The FDA has approved an investigational new drug application for Tumor Paint BLZ-100, a protein-linked dye that highlights cancer cells in images so surgeons can precisely target brain tumors.

The FDA move means Blaze Bioscience can proceed with a clinical trial in Los Angeles, Queensland, Australia and other sites.

Twenty-one adult patients who need surgery for often-deadly glioma brain tumors are expected to enroll in the study, which is aimed at examining the safety of injecting the BLZ-100 molecule into the bloodstream, where it rushes to highlight cancer cells.

The molecule was discovered and first developed by researchers at Fred Hutchinson Cancer Research Center, Seattle Children’s Hospital, and the University of Washington.

BLZ-100 may be especially beneficial for patients whose cancer might otherwise be difficult for surgeons to see — and remove, said Heather Franklin, president and CEO of Blaze Bioscience. It may help solve a long-standing problem in medicine: how to identify tumor cells so surgeons don’t remove too little, leaving disease behind — or too much, removing healthy tissue.

Tests of the compound in skin cancer patients in Australia are ongoing, she added.

This first product based on Tumor Paint technology is a molecule that consists of two parts: a chlorotoxin protein that penetrates tumor cells and a dye that glows under near-infrared light.

“We believe it binds to a target protein on the surface of cancer cells,” said Jim Olson, M.D.. a Fred Hutch pediatric brain cancer expert who pioneered the notion of targeting tumors with fluorescent dye to help surgeons distinguish healthy cells from malignancies. “We believe (the target) is not present on the surface of normal cells.”

Participants are expected to enroll in the new trial through December 2015, according to the federal description. Patients must be adults ages 18 to 75 who meet a variety of criteria; eventually, Blaze researchers hope to test BLZ-100 in children, too.

May be useful or other cancers

The Phase 1 clinical trial is only one step toward routine use of Tumor Paint in hospitals around the world, Franklin said. It will be tested in brain tumors now, but preclinical evidence suggests that it may be helpful for a wide range of cancers, including lung, breast, prostate, colorectal, skin and sarcomas.

Blaze Bioscience has invested nearly $10 million, said Franklin, who estimates that it could take five or more years before the product is ready for the commercial market.