Salarius Pharmaceuticals, Inc. announced that investigators in the Department of Leukemia at the University of Texas MD Anderson Cancer Center presented clinical data on seclidemstat in patients with MDS and CMML at the 64thAmerican Society of Hematology (ASH) Annual Meeting and Exposition underway in New Orleans and virtually. The objective of this investigator-initiated Phase 1/2 dose-escalation study is to evaluate the safety, tolerability, maximum tolerated dose and overall response of seclidemstat in combination with azacitidine in adult patients with higher-risk MDS or CMML who previously failed or relapsed after hypomethylating agent therapy. As of October 2022, nine patients were enrolled with a median follow-up time of 3.9 months.

Typically, overall survival is four to six months for patients after failing therapy with hypomethylating agents. As presented at ASH, no serious adverse events were reported and all adverse events observed in the study were manageable. Of the eight evaluable patients, four (50%) had an objective response including one complete response patient who is planned to receive potentially curative allogeneic stem cell transplantation, two marrow complete responses plus hematological improvement and one marrow complete response.

The Phase 1 dose-escalation portion of this study will evaluate up to six dose levels of seclidemstat. The maximum tolerated dose, which will inform the Phase 2 portion of the study, was not yet reached.