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Salarius Pharmaceuticals Adds Memorial Sloan Kettering Cancer Center and Nationwide Children’s Hospital as Clinical Sites for Phase 1/2 Trial of Seclidemstat in Ewing Sarcoma

Salarius Targeting Key Safety and Efficacy Data Milestones in 2020

HOUSTON, Oct. 08, 2019 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, announced today that Memorial Sloan Kettering Cancer Center (MSKCC) in New York City and Nationwide Children’s Hospital (Nationwide Children’s) in Columbus, OH have been added as clinical trial sites in the ongoing Phase 1/2 clinical trial of Seclidemstat for the treatment of Ewing sarcoma. The addition of MSKCC and Nationwide Children’s brings the total number of active clinical trial sites to eight.

The Phase 1/2 clinical trial of Seclidemstat in patients with relapsed or refractory Ewing sarcoma is an open-label dose escalation and dose expansion study to determine the maximum tolerated dose (MTD) and establish the initial safety profile of Seclidemstat. The dose expansion portion of the study, or phase 2 portion, may provide potential efficacy data. In September, the Safety Review Committee cleared the third dose level (300 mg Seclidemstat twice-daily), and the fourth dose level is currently enrolling (600 mg Seclidemstat twice-daily). Based on current projections, Salarius expects to reach MTD in early 2020 and report initial patient data later in the same year.

“We are excited to now be working with Memorial Sloan Kettering Cancer Center and Nationwide Children’s Hospital to further develop our lead cancer drug candidate Seclidemstat as a potential treatment for Ewing sarcoma,” stated David Arthur, President and Chief Executive Officer of Salarius. “Ewing sarcoma is a rare and devastating pediatric bone and soft-tissue cancer for which there are no targeted treatments currently available. We believe Seclidemstat could have a meaningful impact in Ewing sarcoma as a potential new and less toxic treatment, benefitting patients and their families.”

Study enrollment at Memorial Sloan Kettering will be led by Paul A. Meyers, M.D., Chief of Pediatric Sarcoma Service and Vice-Chair for Clinical Affairs. Study enrollment at Nationwide Children's Hospital will be led by Bhuvana A. Setty, M.D., Nationwide Children's principal investigator.

In addition to MSKCC and Nationwide Children’s, active clinical trial site locations include, Johns Hopkins All Children’s Hospital in St. Petersburg, FL; Children’s Hospital of Los Angeles in Los Angeles, CA; Moffitt Cancer Center in Tampa, FL; Dana-Farber Cancer Institute in Boston, MA; MD Anderson Cancer Center in Houston, TX; and the Sarcoma Oncology Center in Santa Monica, CA.

More information on the Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma is available at: https://clinicaltrials.gov/ct2/show/NCT03600649.

About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage oncology company targeting the epigenetic causes of cancers and is developing treatments for patients that need them the most. Epigenetics refers to the regulatory system that affects gene expression. In some cancers, epigenetic regulators often become dysregulated and incorrectly turn genes on or off leading to cancer progression. Drugs that are able to safely modify the activity of these epigenetic regulators may correct the gene changes that are driving the disease. The company’s lead candidate, Seclidemstat, is currently in clinical development for treating Ewing sarcoma, for which it has Orphan Drug designation and Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. Salarius believes 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. Salarius is also developing Seclidemstat for a number of cancers with high unmet medical need, with a second Phase 1 clinical study in advanced solid tumors, including prostate, breast and ovarian cancers. Salarius receives financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and is also the recipient of an $18.7 million Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com.

About Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center (MSK) — the world’s oldest and largest private cancer center — has devoted more than 130 years to exceptional patient care, innovative research, and outstanding educational programs. Today, MSK is one of 50 National Cancer Institute–designated Comprehensive Cancer Centers, with state-of-the-art science flourishing side by side with clinical studies and treatment. The close collaboration between MSK’s physicians and scientists is one of the cancer center’s unique strengths, enabling it to provide patients with the best care available as its physicians and researchers work to discover more-effective strategies to prevent, control, and ultimately cure cancer in the future. Through its educational programs, MSK also trains future physicians and scientists, and the knowledge and experience they gain has an impact on cancer treatment and biomedical research around the world. To learn more about Memorial Sloan Kettering, please visit mskcc.org.

About Nationwide Children’s Hospital
Named to the Top 10 Honor Roll on U.S. News & World Report’s 2019-20 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric health care systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease. Nationwide Children’s has a staff of more than 13,000 providing state-of-the-art pediatric care during more than 1.5 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Abigail Wexner Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded freestanding pediatric research facilities. For more information on Nationwide Children’s Hospital, please visit nationwidechildrens.org.

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. Examples of such statements include, but are not limited to, statements relating to: the potential for Seclidemstat to target the epigenetic causes of cancers including prostate, breast and ovarian cancers; expected timing and results of clinical studies, including the company’s expectations on reaching maximum tolerated dose early 2020 and reporting initial patient data later in the same year; Seclidemstat’s impact in Ewing sarcoma as a potential new and less toxic treatment and potential benefits to patients and their families; the nature, strategy and focus of the company; and the development and commercial potential of any product candidates of the company. 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; 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; and the competitive landscape and other industry-related risks. 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
LifeSci Advisors, LLC
Jeremy Feffer
Managing Director
(212) 915-2568

Media Relations:
Tiberend Strategic Advisors, Inc.
Johanna Bennett
Senior Vice President
(212) 375-2686