SEATTLE--(BUSINESS WIRE)--Blaze Bioscience, the Tumor Paint Company®, a biotechnology company focused on guided cancer therapy, today announced that the company has received Orphan Drug Designation for BLZ-100 from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) for malignant brain tumors.
“Improvements in brain cancer surgery represent one of the highest unmet medical needs for both adults and children with brain cancer,” said Blaze co-founder and CEO Heather Franklin. “We continue to enroll patients in our ongoing Phase 1 studies in adult and pediatric patients with brain cancer and our goal is to rapidly advance the development of BLZ-100 to address the needs of these patients with the added support of the FDA’s Orphan Drug program.”
BLZ-100 is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide), which binds and internalizes into cancer cells, 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, enabling more precise, complete resection of cancer throughout surgery. Preclinical utility of Tumor Paint technology has been demonstrated in a wide range of cancer types, including brain, lung, breast, prostate, and colorectal. BLZ-100 is currently in multiple Phase 1 proof-of-concept clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumor cancers.
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