Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced the launch of
its U.S. phase III/pivotal trial to study the efficacy of its ECCS-50
cellular therapeutic in patients with scleroderma associated hand
dysfunction.
In July 2015, Cytori received follow-on U.S. FDA investigational device
approval for recent updates to the Celution® System, which is being used
in the STAR trial. The updates include recent technologic advances such
as enhanced software code that substantially improves the efficiency of
the bedside therapeutic manufacturing process for ECCS-50.
Currently three U.S. centers have been initiated. Cytori anticipates
that the majority of investigational sites will be active by October
2015. Screening of patients has begun and it is expected that the first
U.S. patients will be treated this month. A variety of promotional
activities for the STAR trial will begin after Labor Day; however, the
STAR microsite is currently active at: http://www.startrial-us.com/.
Enrollment duration is expected to be approximately 1 year.
“Hand involvement creates one of the most significant quality-of-life
issues faced by people living with scleroderma, causing pain and
significant disability,” commented Robert Riggs, Chief Executive Officer
of the Scleroderma Foundation, Inc., the leading patient advocacy and
research nonprofit organization for the scleroderma community. “It’s
exciting to see a therapy advance through clinical trials that is
intended to address this debilitating and disfiguring manifestation of
scleroderma.” More information on the Scleroderma Foundation can be
found at the following link: http://www.scleroderma.org/site/PageServer#.VcJOjUu3bfM
STAR is an eighty patient randomized, double blinded controlled trial of
a single dose of the ECCS-50 therapeutic compared to placebo. Details of
the trial including inclusion and exclusion criteria can be found at the
following link: https://clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5
The STAR trial was predicated on promising data from the European phase
II/pilot trial named SCLERADEC which was published in 2014 (Granel et
al. Annals of Rheumatic Diseases) and reported data suggesting that the
treatment was safe and potentially effective in improving certain hand
symptoms in patients with scleroderma. The data can be found at the
following link: http://ard.bmj.com/content/early/2014/08/10/annrheumdis-2014-205681.full.
Subsequent follow up of the SCLERADEC patients at 12 months revealed
that the beneficial effect of Cytori’s ECCS-50 therapy in scleroderma
was found to persist beyond 12 months and that data has been accepted
for publication and is currently in press.
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing
autologous cell therapies from adipose tissue to treat a variety of
medical conditions. Data from preclinical studies and clinical trials
suggest that Cytori Cell Therapy™ acts principally by improving blood
flow, modulating the immune system, and facilitating wound repair. As a
result, Cytori Cell Therapy™ may provide benefits across multiple
disease states and can be made available to the physician and patient at
the point-of-care through Cytori’s proprietary technologies and
products. For more information: visit www.cytori.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, without
limitation, those regarding site initiation, patient screening,
enrollment and treatment, and conduct of clinical trials generally, as
well as product modification and performance, 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 intellectual property rights,
regulatory uncertainties, risks in the conduct of clinical trials, risks
in the collection and results of clinical data, final clinical outcomes,
dependence on third party performance, performance and acceptance of our
products in the marketplace, as well as other risks and uncertainties
described under the heading "Risk Factors" in Cytori's Securities and
Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no
responsibility to update or revise any forward-looking statements to
reflect events, trends or circumstances after the date they are made.
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