Cytori to Expand Scleroderma Focus to Broader Hand Therapy Franchise Under the Habeo™ Cell Therapy Brand
January 10 2017 - 9:30AM
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
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