Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a
clinical-stage biopharmaceutical company using protein inhibition
and protein degradation to develop cancer therapies for patients in
need of new treatment options, announces that the U.S. Food and
Drug Administration (FDA) has removed its partial clinical hold on
Salarius’ Phase 1/2 Ewing sarcoma clinical trial evaluating
seclidemstat, Salarius’ novel oral, reversible, targeted LSD1
inhibitor.
The FDA previously granted seclidemstat Fast
Track Designation, Orphan Drug Designation and Rare Pediatric
Disease Designation for Ewing sarcoma.
“We are confident in seclidemstat’s ability to
improve the lives of patients with Ewing sarcoma and are delighted
the FDA has removed the partial clinical hold,” said David Arthur,
president and chief executive officer of Salarius. “I want to
commend the team at Salarius for their tireless work to provide the
necessary safety and clinical information to assure the FDA of
seclidemstat’s compelling risk-benefit profile. Ewing sarcoma is a
devasting bone and soft tissue cancer with limited treatment
options that afflicts children, adolescents and young adults. We
look forward to working with our clinical trial investigators to
resume enrollment with the goal of advancing the development of
seclidemstat as a potential treatment option.
“The FDA’s decision to remove the clinical hold
puts us back on track to engage in dialogue with the FDA on various
topics relating to further clinical development of seclidemstat and
possible registration pathways. As we gain clarity in those
discussions, we intend to provide updates to our investors,” Mr.
Arthur added.
Previously Reported Seclidemstat
Clinical Data
In December 2022 Salarius reported interim
clinical results from its Phase 1/2 trial showing that treatment
with seclidemstat in combination with topotecan and
cyclophosphamide had 60% confirmed disease control and 7.4 months
median time to tumor progression for Ewing sarcoma first-relapse
patients. The results also suggest that first- and second-relapse
Ewing sarcoma patients treated with seclidemstat in combination
with topotecan and cyclophosphamide who achieve disease control may
have an increased time to tumor progression (TTP) compared with
treatment of topotecan and cyclophosphamide alone, per published
data from the Phase 3 rEECur (International Randomized Controlled
Trial of Chemotherapy for the Treatment of Recurrent and Primary
Refractory Ewing Sarcoma) study. At ASCO 2022 the Euro Ewing
Consortium presented rEECur Phase 3 study results in
relapsed/refractory Ewing sarcoma patients that showed median
event-free survival of 3.5 months in the topotecan/cyclophosphamide
arm (n=73) compared with 5.7 months in the high-dose ifosfamide arm
(n=73). The rEECur data includes approximately 80% primary
refractor or first-relapse. Ewing sarcoma patients after relapse
have 5-year overall survival of about 13% and 10-year overall
survival of about 9%.1 Single-agent activity has not been observed
in the FET-rearranged sarcoma cohort of the trial.
In December 2022 investigators in the Department
of Leukemia at the University of Texas MD Anderson Cancer Center
(MD Anderson) presented clinical data on seclidemstat in patients
with MDS or CMML at the 64th American Society of Hematology Annual
Meeting showing no serious adverse events were reported, and that
all adverse events observed in the study were manageable. Of the
eight evaluable patients, four (50%) had an objective response
including one complete response patient who planned to receive
potentially curative allogeneic stem cell transplantation, two
marrow complete responses plus hematological improvement and one
marrow complete response. The Phase 1 dose-escalation portion of
this trial is designed to evaluate up to six dose levels of
seclidemstat. The maximum tolerated dose, which will inform the
Phase 2 portion of the trial, had not yet been reached.
About the Phase 1/2 Ewing Sarcoma
Clinical Trial
The Phase 1/2 trial is now in its dose-expansion
stage with one arm planned to enroll up to 30 patients with Ewing
sarcoma, a rare and deadly pediatric bone cancer, that will
investigate seclidemstat in combination with topotecan and
cyclophosphamide, a commonly used second- and third-line
chemotherapy regimen. Salarius believes data released during ASCO
2021 demonstrated synergy in an Ewing sarcoma cell line when
seclidemstat was used in combination with these agents. Salarius
also believes this treatment combination and its use as a second-
and third-line therapy has the potential to expand the addressable
patient population for seclidemstat and improve outcomes by
allowing physicians to introduce seclidemstat earlier in the Ewing
sarcoma continuum of care. As previously reported, single-agent
activity has not been observed in the FET-rearranged sarcoma cohort
of the trial, and at the time of the partial clinical hold Salarius
was no longer enrolling patients in this cohort. Salarius has
closed the FET-rearranged sarcoma patient cohort in the sarcoma
clinical trial.
