BioCardia Announces FDA Approval of IND Application for Allogeneic NK1R+ Human Mesenchymal Stem Cells for Ischemic Heart Failure
December 06 2022 - 07:00AM
Business Wire
Approval marks second clinical trial approved
by FDA this year for Company’s NK1R+ MSC platform
Allogeneic CardiALLO therapy for heart failure
to complement autologous cell therapy currently enrolling in Phase
III CardiAMP Heart Failure clinical trial
BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today announced Food and Drug Administration
(FDA) approval of its Investigational New Drug (IND) application to
initiate a first-in-human Phase I/II clinical trial of its
Neurokinin-1 receptor positive (NK1R+) allogeneic human mesenchymal
stem cell (MSC) therapy for the treatment of patients with ischemic
heart failure.
This trial is designed for patients with New York Heart
Association Class II and III ischemic heart failure with reduced
ejection fraction (ischemic HFrEF) whose own cell composition makes
them ineligible for the Company’s Phase III CardiAMP® Heart Failure
Trial studying autologous cell therapy that has received FDA
Breakthrough Device Designation.
“We intend to provide a complete cell therapy solution for
ischemic heart failure patients that encompasses both autologous
and ‘off the shelf’ allogeneic cell therapies. Our therapies are
synergistic in serving the full patient spectrum, as only about
two-thirds of patients are expected to be responders to our
autologous therapy,” said Peter Altman, PhD, BioCardia’s President
and Chief Executive Officer. “We expect to see efficiencies in the
upcoming CardiALLO™ trial for several reasons: we can leverage
screening activity from the currently enrolling CardiAMP trial to
direct ineligible patients into the CardiALLO trial; our allogeneic
cell therapy is already manufactured and ready for use; and it will
be delivered with our proprietary delivery system demonstrated in
literature to be the safest and most efficient delivery method
available today.”
He added, “We are excited to study the role our allogeneic NK1R+
MSC therapy may play in helping hearts recover from injury as its
mechanism of action involves Substance P. This binds to NK1R+ and
has been shown to be an important factor in the development of
inflammation, which plays a central role in both heart failure and
regenerative processes following myocardial injury.”
About Allogeneic CardiALLO NK1R+ MSC
Allogeneic NK1R+ MSC are culture-expanded, bone marrow-derived,
mesenchymal stem cells that are Neurokinin 1 receptor positive.
Neurokinin 1 is the primary receptor for Substance P, an important
neuropeptide mediator of inflammation. The BioCardia cell therapy
consists of cells from younger, extensively prescreened donors that
are expanded to provide multiple dosage forms from a single donor.
The cells are manufactured by BioCardia at its Sunnyvale facility.
For the heart failure indication, these cells will be delivered to
the heart using BioCardia’s Helix biotherapeutic delivery system,
which is approved in the European Union and has been shown to
result in three times as many cells being retained in the target
heart tissue as competitive delivery approaches while having the
lowest incidence of serious adverse events.
About BioCardia
BioCardia, Inc., headquartered in Sunnyvale, California, is a
developer of cell and cell-derived therapies for cardiovascular and
pulmonary disease. The Company has two biotherapeutic platforms,
CardiAMP autologous bone marrow-derived mononuclear cell therapy
for cardiovascular indications and the NK1R+ allogeneic bone
marrow-derived mesenchymal stem cell therapies for cardiovascular
and pulmonary diseases. These platforms underly several
clinical-stage product candidates, each with the potential to
meaningfully benefit millions of patients.
Forward Looking Statements:
This press release contains forward-looking statements that are
subject to many risks and uncertainties. Forward-looking statements
include synergies and efficiencies in completing our clinical
trials, the mechanism of action of our NK1R+ therapy and the future
safety and efficacy of our investigational therapies. These
forward-looking statements are made as of the date of this press
release, and BioCardia assumes no obligation to update the
forward-looking statements.
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. 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, 2022,
under the caption titled “Risk Factors.” BioCardia expressly
disclaims any intent or obligation to update these forward-looking
statements, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20221206005418/en/
INVESTOR CONTACT: David McClung, Chief Financial Officer
investors@BioCardia.com, (650) 226-0120
MEDIA CONTACT: Michelle McAdam, Chronic Communications
Inc. michelle@chronic-comm.com, (310) 902-1274
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