Sustained Clinical Benefit After 3 Year Follow Up in Scleroderma Trial
December 05 2016 - 11:30AM
Cytori Therapeutics, Inc. (NASDAQ:CYTX) Topline review of
early three-year follow-up data from the SCLERADEC I trial shows
sustained benefit in treated patients over baseline in major study
endpoints. The data indicate the following:
- Sustained improvement from baseline in all four key endpoints,
the Cochin hand Function Score, scleroderma-related disability and
pain, and Raynaud’s Condition Score (average scores for each
essentially unchanged over than those recently reported for two
year follow-up)
- 83% (10/12) patients in the trial reported no Raynaud’s
Phenomenon symptoms in the week leading to the follow up visit
- Mean hand strength and mobility scores remain substantially
improved over baseline
- Mean follow-up was 3 years, 4 months; range 3 years 1 month to
3 years 7 months
The full data set will be presented by the Investigators at a
forthcoming scientific meeting.
“The longevity of the clinical response of a single therapeutic
administration of ECCS-50 is an importing finding,” said Dr. Marc
H. Hedrick, Cytori President and Chief Executive Officer. “As we
prepare for commercial launch and interview payors, duration of
effect seems to be one of many potentially attractive aspects of
the therapy when compared to current available options.”
The SCLERADEC I trial was a 12-patient, open label, single arm,
investigator-initiated study conducted at Assistance Publique
Hôpitaux de Marseille (APHM), France led by Drs. Brigitte Granel
and Guy Magalon supported by the team of Pr. Florence Sabatier of
the Cell Therapy Department of Hôpital de le Conception, APHM, with
financial support from the French Scleroderma Research Group (GFRS)
and with additional support from Cytori.
Furthermore, Cytori recently announced publication of two-year
clinical follow-up of the SCLERADEC I trial. The results were
published in the journal Current Research in Translational
Medicine, and is accessible online.
Cytori has recently enrolled the STAR trial, a Phase 3, U.S.
multi-center, randomized controlled trial of Cytori Cell Therapy™
in the same indication as the SCLERADEC I trial, hand dysfunction
and Raynaud’s Phenomenon associated with scleroderma. The STAR
trial randomized 88 subjects and completed enrollment in
mid-2016. Data unblinding and analysis will commence once the
last enrolled subject has competed their 48 week follow-up visit,
anticipated to be in mid-2017.
About CytoriCytori 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
StatementsThis 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 statements regarding availability and
publication of clinical data regarding Cytori’s scleroderma
therapeutic (ECCS-50), and ECCS-50’s potential duration of effect
(as a possibly attractive aspect of the therapy to payers), 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, inherent
risk and uncertainty in the conduct of clinical trials and clinical
trial results (including risks associated with
investigator-initiated trials), risks in the collection of clinical
data (including collection and accuracy of the limited, open-label
12-patient SCLERADEC I pilot trial data), final clinical outcomes
risks, risk regarding protection of intellectual property rights,
regulatory uncertainties, risks regarding dependence on third party
performance, competitive risks (including potential introduction of
superior alternative therapeutic approaches to scleroderma),
and 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.
CYTORI THERAPEUTICS CONTACT
Tiago Girao
+1.858.458.0900
ir@cytori.com
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