Cytori Logs Final 48 Week Patient Follow Up Visit in Scleroderma Trial
May 23 2017 - 8:30AM
Cytori Therapeutics, Inc. (NASDAQ:CYTX) ("Cytori" or the
"Company"), today announced that it has now completed all 48 week
follow up monitoring visits in its U.S. FDA approved Phase III STAR
trial. A total of 88 subjects were enrolled and the last subject’s
48 week visit was conducted earlier this week.
STAR is a double-blind, randomized, placebo-controlled, parallel
group phase III pivotal study investigating the efficacy and safety
of HABEO™ Cell Therapy™on subjects with impaired hand function from
scleroderma. The subjects were randomized 1:1 to either HABEO Cell
Therapy or placebo. HABEO™ and placebo were administered
subcutaneously in subject’s fingers. Final assessments were done at
48 weeks. Upon unblinding and evaluation of the data,
subjects who received placebo will be offered participation into
the crossover portion of the protocol, using HABEO™ Cell Therapy™,
should they desire treatment and continue to qualify. Details of
the STAR trial including inclusion and exclusion criteria can be
found at the following link: clinicaltrials.gov
In the United States, the scleroderma affected population
appears to be approximately 184 per million, which would represent
a market size of aproximately 45,000 scleroderma patients.1
Additionally, in Europe, scleroderma is estimated to have a
prevalence between 31 per million and 277 per million which equates
to approximately 17,000 to 149,000 scleroderma affected people in
the Europe.2
About Cytori Therapeutics
Cytori is a therapeutics company developing regenerative and
oncologic therapies from its proprietary cell therapy and
nanoparticle platforms for 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. Cytori Nanomedicine™ is developing liposome encapsulated
therapies for regenerative medicine and oncologic indications. 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, but not limited to, statements regarding Cytori’s
conduct of its STAR phase III clinical trial, are subject to
risks and uncertainties that could cause our actual results and
financial position to differ materially. Some of these risks and
uncertainties include: risks in the conduct of clinical trials;
risks associated with potential benefits of our products; risks in
the collection and results of clinical data; risks associated with
development of our clinical pipeline; final clinical outcomes;
regulatory risks and uncertainties; risks related to dependence on
third party performance; and other risks and uncertainties
described under the "Risk Factors" section in Cytori's Securities
and Exchange Commission Filings on Form 10-K and Form 10-Q.
Cytori assumes no responsibility to update or revise any
forward-looking statements contained in this press release to
reflect events, trends or circumstances after the date of this
communication.
1. Furst, Daniel et al. “Epidemiology of systemic sclerosis in a
large US managed care population.” J Rheum 2012; 38:784-6.
2. Varga, John et al. “Scleroderma: From Pathogenesis to
Comprehensive Management.” 2012
Cytori Therapeutics, Inc.
Tiago Girao, 1-858-458-0900
ir@cytori.com
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