Race Oncology Limited announced it has received human ethics approval from the Hunter New England Human Research Ethics Committee
(NSW, Australia) for the observational stage of a planned Phase 1/2b clinical trial of Zantrene (bisantrene dihydrochloride) in breast cancer patients, to be treated with doxorubicin and cyclophosphamide and who have two or more cardiovascular risk factors. Details of the trial design and purposes have been previously described. Before patients can be enrolled and treated Race must first submit and then receive research institutional governance (site budget and contracting) approval. Submission is expected to take place in the coming weeks. Governance approval is typically received within 4 to 8 weeks of submission. The study will recruit and monitor up to 50 patients being treated for breast cancer using the standard of care (SoC) regimen of doxorubicin (Adriamycin®) and cyclophosphamide - referred to as "AC chemotherapy". The aim of this study is to identify the rate and level of heart damage caused by AC chemotherapy, using modern advanced cardiac imaging and biochemical methods. In addition, the anti-cancer efficacy of AC chemotherapy will be monitored using a liquid biopsy (DNA) approach. The data from this study will be directional for the design of a subsequent Phase 1/2b interventional trial that may help patients to avoid the permanent heart damage that can be caused by AC chemotherapy as well as potentially improving anti-cancer outcomes. These human trials are fully funded from capital raised in December 2021.