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Clinical Trial Underway Testing Cancer Surgery Aid

Cedars-Sinai Medical Center

Cedars-Sinai Medical Center. Los Angeles, California (cedars-sinai.edu)

22 September 2015. A clinical trial is enrolling patients with soft tissue sarcoma to test a synthetic peptide that illuminates cancer cells to make them more easily removed during surgery. The early-stage study is testing the safety of the peptide made by Blaze Bioscience Inc. in Seattle and conducted at Cedars-Sinai Medical Center in Los Angeles.

The study is enrolling 21 patients with soft tissue sarcoma, a type of cancer that begins in the body’s connective tissue, such as skin, fat, muscles, tendons, and blood vessels. The most common types of soft tissue sarcoma occur in the abdomen, as well as arms and legs, but can happen anywhere in the body. American Cancer Society says nearly 12,000 people in the U.S. will be diagnosed with soft tissue sarcoma in 2015, causing more than 4,800 deaths.

Blaze Bioscience is a spin-off enterprise from Fred Hutchinson Cancer Research Center, also in Seattle, to develop and commercialize drug candidates based on engineered peptides that better target tumor cells than conventional cancer drugs. The company is commercializing research begun at the Hutchinson center on optides — short for optimized peptides — engineered protein molecules that more precisely target cancer cells than most of today’s chemotherapy drugs. The better that cancer treatments can zero-in on and bind to tumor cells, the fewer the side-effects, often severe, that affect cancer patients undergoing chemotherapy.

The clinical trial is testing the safety of Blaze’s optide code-named BLZ-100 that refines the optide technology into what the company calls tumor paint. BLZ-100 combines optides with a fluorescent dye, emitting light in the near-infrared range. The company says BLZ-100 is based on a peptide variant called chlorotoxin, originally derived from scorpion venom, which in its natural state has been shown to bind to some tumors. Treatments with BLZ-100 are expected to provide high-resolution visualization of cancer cells during surgery, making possible more precise and complete removal.

The study team plans to look mainly for adverse effects of BLZ-100 among patients during their cancer surgery. Participants will be randomly assigned to various dosage levels of BLZ-100, given intravenously.

Participants will also be observed for the chemical activity of BLZ-100 in the body, particularly changes in blood concentration at various time intervals and fluorescent signals measured by near infrared imaging in sections of excised tumor and adjacent normal tissue. These observations are expected to help determine the optimal dose and imaging interval for BLZ-100.

The trial is funded mainly by a $1.5 million Small Business Innovation Research grant from National Cancer Institute, part of National Institutes of Health. As reported by Science & Enterprise in July, BLZ-100 received orphan drug status from the Food and Drug Administration.

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