BioCardia Announces Clarification and Next Steps on its Autologous CardiAMP Cell Therapy Programs
September 06 2023 - 7:15AM
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary disease, today announced a clarification and next steps
on its autologous CardiAMP cell therapy programs.
Based on the recent interim results in the CardiAMP autologous
cell therapy for the treatment of heart failure (BCDA-01), the
Company is exploring development of a new Phase III clinical trial
protocol. The Finkelstein Schoenfeld (FS) primary composite
endpoint used in the CardiAMP HF Trial has tiers of outcomes in
decreasing order of importance: heart death equivalent, major
adverse cardiac and cerebrovascular MACCE, and Six Minute Walk
Distance (6MWD). Since the primary FS endpoint is a composite of
these elements, meeting the FS endpoint may be met even if one or
more of the components does not individually demonstrate
statistical significance. This has implications for the future
trial design.
The CardiAMP HF Trial interim results showed that the first two
most important tier outcomes, occurring in 30% of the study
patients, could have contributed sufficiently toward efficacy given
a longer follow-up period than one year. If these interim results
are replicated in a future study in which the third tier 6MWD is
replaced with a more objective endpoint, there may be a pathway to
a successful trial for product registration in the United States.
The FDA has previously expressed a preference for replacing the
6MWD with Cardiopulmonary Exercise Testing, which is a more
objective outcome. We are exploring with the CardiAMP HF Study
Executive Steering Committee whether to fine tune eligibility
criteria for patients based on current data and to replace the 6MWD
with Cardiopulmonary Exercise Testing or another other more
objective third-tier outcome measurement.
Such a protocol may also be capital efficient by eliminating
measures that have already been gathered in the ongoing CardiAMP HF
study while continuing to utilize the CMS reimbursement program
currently in place. Using the cell population analysis screening
criterion to set patient dosage, rather than using it to exclude
patients from the study, could accelerate enrollment.
CardiAMP in Chronic Myocardial Ischemia, or BCDA-02, has a
generally accepted mechanism of action of microvascular
revascularization driven by the CD34 and CD133 components of the
dosage. It is a different indication from the heart failure
indication and members of the Steering Committee believe it has
great potential to be successful even if the heart failure
indication is not ultimately successful. Microvascular
revascularization and repair to reduce pain and enhance heart
performance in a relatively healthy heart is viewed as an easier
challenge for the cells to overcome than helping a heart already in
failure to recover. This study is on track to complete the roll in
cohort enrollment in Q4 and advance to its randomized double blind
pivotal trial. BioCardia expects to focus its resources on
accelerating this pivotal program ahead and will be incorporating
strategies to enhance enrollment.
“We have three synergistic clinical programs for the treatment
of ischemic heart disease utilizing the leading transendocardial
delivery platform which we also developed,” continued Peter Altman.
“Our expectation is that we can move all of these programs through
significant milestones in the next year on less capital than we
have utilized in previous years.”
Anticipated Upcoming Milestones and Events:
- BCDA-01: CardiAMP Cell Therapy for
Heart Failure Phase III Trial
- Q3 2023: Clarity on Second Pivotal
Study Design
- 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
- Q3 2023: First Patient Enrolled
- Helix Biotherapeutic Delivery System
- Q4 2023: Completion of Enrollment in
Partner CellProthera’s EXCELLENT Trial
- Q4 2023: Update on Licensing /
Partnerships
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. The
CardiAMP Cell Therapy Heart Failure Trial investigational product
has been granted Breakthrough designation by the FDA, has CMS
reimbursement, and is supported financially by the Maryland Stem
Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial
also has CMS Reimbursement. 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 future data
analysis, future protocol submissions to FDA, anticipated
milestones and events, conclusions of results based on interim data
generated by the CardiAMP Heart Failure statistics core, 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 RelationsEmail: mpeto@BioCardia.comPhone:
650-226-0120
Investor Contact:David McClung, Chief Financial
OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
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