Tumor Paint approved for first U.S. trial

Molecule that highlights cancer cells for surgery was pioneered by Fred Hutch’s Dr. Jim Olson, licensed by Blaze Bioscience Inc.
Tumor cells lit by Tumor Paint
These images of a soft tissue sarcoma from a dog demonstrate the use of Tumor Paint BLZ-100, which has been approved for a clinical trial in the U.S. The photograph on the right is a standard histological stain showing the morphology of the tissue. The photo on the left shows the fluorescence provided by Tumor Paint, with the cancerous cells highlighted in red. Photo courtesy Blaze Bioscience Inc.

A new protein-linked dye derived from scorpion venom that lights up cancer cells so surgeons can precisely target brain tumors will get a trial run in the U.S., Blaze Bioscience Inc. officials announced Thursday.

Food and Drug Administration officials have approved an investigational new drug application, or IND, for Tumor Paint BLZ-100, a molecule discovered and first developed by researchers at Fred Hutchinson Cancer Research Center, Seattle Children’s Hospital and the University of Washington.

“I think it really is a dream come true – to be outdone only by seeing these cancers light up in patients,” said Dr. Jim Olson, 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.

The FDA move means officials at Blaze Bioscience, the private Seattle biotechnology firm formed in 2010 to launch the Tumor Paint platform, can proceed with the clinical trial, which includes sites at Cedars-Sinai Medical Center in Los Angeles, California, and the NEWRO Foundation in Brisbane, Queensland, Australia.

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.

It may be especially beneficial for patients whose cancer might otherwise be difficult for surgeons to see – and remove, said Heather Franklin, the president and chief executive of Blaze Bioscience.

“We think that one of the benefits of this particular product is they may be able to see low-grade tumors,” she said.

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.

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,” Olson explained. “We believe (the target) is not present on the surface of normal cells.”

The chlorotoxin is the part that comes from death stalker scorpion venom, a discovery that Olson said came only after sorting through hundreds, if not thousands, of potential targets.

It’s chemically produced now; there’s no actual venom involved, Franklin said. Tests of the compound in skin cancer patients in Australia are ongoing, she added.

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.

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.

Olson, who is a founder of Blaze Bioscience, serves on the board of directors and is the firm's scientific director, said Franklin and others should be commended for getting a new product to this point so quickly. 

"They moved from a licensed molecule to human clinical trials in record time and at a record low cost," he said. "When I tell pharmaceutical executives what the Blaze team has accomplished, it's a jaw dropper."

The firm has poured nearly $10 million from investors into the effort, said Franklin, who estimates that it could take five or more years before the product is ready for the commercial market. 

"We will get it there as fast as we can," she added.

JoNel Aleccia is a staff writer at Fred Hutchinson Cancer Research Center. From 2008 to 2014, she was a national health reporter for NBC News and msnbc.com. Prior to that she was a reporter, editor and columnist for more than two decades at newspapers in the Northwest. Reach her at jaleccia@fredhutch.org

Solid tumors, such as those of the brain, are the focus of Solid Tumor Translational Research, a network comprised of Fred Hutchinson Cancer Research Center, UW Medicine and Seattle Cancer Care Alliance. STTR is bridging laboratory sciences and patient care to provide the most precise treatment options for patients with solid tumor cancers.

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