CellProthera and BioCardia Collaborate on Successful Phase II Trial of ProtheraCytes™ for the Treatment of Acute Myocardial Infarction
July 08 2024 - 7:00AM
CellProthera, a private company specializing in cell-based
therapies for repairing ischemic tissues, and BioCardia, Inc.
[Nasdaq: BCDA], a developer of cellular and cell-derived
therapeutics for the treatment of cardiovascular and pulmonary
diseases, today announce success from a collaborative Phase II
trial of ProtheraCytes for the treatment of acute myocardial
infarction (AMI) led by CellProthera, as well as plans to continue
the relationship into Phase III.
CellProthera’s clinical results from the Phase I/IIb EXCELLENT
Trial, which studied the feasibility of transendocardial injection
of ProtheraCytes for acute myocardial infarction when delivered in
combination with the standard of care, suggested an effective
solution for preventing heart failure progression in the patients
at high risk following a heart attack.
The ProtheraCytes, which are autologous, expanded CD34+ stem
cells, were well tolerated with no unexpected serious adverse
events reported. Transendocardial administration of ProtheraCytes,
performed utilizing the percutaneous catheter delivery system from
BioCardia, was associated with improvements in multiple efficacy
endpoints including a significant improvement of the viability of
segments from baseline to six months, a consistent positive trend
of improvement of LV volumes at six months, and a faster decrease
in an important biomarker of heart failure, NTproBNP.
“The promising results of the study confirm the potential of our
therapy to provide an effective one-off solution to prevent heart
failure progression in AMI patients,” said Matthieu de
Kalbermatten, CEO, CellProthera. “We are actively planning for what
comes next and we have valued the responsiveness of the BioCardia
team throughout the EXCELLENT trial in supporting training,
attending clinical cases, and providing delivery systems. We have
great learnings today that will enhance our efforts in what comes
next, together.”
“The EXCELLENT trial has meaningful results for patient benefit
using an approach that we feel makes enormous sense for locally
administered high effective dosage of autologous CD34+ cells for
these patients,” said Peter Altman, PhD, President and CEO of
BioCardia. “I am personally impressed by their approach. It has
been an honor to support CellProthera and we look forward to
collaborating in the study to follow. We are ready for what comes
next with enhancements to our delivery capabilities.”
About CellProthera
CellProthera is a regenerative cell therapy developer
specializing in cardiovascular diseases with a leading program in
myocardial infarction. CellProthera has developed a unique
GMP-compliant cell expansion process as well as a proprietary
automation technology for in vitro production of large quantity of
purified, CD34+ stem cells. Its lead therapy ProtheraCytes™, is an
autologous cell therapy and has been developed for body
regeneration and targeted to regenerate various damaged tissues,
including cardiac tissue. ProtheraCytes is registered as an
Advanced Therapy Medicinal Product by the European Medicines Agency
(EMA). CellProthera’s proprietary technology platform comprises an
automated expansion device called StemXpand® and its
disposable kit StemPack®. CellProthera is headquartered in
France.
www.cellprothera.com/en/home
About BioCardia
BioCardia, Inc., 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 in three
clinical stage product candidates in development. BioCardia also
partners with other biotherapeutic companies to provide its
delivery systems and development support to their programs.
www.biocardia.com
BioCardia 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, success of the future
collaboration. 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. 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 27,
2024, under the caption titled “Risk Factors” and in its
subsequently filed Quarterly Reports on Form 10-Q. The Company
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
BioCardia (NASDAQ:BCDA)
Historical Stock Chart
From Jun 2024 to Jul 2024
BioCardia (NASDAQ:BCDA)
Historical Stock Chart
From Jul 2023 to Jul 2024