BLZ-100 and the high-sensitivity Canvas Imaging System are currently being tested in a Phase 2/3 clinical study in patients with pediatric central nervous system tumors

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Blaze secures FDA fast track designation for its clinical study of its BLZ-100. (Credit: VSRao from Pixabay.)

US-based biotechnology firm Blaze Bioscience has secured the US Food and Drug Administration (FDA) fast track designation for its clinical programme evaluating tozuleristide (BLZ-100) for pediatric brain tumours.

BLZ-100 is an optical imaging agent designed to target tumours and is said to provide real-time, high-resolution visualization of cancer cells during surgery, potentially enabling more effective removal of cancerous tissue while sparing healthy tissue.

Blaze Bioscience development executive vice president Dennis Miller said: “Receiving Fast Track designation is an important recognition of the importance of our pediatric brain cancer surgery program and the promise of tozuleristide in this patient population.

“Pediatric brain tumours remain the leading cause of cancer-related death among children and adolescents. We look forward to our continued collaborative relationship with the FDA as we work to complete the clinical and other product development work needed to speed the product to approval.”

BLZ-100 is an optical imaging agent that provides high-resolution visualization of cancer cells

The company said that the enhanced precision in surgery would improve downstream treatment options for people with cancer. Its BLZ-100 and the high-sensitivity Canvas Imaging System are currently being tested in a Phase 2/3 clinical study on patients with pediatric brain tumours.

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 system was developed and manufactured by Teal Light Surgical and is under development.

Also, BLZ-100 is the first product candidate from the company’s tumour paint platform and is comprised of a targeting peptide and a fluorescent dye, which emits near-infrared (NIR) light.

The products in its tumour paint platform are designed to provide real-time, high-resolution intraoperative visualisation of cancer cells throughout surgery, potentially enabling more precise, complete resection of cancer while sparing normal adjacent tissue.

Blaze said that its BLZ-100 has been tested in four Phase 1 clinical trials and has shown clinical proof of concept in brain, breast and skin cancers. The drug can also be used for prostate, lung, colorectal and other solid tumour cancers.