Lisata Therapeutics Announces European Medicines Agency Has Granted LSTA1 Orphan Drug Designation for the Treatment of Pancreatic Cancer
October 17 2023 - 8:00AM
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 that the European
Medicines Agency (“EMA”) Committee for Orphan Medicinal Products
has granted orphan drug designation to LSTA1, the Company’s
lead product candidate for the treatment of pancreatic cancer.
Currently, LSTA1 is the subject of multiple ongoing and planned
clinical studies being conducted globally in a variety of solid
tumor types, including pancreatic cancer, in combination with a
variety of anti-cancer regimens.
“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,” stated Kristen K. Buck, M.D., Executive Vice President of
R&D and Chief Medical Officer of Lisata. “To date, LSTA1 has
demonstrated favorable safety, tolerability, and activity to
enhance delivery of standard-of-care chemotherapy for patients with
metastatic pancreatic cancer. Obtaining orphan drug designation
from the EMA reinforces our belief that LSTA1 offers major
improvement in treating patients with this terrible disease. We are
excited by the promise of LSTA1 for the treatment of pancreatic
cancer and other solid tumors and are committed to advancing our
development programs with the goal of providing a benefit to
patients.”
Orphan drug designation in the European Union (“EU”)
is granted by the European Commission based on a positive
opinion adopted by the EMA Committee for Orphan Medicinal
Products. The EMA’s orphan designation is given to drugs and
biologics in the EU for conditions defined as rare
diseases, which affect no greater than 5 in 10,000 people in the
EU. Companies that meet the EMA’s orphan designation criteria are
eligible for incentives that may include protocol assistance from
the EMA, potential fee reductions, and EU marketing exclusivity of
the particular indication for 10 years after approval.
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, 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 expects
to announce numerous clinical study and business milestones over
the next two years and has projected 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.
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 and capital, 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 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 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; 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
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