Caladrius Biosciences, Inc. (Nasdaq: CLBS), a late-stage
biopharmaceutical company focused on developing treatments for
select cardiovascular diseases, along with researchers from
Cedars-Sinai (Los Angeles), Mayo Clinic (Rochester, Minn.) and The
Christ Hospital (Cincinnati), today presented results from the
ESCaPE-CMD trial of Caladrius’s autologous CD34+ cell therapy,
CLBS16, at the American Heart Association Scientific Sessions 2019.
Data showed highly statistically significant improvement in
coronary flow reserve correlating with symptom relief for patients
with coronary microvascular dysfunction after a single
intracoronary injection of CLBS16. The results for patients who
have completed the six-month follow-up to date (17 of 20) were
presented, with the results from the remaining patients expected by
the end of 2019.
“CLB16 represents a potential breakthrough for the treatment of
CMD, a condition that affects millions in the U.S. and that
disproportionately afflicts women. This is the first time that a
therapy has shown the ability to durably increase coronary flow
reserve and potentially reverse CMD after a single dose. These
reported results clearly support the premise that manageable
cell-based tissue regeneration is possible in patients with CMD,”
said David J. Mazzo, Ph.D., President and CEO of Caladrius. “The
reported results from the ESCaPE-CMD trial bring us one step closer
to realizing the promise of CD34+ cell therapy to augment
microvasculature in the heart enabling the restoration of health
rather than simply management of disease.”
Trial investigators observed that patients experienced a highly
statistically significant (p=0.0087) increase in coronary flow
reserve after a single intracoronary administration of CLBS16. The
trial also evaluated changes from baseline to six months in chest
pain frequency, Canadian Cardiovascular Society angina
classification and Seattle Angina Questionnaire scores. A single
administration of CLBS16 resulted in statistically significant
improvements in all these measures of patient symptoms and
function.
“Coronary microvascular dysfunction is becoming increasingly
recognized as a major health problem that disproportionately
affects women. Unfortunately, there are no currently available
therapies that directly target this condition. The reported data
from this study provide objective evidence that CD34+ cell therapy
results in long-lasting improvement in microvascular function,
something that has not been shown with any other therapy to date,”
said Timothy D. Henry, M.D., Medical Director of the Carl and Edyth
Lindner Center for Research at The Christ Hospital Health Network.
“The CLBS16 program has demonstrated real promise and I am looking
forward to seeing Caladrius further develop this new therapeutic
option for CMD patients.”
The ESCaPE-CMD1 trial is an interventional, proof-of-concept
study designed to evaluate the effect of Caladrius’s autologous
CD34+ cell therapy (CLBS16) on CMD symptoms and indicators while
also evaluating treatment tolerance. The key endpoint was
measurement of the change from baseline of coronary flow reserve, a
direct measure of microvascular function, at six months following a
single injection of CLBS16. The trial completed enrollment of the
targeted 20 patients in May of 2019. The study’s three principal
investigators are Dr. C. Noel Bairey Merz, Cedars-Sinai, Dr.
Timothy D. Henry, The Christ Hospital, and Dr. Amir Lerman, Mayo
Clinic. All patients received a single infusion of their own
GCSF-mobilized CD34+ cells formulated as CLBS16.
“CMD patients often are frustrated and in despair due to
unresolved symptoms even after exhausting all other available
therapies. These data indicate that the naturally-occurring CD34+
repair cell could provide a durable improvement in symptoms and
reduced risk of adverse cardiovascular outcomes,” said Douglas W.
Losordo, M.D., FACC, FAHA, Chief Medical Officer at Caladrius. “We
are extremely encouraged by these results from the trial and look
forward to advancing the development of CLBS16 expeditiously with
the goal of one day soon helping the large and underserved
population of patients suffering from CMD.”
Results from the six-month follow-up of the remaining treated
patients will be available by year-end 2019.
About Coronary Microvascular
DysfunctionCoronary microvascular dysfunction is a type of
non-obstructive coronary artery disease that causes decreased blood
flow to the heart muscle that affects approximately 8.3 million2,3
people in the U.S. With common symptoms such as recurring,
debilitating chest pain, tiredness, and shortness of breath, many
CMD patients are undiagnosed because of the absence of large vessel
obstruction. Due to a misunderstanding of the disease, patients,
the majority of whom are women, often go years without proper
treatment. When a diagnosis of CMD is missed, patients are
untreated and remain at high risk of heart attack and/or
cardiovascular-related death.
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 Japan and
advanced therapy medicinal product classification (ATMP) in Europe,
eligible for early conditional approval for the treatment of
critical limb ischemia in Japan based on an ongoing clinical trial;
CLBS16, subject of the proof-of-concept ESCaPE-CMD clinical trial
in the U.S.A. for the treatment of coronary microvascular
dysfunction; and CLBS14, a Phase 3 ready clinical program in no
option refractory disabling angina and recipient of a RMAT
designation in the U.S.A. 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.
Media Contact:W2O GroupAlana RocklandPhone:
+1-301-537-5392Email: arockland@w2ogroup.com
Investors Contact: Caladrius Biosciences, Inc.
John Menditto Vice President, Investor Relations and Corporate
Communications Phone: +1-908-842-0084 Email:
jmenditto@caladrius.com
1 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.2Mittal, S.R.; Indian Heart Journal, Volume 66, 2014, Pages
678–6813Cleveland Clinic/AHA (American Heart Association)
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