Seattle Children's opens enrollment for first clinical trial of Tumor Paint BLZ-100 for children with brain tumors

Seattle Children's today announced the opening of patient enrollment for the first clinical research trial of the drug Tumor Paint BLZ-100, which is designed to improve surgical outcomes in children with brain tumors – the most common solid tumor cancer in kids. The phase 1 trial, which is being conducted under an open U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application, is open to infants through young adults under age 30 who have been diagnosed with a brain tumor.

Complete removal of a brain tumor in surgery is the greatest predictor of survival for patients with brain cancer. However, tumor cells are difficult to distinguish from healthy cells in surgery, and the removal of healthy tissue can lead to serious long-term side effects. Tumor Paint BLZ-100, which was developed by Blaze Bioscience based on technology licensed from Seattle Children's, Fred Hutch and the University of Washington, aims to enable better detection and surgical resection of solid tumors without injuring surrounding healthy tissue. The drug acts as a molecular flashlight that binds to tumors cells and makes them glow, providing surgeons with real-time, high-resolution visualization of cancer cells.

"Cure is not just about successful treatment of a tumor, but successful treatment of a child," said Dr. Sarah Leary, principal investigator for the new trial and an oncologist at Seattle Children's. "Much of cancer treatment for children is a trade-off where curative therapy comes with serious long-term side effects. Tumor Paint BLZ-100 is different. In addition to potentially improving surgical outcomes, Tumor Paint BLZ-100 has the added potential to greatly increase the quality of life for children by reducing treatment-related damage to the healthy brain."

In the pediatric trial, which is funded by a generous $800,000 grant from Gateway for Cancer Research^SM, Tumor Paint BLZ-100 will be administered by intravenous injection prior to surgery. Researchers expect it to make tumor tissue glow in the operating room when exposed to laser light and imaged with a near-infrared camera system. Tumor tissue will be imaged during surgery in the operating room and after surgery in Seattle Children's Department of Laboratory Medicine and Pathology to determine how well the drug targets brain tumors in children.

"Tumor Paint has the potential to completely revolutionize surgical oncology," said Dr. Jim Olson, inventor of Tumor Paint technology, co-founder of Blaze Bioscience, a pediatric neuro-oncologist at Seattle Children's and Fred Hutch, a researcher in the Center for Clinical and Translational Research at Seattle Children's Research Institute, and a professor of pediatrics at the University of Washington. "My patients inspired me to invent this technology, because for many, a complete surgical resection means the difference between life and death. It also means that some patients need only half as much radiation to their brain. We began this work in my lab a decade ago and nothing is more rewarding than seeing this technology reach pediatric patients for the first time through the launch of this clinical trial."

Leary said she hopes this phase 1 trial at Seattle Children's, which has the largest pediatric Brain Tumor Program and the most pediatric neurosurgeons in the Northwest, will be followed by other studies that lead Tumor Paint BLZ-100 to become the standard of care for brain tumor surgery.

"In the future, I think we'll look back and wonder how these surgeries were ever done without the lights on," said Leary, who is also a researcher in the Center for Clinical and Translational Research at Seattle Children's Research Institute and an associate professor of pediatrics at the University of Washington.