BioCardia Announces Positive Preclinical Results Supporting Investigational New Drug Application for Anti-Inflammatory Cell T...
05 Maggio 2020 - 1:00PM
BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development
of comprehensive solutions for cardiovascular regenerative
therapies, today announced data from a recent animal study
performed by the Company that demonstrate meaningful improvements
in heart function for subjects treated with its allogenic (from
another donor, or “off the shelf”) neurokinin 1 receptor positive
mesenchymal stem cell (NK1R+ MSC) program for heart failure, known
as CardiALLO™. In addition, the Company is planning further
exploration and discussion with the U.S. Food and Drug
Administration (FDA) on the use of its allogenic cells for COVID-19
related Acute Respiratory Distress Syndrome (ARDS).
In the 26 animals treated with both low dose and high dose NK1R+
MSC, echocardiographic measures of cardiac ejection fraction,
fractional shortening and cardiac outflow were meaningfully
improved, with all three measures being statistically significant
for both dosage levels over control animals.
The CardiALLO cell therapy is being developed initially to treat
heart failure patients whose cells do not qualify for its lead
autologous cell therapy, CardiAMP® (BCDA-01).
BioCardia Chief Scientific Officer Ian McNiece, PhD, said, “In
light of these positive data on our allogenic NK1R+ MSC therapy, we
expect to meet our internal timeline to complete our submission to
the FDA for our first indication for CardiALLO, and potentially
receive IND acceptance by the end of the second quarter. The MSCs
that were studied are subtypes of MSC that we have delivered
previously in our co-sponsored trials, which we believe have
enhanced potency over MSC generated from unselected bone marrow
cells. We look forward to seeing additional data from this animal
study that are currently being analyzed, including histology and
pathology of the heart and lungs.”
COVID-19 Induced Acute Respiratory Distress Syndrome
(ARDS) Exploration
The Company also intends to submit an IND for the use of its
NK1R+ MSC delivered via intravenous (IV) infusion for Acute
Respiratory Distress Syndrome (ARDS) caused by COVID-19.
Based on preliminary clinical reports on COVID-19, respiratory
failure complicated by ARDs is the leading cause of death for
COVID-19 patients.1 ARDS is a type of respiratory failure
characterized by the rapid onset of widespread inflammation in the
lungs.
The anti-inflammatory effects of MSC have been well-documented
and MSC have been shown to reduce inflammation and injury in models
of lung disease.2 The specific MSCs used in BioCardia’s allogenic
cell therapy are expanded from cells selected for the presence of
the NK1 receptor, which is known to bind to substance P, an
important neuropeptide associated with inflammation throughout the
body and a primary mediator of inflammation in the airways.3,4
“Our NK1R+ allogenic MSC may have more potential than other MSC
approaches being advanced today due to their interaction with
Substance P,” said BioCardia CEO Peter Altman, PhD. “This COVID-19
related work will be the Company’s first clinical investigation
outside of the cardiac space and our first exploring therapy for
the lung. A recent patent publication (US 2020/0101113 A1) shows
that BioCardia has long intended for these remarkable reparative
cells to be targeted for respiratory disorders, in addition to
cardiovascular disease. Addressing inflammation in the lungs is an
important contribution we may be able to make using our NK1R+
allogenic MSC therapy.”
The Company’s allogenic cells are expected to be manufactured at
BioCardia’s clinical stage cell manufacturing facility in San
Carlos, California.
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, references to the development of NK1R+ cells
for the treatment of heart failure and ARDS secondary to COVID-19,
potential FDA IND acceptances, and potential FDA filings,
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. 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.
- Rajagopal K, Keller SP, Akkanti B, et al. Advanced
pulmonary and cardiac support of COVID-19 patients, emerging
recommendations from ASAIO—a living working document. Circ Heart
Fail. 2020 May;13(5):e007175.
- Iter SS, Rojas M. Anti-inflammatory effects of mesenchymal stem
cells: novel concept for future therapies. Expert Opin Biol Ther.
2008 May;8(5):569-81.
- Colten HR, Krause JE. Pulmonary inflammation - a balancing act,
N Engl J Med. 1997;336(15):1094-1096.
- O'Connor TM, O'Connell J, O'Brien DI, Goode
T, Bredin P, Shanahan F. The role of substance P in inflammatory
disease, J Cell. 2004 March;201:167-180.
Media Contact: Michelle McAdam, Chronic
Communications, Inc.michelle@chronic-comm.com (310) 902-1274
Investor Contact: David McClung, Chief
Financial Officer investors@BioCardia.com (650) 226-0120
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