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Trial Underway Testing Breast Cancer Surgical Aid

Breast self exam

(National Cancer Institute)

29 October 2015. An early-stage clinical trial is recruiting participants to test a peptide that illuminates tumor cells to be removed in breast cancer surgery. The study is testing the experimental product made by Avelas Biosciences Inc., a biotechnology company in La Jolla, California.

The clinical trial is enrolling individuals with primary, non-recurring breast cancer, scheduled for mastectomy or lumpectomy surgery at University of California in San Francisco. The study is testing an engineered peptide, a short chain of amino acids, code-named AVB-620, which lights up and changes the color of tumor cells to distinguish the cancer from healthy tissue, and make the tumor easier to remove during surgery.

AVB-620 is the lead product from Avelas’s technology platform developing cell-penetrating peptides that act on enzymes produced by cancer cells. The company licenses research on cell-penetrating peptides from the lab of neuroscientist Roger Tsien at UC-San Diego. Tsien, a winner of the Nobel Prize for chemistry in 2008, studies cell signaling in neuron and cancer cells, responding to engineered molecules, such as those in AVB-620, as well as photochemical manipulation.

The trial plans to recruit 39 patients at UC-San Francisco and Moores Cancer Center at UC-San Diego. Its main goal is to assess the safety and tolerability of AVB-620, after a single dose of the peptide with an intravenous infusion. The study is also looking for activity of AVB-620 in the body, and determine the dosage needed to generate a fluorescence signal in tumor and lymph node tissue, as well as further image analysis.

“Currently, surgeons have no simple or reliable way to determine boundaries of tumors in real time during surgery,” says Jasmine Wong, a breast cancer surgeon and site leader for the study at UC-San Francisco, in an Avelas statement. “We face a delicate balancing act between removing too much tissue, which can lead to an unacceptable cosmetic outcome, and not removing enough tissue, which means subsequent surgeries will be needed.”

Highlighting tumor cells and distinguishing them from healthy tissue is the objective of an optical device tested in a clinical trial reported last month. In this case, the trial tested a hand-held wand designed by physician and engineering professor Stephan Boppart at University of Illinois in Champaign, and developed by Diagnostic Photonics Inc., a spin-off company co-founded by Boppart. As reported in Science & Enterprise, the results show a high correlation between the images from the device and pathologist reviews of diseased and healthy tissue.

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