SELLAS Life Sciences Group, Inc. (SLS) announced on Tuesday that its novel and highly selective CDK9 inhibitor, formerly known as GFH009 and now called SLS009, has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory acute myeloid leukemia (AML).
Angelos Stergiou, MD, President and CEO of SELLAS, stated, that the SLS009 continues to emerge as a promising treatment for hematologic malignancies and that the company is pleased by the FDA's recognition of its potential by the grant of Fast Track and Orphan Drug Designations for AML.
The Phase 2a clinical trial of SLS009 is evaluating safety, tolerability, and efficacy at two dose levels, 45mg, and 60mg, in combination with venetoclax and azacitidine.
Initial results from the 45mg dose level show that it exhibits anti-leukemic effects with a favorable safety profile in AML patients resistant to venetoclax combination therapies.
Additional data from the 45mg cohort and initial data from the 60mg cohort are expected to be reported in the first quarter of 2024. The 60mg cohort is expected to be analyzed in the second quarter of 2024.
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