Investigators Present Clinical Data on Salarius Pharmaceuticals’ Seclidemstat in Patients with MDS and CMML at the 2022 American Society of Hematology Annual Meeting

2022-12-14

临床结果快速通道ASH会议孤儿药临床研究

HOUSTON, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today 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 64th American Society of Hematology (ASH) Annual Meeting and Exposition underway in New Orleans and virtually.

Seclidemstat is a novel oral, reversible, targeted LSD1 inhibitor. The poster was presented by Guillermo Montalban-Bravo, M.D. of the Department of Leukemia and is available in the Investors Events and Presentations section of Salarius’ website here.

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.

“We are encouraged that this investigator-initiated trial, which is separate from Salarius’ sponsored sarcoma trial, shows promising results at this early stage of the study when seclidemstat is combined with azacitidine,” said David Arthur, president and chief executive officer of Salarius Pharmaceuticals. “Patients who have failed prior treatments including hypomethylating agents typically have an overall survival of four to six months and are in desperate need of new treatment options. With a 50% overall response rate, including a complete remission planned for potential curative allogeneic stem cell transplantation, we are hopeful that seclidemstat will play a role in their treatment paradigm.”

Mr. Arthur added, “In mid-October enrollment in this investigator-initiated trial was voluntarily paused in response to a suspected unexpected serious adverse reaction, or SUSAR, in Salarius’ FET-rearranged portion of our Phase 1/2 sarcoma study. We are working with the FDA to further analyze the available data with the goal of understanding how best to proceed and restart enrollment across both seclidemstat clinical trials.”

About Salarius Pharmaceuticals

Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options, and SP-3164, an oral small molecule protein degrader. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and certain additional sarcomas that share a similar biology. This trial is currently on a partial clinical hold and is not enrolling new patients. Seclidemstat has received fast track, orphan drug and rare pediatric disease designations for Ewing sarcoma from the U.S. Food and Drug Administration. Salarius is also exploring seclidemstat’s potential in several cancers with high unmet medical need, with an investigator-initiated Phase 1/2 clinical study in hematologic cancers at MD Anderson Cancer Center. This trial is currently on a voluntary pause and is not enrolling new patients. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing program and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). SP-3164 is currently in IND-enabling studies and anticipated to enter the clinic in 2023. For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.

机构