ASX-listed precision oncology company Race Oncology (ASX:RAC) has executed contracts to begin the observational stage of a phase 1/2b clinical trial of its phase two/three cancer drug Zantrene.
The company says it has appointed the contract research organisations Resolutum Global, Beyond Drug Development, and NSW Regional Biospecimen and Research Services in order to support the Zantrene breast cancer cardioprotection clinical program.
Race Oncology notes the trial will recruit and monitor up to 50 patients being treated for breast cancer using the standard of care (SoC) regimen of doxorubicin and cyclophosphamide-referred to as “AC chemotherapy”, in order to identify the rate and level of heart damage caused by AC chemotherapy using modern, advanced cardiac imaging and biochemical methods.
“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”
In addition, it is reported the anti-cancer efficacy of AC chemotherapy will aso be monitored using a liquid biopsy (DNA) approach.
The company also notes the data generated by this study will inform the design of a subsequent phase1/2b interventional trial that may help patients to avoid the permanent heart damage that can be caused by AC chemotherapy, while also improving anti-cancer outcomes.
The trials are fully funded from capital raised in December 2021, and all details of the observational trial design and purposes have been previously described, as announced by the company in December 2021 and 2022.
Terms of the contract include Race paying Resolutum Global a sum of $422,389.59 for data management and biostatistics services; Beyond Drug Development $658,296.75 for clinical site management and monitoring, safety management reporting, and clinical study report development services; and NSW Regional Biospecimen and Research Services $206,928.50 for patient sample kit production and processing and samples storage services.
Commenting on the trial, Race Oncology Chief Executive Officer (CEO) Damian Clarke-Bruce said: “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. 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.”
Also commenting on the trial, company Chief Security Officer (CSO) Dr Daniel Tillett said: “I am very pleased Race will be working with Resolutum Global, Beyond Drug Development, and NSW Regional Biospecimen and Research Services to advance our cardioprotection opportunity for Zantrene in the clinic. 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.”
Race Oncology is an ASX-listed precision oncology company focused on developing its phase two/three cancer drug Zantrene. The drug represents a potent inhibitor of the Fatso/Fat mass and obesity associated (FTO) protein which, when overexpressed, has been shown to be a genetic driver of a diverse range of cancers.
The company believes Zantrene can be used as a new therapy for melanoma and clear cell renal cell carcinoma, which are both frequent FTO over-expressing cancers.