Clinical Trial Of Cancer Illuminator To Increase Surgical Accuracy For Breast Cancer Starts At University of California, San Francisco (UCSF)

SAN DIEGO, October 29, 2015 – Avelas Biosciences, a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, announced today that clinical trial enrollment has initiated at the University of California, San Francisco (UCSF) for the company’s in vivo surgical diagnostic agent, AVB-620, for breast cancer.

AVB-620 is a fluorescent, cancer-illuminating probe that is designed to enable cancer surgeons to distinguish tumor tissue from normal during surgery, potentially preventing the need for many secondary surgeries to ensure complete tumor removal.

“Surgeons tend to rely on their opinion of how tissue looks and feels. Since AVB-620 changes color when it interacts with cancer cells, it may provide a new way to distinguish between cancer and healthy tissue,” said Steven Chen, M.D., vice president of Clinical Affairs at Avelas Biosciences. “We believe AVB-620 can offer the necessary real-time information needed by surgeons to visualize and excise the cancerous tissue while they operate and avoid the need for additional surgeries.”

“Currently, surgeons have no simple or reliable way to determine boundaries of tumors in real time during surgery,” said Jasmine Wong, M.D., assistant professor for clinical surgery and UCSF site leader for the study. “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.”

The open-label dose escalation study will enroll up to 39 women with stage I-III breast cancer and will evaluate AVB-620 safety and pharmacokinetics, as well as determine the dose needed to generate fluorescence signals in tumor and lymph node tissues sufficient for visualization and image analysis. The study is also enrolling patients at Moores Cancer Center at UC San Diego Health.

“Traditional pathology reports take days and do not provide guidance at the time of surgery. If this agent works, it would provide the necessary information in the operating room during surgery to allow surgeons to know how much tissue to take out and would give patients confidence that they would not have to come back to the operating room a second time because insufficient tissue was taken (positive margins),” said Laura J. Esserman, M.D., MBA, director of the UCSF Carol Franc Buck Breast Care Center. “That is what this trial is all about -- testing a new promising tool to help us do better for our patients.”

For more info on the clinical trial, visit https://clinicaltrials.gov/ct2/show/NCT02391194.

About Avelas Biosciences

Avelas Biosciences is a San Diego-based biotechnology company focused on developing technologies that advance a new standard-of-care for cancer surgery and therapeutic intervention. Lead candidate AVB-620 is in phase 1b trials in up to 39 breast cancer patients, assessing safety, pharmacokinetics and fluorescence properties using tissue image analysis. Avelas was founded by Avalon Ventures on technology from Nobel laureate Roger Y. Tsien, Ph.D. For additional information, please visit www.avelasbio.com.

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