Race Oncology Ltd (ASX:RAC) has received human ethics approval from the Hunter New England Human Research Ethics Committee (NSW, Australia) for the initial observational stage of a planned interventional Phase 1/2b cardioprotection clinical program using Zantrene® (bisantrene dihydrochloride).
This observation trial is the first step in advancing the cardioprotection opportunity for Zantrene in the clinic.
The trial will be conducted in breast cancer patients who will be treated with doxorubicin and cyclophosphamide and who have two or more cardiovascular risk factors.
"Significant unmet need"
“Cardioprotection for breast cancer is a significant unmet need and our preclinical data suggests that Zantrene may help to address the therapeutic gap for patients whilst still delivering clinical efficacy,” Race CEO Damian Clarke-Bruce said.
“I look forward to the team progressing the clinical program and building more knowledge to enable further clarity on the potential commercial opportunity this program represents.”
Research institutional governance submission
Race is required to submit and then receive research institutional governance (site budget and contracting) approval before enrolling patients for the trial.
Submission will occur in the coming weeks, with governance approval generally received within four to eight weeks of submission.
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’ will be recruited and monitored.
RAC aims 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.
Fully funded
The human trials are fully funded from the company’s December capital raise.
“This trial is Race’s first step in advancing the cardioprotection opportunity for Zantrene in the clinic,” Race CSO Dr Daniel Tillett said.
“Gaining high-quality observational data to design our interventional Phase 1/2b trial of Zantrene in breast cancer is critical to the success of this program.
"We look forward to updating our investors on the progress of this trial.”
Investors have welcomed the news with RAC shares as much as 5.86% higher to A$1.99 while the company's market cap is approximately A$319.96 million.