Q: Many shareholders, including myself, are wondering how it has...

Q: Many shareholders, including myself, are wondering how it has been possible to cancel the non-interventional phase of the cardio-protection trial. Todays announcement hasn't shed any further light on this. Has the company found new data that means that this is no longer required? Is there any further information that is able to be provided that can clear this up? Thanks



A: Thank you for your email and question. This topic was addressed within the 7 July 2023 H1 2023 Update, and I have copied the answer below. Please let me know if you have any more questions relating to this. Thanks.

"While awaiting institutional and regulatory approvals, further diligence has been performed on “Trial 1 Non-Interventional”, which was designed to assess cardiac damage and tumour response in breast cancer patients receiving doxorubicin plus cyclophosphamide (AC) therapy only, establishing an effective baseline for comparison purposes. In agreement with the principal investigator, and consultation with international breast cancer specialists and cardio-oncologists, the Company has chosen to terminate this non-interventional AC therapy protocol and allocate related capital (AUD $3m) to RC220 led programs. Upon review, our panel of advisors suggests that readily available datasets can be used for baseline and clinical comparisons. Importantly, we emphasise that the timeframe for the RC220 interventional breast cancer study is not impacted by this decision and the non-interventional trial would have provided no bisantrene-specific insights."