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FDA grants orphan drug designation to BLZ-100 for brain cancer
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The FDA granted orphan drug designation to BLZ-100, an agent intended to improve surgery for malignant brain tumors by providing real-time, high-resolution visualization of cancer cells, according to a press release from the drug’s manufacturer.
BLZ-100 (Blaze Bioscience) is the combination of an optide — or an optimized peptide that binds and internalizes into cancer cells — and a fluorescent dye which emits near–infrared-range light.
BLZ-100 is Blaze Bioscience’s first product candidate from its Tumor Paint platform. Tumor Paint products are designed to enable a more precise and complete tumor resection during surgery while sparing surrounding normal tissue by providing real-time, high-resolution intraoperative visualization of cancer cells, according to the press release.
Ongoing phase 1 proof-of-concept clinical studies are evaluating BLZ-100 in solid tumors.
“Improvements in brain cancer surgery represent one of the highest unmet medical needs for both adults and children with brain cancer,” Heather Franklin, MS, MBA, co-founder and chief executive officer of Blaze Bioscience, said in a press release. “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.”
The FDA’s Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.