Race Oncology Ltd (ASX:RAC) is advancing the trial of its key drug Zantrene® (bisantrene dihydrochloride) for use in cardio protection of breast cancer patients receiving the standard of care regimen of doxorubicin (Adriamycin®) and cyclophosphamide, commonly referred to as AC chemotherapy.
The company has submitted a human ethics application to the Hunter New England Human Research Ethics Committee in NSW, seeking approval to commence the observational stage of a planned Phase 1/2b clinical trial of Zantrene® in breast cancer patients undergoing AC chemotherapy and who have two or more cardiovascular risk factors.
The study aims to identify the rate and level of heart damage caused by AC chemotherapy using modern advanced cardiac imaging and biochemical methods.
Two-year study
The data will then be used to design the Phase 1/2b interventional trial that may help patients to avoid the permeant heart damage caused by AC chemotherapy and improve anti-cancer outcomes.
The study will be led by Associate Professor Aaron Svedlov, a highly-credentialed cardiologist with more than 50 peer-reviewed publications and four book chapters in the field of cardio-oncology.
Dr Sverdlov, who was awarded the 2018 Ministerial Award for Rising Stars in Cardiovascular Research, established and co-chairs the National Cardio-Oncology Working Group under the auspices of the Australian Cardiovascular Alliance.
Up to 50 patients will be recruited for the 24-month study in 2023.
Commercial opportunity
“Cardioprotection remains a significant unmet patient need, and our pre-clinical data suggests that we have in Zantrene the opportunity to effectively address this need,” Race chief executive officer Phillip Lynch said.
“I look forward to us progressing the clinical program and to clarifying the large commercial opportunity this program represents.”
Race chief scientific officer Dr Daniel Tillett added: “This trial is Race’s first step in advancing the cardioprotection opportunity for Zantrene in the clinic. 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.”
The company’s trials are fully funded from capital raised last year.
Safer alternative
Zantrene was originally developed as a safer alternative to anthracyclines, drugs used to treat millions of cancer patients every year, particularly with respect to preservation of the heart muscle.
In the late 1980s, a single agent clinical trial in the US using Zantrene in advanced breast cancer patients showed that the drug had comparable efficacy to doxorubicin but was significantly less damaging to the patients’ hearts.
About 24% of patients who received doxorubicin suffered serious heart failure compared to just 6.6% with Zantrene, the study showed.
In recent studies, Zantrene was found to protect human heart muscle cells grown in cell culture from doxorubicin-induced cell death. It was also found to protect the hearts of mice from the damaging effects of doxorubicin even when the chemotherapeutic dose was increased without significant additional toxicity or bone marrow suppression.