Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the
“Company”), a clinical-stage pharmaceutical company developing
innovative therapies for the treatment of advanced solid tumors and
other serious diseases, today announced protocol changes to the
ongoing ASCEND trial, a Phase 2b trial evaluating LSTA1, Lisata’s
lead investigational drug, in combination with standard-of-care
(“SOC”) gemcitabine/nab-paclitaxel in patients with first-line,
metastatic pancreatic ductal adenocarcinoma (“mPDAC”). The
objective of the original ASCEND trial was to confirm, in a
rigorous, controlled, double-blind study, the positive results of
the Phase 1b/2a open label study evaluating LSTA1 in mPDAC patients
receiving one dose of LSTA1 plus SOC. The amended protocol retains
this objective while adding the goals of optimizing the dose of
LSTA1 in this indication and establishing effect size for a
possible Phase 3 study. The protocol amendment includes an
additional cohort (Cohort B) to assess whether a second dose solely
of LSTA1, administered 4 hours after the original dose of LSTA1
plus SOC, will further improve efficacy and patient outcomes.
The ASCEND trial is now a 155-patient, double-blind, randomized,
placebo-controlled Phase 2b clinical trial being conducted at up to
40 sites in Australia and New Zealand, led by the Australasian
Gastro-Intestinal Trials Group (“AGITG”) in collaboration with the
University of Sydney and with the National Health and Medical
Research Council (“NHMRC”) Clinical Trial Centre (“CTC”) at the
University of Sydney as the Coordinating Centre. The trial is fully
funded by Lisata through an unrestricted research support
agreement. ASCEND, based upon Cohort A (the group receiving a
single dose of LSTA1 plus SOC), has 80% power with 95% confidence
to detect a 16% increase in the 6-month progression free survival
(“PFS”) rate in the experimental arm vs. the control arm (SOC +
placebo). Additionally, the protocol prescribes a futility analysis
to be conducted when 30 enrolled patients on the experimental arms
have been followed for at least six months. Those results, as
determined by an independent data safety monitoring committee, are
expected to be announced during the third quarter of 2023. Trial
enrollment completion is projected for the second quarter of 2024;
however, current enrollment already exceeds 50% of the target, so
earlier enrollment completion may be achieved.
“We are excited to announce the enhancements to the ASCEND trial
design, including the addition of a second cohort for the
evaluation of a second dose of LSTA1 in patients with mPDAC. We
intend to use these results to design an efficient Phase 3 program
and to explore possible conditional approvals globally,” stated
Kristen K. Buck, M.D., Executive Vice President of R&D and
Chief Medical Officer of Lisata. “Pancreatic cancer has one of the
highest mortality rates of all cancers and affects hundreds of
thousands of patients worldwide each year. Although progress has
been made in understanding and treating pancreatic cancer, there
remains significant unmet medical need. We are delighted to be
working with AGITG and CTC, a preeminent clinical trials group in
Australia and New Zealand, to develop this promising potential
treatment for patients in serious need.”
About LSTA1
LSTA1 is an investigational drug designed to activate a novel
uptake pathway that allows co-administered or tethered anti-cancer
drugs to penetrate solid tumors more effectively. LSTA1 actuates
this active transport system in a tumor-specific manner, resulting
in systemically co-administered anti-cancer drugs more efficiently
penetrating and accumulating in the tumor. LSTA1 also has the
potential to modify the tumor microenvironment, with the objective
of making tumors more susceptible to immunotherapies. Lisata and
its collaborators have amassed significant non-clinical data
demonstrating enhanced delivery of a range of existing and emerging
anti-cancer therapies, including chemotherapeutics, immunotherapies
and RNA-based therapeutics. Additionally, LSTA1 has demonstrated
favorable safety, tolerability and activity in clinical trials to
enhance delivery of standard-of-care chemotherapy for pancreatic
cancer. Lisata is exploring the potential of LSTA1 to enable a
variety of treatment modalities to treat a range of solid tumors
more effectively.
