Caladrius Biosciences Announces Registration of HONEDRA® Trademark and New Patent in Japan
September 09 2020 - 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, not
manage, disease, today announced that it has received trademark
registration from the Japan Patent Office (“JPO”) for the Company’s
use of HONEDRA® as the brand name for CLBS12, its
SAKIGAKE-designated product candidate for the treatment of Critical
Limb Ischemia (“CLI”) and Buerger’s Disease. In addition, the JPO
has awarded Caladrius a new patent that will further build out the
Company’s robust intellectual property portfolio. This marks the
fourth patent (Japan Patent Appl. No. 2015-219241) granted in Japan
to Caladrius for its CD34+ cellular therapy technology and will
provide additional, broadened protection of HONEDRA®, anticipated
to be approved and commercialized in Japan as early as mid-2022.
“The registration of the HONEDRA® trademark and the new patent
issuance in Japan both represent key steps towards the potential
approval and subsequent commercialization of CLBS12 in Japan,”
stated David J. Mazzo, Ph.D., President and Chief Executive Officer
of Caladrius. “We are committed to bringing this product to market
as rapidly as possible and believe that HONEDRA® will make a
meaningful difference in the lives of many patients with CLI and
Buerger’s Disease.”
About Critical Limb Ischemia
CLI is a result of severe obstruction of the arteries that
markedly reduces blood flow to the extremities, principally the
feet and legs. CLI can lead to pain, skin ulcers and dermal sores,
and, if not successfully addressed, amputation. No-option CLI means
that pharmacotherapy has been ineffective and options for bypass or
angioplasty have been exhausted.
About Caladrius Biosciences
Caladrius Biosciences, Inc. is a clinical-stage
biopharmaceutical company dedicated to the development of cellular
therapies designed to reverse, not manage, disease. We are
developing first- in-class cell therapy products 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 have
experienced respiratory failure, for which the Company plans to
initiate a clinical trial in the coming weeks as well as three
developmental treatments for ischemic diseases based on its CD34+
cell therapy platform: HONEDRA® (formerly 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
financings 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
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