Salarius Pharmaceuticals Invited to Present Seclidemstat Research at Meeting of the Pediatric Oncology Subcommittee of the Food and Drug Administration’s Oncologic Drugs Advisory Committee

Seclidemstat is currently being studied in a Phase 1/2 clinical trial for Ewing sarcoma, a rare and deadly pediatric bone cancer

HOUSTON, June 02, 2020 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting cancers caused by dysregulated gene expression, today announced that the U.S. Food and Drug Administration (FDA) has invited the company to present information regarding its lead investigational compound, seclidemstat, at the public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) scheduled for June 17 - June 18, 2020.

Seclidemstat is a reversible LSD1 inhibitor currently being studied in a Phase 1/2 clinical trial for Ewing sarcoma, a rare and deadly pediatric bone cancer for which there are no approved targeted treatments available. The FDA has granted seclidemstat Fast Track Designation, as well as Orphan and Rare Pediatric Disease Designations, in recognition of the high unmet medical need facing Ewing sarcoma patients.

The ODAC Pediatric Subcommittee will provide Salarius the opportunity to share information regarding its pediatric development plan for patients with relapsed or refractory Ewing sarcoma. The subcommittee will consider and discuss the development of seclidemstat for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate.

The public advisory committee meeting will be held in a virtual-only format due to the continued public health concerns related to the COVID-19 outbreak with presentations scheduled over a two-day span. Background materials will be available on the FDA web site at least two business days before the meeting. Interested persons from the public may present data, information, or views, orally or in writing, on issues pending before the subcommittee.

Details of the Salarius presentation are as follows:

Date and Time: Wednesday, June 17, 2020, 10:00 a.m. ET
Format: A 20-minute presentation by Salarius; a 10-minute Q&A session for the subcommittee; 1 hour for discussion

“We are honored to have the opportunity to present our ongoing research of seclidemstat and data from the Phase 1/2 clinical trial in Ewing sarcoma to the ODAC Pediatric Oncology Subcommittee,” said David Arthur, Chief Executive Officer of Salarius Pharmaceuticals. “This invitation, further validates our belief that seclidemstat has the potential to improve the lives of patients and their families suffering with this devastating disease and we look forward to advancing the clinical development of seclidemstat with the support and guidance of the FDA.”