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company
dedicated to the discovery, development and commercialization of
innovative therapies for the treatment of advanced solid tumors and
other major diseases. Lisata’s lead product candidate, LSTA1, is an
investigational drug designed to activate a novel uptake pathway
that allows co-administered or tethered anti-cancer drugs to target
and penetrate solid tumors more effectively. Based on Lisata’s
CendR Platform® Technology, Lisata has already established
noteworthy commercial and R&D partnerships. The company
projects the announcement of many clinical study and business
milestones over the next 2 years, having indicated that its current
business and development plan is funded with available capital
through these milestones and into early 2026. For more information
on the Company, please visit www.lisata.com.
About the AGITG
The Australasian Gastro-Intestinal Trials Group (AGITG) is a
multi-disciplinary collaborative group that undertakes
patient-centric research to advance medical care and practice in
the treatment of gastro-intestinal cancer. Since 1991, the AGITG
has led 74 GI cancer clinical trials, enrolling 8,800 patients
across 129 hospitals in Australia and New Zealand, and 125 sites
globally.
About the University of Sydney
As Australia’s first university – founded in 1850 – the
University of Sydney has a proud history of global leadership in
education and research and inspiring people from all backgrounds to
contribute to positive real-world change. We’re a world-renowned
teaching and research institution – our research combines the
expertise and talents of scholars from many disciplines. Learn
more
About the NHMRC Clinical Trials Centre, University of
Sydney
Based at the University of Sydney, the NHMRC Clinical Trials
Centre designs and manages clinical trials. This includes
responsibility for study coordination, monitoring, data acquisition
and management and statistical analysis. Our health economics,
biostatistics, systematic reviews and biomarker teams work with
trial data and inform healthcare providers about best
practice. Learn more
Forward-Looking Statements
This communication contains “forward-looking statements” that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. All statements, other than statements of historical
facts, included in this communication regarding strategy, future
operations, future financial position, future revenue, projected
expenses, prospects, plans and objectives of management are
forward-looking statements. In addition, when or if used in this
communication, the words “may,” “could,” “should,” “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and
similar expressions and their variants, as they relate to Lisata or
its management, may identify forward-looking statements. Examples
of forward-looking statements include, but are not limited to,
statements relating to the long-term success of Lisata’s recently
completed Merger, including the ongoing integration of Cend’s
operations; Lisata’s continued listing on the Nasdaq Capital
Market; expectations regarding the capitalization, resources and
ownership structure of Lisata; the approach Lisata is taking to
discover and develop novel therapeutics; the adequacy of Lisata’s
capital to support its future operations and its ability to
successfully initiate and complete clinical trials; and the
difficulty in predicting the time and cost of development of
Lisata’s product candidates. Actual results could differ materially
from those contained in any forward-looking statement as a result
of various factors, including, without limitation: the ongoing
COVID-19 pandemic on Lisata’s business, the safety and efficacy of
Lisata’s product candidates, decisions of regulatory authorities
and the timing thereof, the duration and impact of regulatory
delays in Lisata’s clinical programs, Lisata’s ability to finance
its operations, the likelihood and timing of the receipt of future
milestone and licensing fees, the future success of Lisata’s
scientific studies, Lisata’s ability to successfully develop and
commercialize drug candidates, the timing for starting and
completing clinical trials, rapid technological change in Lisata’s
markets, the ability of Lisata to protect its intellectual property
rights; unexpected costs, charges or expenses resulting from the
Merger; potential adverse reactions or changes to business
relationships resulting from the completion of the Merger;
potential underperformance of Lisata’s business following the
Merger as compared to management’s initial expectations; and
legislative, regulatory, political and economic developments. The
foregoing review of important factors that could cause actual
events to differ from expectations should not be construed as
exhaustive and should be read in conjunction with statements that
are included herein and elsewhere, including the risk factors
included in Lisata’s Annual Report on Form 10-K filed with the SEC
on March 30, 2023, and in other documents filed by Lisata with the
Securities and Exchange Commission. Except as required by
applicable law, Lisata undertakes no obligation to revise or update
any forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact:
Investors and Media:Lisata Therapeutics, Inc.John MendittoVice
President, Investor Relations and Corporate
CommunicationsPhone: 908-842-0084Email: jmenditto@lisata.com
Lisata Therapeutics (NASDAQ:LSTA)
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Lisata Therapeutics (NASDAQ:LSTA)
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