Avelas Biosciences, a clinical stage oncology-focused company that is developing products to advance a new standard-of-care for cancer surgery and therapeutic intervention, announced the completion of Period 1 patient enrollment in its phase 2 clinical trial of AVB-620 in women with primary, nonrecurrent breast cancer undergoing surgery. Period 1 was designed to enroll approximately 30 patients to evaluate optimal conditions to achieve differences in fluorescent signals between malignant and nonmalignant tissues.
“We are pleased to have completed enrollment in the first stage of our phase 2 study of AVB-620 and with the progress of this trial to date,” said Carmine Stengone, president and chief executive officer of Avelas Biosciences. “This study is designed to confirm the findings of our phase 1b study, which demonstrated that AVB-620 generates fluorescent signals that can distinguish breast cancer from adjacent non-cancerous tissue. We believe this technology has the potential to reduce the number of repeat surgeries from incomplete initial resections, potentially resulting in substantial cost savings and superior outcomes for patients.”
The phase 2 study of AVB-620 is a multi-center, open-label, single-arm study designed to evaluate approximately 100 patients during two separate trial periods. Period 1 has reached its goal of enrolling 30 patients to evaluate conditions to achieve differentiation between malignant and nonmalignant tissue using fluorescent signals. Period 2 of the study will assess approximately 70 additional patients to test dosing and imaging conditions determined in Period 1, and the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT03113825.