Yes, Bisantrene has failed. That's why it achieved a 40% ORR in the recent combo trial. What was CF33s ORR again?
Not really. There are 8 P2 trials in R/R AML where the average complete response rate is 53.5%. That data can be used for accelerated approvals. The second RAC demonstrate m6A levels change in humans in response to Bisantrene, every clinical trial ever completed with Bisantrene is viewed through the eyes on an FTO inhibitor by the world. New drug classes with meaningful therapeutic benefit drive significant value.
The past performance of the drug indicates that infrequent dosing is not effective, whereas frequent daily dosing increases responses significantly. 99% of solid tumor trials dosed every 3-4 weeks. When you dose Bis in AML every 3-4 weeks, you get no responses. Of the 9 patients with EMD AML (essentially solid tumor metastatic AML) included into the two recent P2 trials, where EMD AML is now a known feature of AML (not well know 40 years ago), Bisantrene has a 77.8% response rate. Response rates increased 43% from once-every-three-week (Q3W) to every day for 5 days at low doses. Dose frequency matters for the inhibition of FTO. Think of switching off a powerplant of a city for one day vs one week. One day is bearable, but one week causes chaos.
You bring little more than a clear misunderstanding of the reformulation process, biology, clinical efficacy, and mechanistic targeting of intracellular proteins to the table.
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