Cytori (NASDAQ: CYTX) announced publication of the first preclinical
study to demonstrate adipose-derived stem and regenerative cells (ADRCs)
significantly improved cardiac function after a heart attack. This
preclinical cardiac cell therapy study was reported online ahead of
print in the International Journal of Cardiology. The study was
funded by Cytori Therapeutics and conducted at Tulane University.
“Treatment of cardiovascular disease, which places one of the greatest
burdens on our healthcare system, could be revolutionized by cell
therapy,” said Marc H. Hedrick, M.D., president of Cytori. “We observed
a statistically significant improvement in heart function that
contributed to our decision to proceed with our APOLLO study.
Cardiovascular disease is the most advanced application in Cytori’s
product pipeline and could eventually make a substantial contribution to
our future commercial activities.”
The APOLLO study is the first clinical trial to investigate uncultured
adipose-derived stem and regenerative cells in heart attacks in human
patients. Enrollment was recently completed in APOLLO, a double blind,
placebo controlled, safety and feasibility trial. Data are expected to
be reported in early 2010. The APOLLO study is sponsored by Cytori and
has incorporated the Company’s Celution® System to automate the
processing of the patients’ cells at the point of care.
In Cytori's preclinical study, 17 large animals (pigs) were treated with
their own uncultured adipose-derived stem and regenerative cells
immediately following induction of a severe myocardial infarction.
Uncultured cells include a multitude of heterogeneous cell types that
Cytori believes facilitate several therapeutic mechanisms. Several
functional measurements within the study indicated statistically
significant improvement in both heart function and structure. The
results are summarized in the table below.
|
Measurement
|
|
Cells
|
|
Control
|
|
Improvement
|
|
p
|
|
Perfusion Defect
% decrease
|
|
35 ± 9%
|
|
44 ± 5%
|
|
20%
|
|
<0.05
|
|
Ejection Fraction
% increase
|
|
43 ± 7%
|
|
35 ± 3%
|
|
19%
|
|
<0.05
|
|
Heart Wall Thickness
mm
|
|
11.2 ± 2.2
|
|
8.6 ± 1.6
|
|
23%
|
|
<0.05
|
|
Capillary Density
per 0.1 mm2
|
|
41.6 ± 17.9
|
|
32.9 ± 12.6
|
|
21%
|
|
<0.05
|
About Cytori
Cytori develops and globally commercializes regenerative medicine
technologies, which provide real-time, point-of-care access to clinical
grade regenerative cells. Our technology is incorporated into two
product families. The Celution®-related products are sold throughout
Europe and Asia primarily into the cosmetic and reconstructive surgery
market and are under evaluation by the U.S. FDA. Our StemSource®
products are sold globally for cell banking and research applications.
We are also developing additional clinical uses of our technology for
the treatment of multiple medical conditions, including cardiovascular
disease, urinary tract disorders, and wound related conditions. To
commercialize our technology, Cytori has partnered with global and
regional leaders in healthcare such as Olympus Corporation, GE
Healthcare, and Green Hospital Supply. www.cytoritx.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events,
trends and business prospects, which may affect our future operating
results and financial position. Such statements, including, but not
limited to, those regarding our preclinical research, clinical
development, our ability to achieve or expand regulatory status or
marketing approvals and executing on our commercialization activities,
are all subject to risks and uncertainties that could cause our actual
results and financial position to differ materially. Some of these risks
and uncertainties include, but are not limited to, risks related to our
history of operating losses, the need for further financing and our
ability to access the necessary additional capital for our business,
inherent risk and uncertainty in the protection of intellectual property
rights, regulatory uncertainties regarding the collection and results
of, clinical data, dependence on third party performance, as well as
other risks and uncertainties described under the "Risk Factors" in
Cytori's Securities and Exchange Commission Filings. We assume no
responsibility to update or revise any forward-looking statements to
reflect events, trends or circumstances after the date they are made.
Cytori Therapeutics
Investor Contact:
Tom Baker
858.875.5258
tbaker@cytoritx.com