On July 22, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported it has enrolled the first patient in a Phase 1 clinical study of the company’s lead compound, Seclidemstat, in patients with advanced solid tumors resistant to standard-of-care therapies. Seclidemstat is a differentiated reversible inhibitor of the widely studied epigenetic enzyme lysine-specific demethylase 1 (LSD1) (Press release, Flex Pharma, JUL 22, 2019, View Source [SID1234537641]). This is Salarius’ second Phase 1 clinical study for Seclidemstat, which is also the subject of an ongoing clinical study focused on Ewing sarcoma, a devastating bone and soft tissue cancer for which Seclidemstat has Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA). Salarius expects to report early cohort data from both Phase 1 clinical studies in 2020.
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David Arthur, President and CEO of Salarius Pharmaceuticals, stated, "We are excited to expand our clinical pipeline for Seclidemstat to include patients with advanced solid tumors and we believe addressing the epigenetic dysregulation underlying certain cancers represents a potentially powerful approach to providing a therapeutic benefit for patients with limited or no other treatment options. With potential data readouts from both clinical programs expected next year, we hope to further establish Salarius in this exciting and growing field."
Seclidemstat is an oral small molecule inhibitor of LSD1, a validated drug target for clinical development. LSD1 is known to associate with more than 60 different gene regulatory proteins to drive a variety of cancer types. High levels of LSD1 expression are often correlated with poor patient prognosis. The open-label, dose escalation/dose expansion Phase 1 clinical study in advanced solid tumor cancers is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of Seclidemstat, as well as establish a recommended dose for Phase 2 studies. The study is enrolling patients with advanced (non-Ewing’s) solid tumors, with a focus on prostate, breast, ovarian, melanoma, colorectal, non-Ewing’s sarcomas and other cancers where Seclidemstat demonstrated single-agent preclinical activity. The study will also use established and exploratory biomarkers to assess sensitivity and early signs of therapeutic activity in these patients.
Michael Gordon, M.D., Medical Director of Oncology Clinical Trials at the HonorHealth Research Institute and principal investigator of the advanced solid tumor Phase 1 study, commented, "Epigenetics is a rapidly growing field within oncology, and selective yet reversible inhibitors such as Seclidemstat represent the cutting-edge progress being made in this space. We know that epigenetic modulation by LSD1 occurs not only through its enzymatic activity as a demethylase, but also via its scaffolding properties. If clinical studies prove Seclidemstat is able to safely and effectively inhibit both mechanisms of gene regulation by LSD1, which is supported by substantial preclinical work, Seclidemstat will have a highly differentiated profile that could translate into improved outcomes for patients."