Ph 2 volasertib program receives “Clearance to Proceed” from the FDA and agreement on the dosing plan for Ph 2 clinical trial
“We are pleased to report positive progress in our clinical development program to evaluate the use of volasertib, in combination with decitabine, for patients with R/R AML. Receiving FDA’s clearance and agreement on a Phase 2 dosing plan positions us to move forward to activate study sites,” said Thomas Bock, M.D., Chief Executive Officer of Notable. “AML remains a devastating and life-threatening unmet need, especially for patients whose disease has progressed after first-line treatment, and especially in those who have received venetoclax-based therapies. Advancing the volasertib program through the next Phase 2 implementation steps represents meaningful progress for the Company. We are excited about the potential of volasertib, our predictive platform, and our carefully designed clinical program to enhance patient clinical outcomes and tolerability. We look forward to updating our investors and key stakeholders as we proceed.”
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