BioCardia Announces Completion of Enrollment in Phase III CardiAMP HF Trial and Plans for CardiAMP HF Trial II
11 Oktober 2023 - 12:00PM
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary disease, today announces completion of enrollment in its
CardiAMP Heart Failure Trial and initiation of a discussion with
the FDA on a second pivotal study protocol adapted for the
responders in the initial trial with the objective of gaining FDA
marketing approval.
As previously disclosed, interim trial results reviewed by the
Data Safety Monitoring Board (DSMB) in July 2023 indicated that the
Phase III CardiAMP Heart Failure trial is not likely to meet the
primary endpoint for efficacy at 12 months, in part, because both
study groups of randomized patients have had good outcomes. There
were no treatment emergent safety concerns by the DSMB. Notably,
patients receiving CardiAMP Cell Therapy followed up to 24 months
showed a 37% relative risk reduction of cardiac death equivalents
and an 18% relative risk reduction in major adverse cardiac and
cerebrovascular events (MACCE).
For an important subset of patients with higher levels of
NT-proBNP, a well-established biomarker of increased heart failure
and stress to the heart, the benefits were even greater. In
patients with NT-pro BNP levels greater than 500 pg/ml at baseline,
an analysis of all available data up to two years shows
improvements over controls including a 59% relative risk reduction
in mortality [13% reduction in all-cause death and cardiac death
equivalents with CardiAMP therapy (9%) over the control group
(22%)] and a 54% relative risk reduction of MACCE [21% reduction
with CardiAMP therapy (18%) over the control group (39%)]. Further,
all clinical outcomes included in this analysis favored therapy
including: quality-of-life as measured by the Minnesota Living with
Heart Failure Questionnaire, NT-proBNP, Six Minute Walk Distance,
left ventricular ejection fraction, left ventricular end systolic
volume, and left ventricular end diastolic volume.
BioCardia, with its clinical leadership, has developed a
modified study design anticipated to have a high probability of
success based on existing data and has initiated discussion with
the FDA. The proposed CardiAMP Heart Failure II study includes the
requirement that all patients have an NT-proBNP at baseline greater
than 500 pg/ml and has a modified primary endpoint. The new
endpoint is a similar hierarchical composite endpoint consisting of
all-cause death, the cardiac death equivalents of heart transplant
and left ventricular assist device (LVAD) implantation, heart
failure hospitalizations, worsening heart failure events treated as
an outpatient, and change in quality-of-life with a follow-up
duration ranging from a minimum of 12 to a maximum of 24 months.
This endpoint is nearly identical to other ongoing clinical studies
of other therapies for this indication which also utilize NT-proBNP
threshold inclusion criteria. Statistical calculations for this
clinical study design support that a modestly sized clinical trial,
based on the interim results, would achieve high power (probability
of success). Additional modifications to the trial
design proposed include elements to simplify clinical logistics and
reduce the cost of performing the study.
“Together with our clinical partners, we have completed
enrollment in the largest autologous cell therapy study for heart
failure ever performed, with no treatment emergent safety concerns
from the DSMB and interim results with both improved survival and
reduced MACCE in the treatment group,” said BioCardia CEO Peter
Altman, PhD. “Our world-class clinical leadership is supportive of
pursuing the compelling and consistent interim results for patients
with elevated NT-proBNP at baseline. The data supports that if we
had focused on this subset of patients with the updated composite
endpoint, we should have met the primary endpoint in the study.” He
continued, “With FDA alignment on the plan forward, we intend to
secure the means required for the second study through the
established Medicare reimbursement and partnering.”
Anticipated Upcoming Milestones and Events:
- BCDA-01: CardiAMP Cell Therapy for
Heart Failure Phase III Trial(s)
- Q4 2023 CardiAMP HF Trial II FDA
Protocol Approval
- Q4 2023: Japan PMDA Formal
Consultation
- BCDA-02: CardiAMP Cell Therapy for
Chronic Myocardial Ischemia Phase III Trial
- Q4 2023: Completion of Roll-in Cohort
and Transition to Randomized Pivotal Trial
- BCDA-03: NK1R+ MSC Allogeneic Cell
Therapy in ischemic HFrEF Phase I/II Trial
- Q4 2023: Completion of low dose
cohort
- Helix Biotherapeutic Delivery System
- Q4 2023: Updates on Licensing /
Partnerships
About the CardiAMP Cell Therapy Program
CardiAMP Cell Therapy – FDA designated as a Breakthrough therapy
– uses a patient’s own (autologous) bone marrow cells delivered to
the heart in a minimally invasive, catheter-based procedure to
potentially stimulate the body’s natural healing response. The
CardiAMP Cell Therapy for Heart Failure Trial is the first known
multicenter clinical trial of a cell therapy to prospectively
screen for cell characteristics in order to improve patient
outcomes. CardiAMP Cell Therapy incorporates three proprietary
elements not previously utilized in investigational cardiac cell
therapy: a pre-procedural cell analysis for patient selection, a
high target dosage of cells, and a proprietary delivery system that
has been shown to be safer than other intramyocardial delivery
systems and exponentially more successful in cell retention. The
trial is supported by the Maryland Stem Cell Research Fund and the
Centers for Medicare and Medicaid Services. The trial enrolled ten
roll-in cohort patients, 115 randomized cohort patients, and eleven
control patients who elected to cross over to treatment after
completion of follow-up, for a total of 136 procedures. After the
last patient reaches their one-year follow-up in Q4 2024, complete
data from the trial will be available. CAUTION -
Limited by United States law to investigational
use.
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
NK1R+ allogeneic cell therapies are the Company’s biotherapeutic
platforms that enable four product candidates in development.
BioCardia also partners with other biotherapeutic companies to
provide its delivery systems and development support to their
programs studying 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 probability of
completing follow-up in the CardiAMP Heart Failure Trial, securing
FDA approval for the CardiAMP Heart Failure II trial, and the
probability of success of the trials, anticipated milestones and
events, 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 RelationsEmail: mpeto@BioCardia.comPhone:
650-226-0120
Investor Contact:David McClung, Chief Financial
OfficerEmail: investors@BioCardia.comPhone:
650-226-0120
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