Caladrius Biosciences Announces Presentation of Full Results for CLBS16 from the ESCaPE-CMD Trial at SCAI 2020 Scientific Ses...
May 06 2020 - 8:30AM
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 it will present 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
being held virtually May 13-16, 2020.
Oral presentation details:
Session Type: |
Featured
Clinical Research |
Title: |
Autologous CD34 Cell Therapy for Treatment of Coronary
MicrovascularDysfunction in Patients with Angina and
Non-Obstructive Coronary Arteries |
Date & Time: |
Thursday, May 14, 2020 at 3:40p.m. (ET) |
Link to Session: |
https://scai.confex.com/scai/2020/meetingapp.cgi/Paper/11492 |
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 measurement of the change from baseline of
coronary flow reserve, a direct measure of microvascular function,
at six months following a single injection of CLBS16. The trial
completed enrollment of the targeted 20 patients in May of 2019 and
the last patient completed the 6-month follow up in December of
2019. Dr. Timothy Henry will present the findings. 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, The Mayo
Clinic, Rochester, MN. All patients received a single
infusion of their own GCSF-mobilized CD34+ cells formulated as
CLBS16.
About Coronary Microvascular
DysfunctionCoronary 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 BiosciencesCaladrius
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 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"); 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"); and 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. For more information on the company, please
visit www.caladrius.com.
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
1 Funding 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.2 Mittal, S.R.; Indian Heart Journal, Volume 66, 2014,
Pages 678–6813 Cleveland Clinic/AHA (American Heart
Association)
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