There doesn't appear to be much difference by risk factors in how much damage anthracyclines cause the heart, where the difference shows up is those with other cardiac risk factors are more likely to end up functionally disabled from the damage. The best explanation of this is those with cardiac risk factors have less spare capacity so that even limited damage can result in very serious health impacts.
Race does not have a terrible record of running clinical trials. The EMD AML trial was set up and run with no issues, the issue with the trial had nothing to do with how it was designed and run and everything to do with current clinical practice. If we had been terrible we would have launched straight into a multisite trial costs $10s million of dollars and only then found out that there were issues. Given we are not advancing RC110 we haven't even lost time or progress, and by being careful, we have minimised the cost incurred. The EMD AML opportunity remains live and it may be something we continue when we have more resources. We are still supporting the EMD AML screening trial running at MD Anderson - the results of this trial may well change AML practice in regards EMD.
The two investigator AML trials in Israel were very cheap and they have provided us with data that not only shows bisantrene's relevance in the modern clinical environment, but has also attracted interest from other clinicians who want to run more low cost trials. A great outcome I think.
The Phase 2 trial will be designed based on the results of the Phase 1a/b trial. The structure of the trial design is built up front, but the specific indications will be chosen based on the data that comes out of the Phase 1 trial. This minimises cost and time and maximises the chance of success.
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