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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 an acute wound 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 employed during elective surgery, 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
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. A full-thickness
skin sample was excised from the upper arm of six volunteers and
replaced with ICX-SKN. The safety and tolerability of the product
were determined at one month from the application of ICX-SKN to the
wound area. After 28 days both visual and
histological analysis showed that in all
volunteers, the ICX-SKN grafts were vascularised and overgrown with
the hosts’ own cells, resulting in a fully integrated skin
graft that had closed and healed the wound site. An extension
of the Phase I trial, to assess the longer-term benefits of
ICX-SKN, is underway in a further six subjects. At three
months, all six subjects showed the continued integration of
ICX-SKN. Further results will be due in the third quarter of
2008.
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 patients
who are undergoing skin cancer excisions (e.g. basal cell
carcinomas) will start during 2008. It is
anticipated that this will generate data that would enable
rapid progress to pivotal trials and granting of a marketing
licence.
Intercytex will develop ICX-SKN
through all stages of clinical development and registration to
launch and plans to appoint appropriate healthcare sales partners
for its distribution.
Manufacturing
Intercytex
will manufacture ICX-SKN at its
GMP compliant manufacturing facilities.
*Source: Collins Therapeutic Consulting
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