Salarius Pharmaceuticals Announces New Clinical Trial to Study Seclidemstat in Hematologic Cancers
The trial will be an open label, dose-finding, dose-expansion study to determine the maximum tolerated dose (MTD) and the safety and tolerability of seclidemstat when used in combination with azacytidine as a treatment for Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML). MDS and CMML are blood cancers that can progress into a deadly form of leukemia, Acute Myeloid Leukemia (AML). The trial was initiated because of compelling preclinical data in which seclidemstat demonstrated anti-proliferative activity across hematologic cancers and synergy when used in combination with azacytidine.
Seclidemstat is a differentiated, oral, reversible inhibitor of LSD1, a key enzyme implicated in several cancer types. Seclidemstat is being studied in various solid tumor trials that have indicated seclidemstat has a manageable safety profile with preliminary evidence of anti-tumor activity.
"We look forward to exploring the potential of seclidemstat in Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia,” said
The dose-escalation stage of the Phase 1/2 trial will enroll patients aged 18 and older with MDS or CMML. Patients will receive 75 mg/m2 of azacytidine, administered intravenously (IV) or subcutaneously (SC), on days one through seven of each 28-day cycle in combination with an escalating, twice-daily dose of seclidemstat administered as an oral tablet. Once MTD of the combination is determined by the Safety Review Committee, the study enters a dose-expansion stage that will enroll additional patients to confirm the safety and tolerability profile for seclidemstat in combination with azacytidine and capture efficacy data regarding overall response rate, duration of response, leukemia-free survival, relapse-free survival, and overall survival.
“We are very excited about this collaboration to research seclidemstat as a potential new treatment for Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia, two aggressive and potentially deadly blood cancers,” stated
Funding for the trial will be provided by MD Anderson and Salarius, with Salarius also providing seclidemstat to investigators for the clinical trial. More information on the clinical trial is available at www.clinicaltrials.gov.
About Salarius Pharmaceuticals
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties and include statements: about the scope of the expected collaboration; about the findings of any study conducted through the collaboration including any findings regarding the safety and tolerability of seclidemstat in combination with azacytidine in the treatment of Myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML); that discuss the role of seclidemstat in any studies conducted through the collaboration; related to how findings in any study involving seclidemstat may conform to any findings from previous preclinical and clinical trials; preclinical and clinical research results and the ability and potential for LSD1 inhibition to address hematological cancers; and related to the ability to determine the MTD of the combination or entering a dose-expansion stage. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "estimate," "project," "intend," "expect," "believe," "anticipate," "will,” "plan," "could," "may" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements including receipt of regulatory approvals and market conditions. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Salarius Pharmaceuticals, Inc.