The RAC 3-Pillar Trifecta, page-197

Breast Cancer and AML were the conditions where there were extensive historic trials, although the trials were mostly in patients refractory to other drugs. These are the conditions where there is the highest probability of success - the reason being the historic data that can guide both treatment (protocol) design and also design of trial endpoints. I think historic data for AML covers trials over 100 patients and historic data for Breast Cancer covers over 300 patients.

In Breast Cancer the main takeaway is that Bisantrene has similar cumulative survival to Doxorubicin but with better heart safety.

This post has the results for heavily pre-treated (or refractory) breast cancer patients. This means they were tough to treat patients that had already failed chemo. 20% response for Doxorubicin, 22% response for Bisantrene.

https://hotcopper.com.au/posts/49305941/single


It's important to remember that the historic trials where at high dose as a chemotherapeutic, not at low dose to inhibit the activity of FTO. Bisantrene at low dose is being used to have a very precise effect, a bit like very careful controlled flipping of a sensitive switch.That means historic results at high-dose don't necessarily tell us how Bisantrene will work as an FTO Inhibitor ( for Kidney Cancer and Melanoma ).

The choice of targets for FTO is basically from DrT's deep research with I guess input from others in the team ( as well as regulatory and clinical advisors ).

In the case of Melanoma, the idea is that Bisantrene at low-dose as FTO inhibitor makes the PD-1 inhibitor work better. That means Bisantrene at low dose would be given in combination with either Keytruda or Opdivo.

Renal Cancer is a bit different. See video as it is best for Dr T to explain ( but worth watching the whole section on FTO ).

Starts at about 11 minutes 30.