Notable Labs receives FDA clearance to proceed further with volasertib study

Notable Labs announced progress for the Phase 2 volasertib program following receipt of “Clearance to Proceed” from the FDA and agreement on the dosing plan for its Phase 2 clinical trial. With trial start-up activities launched in the first quarter of this year, Notable intends to initiate enrollment in the Phase 2 study for PMP-enabled development of volasertib for relapsed refractory acute myeloid leukemia, AML, in the coming months. The Phase 2 study will begin with a dose optimization lead-in and incorporate body-surface area (BSA) dosing, prophylactic antibiotic treatment and best supportive care. The second part of the study is planned to enroll patients with R/R AML who are PMP-predicted responders. The Company is working towards initiating dosing of the first subjects in the Phase 2 trial. Based on our plan, Notable expects to have initial data from the dose optimization lead-in during the fourth quarter of 2024, initiate selective enrollment of PMP-predicted responders after that, and start to report initial efficacy results during H1 2025.