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Salarius Pharmaceuticals Announces Acceptance of Abstract for 2020 ASCO Virtual Scientific Program

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Salarius Pharmaceuticals (Nasdaq: SLRX) announced that an abstract on its Phase 1/2 clinical trial of seclidemstat for Ewing sarcoma has been accepted for presentation at the ASCO Virtual Scientific Program from May 29-31, 2020. The trial aims to assess seclidemstat's safety and tolerability in relapsed/refractory Ewing sarcoma patients. David Arthur, CEO, noted significant advances in dose escalation and enrollment over the past year. Seclidemstat addresses a critical unmet need in treating this rare cancer, with various designations from the FDA supporting its development.

Positive
  • Abstract accepted for ASCO Virtual Scientific Program highlights progress in clinical trial.
  • Seclidemstat addresses unmet need in treating relapsed/refractory Ewing sarcoma.
  • Achieved significant milestones in dose escalation and patient enrollment in the trial.
Negative
  • None.

HOUSTON, May 14, 2020 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biotechnology company targeting cancers caused by dysregulated gene expression, announced today that an abstract on the Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma has been accepted as a poster at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program to be held Friday, May 29, 2020 through Sunday, May 31, 2020.

The poster, titled, “A phase I/II clinical trial of the reversible LSD1 inhibitor, seclidemstat, in patients with relapsed/refractory Ewing sarcoma,” will provide an overview of the ongoing open-label, non-randomized dose-escalation/dose-expansion Phase 1/2 clinical trial of seclidemstat in patients with relapsed or refractory Ewing sarcoma. The primary objective of the trial is to assess seclidemstat’s safety and tolerability while secondary objectives include pharmacokinetics, preliminary efficacy and exploratory pharmacodynamic markers.

“We are pleased to be given the opportunity to provide a clinical trials in progress abstract for our lead investigational candidate, seclidemstat, a reversible LSD1 inhibitor now being evaluated in a Phase 1/2 clinical trial in patients with relapsed or refractory Ewing sarcoma,” said David Arthur, President and Chief Executive of Salarius Pharmaceuticals. “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. Our ongoing study has achieved important dose escalation and enrollment advances over the past year, and we look forward to advancing seclidemstat’s development so that it may soon be available to patients most in need.”

Details of the presentation are as follows:

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Title:A phase I/II clinical trial of the reversible LSD1 inhibitor, seclidemstat, in patients with relapsed/refractory Ewing sarcoma
Abstract Number:TPS11567
Poster Number:455
Session:Sarcoma

About Salarius Pharmaceuticals, Inc.
Salarius Pharmaceuticals, Inc. is a clinical-stage oncology company targeting cancers caused by dysregulated gene expression and is developing treatments for patients that need them the most. Epigenetics refers to the regulatory system that affects gene expression. Salarius’ lead candidate, seclidemstat, is currently in clinical development (Phase 1/2 trial) for treating relapsed/refractory Ewing sarcoma, for which it has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration. Salarius is also developing seclidemstat for a number of cancers, with a second Phase 1/2 clinical study targeting advanced solid tumors, including prostate, breast and ovarian cancers.

Forward-Looking Statements
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,” “could,” “believe,” “plan,” “expect,” “target,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements related to the following: the implication of having achieved certain study milestones, including dose escalation and enrollment milestones; the anticipated progress of Salarius’ clinical programs for seclidemstat; the anticipate release of data from Salarius’ trials; the status (including with respect to patient enrollment), design, conduct, and objectives of Salarius’ two Phase 1/2 clinical trials for seclidemstat; and Salarius’ exploration of additional indications for seclidemstat to expand the drug’s market potential. 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 sufficiency of the company’s capital resources; the ability of, and need for, 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 and timing and accuracy thereof; future clinical trial results and impact of results on the company; 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 and regulatory or contractual restrictions which may impact the ability of Salarius to sell stock to Aspire Capital; the possibility of unexpected expenses or other uses of Salarius’ cash resources; risks related to the COVID-19 outbreak; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including those discussed in the company’s quarterly report on Form 10-Q for the quarter ended March 31, 2020 and in the company’s annual report on Form 10-K for the year ended December 31, 2019. 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.

Investor Relations
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA/Miriam Miller
(212) 375-2664 / 2694
mmcenroe@tiberend.com
mmiller@tiberend.com

Media Relations
Tiberend Strategic Advisors, Inc.
Johanna Bennett
Senior Vice President
(212) 375-2686 
jbennett@tiberend.com

Salarius Pharmaceuticals, Inc.

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