On October 8, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported 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 (Press release, Flex Pharma, OCT 8, 2019, View Source [SID1234540949]). The addition of MSKCC and Nationwide Children’s brings the total number of active clinical trial sites to eight.
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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: View Source