BioCardia Announces FDA Completes Review of Proposed Adaptive Statistical Analysis Design for Ongoing CardiAMP Cell Therapy in Heart Failure Pivotal Study
20 Junho 2023 - 6:14PM
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today announced that FDA Center for Biologics
Evaluation and Research (CBER) has completed review of the CardiAMP
Cell Therapy System adaptive statistical analysis design supplement
for the ongoing pivotal study to treat ischemic heart failure with
reduced ejection fraction (HFrEF). The adaptive statistical
analysis plan is on track to be implemented at the upcoming Data
Safety Monitoring Board (DSMB) meeting, scheduled for July 12,
2023.
Under the adaptive statistical analysis plan, should the
CardiAMP Cell Therapy for Heart Failure study be stopped early for
anticipated efficacy at this, or any future DSMB review, study
sites will continue to follow all enrolled (randomized) patients
until all of them have reached their one-year follow-up visit, at
which time the trial results would be unblinded. Enrollment would
continue after any DSMB meeting that stops randomization for
anticipated efficacy, with all subsequently enrolled patients
receiving the study treatment. The open-label patients receiving
the study treatment are intended to increase the amount of data
available to address safety considerations for the pre-market
application and market approval for the CardiAMP Cell Therapy
System by FDA CBER.
Additional details, including the minimum number of patients
treated open-label and any additional follow-up testing required,
are to be confirmed with the FDA. It is our expectation that the
adaptive statistical analysis plan will not extend the duration of
the trial past the follow-up of the last randomized patient
enrolled. The adaptive statistical analysis plan is expected to
have minimal impact on statistical power of the trial. The DSMB may
stop the trial early for safety or futility at any time.
“There is now potential for the CardiAMP Cell Therapy for Heart
Failure trial to be stopped early for efficacy which could enable
patients to have earlier access to this FDA designated breakthrough
cell therapy. The most important aspect of the ongoing discussion
with the FDA is our mutual focus on what is needed for a marketing
application based on this trial,” said Peter Altman, President and
CEO. “The quality of the data in this actively enrolling clinical
trial is due to our top-tier clinical teams and the many dedicated
patients.”
About the CardiAMP Cell Therapy ProgramCardiAMP
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
diagnostic 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.
About BioCardia®BioCardia, Inc., headquartered
in Sunnyvale, California, is a developer of two biotherapeutic
platforms – the CardiAMP autologous bone marrow derived
mononuclear cell therapy for cardiovascular indications, and the
NK1R+ allogenic bone marrow derived mesenchymal stem cell therapies
for cardiovascular and pulmonary diseases. These platforms
underlie four product candidates, each with the potential to
meaningfully benefit millions of patients. Three of these
investigational therapies are enabled by the Company’s proprietary
biotherapeutic delivery platforms, which the Company also
selectively licenses to other biotherapeutic development
firms.
Upcoming Anticipated Catalysts
- BCDA-01 Submission for Formal Consultation towards Approval in
Japan, Q2 2023
- BCDA-01 Data Safety Monitoring Board Review, July 12, 2023
- BCDA-03 First Patient Enrolled, July 2023
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, references to the Company’s investigational product
candidates, efforts in ongoing regulatory discussions with the FDA
with respect to the adaptive statistical analysis plan, including
its implementation, future DSMB meetings and the impacts of the
study under different regulatory approval scenarios. 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. For information on the factors that could
materially affect these forward-looking statements, please see
BioCardia’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission on March 29, 2023, under the caption titled
“Risk Factors.” As a result of these and other factors, we cannot
assure you that the forward-looking statements in this press
release will prove to be accurate. BioCardia expressly disclaims
any intent or obligation to update these forward-looking
statements, except as required by law.
Media Contact:Anne Laluc,
MarketingEmail: alaluc@biocardia.comPhone: 650-226-0120
Investor Contact:David McClung, Chief Financial
OfficerEmail: investors@biocardia.comPhone: 650-226-0120
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