• Novel blood-based test developed to assess anthracycline cardioprotection
• Test to be used in RAC-010 cardioprotection trial to collect data on RC220's ability to protect against anthracycline cardiotoxicity
• Trial protocol changes required to use the new test, expected to improve patient safety and aid recruitment

Racura Oncology has developed a new blood-based molecular test to assess the cardioprotective potential of its drug candidate RC220. This test will be used to quantify the protective effects of RC220 on the molecular pathways causing anthracycline cardiotoxicity, using patient samples from the RAC-010 cardioprotection and anticancer synergy (CPACS) trial. The development of this test was enabled by Racura's recent discovery of the mechanisms of action of (E,E)-bisantrene. The new blood test is intended to provide early clinical and scientific cardioprotective data from doxorubicin-treated patients in the RC220 dose escalation phase of the RAC-010 trial, more than two years earlier than originally planned. Modifications to the original RAC-010 clinical trial design were necessary to use the new blood test, principally the addition of an initial cycle of doxorubicin monotherapy. This doxorubicin-only cycle establishes a molecular baseline for tissue damage and allows for correction of individual patient differences in doxorubicin metabolism. The significant differences in clinical practice and documentation needs across the sites and jurisdictions necessitated extensive coordination by the Racura clinical team to generate a revised trial protocol acceptable to all parties. While recruitment for the trial was not stopped, investigators have been careful when enrolling patients over the past six months due to the anticipated protocol changes and the need to identify individuals who might not be able to tolerate doxorubicin in combination with RC220. Encouragingly, recruitment activity has recently increased, with three patients now in pre-screening. Approval of the amended trial protocol has been received from the Bellberry Human Research Ethics Committee (HREC) enabling the three Australian sites to start using the updated trial protocol, and final ethics and regulatory data packages have been submitted to the two Hong Kong Institutional Review Boards (IRBs) and the Hong Kong Department of Health (DOH), as well as to the four local Korean IRBs and the Korean Ministry of Food and Drug Safety (MFDS) national regulator.

Racura expects the use of the new blood test in the RAC-010 CPACS trial to provide early clinical and scientific cardioprotective data from doxorubicin-treated patients, more than two years earlier than originally planned.

The new blood test has the potential to identify the optimal cardioprotective dose of RC220 from the escalating dose levels used in the trial. The trial changes are expected to improve patient safety and aid recruitment, with no expected overall change to current trial costs.