Clinical Program

Clinical Program

Race is progressing a robust pipeline of clinical activities for bisantrene to maximise commercialisation and partnership opportunities to benefit cancer patients worldwide.

An ‘all comers’ Bayesian dose escalation Phase 1a trial of bisantrene in any solid tumour patient where anthracycline use is indicated.

Phase 1a will establish optimal bisantrene anthracycline dosing and safety, while Phase 1b will generate proof-of-concept cardioprotection efficacy data in combination with anthracyclines. Effects on m⁶A RNA levels will be measured as an exploratory endpoint.

A placebo-controlled, double-blinded, umbrella Bayesian combination trial of bisantrene. The focus for this trial will be on breast cancer, plus any cancer or patient population that shows exceptional response to treatment in Phase 1.

This trial will generate gold-standard, double-blinded efficacy data of bisantrene as a cardioprotective agent and will provide supportive data on anticancer efficacy & the effect of bisantrene on the m⁶A RNA system.

This trial is a low intensity salvage treatment for patients unable or unwilling to tolerate high intensity chemotherapy who have failed standard of care AML treatments.

The trial will provide clinical efficacy data supporting the use of bisantrene in low intensity AML combination protocols that are compatible with the standard of care use of venetoclax

Preclinical Activities

Continue studies to determine the cardioprotection mechanism of action

Develop the next generation bisantrene with a focus on the m⁶A RNA opportunity

Continue build of the preclinical data package needed to support pharma transaction/partnering activities

Generate data to enable an FDA IND application