US-based biotechnology company Avelas Biosciences has completed the first round of patient enrolment for its Phase ll clinical trial of AVB-620 in women with primary, nonrecurrent breast cancer undergoing surgery.
The first round is designed to include around 30 patients to examine optimal conditions to achieve differences in fluorescent signals between malignant and nonmalignant tissues using fluorescent signals.
The multi-centre, open-label, single-arm Phase ll study is designed to evaluate roughly 100 patients in two separate trial periods.
The trial’s second round aims to evaluate around 70 new patients to test dosing and imaging conditions determined in period one. It will also evaluate the accuracy of AVB-620 imaging data to differentiate between malignant and nonmalignant tissues.
Avelas Biosciences president and CEO Carmine Stengone said: “This study is designed to confirm the findings of our Phase lb 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.”
In addition, Avelas has concluded a Phase lb clinical trial of AVB-620 to evaluate the safety, pharmacokinetics and fluorescence properties using tissue image analysis.
The company is also conducting a Phase ll clinical trial of AVB-620 to treat breast cancer. A therapeutic programme, which employs the same technology platform, has also been advanced by Avelas.