BioCardia Doses First Patient in CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells for the Treatment of Ischemic Heart Failure of Reduced Ejection Fraction
19 Diciembre 2023 - 6:00AM
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary disease, today announced that the first patient was
enrolled and treated in its CardiALLO™ Allogeneic Mesenchymal Cell
Therapy Phase I/II trial for the treatment of patients with New
York Heart Association Class II and III ischemic heart failure of
reduced ejection fraction (HFrEF).
These “off the shelf” mesenchymal stem cells (MSC) utilized for
the study treatment are immunomodulatory with potential for impact
on inflammatory processes in heart failure and have been shown to
release multiple critical angiogenic factors that can enhance
microvascular function and capillary networks in ischemic tissues.
They are closely related to the MSC used in our previous experience
with HFrEF patients, which demonstrated significant and durable
reduction in infarct size and enhanced left ventricular ejection
fraction following a single dose.
The first patient was enrolled at the Division of Cardiovascular
Medicine, University of Florida at Gainesville under the leadership
of Dr. Carl Pepine, MD, Professor of Medicine as the trial’s
National Principal Investigator, and Dr. David Anderson, MS, MD,
Professor of Medicine and Director of Interventional Cardiology and
Cardiac Catheterization Lab, as the treating physician and study
site’s Principal Investigator.
“Ischemic heart failure is a common outcome in people who have
had previous vascular disease and patients are at increased risk
for accelerated decline and serious complications associated with
their condition,” said Debby Holmes Higgin, BioCardia’s Vice
President of Clinical. “CardiALLO mesenchymal stem cell therapy
offers the potential of a one-time treatment to provide immune
modulation and paracrine signaling benefits to the microvasculature
as a treatment to improve patient outcomes.”
The CardiALLO MSC study is a dose escalation Phase I safety
study to be followed by a Phase II randomized double-blind
controlled study to assess therapeutic benefit or efficacy. In
Phase I, the study calls for at least nine New York Heart
Association Class II or III HFrEF patients to be initially
enrolled, with an additional 60 patients enrolled in Phase II. For
Phase I, three patients are to be treated at each of three
escalating doses, 20 million cells, 100 million cells, and 200
million cells, using BioCardia’s minimally invasive Helix catheter
delivery system which enters the heart through a blood vessel. A
two-week waiting period between each dose cohort is built into the
study design with a formal Data Safety Monitoring Board review
following each dose. These proprietary CardiALLO human
cells and their dedicated proprietary catheter delivery system are
manufactured at BioCardia’s facility in Sunnyvale, California.
“The initiation of the CardiALLO MSC clinical trial for HFrEF is
a significant milestone in our efforts to improve patients’ lives
through the development of new treatments that target the
underpinnings of heart disease,” said Peter Altman, Ph.D.,
BioCardia’s President and CEO. “We are grateful for the support of
study sites, patients and families who are actively engaged with
BioCardia in our efforts to explore the potential of BCDA-03 as a
novel treatment for ischemic HFrEF. We look forward to
continuing this close partnership as we actively enroll additional
patients in the CardiALLO MSC Study. Similar to our
autologous CardiAMP cell therapy, which this allogenic cell therapy
compliments, there are no requirements for immunosuppression,
antiarrhythmic drugs, or open chest surgery.”
This study follows BioCardia’s three previous co-sponsored
clinical trials with MSCs in ischemic heart failure: TACHFT1,
POSEIDON2 and TRIDENT3. These trials included 93 patients treated
with culture expanded MSCs or dedicated controls using the Helix
delivery system with no observed treatment emergent serious adverse
events. The CardiALLO MSC trial builds on the compelling early
signals for benefit demonstrated in these previous
trials.
Anticipated 2023 Q4 Milestones:
- Helix Biotherapeutic
Delivery System Update on Licensing / Partnerships
References:
- The Transendocardial Autologous Cells (hMSC or hBMC) in
Ischemic Heart Failure Trial (TAC-HFT, NCT00768066),
- The Percutaneous Stem Cell Injection Delivery Effects on
Neomyogenesis Pilot Study (POSEIDON, NCT01087996),
- The Transendocardial Stem Cell Injection Delivery Effects on
Neomyogenesis Study (TRIDENT, NCT 02013674)
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is
developing cellular and cell-derived therapeutics for the treatment
of cardiovascular and pulmonary disease. CardiAMP™ autologous and
CardiALLO allogeneic cell therapies are the Company’s
biotherapeutic platforms for the treatment of heart disease.
BioCardia also acts as a biotherapeutic delivery partner supporting
therapies for the treatment of heart failure, chronic myocardial
ischemia, and acute myocardial infarction. For more information
visit: www.BioCardia.com.
Forward Looking Statements:
This press release contains forward-looking statements that are
subject to many risks and uncertainties. Forward-looking statements
include, among other things, statements relating to the mechanisms
of action of the CardiALLO MSC therapy, future enrollment in our
ongoing clinical trial, anticipated milestones and events, the
likelihood of safety and patient benefit, and the ultimate success
of our clinical cell therapy programs. These forward-looking
statements are made as of the date of this press release.
We may use terms such as “believes,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should,” “approximately” or other words that convey the
uncertainty of future events or outcomes to identify these
forward-looking statements. Although we believe that we have a
reasonable basis for each forward-looking statement contained
herein, we caution you that forward-looking statements are not
guarantees of future performance and that our actual results may
differ materially from the forward-looking statements contained in
this press release. Factors that could cause or contribute to such
differences include, but are not limited to, the Company’s
liquidity position and its ability to raise additional funds, as
well as the Company’s ability to successfully progress its clinical
trials. As a result of these factors, we cannot assure you that the
forward-looking statements in this press release will prove to be
accurate. Additional factors that could materially affect actual
results can be found in BioCardia’s Form 10-K filed with the
Securities and Exchange Commission on March 29, 2023, under the
caption titled “Risk Factors” and in its subsequently filed
Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any
intent or obligation to update these forward-looking statements,
except as required by law.
Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
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