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 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:
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
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “could,” “believe,” “plan,” “expect,” “target,” “potential,” “develop,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements related to the following: Salarius’ belief as to the potential of seclidemstat and the potential advancement of the clinical development of seclidemstat for the treatment of Ewing sarcoma and other cancers. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the sufficiency of the company’s capital resources; the ability of, and need for, the company to raise additional capital to meet the company’s business operational needs and to achieve its business objectives and strategy; the company’s ability to project future capital needs and cash utilization and timing and accuracy thereof; future clinical trial results and impact of results on the company; that the results of studies and clinical trials may not be predictive of future clinical trial results; the sufficiency of Salarius’ intellectual property protection; risks related to the drug development and the regulatory approval process; the competitive landscape and other industry-related risks; market conditions and regulatory or contractual restrictions which may impact the ability of Salarius to sell stock to
Source: Salarius Pharmaceuticals, Inc.