Salarius Pharmaceuticals Receives FDA Fast Track Designation for Lead Drug Candidate, Seclidemstat, in Relapsed or Refractory Ewing Sarcoma
“Ewing sarcoma is a rare and deadly bone cancer that most often strikes children and young adults and for which there are no targeted therapies approved. Seclidemstat has demonstrated a potential to address this considerable unmet need, and we look forward to rapidly advancing its development so that it soon may be available to those patients most in need,” stated
Fast Track is a process designed by the
Seclidemstat is a first-in-class, oral, small molecule designed for the reversible and noncompetitive inhibition of the LSD1 enzyme. Seclidemstat is based on the research of Dr.
More information about Salarius’ ongoing Ewing sarcoma trial is available at ClinicalTrials.gov and on the company website, salariuspharma.com. Active clinical trial sites include,
About Salarius Pharmaceuticals
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “can,” “could,” “believe,” “feel,” “plan,” “allow,” “will,” “expect,” “provide,” “able to,” “position,” “anticipate,” “progress,” “potential,” “target,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements regarding: the current study of Seclidemstat in a Phase 1/2 clinical trial in Ewing sarcoma; the company’s targeting of key safety and efficacy data milestones in 2020; the company’s belief that it is well positioned to take advantage of the FDA’s expedited programs for drug development and review; the potential of Seclidemstat, including the potential to offer more efficacy, more flexible dosing and less toxicity; the company’s expectation that it may release early cohort data early next year from its Ewing sarcoma study and a second Phase 1 clinical study in advanced solid tumors; the company’s belief that Seclidemstat is one of only two reversible inhibitors of the epigenetic modulator LSD1 currently in human trials, and that it could have potential for improved safety and efficacy compared to other LSD1-targeted therapies; and the company’s development of Seclidemstat for several cancers with high unmet medical need, with a second Phase 1 clinical study in advanced solid tumors, including prostate, breast and ovarian cancers. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the ability of the company to raise additional capital to meet the company’s business operational needs and to achieve its business objectives and strategy; the company’s ability to project future capital needs and cash utilization; available sources of cash, including from CPRIT and its equity line; future clinical trial results; that the results of studies and clinical trials may not be predictive of future clinical trial results; the sufficiency of Salarius’ intellectual property protection; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions which may impact the ability of Salarius access capital under its equity line; the possibility of unexpected expenses or other uses of Salarius’ cash resources; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including those under the heading “Risk Factors.” The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.
Source: Salarius Pharmaceuticals