Race Oncology Ltd (ASX:RAC) is poised to assess the cardiovascular-protective properties of its Zantrene® (bisantrene) treatment in the observational stage of a Phase 1/2b clinical trial in breast cancer patients treated with doxorubicin and cyclophosphamide with at least two cardiovascular risk factors.
The company has appointed Resolutum Global, Beyond Drug Development and NSW Regional Biospecimen & Research Services to support the clinical program.
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“I am very pleased Race will be working with Resolutum Global, Beyond Drug Development and NSW Regional Biospecimen & Research Services to advance our cardioprotection opportunity for Zantrene in the clinic,” Race Oncology chief scientific officer Dr Daniel Tillett said.
“Gaining high-quality observational data to help design our interventional Phase 1/2b trial of Zantrene in breast cancer patients will be critical to the success of this program.”
Study will assess standard of care regimen
The observational 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.
“This study launches our clinical journey of advancing Zantrene to protect vulnerable patients from the serious and irreversible heart damage that can result from current breast cancer treatments,” Race Oncology CEO Damian Clarke-Bruce said.
“After spending a week with Cardio-Oncologists at ACC23 it is evident that chemotherapy-induced heart damage remains a significant concern with limited therapeutic options.
“Improving cancer patients’ quality of life has become an increasing goal for pharmaceutical companies and Zantrene has the potential to fill this unmet clinical need.”
Race Oncology expects to make a clinical trial institutional governance submission soon, after which enrolment of the first patient can begin.