Biocardia Announces FDA-Recommended Modifications to Primary Endpoint for Cardiamp Cell Therapy Heart Failure Trial to Suppor...
April 30 2020 - 8:00AM
BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development
of comprehensive solutions for cardiovascular regenerative
therapies, today reported that it has accepted and implemented
FDA-recommended modifications to the primary endpoint for the
CardiAMP® Cell Therapy Heart Failure Trial and associated
statistical analysis plan. The Agency proposed these modifications
to support the potential for marketing approval for the therapy
based on the currently enrolling pivotal trial.
The primary endpoint going forward will be an outcomes composite
score based on a three-tiered Finkelstein-Schoenfeld (FS)
hierarchical analysis, an established outcomes design that has been
used in other leading heart failure programs. The FS procedure is a
ranked analysis that first compares each subject to each other
subject for occurrence of first-tier events (time to death, in this
case) and then compares patient outcomes for subsequent tiers. The
tiers, starting with the most serious events, would be (1)
all-cause death, including cardiac death equivalents such as heart
transplant or left ventricular assist device placement, ordered by
time to event; (2) non-fatal Major Adverse Coronary and
Cerebrovascular Events (MACCE), excluding those deemed
procedure-related occurring within the first seven days
post-procedure (heart failure hospitalization, stroke or myocardial
infarction), ordered by time to event, and (3) change from baseline
in Six Minute Walk Distance at 12 months.
BioCardia CEO Peter Altman, PhD, said, “The only
major modification to our previous endpoint is that patients who
experience a MACCE event and recover will not be factored into the
benefit seen in the third-tier measure of Six Minute Walk Distance
at one-year follow-up. Since we saw no incidence of MACCE at one
year among treated patients in our Phase II trial, our probability
of achieving a positive result in the primary endpoint in the
ongoing pivotal CardiAMP Heart Failure trial remains unchanged, at
greater than 95 percent. Because the FS composite outcomes endpoint
is already established for heart failure trials, we expect it to
significantly enhance understanding and confidence in our trial
results among physicians and payers alike.”
The CardiAMP Heart Failure Trial is studying CardiAMP cell
therapy, an autologous bone marrow-derived mononuclear cell
formulation designed to stimulate the body’s natural healing
response in treating heart failure which develops after a heart
attack. The trial is evaluating the cell therapy’s ability to
improve patient survival, exercise capacity and quality of life, as
well as its safety. The CardiAMP Heart Failure Trial is the first
multicenter clinical trial of an autologous cell therapy to
prospectively select patients based on cell potency to maximize the
probability of patient benefit. The ongoing multi-center,
double-blinded, randomized (3:2), controlled pivotal CardiAMP Heart
Failure Trial is expected to enroll 260 patients at up to 40
centers nationwide. The national co-principal investigators are
Amish Raval, MD, of the University of Wisconsin and Carl Pepine,
MD, of the University of Florida, Gainesville. In March 2020, the
Data Safety Monitoring Board indicated there were no safety
concerns with the CardiAMP study results and recommended that the
trial continue, as planned. To date, 74 patients have been
enrolled at 25 active centers. The trial is sponsored, in part, by
the Maryland Stem Cell Research Foundation and has reimbursement
from the Centers for Medicare and Medicaid Services
(CMS).
For additional resources and to learn more about the CardiAMP
Heart Failure Trial, visit www.biocardia.com.
About BioCardia®BioCardia, Inc., headquartered
in San Carlos, California, is developing regenerative biologic
therapies to treat cardiovascular disease. CardiAMP and CardiALLO™
cell therapies are the Company’s biotherapeutic product candidates
in clinical development. The Company's approved products include
the Helix™ transendocardial delivery system and its steerable guide
and sheath catheter portfolio. BioCardia also partners with other
biotherapeutic companies to provide its Helix System and clinical
support to their programs studying therapies for the treatment of
heart failure, chronic myocardial ischemia and acute myocardial
infarction.
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, the intended outcomes of our trials, the
availability of data from our clinical trials, filings with the
FDA, FDA product clearances, the efficacy and safety of our
products and therapies and statements regarding our intentions,
beliefs, projections, outlook, analyses or current expectations.
Such risks and uncertainties include, among others, the inherent
uncertainties associated with developing new products or
technologies, regulatory approvals, unexpected expenditures, the
ability to raise the additional funding needed to continue to
pursue BioCardia’s business and product development plans and
overall market conditions. 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 April 9, 2020, under
the caption titled “Risk Factors.” BioCardia expressly disclaims
any intent or obligation to update these forward-looking
statements, except as required by law.
Media Contact: Michelle McAdam, Chronic
Communications, Inc. Email: michelle@chronic-comm.com Phone:
310-902-1274
Investor Contact: David McClung, Chief
Financial Officer Email: investors@BioCardia.com Phone:
650-226-0120
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