Caladrius Biosciences to Assess its CLBS201 CD34+ Cell Therapy in Diabetic Kidney Disease
June 22 2021 - 8:00AM
Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a clinical-stage biopharmaceutical company dedicated to
the development of cellular therapies designed to reverse disease,
today announced that the U.S. Food and Drug Administration (“FDA”)
has authorized its investigational new drug (“IND”) application for
the study of CLBS201, a CD34+ cell therapy for the treatment of
diabetic kidney disease (“DKD”).
“Our latest development program, CLBS201, is designed to assess
the safety and efficacy of CD34+ cell therapy as a treatment for
diabetic patients with reduced kidney function. Specifically, we
will be targeting patients with later stage chronic kidney disease.
Based on a wealth of published preclinical and early clinical data,
it appears that the innate ability of CD34+ cells to promote the
growth of new microvasculature could be a means to attenuate the
progression, or even reverse the course, of DKD,” stated David J.
Mazzo, Ph.D., President and Chief Executive Officer of Caladrius.
“We plan to initiate a phase 1/2 proof-of-concept study of CLBS201
within the next several months. Kidney disease remains a largely
unmet medical need, especially as the general population ages and
the incidence of diabetes and hypertension increases.”
About Caladrius Biosciences
Caladrius Biosciences, Inc. is a clinical-stage
biopharmaceutical company dedicated to the development of cellular
therapies designed to reverse disease. We are developing
first-in-class cell therapy products based on the finely tuned
mechanisms for self-repair that exist in the human body. 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: CLBS16, the
subject of both a recently completed positive Phase 2a study and a
newly initiated Phase 2b study (www.freedom-trial.com) in the U.S.
for the treatment of coronary microvascular dysfunction (“CMD”);
HONEDRA® (CLBS12), recipient of orphan designation for Buerger’s
Disease in the U.S. as well as SAKIGAKE designation and eligible
for early conditional approval in Japan for the treatment of
critical limb ischemia (“CLI”) and Buerger’s Disease based on the
results of an ongoing clinical trial; CLBS201, designed to assess
the safety and efficacy of CD34+ cell therapy as a treatment for
diabetic kidney disease (“DKD”); and OLOGO™ (CLBS14), a
Regenerative Medicine Advanced Therapy (“RMAT”) designated therapy
for which the Company is in discussion with the FDA to finalize a
Phase 3 protocol of reduced size and scope for a 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 completion of the private placement, the
satisfaction of customary closing conditions related to the private
placement and the intended use of net proceeds from the private
placement 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; market and other conditions; 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
February 25, 2021 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 MendittoVice
President, Investor Relations and Corporate
CommunicationsPhone: 908-842-0084Email: jmenditto@caladrius.com
Media: Real ChemistryRachel GirardReal ChemistryPhone:
401-477-4030Email: rgirard@realchemistry.com
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