Blaze Bioscience, Inc. and its subsidiary, Blaze Bioscience Australia Pty Ltd, today announced the initiation of the first Phase 1 clinical study of the first Tumor Paint product candidate, BLZ-100. The study, titled "A Phase I Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects with Skin Cancer," will enroll up to 30 patients with basal cell carcinoma, squamous cell carcinoma, or amelanotic melanoma. The primary objective is to evaluate the safety and tolerability of BLZ-100 after a single intravenous injection of BLZ-100 administered prior to surgery. The study will also examine the pharmacokinetics of BLZ-100 and the fluorescent signal from skin tumors.
"Initiation of the first-in-human clinical trial just a little over two years after moving the technology out of my lab at the Fred Hutchinson Cancer Research Center is a tremendous accomplishment and marks a major milestone in the development of the Tumor Paint platform," said Jim Olson, M.D., Ph.D., co-founder of Blaze.
"Skin cancer surgery is just one of many cancer surgery settings that we think could benefit from real-time fluorescent imaging using BLZ-100," said Dennis Miller, Ph.D., Senior Vice President of Development. "Blaze anticipates initiating a U.S. clinical program in additional tumor types by the end of 2014."
The study will be conducted at two sites: Q-Pharm Pty Limited and the dermatology clinic of Specialist Connect Pty Limited, both located in Brisbane, Queensland, Australia. Dr. Lynda Spelman of Specialist Connect is the Principal Investigator. Dr. Lauren Kunde and Dr. Paul Griffin are co-investigators.
SOURCE Blaze Bioscience, Inc.