SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for its CDK9 inhibitor, SLS009, targeted at treating relapsed/refractory (r/r) acute myeloid leukemia (AML). This designation expedites the drug's development and review process due to its potential to address serious conditions with unmet medical needs.

Dr. Angelos Stergiou, President and CEO of SELLAS, highlighted the significance of Fast Track Designation alongside the recent Orphan Drug Designation for r/r AML. He emphasized the promising Phase 2a data, showing anti-leukemic effects and a favorable safety profile when combining SLS009 with venetoclax and azacitidine. Notably, eight of nine patients in the 45 mg cohort were alive during the last follow-up, with positive treatment responses observed.

Dr. Stergiou expressed optimism about SLS009's potential in hematologic malignancies, praising the FDA's recognition through Fast Track and Orphan Drug Designations. The ongoing 60 mg dose cohort has also been initiated, with further development aimed at providing effective treatment options for AML patients.

In the Phase 2a trial, nine patients at the 45 mg safety dose level showed encouraging results, including a high survival rate, complete responses, and significant anti-leukemic effects. No dose-limiting toxicities were observed. The Phase 2a trial is ongoing, evaluating safety, tolerability, and efficacy at 45 mg and 60 mg doses in combination with aza/ven. Data from the 45 mg cohort and initial results from the 60 mg cohort are expected in the first quarter of 2024, with further analysis in the second quarter. The drug's potential to address the unmet needs of AML patients is promising, offering hope for improved outcomes in this challenging condition.

 

Source: globenewswire.com

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