Phase 1/2 Trial of Seclidemstat Plus Azacitidine for Hematologic Cancers Reopens Enrollment

Salarius Pharmaceuticals, a biopharmaceutical firm, has reported positive developments in the Phase 1/2 clinical trial of its drug candidate seclidemstat. The trial, which is focused on hematologic cancer treatment, is currently listed as active and enrolling participants on clinical trials.gov. The trial, conducted at the University of Texas MD Anderson Cancer Center, has seen a significant improvement in Ewing sarcoma patients treated with seclidemstat, topotecan, and cyclophosphamide. The objective response rate among first-relapse Ewing patients has reached 60%, with a disease control rate of the same percentage.

In August 2023, Salarius engaged Canaccord Genuity to conduct a strategic review aimed at maximizing shareholder value. Despite this ongoing process, the company is committed to advancing its clinical programs. The FDA had previously placed the trial under a partial clinical hold due to a suspected serious adverse reaction in another arm of the study. However, this issue has not been observed in the MD Anderson trial.

Salarius Pharmaceuticals' CEO, David Arthur, expressed satisfaction with the FDA's decision to lift the partial clinical hold and the potential for additional patient enrollment and data collection. The company is preparing to file an amended Ewing protocol focusing on first-relapse patients, who are expected to benefit from the combination therapy of seclidemstat and TC.

Seclidemstat is an innovative oral inhibitor of the LSD1 enzyme and has received several FDA designations for its potential use in treating Ewing sarcoma. The company-sponsored clinical trial for Ewing sarcoma has enrolled 13 patients, with five experiencing first relapse and eight experiencing second relapse. The first-relapse patients showed a 60% objective response rate and a 60% disease control rate. Among these, the median progression-free survival has not been reached, with patients maintaining disease control and objective responses for over 17 to 27 months.

Salarius Pharmaceuticals is a clinical-stage company dedicated to developing cancer therapies, particularly for pediatric cancers and sarcomas. The company has received support from the National Pediatric Cancer Foundation and a Product Development Award from the Cancer Prevention and Research Institute of Texas.

The company's press release highlights the interim results of the clinical trial, which show promising outcomes for patients treated with seclidemstat in combination with azacitidine for myelodysplastic syndrome and chronic myelomonocytic leukemia. Of the eight patients evaluated, four had an objective response, and a 90% survival probability was reported for 11 months.

Salarius Pharmaceuticals is advancing its mission to provide new treatment options for cancer patients, focusing on seclidemstat as a potential therapy for various cancers with limited treatment options. The company's commitment to clinical research and development is evident in its ongoing trials and partnerships with institutions like MD Anderson.