Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a clinical-stage biopharmaceutical company dedicated to
the development of cellular therapies designed to reverse, not
manage, disease, along with researchers from Cedars-Sinai (Los
Angeles), Mayo Clinic (Rochester, Minn.) and The Christ Hospital
(Cincinnati), today presented full data results from the ESCaPE-CMD
trial of Caladrius’s autologous CD34+ cell therapy, CLBS16, at the
Society for Cardiovascular Angiography and Interventions (“SCAI”)
2020 Scientific Sessions Virtual Conference. Data showed highly
statistically significant improvement in coronary flow reserve
(“CFR”) correlating with symptom relief for patients with coronary
microvascular dysfunction (“CMD”) after a single intracoronary
injection of CLBS16.
“We are extremely pleased, yet not surprised, that the full
results for the ESCaPE-CMD corroborate the previously reported and
very positive partial data from the study,” said Douglas W.
Losordo, M.D., FACC, FAHA, Chief Medical Officer at Caladrius. “The
results show an encouraging ability to increase CFR and potentially
reverse CMD, a disease that disproportionately afflicts more women
than men, after a single administration. The outcome from this
study brings 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. We look forward to initiating the next trial for
this program, a Phase 2b study, in the fall of 2020.”
Trial investigators observed that patients experienced a highly
statistically significant (p=0.0045) increase in coronary flow
reserve at six months 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.
“As predicted, these data provided further evidence that CD34+
cell therapy can be a game changer resulting in long-term
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, who presented the data from
the study at SCAI. “The CLBS16 program has demonstrated great
promise and I am looking forward to seeing Caladrius further
develop this new therapeutic option for CMD patients.”
The ESCaPE-CMD1 trial was an interventional, proof-of-concept
study designed to evaluate the ability of Caladrius’s autologous
CD34+ cell therapy (CLBS16) to reverse the underlying pathology of
CMD, the loss of microcirculation, and thereby alleviate symptoms.
The key endpoint was change from baseline of coronary flow reserve,
a direct measure of microvascular function, at six months following
a single administration of CLBS16. The trial completed enrollment
of the targeted 20 patients in May 2019 and the last patient
completed the 6-month follow up in December 2019. The study’s three
principal investigators are Dr. C. Noel Bairey Merz, Cedars-Sinai
Medical Center, Los Angeles, CA, Dr. Timothy D. Henry, The Christ
Hospital, Cincinnati, OH and Dr. Amir Lerman, Mayo Clinic,
Rochester, MN. All patients received a single infusion of
their own GCSF-mobilized CD34+ cells formulated as CLBS16. For more
information on the ESCaPE-CMD study, please visit
https://clinicaltrials.gov/ct2/show/NCT03508609.
About Coronary Microvascular Dysfunction
Coronary 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 that include 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 Biosciences
Caladrius Biosciences, Inc. is a clinical-stage
biopharmaceutical company dedicated to the development of cellular
therapies designed to reverse, not manage, cardiovascular disease.
We are developing a first- in-class cell therapy product that is
based on the notion that our body contains finely tuned mechanisms
for self-repair. Our technology leverages and enables these
mechanisms in the form of specific cells, using formulations and
modes of delivery unique to each medical indication.
The Company's current product candidates include CLBS119, a
CD34+ cell therapy product candidate for the repair of lung damage
found in patients with severe COVID-19 infection who experienced
respiratory failure, for which the Company plans to initiate a
clinical trial in the coming months as well as three developmental
treatments for ischemic diseases based on its CD34+ cell therapy
platform: CLBS12, recipient of SAKIGAKE designation and eligible
for early conditional approval in Japan for the treatment of
critical limb ischemia ("CLI") based on the results of an ongoing
clinical trial; CLBS16, the subject of a recently completed
positive Phase 2 clinical trial in the U.S. for the treatment of
coronary microvascular dysfunction ("CMD"); and CLBS14, a
Regenerative Medicine Advanced Therapy ("RMAT") designated therapy
for which the Company has finalized with the U.S. Food and Drug
Administration (the "FDA") a protocol for a Phase 3 confirmatory
trial in subjects with no-option refractory disabling angina
("NORDA"). For more information on the company, please
visit www.caladrius.com.
Safe Harbor for Forward Looking Statements
This 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 the intended use of net proceeds from the
registered direct offering as well as 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 5, 2020 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, except as
required by law.
Contact:
Investors: Caladrius Biosciences, Inc. John Menditto Vice
President, Investor Relations and Corporate Communications
Phone: +1-908-842-0084
Email: jmenditto@caladrius.com
Media: W2O Group Christiana Pascale Phone: +1-212-257-6722
Email: cpascale@w2ogroup.com
1Funding 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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