Caladrius Biosciences Announces Orphan Drug Designation for CLBS12 for the Treatment of Buerger’s Disease
March 08 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 granted orphan drug designation to the
Company’s CD34+ cell therapy product, CLBS12, for the treatment of
Buerger’s disease – also known as thromboangiitis obliterans – a
condition related to critical limb ischemia (“CLI”) with no
approved treatments to date in the U.S. .
“We are very pleased that the FDA has granted orphan drug
designation to CLBS12 in Buerger’s disease. Without a currently
approved or effective treatment for this condition in the U.S., a
significant unmet need remains for therapies that slow, stop or,
ideally, reverse this debilitating disease,” stated David J. Mazzo,
Ph.D., President and Chief Executive Officer of Caladrius. “The
Company’s ongoing open-label, registration-eligible study of
HONEDRA® (CLBS12) as a treatment for CLI and Buerger’s Disease in
Japan has shown strong results to date with approximately 60% of
subjects in the completed Buerger’s Disease cohort reaching a
positive ‘CLI-free’ endpoint despite the natural history of
continuous disease progression leading to amputation. With this
designation we can now engage FDA in discussions to define the most
efficient and rapid development pathway to registration in the U.S.
Achieving orphan designation for CLBS12 takes us one step closer to
realizing our goal of fulfilling the unmet medical need for
Buerger’s Disease patients around the world.”
Orphan drug designation is granted by the FDA’s Office of Orphan
Products Development, which provides orphan status to drugs or
biologics that are intended to treat rare diseases or disorders
that affect fewer than 200,000 people in the United States. This
designation provides the sponsor of the drug certain incentives,
including tax credits, for qualified clinical trials and fee
waivers. Orphan Drug designation confers eligibility for seven
years of market exclusivity to an orphan drug post-approval,
subject to a receipt by the FDA of marketing approval.
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 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 chronic kidney disease
(“CKD”); 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.
Contact:
Investors:Caladrius Biosciences, Inc.John MendittoVice
President, Investor Relations and Corporate CommunicationsPhone:
+1-908-842-0084Email: jmenditto@caladrius.com
Media: W2O GroupChristiana PascalePhone: +1-212-257-6722Email:
cpascale@w2ogroup.com
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