Caladrius Biosciences Plans to Assess its CLBS119 Cell Therapy for Repair of COVID-19 Induced Lung Damage
April 23 2020 - 8:55AM
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 today announced that the U.S. Food and Drug
Administration (“FDA”) has authorized its investigational new drug
(“IND”) application for the study of CLBS119, a CD34+ cell therapy
for repair of COVID-19 induced lung damage. The study will target
patients with severe SARS-CoV-2 infection that required ventilatory
support due to respiratory failure.
“We appreciate the FDA’s expeditious review and approval of the
IND for CLBS119. Early reports indicate that many of the
survivors of COVID-19 that required ventilatory support remain
debilitated due to the lung injury sustained as a result of the
virus. COVID-19 appears to damage the vasculature of the lungs and
repair of that vasculature will be necessary for patients to
achieve a full recovery. Although many therapies are targeting the
SARS-CoV-2 virus itself or the reduction of severe inflammation
during the acute phase of the illness, no therapy has been shown to
repair COVID-19 induced lung damage,” said Douglas W. Losordo,
M.D., FACC, FAHA, Chief Medical Officer at Caladrius. “CLBS119
offers the potential to repair the lung damage caused by COVID-19
and to address a serious unmet need for patients. In previous
clinical trials and preclinical models, CD34+ cells consistently
have shown evidence of vascular repair in multiple organs including
models of severe lung inflammation. In the proposed trial,
Caladrius plans to evaluate whether CD34+ cells can be used to
effectively restore lung function in patients with severe
SARS-CoV-2 infection that required ventilatory support due to
respiratory failure.”
About Caladrius BiosciencesCaladrius
Biosciences, Inc. is a clinical-stage biopharmaceutical company
dedicated to the development of cellular therapies designed to
reverse, not manage, 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.
Our leadership team collectively has decades of
biopharmaceutical development experience and world-recognized
scientific achievement in the field of cardiovascular disease,
among other fields. Our goal is to build a broad portfolio of novel
and versatile products that address important unmet medical needs
and bring these products to market to benefit patients, the medical
community and our shareholders. Our current product candidates
include three developmental treatments for ischemic diseases based
on our CD34+ cell therapy platform: CLBS12, recipient of SAKIGAKE
designation (a Japanese regulatory status that is similar in
certain respects to "breakthrough therapy" designation granted by
the U.S. Food and Drug Administration (the "FDA") to eligible
investigational treatments) 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,
a recently completed Phase 2 proof-of-concept clinical trial in the
U.S. for the treatment of coronary microvascular dysfunction
("CMD"); and CLBS14, an RMAT designated therapy for which we have
finalized with 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 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
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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.
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
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