Cytori Announces Two Year Follow-Up Published on EU Scleroderma Trial
November 29 2016 - 7:00AM
Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today
publication of two-year clinical follow-up of patients treated with
a single administration of ECCS-50 in the SCLERADEC-I pilot trial
of Cytori Cell Therapy in patients with hand dysfunction associated
with scleroderma. The results, published by Dr. Brigitte Granel and
colleagues of the Assistance Publique des Hôpitaux de Marseille,
were published in the journal Current Research in Translational
Medicine. The manuscript is now accessible online.
The authors report that key clinical benefits reported at the
6-month time point of the trial were sustained at two years (follow
up range of 22–30 months). The primary endpoint, Cochin Hand
Function Score improved 62.5% over baseline (18.6±13.8 at two years
vs. 48.5±10.8; p<0.0001). Key secondary endpoints also
improved from baseline. Specifically, pain was reduced from
59.4±17.2 at baseline to 29.5±25.2 at two years (p=0.02),
scleroderma-associated disability was reduced by 51.1% (0.7±0.5 vs.
1.4±0.3; p=0.0051), and Raynaud’s Condition Score improved by 88.3%
(0.8±0.9 vs. 7.2±0.9; p<0.0001).
In addition, key objective measures of scleroderma hand
involvement showed sustained benefit: digital ulcers remained
reduced from baseline by 60% (6 vs. 15 at baseline) and improvement
in pinch strength was also sustained. Trends indicating improvement
in hand mobility were also reported. An interesting finding noted
by the authors was that eight patients who had been treated
previously with prostanoids had not required subsequent
re-treatment with these agents in the two year follow up
period.
“The long-term follow data from this small, open label trial,
continues to suggest that a single administration is safe and may
provide long term benefits across multiple scleroderma symptoms,”
said Dr. Marc H. Hedrick, M.D., Cytori’s President & Chief
Executive Officer. “Scleroderma is a very complex disease but
shares common features with other connective tissue disorders that
may be attractive future targets for the therapy.”
The SCLERADEC I trial was a 12 patient, single arm, open label
study led by Drs. Brigitte Granel and Guy Magalon of APHM supported
by the team of Pr. Florence Sabatier of the Cell Therapy Department
of Hôpital de le Conception, Assistance Publique-Hôpitaux de
Marseille.
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 without limitation, statements regarding
safety and potential benefits of Cytori Cell Therapy (including
statements suggesting that Cytori Cell Therapy may provide long
term benefits across multiple scleroderma symptoms), and the
possibility that other connective tissue disorders may be
potentially attractive future targets for Cytori Cell Therapy, 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.
CONTACT:
Tiago Girao
Email: ir@cytori.com
Cytori Therapeutics (NASDAQ:CYTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytori Therapeutics (NASDAQ:CYTX)
Historical Stock Chart
From Apr 2023 to Apr 2024