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ICX-SKN
comprises allogeneic
human dermal fibroblasts set in a natural human
collagen matrix, which mimics the structure
of skin and is intended as a skin graft replacement. An
additional layer of human
keratinocytes may be included to form an
epidermal layer.
ICX-SKN is designed to be sufficiently durable
to integrate and persist in burns and acute wounds
providing immediate and long-term closure. It is intended that
ICX-SKN will be used by surgeons, plastic surgeons and other
specialists in hospitals and clinics in place of a skin
graft, for example, in skin cancer excisions such as
basal cell carcinomas and
squamous cell carcinomas. ICX-SKN will be
provided in a sealed sterile, flat, foil pack
Background
and market opportunity
Burns: Intercytex is the only non-US member of a
group that has been selected to establish the US Armed Forces
Institute of Regenerative Medicine (AFIRM), supported by a
foundation grant from the US Government totalling $85
million. The purpose of AFIRM is to use the science of
regenerative medicine to develop new treatments for battlefield
injuries. Under this programme, ICX-SKN will be developed for
the treatment of battlefield burns in collaboration with the US
army, with US government funding. Following a successful
development programme, Intercytex would supply the US armed forces
with ICX-SKN, and the product would also be available for use in
civilian burns patients, of which it is estimated that there are
around 80,000 cases requiring hospitalisation in the US each
year.
Acute
wounds: An excision is currently treated in different
ways. If possible, the sides of the wound are pulled together
and are stitched or sutured (primary closure). This can cause
tension in the surrounding skin and an unsatisfactory
outcome. In these cases, a flap of skin is carefully
cut from an adjacent area of skin, keeping the blood
supply intact and rotated to cover the excised wound. Other
excisions are left to heal from within (secondary intention)
without any graft or closure or are treated with a skin graft cut
from an entirely different area of the body. Wound healing
and scarring are dependent on movement and tension and the ability
of layers of skin to be
reperfused with a new blood supply.
With a skin
cancer excision there is a compromise between taking the minimum
amount of tissue to enable the wound to close with a satisafactory
functional and cosmetic outcome versus the removal of sufficient
tissue to ensure a safe margin around the tumour. In some
instances, excisions could be more radical if graft skin was
available, therefore improving the outcome.
ICX-SKN is
designed to heal wounds with reduced scarring and an enhanced
aesthetic effect, a significant factor given that most skin cancers
are on the face and hands. Intercytex estimates there is a global
market of $2 billion based on one million excisions carried out
each year worldwide. *
ICX-SKN
clinical and commercial development
ICX-SKN
has completed an
open-label
Phase I trial in the UK designed to evaluate
the safety, tolerability, graft integration and persistence of
ICX-SKN. A full-thickness skin sample was excised from the
upper arm of 12 subjects and replaced with ICX-SKN. Six
subjects were followed for one month, four for three months and two
for six months. All grafts were totally excised at the
end of the follow-up period and
examined histologically. In all subjects,
ICX-SKN was very well tolerated with no serious events
reported. There was no evidence of graft rejection; both
visual and histological analysis showed that in all volunteers,
skin grafts were vascularised rapidly and overgrown with the
hosts own cells, resulting in a fully integrated skin graft that
had closed and healed the wound site.
To download a
copy of the poster that was exhibited at the 17th Annual meeting of
the European Tissue repair Society, please click on the link
below:
A Phase I
study of ICX-SKN, an allogeneic living skin replacement
 A
Phase IIa efficacy trial in trauma
and burns patients at US military hospitals will start
during 2009.
The development of ICX-SKN in
burns, through all stages of clinical development and
registration to launch will be funded by AFIRM.
Intercytex will conduct proof-of-principle studies in excisions
itself and will then seek a partner to assist in later stage trials
and sales and distribution. A succesful burns
programme would allow Intercytex to commence an accelerated
development programme for use of ICX-SKN in surgical incisions.
Manufacturing
Intercytex
will manufacture ICX-SKN at its
GMP compliant manufacturing facilities.
*Source: Collins Therapeutic Consulting
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