SAN DIEGO, Jan. 10, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX), as part of its corporate update at the Biotech
Showcase, announced its intention to broaden its investigation of the ECCS-50 formulation of Cytori Cell Therapy® to
include secondary Raynaud’s phenomenon (RP) beyond scleroderma, a problem that affects over one million patients worldwide.
Habeo Cell Therapy (formerly ECCS-50) is the new brand name of Cytori Therapeutics’ hand therapy franchise.
“Pilot trial data suggest that our ECCS-50 cellular therapeutic may help to address Secondary RP symptoms and other autoimmune
and inflammatory conditions of the hand,” said Dr. Marc H. Hedrick, Cytori President and Chief Executive Officer. “Our plan is to
leverage published and ongoing preclinical and clinical data to expand our investigation of ECCS-50 to a much larger patient
population with secondary RP under the new Habeo brand name.”
In addition to its substantial contribution to the disease burden of scleroderma, RP is a source of significant morbidity in
several more common autoimmune and inflammatory conditions including rheumatoid arthritis, systemic lupus erythematosus (lupus),
and Sjogren’s syndrome. The worldwide prevalence of moderate-to-severe RP in these three diseases alone exceeds one million
patients, providing an estimated peak annual revenue potential of $1.6 billion.
“Habeo, pronounced ‘habēō,’ means ‘to hold’ in Latin,” explained John Harris, Vice President & General Manager, Cell
Therapy. “The name embodies the promise that we believe Cytori Cell Therapy holds for patients with a number of disorders that
affect the hand by potentially improving function, reducing pain, and restoring activities of daily living.”
Broadening of clinical interest to secondary RP in other autoimmune and inflammatory diseases is based in large part on 36-month
follow-up data from the investigator-initiated, 12-patient, open-label SCLERADEC I trial, which reported a 90 percent reduction in
the Raynaud’s Condition Score, a clinically validated scale for determining the degree of difficulty experienced by patients with
RP. Earlier limited published data has also reported improvement in vascular architecture, hand color, and other direct and
indirect indicators of vascular function. Cytori’s internal preclinical data provide further support for a potential role of
Habeo Cell Therapy in the stabilization of the vascular endothelium, an important contributor to the vascular dysfunction found in
patients with RP.
RP is a key secondary endpoint in the STAR clinical trial, Cytori’s randomized, double-blind, placebo-controlled Phase 3
clinical trial in patients with scleroderma. Cytori anticipates unblinding of the trial data in mid-2017. The combination of
the anticipated US-based STAR data with clinical data from the completed SCLERADEC I pilot trial, anticipated clinical data from
the ongoing SCLERADEC II trial in Europe, the accumulated preclinical data, patient advocacy awareness, extensive market analysis,
and Cytori’s intellectual property position provide compelling support for continued research, development and commercial
planning of Habeo Cell Therapy in Secondary RP.
About Cytori Therapeutics
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.
- About the STAR Trial — The STAR trial is a Phase 3, US-based, multi-center (19 sites), randomized,
controlled trial of Cytori Cell Therapy™ in 88 patients with hand dysfunction and Raynaud’s phenomenon associated with
scleroderma. Enrollment was completed 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 the SCLERADEC I Trial — The SCLERADEC I trial was a single-center, open-label study of the use of
Cytori Cell Therapy (Habeo) in 12 patients with scleroderma. Short- (6-month) and long-term (24-month) results of the trial have
been published in the peer-reviewed literature. Cytori recently released preliminary top-line data from 36 months of
follow-up that indicated general persistence of the apparent benefit. Cytori anticipates publication or presentation of
these data in the first half of 2017.
- About the SCLERADEC II Trial — The SCLERADEC II trial is a multi-center, randomized, double-blind,
placebo-controlled trial of Cytori Cell Therapy (Habeo) in up to 40 patients with hand dysfunction associated with scleroderma.
Enrollment in this trial is ongoing at three centers in France. Completion of enrollment is anticipated in mid-2017
with data unblinding and analysis estimated to occur by the end of 2017. Subjects assigned to the control arm of this study
have their cell therapy product stored (cryopreserved) and will be given the opportunity to receive their cells once the study is
unblinded.
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, statements regarding potential
benefits of Habeo Cell Therapy for patients with Secondary RP (including the potential to improve function, reduce pain, and
restore activities of daily living), Cytori’s plan to leverage existing preclinical and clinical data to investigate possible use
of Habeo Cell Therapy in Secondary RP, and projected availability of clinical data, 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 (including risks associated with conduct of
investigator-initiated trials) and clinical trial results, risks in the collection of clinical data, final clinical outcomes risks
(including continued access to capital necessary to initiate, run and complete development and clinical programs for Secondary RP),
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
Secondary RP), 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 unless we have an obligation under U.S. Federal securities laws to do so.
Cytori Therapeutics, Inc. Tiago Girao, +1 (858) 458.0900 ir@cytori.com
