On September 24, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that the Safety Review Committees overseeing the Phase 1/2 clinical study of Seclidemstat in Ewing sarcoma and the Phase 1 study of Seclidemstat in patients with advanced solid tumors (AST) have approved the advancement of each study to the fourth level dosing cohort (Press release, Flex Pharma, SEP 24, 2019, View Source [SID1234539734]).
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The Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma and Phase 1 AST clinical trial are designed as open-label dose-finding studies to determine the maximum tolerated dose (MTD) and initial safety profile of Seclidemstat. Seclidemstat is administered daily as an oral tablet, with each cohort receiving an increased dose of study medication. This MTD, as determined by the Safety Review Committee, will then be used to treat a larger group of patients to confirm the safety profile for Seclidemstat and capture additional information regarding pharmacokinetics and potential preliminary efficacy.
David Arthur, President and Chief Executive Officer of Salarius, stated, "Clearance from the Safety Review Committees to proceed to the higher dosing cohort is an important milestone in the ongoing clinical trials. Ultimately, our goal with these studies is to pinpoint the optimal dose of Seclidemstat, which, in addition to determining the safety parameters of the drug, will enable us to obtain key pharmacokinetic information and, potentially, initial efficacy data. Based on current projections we are on track to reach maximum tolerated dose early next year and report early patient data from both studies in 2020."
The Ewing sarcoma study opened patient enrollment in Q3 2018 and is currently enrolling patients of 12 years of age or older at leading cancer centers in the U.S., including Johns Hopkins All Children’s Hospital, Children’s Hospital of Los Angeles, Moffitt Cancer Center, Dana-Farber Cancer Institute and MD Anderson Cancer Center. Most recently, the Sarcoma Oncology Center in California was added, bringing the total number of active clinical trial sites to six. The Safety Review Committee recently 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 the first 3 dose levels, the pharmacokinetic profile (i.e., how the drug is distributed in the body following administration) appears to be dose proportional.
In June 2019, the Advanced Solid Tumor study began enrolling patients with advanced or recurrent solid tumors including, but not limited to, breast, ovarian and prostate cancer. All study patients had received standard of care therapies but continued to experience progression of their disease. Similar to the Ewing sarcoma study, the Safety Review Committee has cleared the 300 mg dose twice-daily and the 600 mg twice-daily dosing group is currently enrolling patients across the two active sites, HonorHealth in Arizona and the Sarcoma Oncology Center in California.