On September 12, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancer, reported its support for Childhood Cancer Awareness Month, designated as the month of September (Press release, Flex Pharma, SEP 12, 2019, View Source [SID1234539488]). Recognizing the work underway by the National Pediatric Cancer Foundation and the many other organizations, foundations and associations around the world to raise awareness of childhood cancers, Salarius joins with these groups in exploring targeted treatments for children and their families seeking new therapeutic options.
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According to data from the U.S. Centers for Disease Control and Prevention, approximately 15,000 U.S. children and adolescents younger than 20 years will receive a cancer diagnosis each year. In the past 40 years, less than 10 drugs have been developed for use in children with cancer, a number that pales in comparison to the hundreds developed for adult cancers. Despite improvements in overall survival rates, survival rates for some types of childhood cancer remain discouragingly low, and some childhood and adolescent cancer survivors often face long-term complications, including heart disease, infertility or secondary cancers related to their treatment.
Salarius is developing Seclidemstat, a differentiated reversible inhibitor of the widely studied epigenetic enzyme lysine-specific demethylase 1 (LSD1), as a treatment for Ewing sarcoma, a rare, devastating and deadly pediatric bone and soft-tissue cancer for which there are no targeted therapies currently available. For these children, the standard of care is adult chemotherapy, radiation and often disfiguring surgeries.
Seclidemstat has received Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration. It is now in a Phase 1 clinical trial for Ewing sarcoma, and a second Phase 1 study for patients with advanced solid tumors resistant to standard-of-care therapies.
David Arthur, Chief Executive Officer of Salarius, stated, "There are 400 to 500 children diagnosed with Ewing sarcoma every year in the U.S., and the average age of diagnosis is about 15. These are children and young adults with their whole lives ahead of them. But figures show that roughly 40% to 45% either do not respond or relapse from the standard of care. With those patients, there is approximately an 80% five-year mortality rate. We are developing Seclidemstat to address this high-need pediatric cancer population and, in doing so, potentially offer hope for these children and their families."
Mr. Arthur added, "Our Phase 1 clinical trial of Seclidemstat in the Ewing sarcoma program is currently in the dose escalation phase, and we expect to establish the maximum tolerable dose in early-2020. We then expect to commence dose expansion with the potential for reporting early cohort data later in 2020."
About Seclidemstat
Seclidemstat (also known as SP-2577) is an investigational agent currently being evaluated in clinical trials. It is a small molecule in development by Salarius Pharmaceuticals, Inc. which inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme involved in regulating gene expression. LSD1 is often overexpressed in cancers and can promote disease progression. In certain cancers, higher levels of LSD1 are associated with poor patient prognosis. Seclidemstat has been shown to inhibit LSD1’s demethylation and scaffolding properties and has demonstrated potent therapeutic activity in preclinical models of Ewing sarcoma, a rare pediatric/adolescent bone and soft-tissue cancer.