Caladrius Biosciences Completes Enrollment in Phase 2 ESCaPE-CMD Trial for Coronary Microvascular Dysfunction
June 04 2019 - 8:30AM
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 the
completion of enrollment and dosing in the Phase 2 ESCaPE-CMD study
for CLBS16 (formerly known as CLBS14-CMD) in patients with coronary
microvascular dysfunction (“CMD”). The Company expects to announce
topline results shortly after the last patient completes follow up
at the end of 2019.
“The completion of enrollment and dosing for this important
study marks the first of several clinical milestones Caladrius
expects to announce during the next 12-18 months and we look
forward to sharing the results of the ESCaPE-CMD study after the
last patient completes the 6 month follow up at the end of this
year,” said Douglas W. Losordo, MD, FACC, FAHA, Executive Vice
President, Global Head of Research and Development, Chief Medical
Officer at Caladrius. “A preponderance of patients with CMD are
reported to be females, many of whom have not been diagnosed or
treated, making this condition that has no targeted therapy
currently available an emerging and important women’s health
issue.”
This Phase 2 interventional, open label, proof-of-concept study
was conducted at two centers in the United States, Cedars-Sinai in
Los Angeles, CA and the Mayo Clinic in Rochester, MN. In the study,
20 patients with diagnosed CMD received CLBS16 via a routine
intracoronary infusion. The safety and efficacy endpoints include
changes from baseline to six months for coronary flow reserve, or
CFR (a direct measure of microvascular function),
endothelial-dependent microvascular function, time to angina and
other cardiovascular metrics. For more information on the
ESCaPE-CMD study, please visit
https://clinicaltrials.gov/ct2/show/NCT03508609?term=clbs14&rank=1.
Preliminary results from the first 30% of the patients to complete
the 6-month follow-up are highly promising with evidence that
improved CFR is associated with symptomatic improvement (as
reported by the Company during its recent quarter conference call
and as described in the corporate presentation posted on the
Company's website). The results from this study are particularly
important because they may provide information as to the impact of
CLBS16 on patients with CMD while also providing potential
corroboration of the mechanism of action of CD34+ cells in humans
of promoting the growth of new microvasculature in response to
myocardial ischemia. We will also look to these results for further
support for the proposed mechanism of action of CLBS14 in no option
refractory disabling angina, an indication for which Caladrius is
preparing to commence a registration Phase 3 study.
Funding for the Phase 2 ESCaPE-CMD study came, in part, from a
$1.9 million grant from the National Institutes of Health under
award number R44 HL135889. The content of this press release
is solely the responsibility of the authors and does not
necessarily represent the official views of the National Institutes
of Health.
About CLBS16 (formerly CLBS14-CMD) CLBS16 is a
proprietary formulation of autologous G-CSF mobilized peripheral
blood derived CD34+ cells - endothelial progenitor cells that
reside naturally in the bone marrow. Among the functions of these
cells is the preprogrammed ability to induce capillary growth to
regenerate microcirculation in damaged tissue experiencing
microvascular insufficiency. CLBS16, administered via infusion into
a coronary artery, is formulated specifically to enhance the
potency of the natural process whereby CD34+ cells repair and
regenerate microvasculature.
About Coronary Microvascular Dysfunction
(CMD)CMD, previously known as syndrome X, is a heart
disease that occurs in the presence or absence of obstructions in
the large arteries and involves damage to the inner lining of the
tiny arterial blood vessels in the heart. It has been reported that
a significant number of patients with coronary artery disease have
CMD with a preponderance of those patients reported to be female.
As many as half of patients with chest pain due to a lack of blood
supply to the heart muscle have been shown to have non-obstructive
coronary arteries, and studies indicate that the majority of those
patients have CMD1 and could be eligible for CLBS16. There is
currently no available targeted therapy for CMD.
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 Phase 2
testing 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
preparations 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.
1Coronary Microvascular
Dysfunction― Epidemiology, Pathogenesis, Prognosis,
Diagnosis, Risk Factors and Therapy ―Circulation Journal 2017
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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