• Race executes work order contract with George Clinical to support Phase 1 trial of anticancer treatment RC220
• Total cost of work order ~$8.6 million, with final trial cost to depend on number of recruited patients and other trial variables
• CEO Dr Daniel Tillett said the work order with George Clinical was a “significant milestone” for Race

Special Report: Race Oncology has announced it has teamed up with leading contract research organisation (CRO) George Clinical International to support the clinical development of its cardioprotective anticancer treatment RC220 bisantrene.

Race Oncology (ASX:RAC) has started working with George Clinical under a work order (WO) agreement for its Phase 1 RAC-010 trial of RC220 in combination with standard-of-care doses of doxorubicin (Adriamycin®) in patients with advanced solid tumours.

The company said the WO covered all outsourced trial-related services, investigator grants and pass-through costs for up to 53 patients for the dose escalation and dose expansion stages of the trial.

Race said the total cost of the WO was ~$8.6 million, with the final trial cost to depend on the number of recruited patients and other variables of trial execution.

The company said George Clinical was a leading global CRO with more than 20 years of operation with an impressive track record of success conducting oncology trials at all phases in the US, Europe, China, South-East Asia, New Zealand and Australia.

Reformulated drug to reduce cardiotoxicity

Bisantrene is an anthracene-based anticancer drug originally developed by Lederle Laboratories in the 1970s and 1980s.

It is known for reduced cardiotoxicity and providing cardioprotection when used in combination with anthracyclines, a major class of cancer-treatment drugs. Anthracyclines have been the most widely used and effective category of cancer chemotherapeutics for decades.

Although effective and approved for treating acute myeloid leukaemia in France, Race said bisantrene had a complex administration hindered commercial use.

Race’s lead asset RC220 is a reformulated version of bisantrene designed for easy clinical use through standard infusion via peripheral veins with the company exploring its anticancer and cardio-protective properties.

Trial to be held at multiple sites

The RAC-010 Phase 1 trial will be open-label and conducted across multiple sites in Australia, Hong Kong and South Korea.

Race said the trial would use ascending doses of RC220 to determine its safety, tolerability, pharmacokinetics and maximum tolerated combined dose in combination with doxorubicin, as well as the effects on a range of clinical biomarkers including m⁶A RNA.

After interim analysis of the data, the optimal dosage of RC220 in combination with doxorubicin will be assessed in additional patients for further safety, tolerability and preliminary cardioprotective and anticancer efficacy signals.

The company said the Phase 1 trial would use a Bayesian design enabling greater trial flexibility and speed.

‘Significant milestone’ for Race

Race Oncology’s CEO Dr Daniel Tillett said the WO with George Clinical was a “significant milestone” for Race.

“Bringing RC220 to the clinic as a new treatment to potentially protect patients from the heart damage caused by anthracyclines like doxorubicin, while also improving the treatment of their cancer, is groundbreaking,”

“I wish to thank George Clinical and the entire Race clinical team for their hard work and dedication in establishing this agreement.”

This article was developed in collaboration with Race Oncology, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.