Avelas Biosciences Completes Patient Enrollment for AVB-620 Phase 1b Clinical Trial
Topline Results Expected by year-end 2016
SAN DIEGO, Sept. 8, 2016 — Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced the completion of patient enrollment in its Phase 1b clinical trial for AVB-620, a surgical marker, in women with primary, non-recurrent breast cancer undergoing surgery. Avelas will announce data from the trial at a future medical meeting.
“I’m pleased to announce that we have completed enrollment in our Phase 1b trial of AVB-620 in women with primary, non-recurrent breast cancer undergoing surgery,” said Carmine N. Stengone, president and chief executive officer of Avelas Biosciences. “I believe that AVB-620 could contribute materially and positively to the diagnosis and treatment of this highly prevalent disease and look forward to sharing the results from this program in the coming months.”
AVB-620 Phase 1b Clinical Program
Fifteen patients were enrolled in the initial dose-escalation portion of the Phase 1b trial, the purpose of which was to evaluate safety and pharmacokinetics and to determine the dose for additional imaging analysis in the second stage of the study. Interim analysis showed no toxicity issues and identified a preferred dose to take forward into the expansion phase of the trial. A total of 12 additional patients have been enrolled in the dose-expansion stage of the trial, where the focus remains on safety, pharmacokinetics, and the timing of imaging after AVB-620 administration. The company expects to announce data from its completed Phase 1b trial later this year.
AVB-620 is an intravenously administered in vivo fluorescent protease-activatable peptide that detects, labels, and visualizes cancer. The initial potential use for AVB-620 is the intraoperative identification of primary tumor extent and metastatic lymph nodes in breast cancer patients. AVB-620 displayed outstanding preclinical data with sensitivity of greater than 95% in preclinical breast cancer models and ex vivo analysis of human breast cancer tissue.
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. The company’s lead candidate, AVB-620, is in a Phase 1b trial that has enrolled 27 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.