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."
About Salarius Pharmaceuticals, Inc.
Salarius Pharmaceuticals, Inc. is a clinical-stage oncology company targeting cancers caused by dysregulated gene expression, or epigenetic causes of cancers, and is developing treatments for patients that need them the most. Epigenetics refers to the regulatory system that affects gene expression. Salarius' lead candidate, seclidemstat, is currently in clinical development for treating Ewing sarcoma, for which it has Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. Salarius is also developing seclidemstat for a number of cancers, with a second Phase 1/2 clinical study in advanced solid tumors, including prostate, breast and ovarian cancers.
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 Aspire Capital; the possibility of unexpected expenses or other uses of Salarius' cash resources; risks related to the COVID-19 outbreak; and other risks described in Salarius' filings with the Securities and Exchange Commission, including those discussed in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2020 and in the company's annual report on Form 10-K for the year ended December 31, 2019. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management's assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward- looking statements to reflect events or circumstances that exist after the date on which they were made.
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