinical study in pediatric central nervous system tumors. More details about ongoing trials are available at www.clinicaltrials.gov.
About the Canvas Imaging System
The Canvas Imaging System is an investigational medical device designed to provide high-sensitivity detection of NIR light in the operating room under ambient light conditions. The Canvas Imaging System was developed and is manufactured by Teal Light Surgical, Inc. (a wholly owned subsidiary of Blaze Bioscience, Inc.). The first Canvas Imaging System under development is adapted for use with surgical microscopes and detects both BLZ-100 and indocyanine green (ICG).
About Blaze Bioscience
Blaze Bioscience, Inc. 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. Blaze 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. For additional information, please visit www.blazebioscience.com.