Salarius Pharmaceuticals to Present Trial in Progress Poster at ASCO20 Virtual Scientific Program
May 27 2020 - 8:00AM
Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage
biotechnology company targeting cancers caused by dysregulated gene
expression, today announced that a Trial in Progress poster of the
ongoing Phase 1/2 clinical trial of seclidemstat in patients with
relapsed or refractory Ewing sarcoma will be presented during the
2020 American Society of Clinical Oncology Virtual Scientific
Program (ASCO20 Virtual). The poster describes the trial’s design
and highlights important dose escalation enrollment advances
achieved during the past year.
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: Friday, May 29, 2020, 8 a.m. ET
(Oral, Poster Discussion, and Poster Sessions, as well as
track-based Clinical Science Symposia, will be available on
demand)
Abstract Number: TPS11567
Poster Number: 455
Session: Sarcoma
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 David Arthur, President and CEO of Salarius. “Ewing sarcoma
is a rare and deadly bone cancer that most often strikes children
and young adults. The continued progress of this study, despite the
challenges resulting from the COVID-19 outbreak, has demonstrated
the tremendous dedication and resilience of our investigators and
the patients and families who have volunteered to participate.”
About Salarius Pharmaceuticals, Inc.
Salarius Pharmaceuticals, Inc. is a clinical-stage oncology
company targeting cancers caused by dysregulated gene expression
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 (Phase 1/2 trial) for treating
relapsed/refractory Ewing sarcoma, for which it has received Fast
Track Designation, Orphan Drug Designation and Rare Pediatric
Disease Designation from 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 targeting advanced solid
tumors, including prostate, breast and ovarian cancers.
Forward-Looking Statements
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 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.
Investor RelationsTiberend Strategic Advisors,
Inc. Maureen McEnroe, CFA/Miriam Miller(212) 375-2664 /
2694mmcenroe@tiberend.commmiller@tiberend.com
Media Relations Tiberend Strategic Advisors,
Inc. Johanna Bennett (212) 375-2686
jbennett@tiberend.com
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