Salarius Pharmaceuticals to Present Trial in Progress Poster at ASCO20 Virtual Scientific Program
Details of the presentation are as follows:
Title: A phase I/II clinical trial of the reversible LSD1 inhibitor, seclidemstat, in patients with relapsed/refractory Ewing sarcoma
Date and Time:
Abstract Number: TPS11567
Poster Number: 455
Designed as an open-label, non-randomized dose-escalation/dose-expansion study, the primary objective of the Phase 1/2 clinical trial is to assess seclidemstat’s safety and tolerability in patients with relapsed or refractory Ewing sarcoma. Secondary objectives include studying the pharmacokinetics and assessing preliminary anti-tumor activity of seclidemstat. Exploratory objectives include collecting potential pharmacodynamic markers to study drug activity and disease burden.
As reported recently, the Safety Review Committee overseeing the Ewing sarcoma clinical trial approved the advancement of the study to the sixth dosing cohort (1,200mg BID) out of seven potential cohorts, patient enrollment is ongoing, and, to date, we have not seen dose limiting toxicities that would prevent further dose escalation. Thus far, pharmacokinetic data from the trial suggest that plasma drug levels of the first five cohorts are increasing in a dose proportional manner and there is no evidence of a plateau in exposure levels. Also recently reported, seclidemstat plasma levels in patients are now at or above the levels where pharmacological activity was observed in pre-clinical studies. Based on current projections, Salarius believes the Phase 1/2 Ewing sarcoma trial is on track to reach maximum tolerated dose (MTD) in 2020, and shortly after, begin the dose-expansion phase of the study. Salarius expects to report early safety and pharmacokinetic data before year-end 2020.
“We are very appreciative of the ongoing efforts of the investigators involved in our Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma and are grateful for the opportunity to present this Trial in Progress poster during ASCO20 Virtual,” stated
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,” “objective,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements related to the following: the anticipated presentation of the Trial in Progress Poster of the ongoing Phase 1/2 clinical trial of seclidemstat in patients with relapsed or refractory Ewing sarcoma; the trial’s design; the objectives of Salarius’ Phase 1/2 clinical trial to assess seclidemstat’s safety and tolerability in patients with relapsed or refractory Ewing sarcoma and to study the pharmacokinetics and assess preliminary anti-tumor activity of seclidemstat; Salarius’ belief that the Phase 1/2 Ewing sarcoma trial is on track to reach maximum tolerated dose in 2020 and that the dose-expansion phase of the study may occur shortly thereafter; and Salarius’ expectations regarding the reporting of early safety and pharmacokinetic data before year-end 2020. 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.