San Diego’s Avelas Biosciences says today that UC San Francisco has begun enrolling women who face breast cancer surgery in a clinical trial for AVB-620, a diagnostic agent that helps surgeons differentiate cancerous tissue from healthy tissue in real time.
The technology behind AVB-620 was developed by Roger Tsien, a UC San Diego biochemist who shared the 2008 Nobel Prize in chemistry for his role in the discovery and development of fluorescing peptides. Tsien co-founded Avelas in 2009 with investor Kevin Kinsella, the founder of San Diego’s Avalon Ventures.
AVB-620 is a fluorescing peptide that glows (under UV light) in the presence of protease, an enzyme that breaks down proteins and peptides. Tumors and metastases produce excessive amounts of protease, so a peptide that fluoresces in a particular way in tissue with high protease activity could be used to help a surgeon tell the difference between healthy and cancerous lymph nodes.
The early stage trial is intended to evaluate the biologic agent, which is administered intravenously before surgery. The study at UC San Francisco is expected to enroll about 39 women with primary, non-recurrent breast cancer, according to a summary at the website ClinicalTrials.gov.
While there are guidelines to help breast surgeons decide how much tissue to excise, surgeons tend to rely on their opinion of how tissue looks and feels, according to Stephen Chen, a vice president of clinical affairs at Avelas. Depending on the case, a surgical team today typically would await the results of tissue samples sent to pathology for analysis, or if necessary, schedule a follow-up surgery to remove more tissue.
One study published last year in JAMA Surgery estimated that one in four women who undergo such procedures return for additional surgery.
“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,” Jasmine Wong, an assistant professor for clinical surgery and UCSF site leader for the study, said in a statement released by Avelas.
The first-in-human trials began earlier this year at UC San Diego’s Moores Cancer Center, according to Avelas.
In a statement issued late yesterday, Avelas CEO Carmine Stengone said, “The clinical sites continue to execute on our enrollment goals and we have been very encouraged by the results we have generated so far.”
The primary goal of the UCSF trial is to assess the safety of AVB-620 by measuring the incidence of adverse events and abnormal lab values. The trial also is intended to build a pharmacokinetic profile of the biologic agent, and determine the dose needed to generate fluorescence signals in tumor and lymph node tissues sufficient for visualization and image analysis.