Caladrius Biosciences Receives Advanced Therapy Medicinal Product Classification for CLBS12, its CD34+ Cell Therapy for Criti...
July 15 2019 - 08:30AM
Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a late-stage therapeutics development biopharmaceutical
company pioneering advancements of cell therapies in select
cardiovascular and autoimmune diseases, announced today that
the European Medicines Agency (“EMA”) has granted Advanced Therapy
Medicinal Product (“ATMP”) classification to the Company’s CD34+
cell therapy product, CLBS12, for the treatment of critical limb
ischemia (“CLI”). Advanced therapy medicinal products are defined
as medical treatments that are based on genes or cells and are
intended as long-term or permanent therapeutic solutions to acute
or chronic human diseases at a genetic, cellular or tissue level.
CLBS12 has previously been awarded a SAKIGAKE designation in Japan,
a status which makes the product eligible for early conditional
approval based on the on-going clinical trial in that country.
“We are delighted and encouraged that the EMA has recognized our
CD34+ cell therapy product, CLBS12, with an ATMP classification.
This classification sets the stage for us to work closely with
European regulators to define the most expeditious development and
regulatory plan to registration for CLBS12 for the treatment of
critical limb ischemia,” said Douglas W. Losordo, M.D., FACC, FAHA,
Executive Vice President, Global Head of Research and Development,
Chief Medical Officer at Caladrius. “Critical limb ischemia is a
serious unmet medical need in which there exists a severe
obstruction of arterial blood flow to the extremities resulting in
severe pain, eventual amputation and potential mortality. Obtaining
the ATMP classification takes us one step closer to realizing our
objective of making CLBS12 available to patients as an innovative
new treatment for CLI.”
ATMP classifications are granted for new therapeutics which
fulfill the definitions for medicinal products that are gene
therapy, somatic cell therapy and/or tissue engineered products.
The ATMP program at EMA provides specific regulatory guidelines for
preclinical development, manufacturing and product quality testing
of ATMPs and also offers incentives including fee reductions for
regulatory advice, recommendations and evaluation and certification
of quality and non-clinical data. For additional information on
ATMP classifications, please visit www.ema.europa.eu/ema.
About Critical Limb IschemiaCLI is a result of
severe obstruction of the arteries that markedly reduces blood flow
to the extremities, principally the feet and legs. CLI can lead to
pain, skin ulcers and dermal sores, and, if not successfully
addressed, amputation. No-option CLI means that
pharmacotherapy has been ineffective and options for bypass or
angioplasty have been exhausted.
About Caladrius BiosciencesCaladrius is a
late-stage therapeutics development biopharmaceutical company
pioneering advancements of cell therapies for select cardiovascular
and autoimmune diseases. Our leadership team collectively has
decades of biopharmaceutical development experience and
world-recognized scientific achievement in the fields of
cardiovascular and autoimmune disease, among other areas. Our
current product candidates include three developmental treatments
for cardiovascular diseases based on our CD34+ cell therapy
platform: CLBS12, recipient of a SAKIGAKE designation, in a
registration-eligible trial in Japan and eligible for early
conditional approval for the treatment of critical limb ischemia;
CLBS16 (formerly known as CLBS14-CMD), subject of the
proof-of-concept ESCaPE-CMD clinical trial in the U.S.A. for the
treatment of coronary microvascular dysfunction; and CLBS14
(formerly known as CLBS14-NORDA), recipient of a RMAT designation
in the U.S.A. and for which we are in preparation to commence a
Phase 3 clinical trial in no option refractory disabling angina.
For more information on the company, please
visit www.caladrius.com.
Safe Harbor for Forward Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements reflect management’s current
expectations, as of the date of this press release, and involve
certain risks and uncertainties. All statements other than
statements of historical fact contained in this press release are
forward-looking statements including, without limitation, all
statements related to any expectations of revenues, expenses, cash
flows, earnings or losses from operations, cash required to
maintain current and planned operations, capital or other financial
items; any statements of the plans, strategies and objectives of
management for future operations; any plans or expectations with
respect to product research, development and commercialization,
including regulatory approvals; any other statements of
expectations, plans, intentions or beliefs; and any statements of
assumptions underlying any of the foregoing. Without limiting the
foregoing, the words “plan,” “project,” “forecast,” “outlook,”
“intend,” “may,” “will,” “expect,” “likely,” “believe,” “could,”
“anticipate,” “estimate,” “continue” or similar expressions or
other variations or comparable terminology are intended to identify
such forward-looking statements, although some forward-looking
statements are expressed differently. Factors that could cause
future results to differ materially from the recent results or
those projected in forward-looking statements include the “Risk
Factors” described in the Company’s Annual Report on Form 10-K
filed with the Securities and Exchange Commission (“SEC”) on March
14, 2019 and in the Company’s other periodic filings with the SEC.
The Company’s further development is highly dependent on, among
other things, future medical and research developments and market
acceptance, which are outside of its control. You are cautioned not
to place undue reliance on forward-looking statements, which speak
only as of the date of this Press Release. Caladrius does not
intend, and disclaims any obligation, to update or revise any
forward-looking information contained in this Press Release or with
respect to the matters described herein.
Contacts:Investors: Caladrius Biosciences, Inc.
John Menditto Vice President, Investor Relations and Corporate
Communications Phone: +1-908-842-0084
Email: jmenditto@caladrius.com
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