The CPACS trial includes a lead-in dose of Bisantrene as a single agent to measure changes in m6A levels. Demonstrating that altered m6A levels correlate with tumor responses and synergy with anthracyclines will validate Bisantrene as an entirely new drug class. Drugs from a new class that meet breakthrough therapy criteria receive particular attention due to their innovative nature. Clinical validation of Bisantrene as an FTO inhibitor, along with its effects on m6A in cancer, redefines Bisantrene's entire clinical history. The phase 3 clinical trial in breast cancer, where Bisantrene outperformed doxorubicin and mitoxantrone, gains significant attention, especially if Bisantrene demonstrates synergy with anthracyclines and proven cardioprotection.
This will accelerate rapidly if the data aligns with our expectations.
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