Clinical Program

Clinical Program

Race is progressing a robust pipeline of clinical activities for RC220 bisantrene.

RC220 is a proprietary formulation designed to enable peripheral and central intravenous administration of bisantrene.

Bisantrene has proven clinical efficacy in a range of solid tumour cancers with lower heart toxicity than other widely used chemotherapies.

Bisantrene was explored as a new breast cancer treatment in seven Phase 2 and 3 clinical trials in the 1980s. In the large Phase 3 trial, bisantrene showed equivalent patient survival efficacy as doxorubicin, a current standard of care chemotherapeutic, but with significantly lower rates of serious damage to the heart (4% bisantrene verses 23% doxorubicin). Bisantrene also showed much lower rates of hair loss (alopecia) than doxorubicin.

In recent discoveries made by Race Oncology scientists have also identified animal models, in which the combination of bisantrene and doxorubicin can better treat cancers while also protecting the heart from the permanent damage caused by doxorubicin chemotherapy.

Race is undertaking a Phase 1 clinical trial of RC220 in patients with solid tumours where the use of doxorubicin is indicated. For further information about this trial please contact us at trials@raceoncology.com.

Bisantrene has an extensive clinical history in treating AML and was approved in France for the treatment of relapsed or refractory (R/R) AML in 1988.

Race Oncology in collaboration with the Sheba Medical Center in Israel has run two Phase 2 clinical trials in R/R AML patients using RC110 (bisantrene). The first, completed in 2020, demonstrated a 40% response rate in late-stage AML patients who had failed a median of three prior lines of treatment. The second, which reported interim results in 2023, demonstrated a 40% response in very advanced AML patients (median of four lines of prior treatment) when used in combination with fludarabine and clofarabine.

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