Avelas Biosciences has dosed the first patient in the Period 2 of a Phase ll clinical trial that aims to evaluate AVB-620 for the treatment of women with primary, non-recurrent breast cancer undergoing surgery.
The multi-centre, open-label, single-arm Phase ll trial comprises two separate trial periods.
The Period 1 trial was completed in December last year with the enrolment of 31 patients, who were analysed for optimal conditions to achieve differentiation between malignant and non-malignant tissue using fluorescent signals.
Period 2 is expected to enrol around 108 additional patients to evaluate the ability of AVB-620 to identify malignant tissue at or close to the surface of excised tissue and of tissue that would otherwise have been left behind.
The trial's primary objective is to determine the accuracy of AVB-620 imaging data to distinguish between malignant and non-malignant tissues over a period of one month.
The trial’s secondary objectives are safety, identification of malignant tissue types, and evaluation of the timing of avb-620 administration on optical fluorescence characteristics.
Avelas Biosciences chief medical officer Steven Chen said: “A technology like AVB-620 has the potential to revolutionise cancer surgery by enabling surgeons to visualise cancer while still in the operating room, and make informed, real-time decisions to improve surgical treatment.
“We believe that AVB-620 has the potential to significantly reduce the number of breast cancer re-operations, which would result in better outcomes for patients and substantial cost savings for healthcare payers.”
AVB-620 is an investigational synthetic protease-activated peptide dye conjugate designed to administer intravenously for the fluorescence detection and localisation of potentially malignant tissue in primary tumour, tumour margins, or lymph nodes.