Salarius supports patient referrals to its
sarcoma trial sites and provides travel assistance for clinical
trial patients and families who are evaluating and participating in
the sarcoma trial. Clinical trial sites include Seattle Cancer Care
Alliance (SCCA), Seattle, WA, which is comprised of the Fred
Hutchinson Cancer Research Center, Seattle Children's Hospital and
University of Washington Medical Center; Oregon Health &
Sciences University in Portland, OR; Johns Hopkins All Children’s
Hospital in St. Petersburg, FL; Children’s Hospital of Los Angeles
in Los Angeles, CA; Moffitt Cancer Center in Tampa, FL; Dana-Farber
Cancer Institute in Boston, MA; MD Anderson Cancer Center in
Houston, TX; Nationwide Children’s Hospital in Columbus, OH;
Memorial Sloan Kettering Cancer Center in New York, NY; Virginia
Cancer Specialists in Fairfax, VA; Cleveland Clinic, Cleveland, OH;
Washington University in St. Louis, MO and Fox Chase Cancer Center
in Philadelphia, PA.
About the Phase 1/2
Investigator-initiated Hematological or Blood Cancer Clinical
Trial
The objective of this investigator-initiated
Phase 1/2 dose-escalation trial at MD Anderson is to evaluate the
safety, tolerability, maximum tolerated dose and overall response
of seclidemstat in combination with azacytidine in adult patients
with higher-risk MDS or CMML who previously failed or relapsed
after hypomethylating agent therapy. As of October 2022, nine
patients were enrolled with a median follow-up time of 3.9 months.
Typically, overall survival is four to six months for patients
after failing therapy with hypomethylating agents. Following the
partial clinical hold on Phase 1/2 Ewing Sarcoma Clinical Trial,
FDA also placed this investigator-initiated trial on partial
clinical hold. Salarius is supporting MD Anderson in its efforts to
have its partial clinical hold lifted.
2023 BIO International Convention and
European Hematology Association 2023 Congress
Salarius also announces that it will be
participating in the 2023 BIO International Convention being held
in Boston from June 5th through 8th, 2023 and the European
Hematology Association 2023 Congress being held in Frankfurt,
Germany from June 8th through 11th, 2023. Management plans to hold
business development meetings with representatives of biotechnology
and pharmaceutical companies to expand awareness of both
seclidemstat and its lead targeted protein degrader, SP-3164. As
previously announced, Salarius is planning to submit an
Investigational New Drug Application (IND) for SP-3164 in the
second quarter of 2023 and begin a Phase 1 clinical trial shortly
thereafter.
About Salarius
PharmaceuticalsSalarius Pharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company developing therapies for
patients with cancer in need of new treatment options. Salarius’
product portfolio includes seclidemstat, Salarius’ lead candidate,
which is being studied as a potential treatment for pediatric
cancers, sarcomas and other cancers with limited treatment options,
and SP-3164, an oral small molecule protein degrader. Seclidemstat
is currently in a Phase 1/2 clinical trial for relapsed/refractory
Ewing sarcoma. Seclidemstat has received fast track, orphan drug
and rare pediatric disease designations for Ewing sarcoma from the
U.S. Food and Drug Administration. Salarius is also exploring
seclidemstat’s potential in several cancers with high unmet medical
need, with an investigator-initiated Phase 1/2 clinical trial in
hematologic cancers at MD Anderson Cancer Center. Salarius has
received financial support from the National Pediatric Cancer
Foundation to advance the Ewing program and was a recipient of a
Product Development Award from the Cancer Prevention and Research
Institute of Texas (CPRIT). SP-3164 is currently in IND-enabling
studies and is anticipated to enter the clinic in the second half
of 2023. For more information, please visit salariuspharma.com or
follow Salarius on Twitter and LinkedIn.
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,” “believe,” “developing,” “expect,” “may,” “progress,”
“potential,” “plan,” “could,” “look forward,” “encouraging,”
“might,” “should,” and similar terms or expressions or the negative
thereof. Examples of such statements include, but are not limited
to, statements relating to the following: the impact that the
addition of new clinical sites will have on the development of
Salarius’ product candidates; the timing of Salarius’ IND
submissions to the FDA and subsequent timing for initiating
clinical trials; interim data related to Salarius’ clinical trials,
including the timing of when such data is available and made
public; Salarius’ growth strategy; the value of seclidemstat as a
treatment for Ewing sarcoma, Ewing-related sarcomas, and other
cancers and its ability to improve the life of patients; expanding
the scope of Salarius’ research and focus to high unmet need
patient populations; milestones of Salarius’ current and future
clinical trials, including the timing of data readouts. 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 Salarius’
capital resources; the ability of, and need for, Salarius to raise
additional capital to meet Salarius’ business operational needs and
to achieve its business objectives and strategy; future clinical
trial results and the impact of such results on Salarius; that the
results of studies and clinical trials may not be predictive of
future clinical trial results; risks related to the drug
development and the regulatory approval process; the competitive
landscape and other industry-related risks; and other risks
described in Salarius’ filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for the fiscal
year ended December 31, 2022, as revised or supplemented by its
Quarterly Reports on Form 10-Q and other documents filed with the
SEC. 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.
CONTACT:
LHA Investor RelationsKim Sutton Golodetz
kgolodetz@lhai.com212-838-3777
____________________________
1 Risk of recurrence and survival after relapse in patients with
Ewing sarcoma, Pediatric Blood & Cancer, Volume 57, Issue 4.
First published October 2011.
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