Cytori Reports Reduction in Fibrosis Parameters in Scar Study
November 20 2017 - 9:00AM
Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today the
publication of preclinical data from a study using Cytori Cell
Therapy™ in a model of fibrotic scar formation. This study was
performed with support from the Biomedical Advanced Research and
Development Authority (BARDA) as a component of the preclinical
proof of concept data package incorporated into the FDA approved
United States RELIEF Trial.
The publication describes a study in which Adipose Derived
Regenerative Cells (ADRCs), the active component of Cytori Cell
Therapy™, were injected into deep partial thickness wounds in a
porcine model, considered the gold standard preclinical model of
hypertrophic scarring. Six months after treatment, wounds that were
treated with ADRCs showed reduction in parameters associated with
hypertrophic scarring compared to control wounds. Parameters that
were improved by treatment included skin hardness, organization,
vascularity, and discoloration. Molecular analysis implicated the
temporal modulation of Interleukin-6 expression, a key regulator of
the inflammatory response, as a potential mediator of the
effect.
The paper entitled “Autologous adipose-derived
regenerative cell therapy modulates development of hypertrophic
scarring in a red Duroc porcine model ” just
published in the journal Stem Cell Research and Therapy and is now
available online.
The findings from this preclinical study were incorporated into
the design of the RELIEF clinical trial of Cytori Cell Therapy™
which is also funded by BARDA. The RELIEF trial will assess Cytori
Cell Therapy in human patients with substantial thermal burn
injury. In addition to assessment of early healing, the RELIEF
trial will evaluate several scar-related parameters using
approaches similar to those applied in this study.
“Fibrosis is a common factor in both burns and
scleroderma.” said Dr. John Fraser, Chief Scientist at Cytori.
“This preclinical study is consistent with a number of emerging
studies indicating a beneficial effect of Cytori’s ADRC technology
in fibrotic disease.”
The treatment of thermal burns remains a
critical unmet medical need. Despite standard of care primarily
consisting of dressings, skin grafts and skin substitutes, patients
frequently suffer from pain, scarring, skin contracture and reduced
range of motion. Hypertrophic scarring is characterized by raised,
discolored, itchy and painful scars that are a common fibrotic
consequence of deep-partial thickness burn injury.
Autologous cell therapies such as those offered
by Cytori have the potential to improve the quality and rate of
wound healing and reduce scarring. In a mass casualty event,
the Government Accountability Office estimates that as
many as 10,000 patients could require thermal burn care. The
limited number of specialist surgeons and burn centers in the U.S.
creates a public health need for a burn wound therapy that can be
quickly and broadly applied by non-specialist medical personnel
following such an event. Therefore, autologous Cytori’s Cell
Therapy represents a novel medical countermeasure not only to
address these challenges but also to promote wound healing and
tissue repair and improve casualty care.
About RELIEF
The RELIEF trial will assess safety and feasibility of
intravenous delivery of Cytori Cell Therapy™ as an adjunct to usual
care in patients with thermal burn injuries covering between 20%
and 50% of their body surface area. Subjects will have at least one
deep partial or full thickness burn wound that is to be treated
with a meshed autologous split thickness skin graft (STSG).
Subjects will be randomized (1:2) to receive either usual care
alone or usual care supplemented with Cytori Cell Therapy. While
primarily focusing on safety and feasibility, the RELIEF trial will
also assess a series of parameters related to skin graft healing.
The trial is approved to enroll up to 30 patients in up to 10 U.S.
sites with study initiation expected to occur soon.
About Cytori
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 encapsulated therapies for regenerative medicine and
oncologic indications using technology that allows Cytori to use
the benefits of its encapsulation platform to develop novel
therapeutic strategies and reformulate other drugs to optimize
their clinical properties. 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, without limitation, statements regarding the potential
for autologous cell therapies such as those offered by Cytori to
improve the quality and rate of wound healing and reduce scarring
and Cytori Cell Therapy’s potential to provide benefits across
multiple disease states, are subject to risks and uncertainties
that could cause our actual results and financial position to
differ materially. These risks and uncertainties, which include
inherent uncertainties in conduct of clinical studies and trials
and the results of such trials (including risks that further
studies may not support efficacy or safety of Cytori Cell Therapy),
risks associated with clinical use of Cytori Cell Therapy in
studies and trials not controlled by Cytori and risks to Cytori’s
intellectual property portfolio are described under the heading
"Risk Factors" 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
to reflect events, trends or circumstances after the date they are
made.
CONTACTCYTORI THERAPEUTICS
Tiago Girao+1.858.458.0900 ir@cytori.com
Cytori Therapeutics (NASDAQ:CYTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cytori Therapeutics (NASDAQ:CYTX)
Historical Stock Chart
From Sep 2023 to Sep 2024