Chronic woundcare product (ICX-PRO) commences Phase II trial in diabetic foot ulcers
5th September 2006
Cambridge, UK, 05 September 2006 –
Intercytex (LSE: ICX), the cell therapy company developing products
for the advanced woundcare and aesthetic medicine markets, today
announces that it has started a Phase II trial of ICX-PRO for the
treatment of diabetic foot ulcers (DFUs).
ICX-PRO is a topical woundcare product designed to stimulate
active repair in persistent chronic wounds, including DFUs. It
comprises active, allogeneic, human dermal fibroblasts in a human
fibrin-based gel.
This open-label trial is being conducted by Professor Andrew
Boulton, Professor of Medicine at the Manchester Royal Infirmary.
Up to 15 subjects with chronic DFUs that have failed to heal,
despite conventional treatment, will be enrolled. Wound closure
will be evaluated over a six-month period.
Nick Higgins, Chief Executive Officer, commented:
“Diabetic foot ulcers remain a major medical problem with
over half a million cases in the US alone. ICX-PRO has the
potential to provide significant patient benefit”.
Intercytex is currently recruiting for a Phase III multi-centre
trial of ICX-PRO for the treatment of venous leg ulcers (VLUs).
Enquiries:
Intercytex
Nick Higgins, Chief Executive Officer: +44 (0) 161 904 4500
Financial Dynamics
David Yates/Anna Keeble: +44 (0) 20 7831 3113
About chronic wounds and ICX-PRO:
Chronic wounds are wounds that will not heal following a course
of standard therapy. For DFUs this comprises sharp surgical
debridement, maintenance of a clean, moist ulcer environment,
pressure relief and infection management.
DFUs are the most common cause of non-traumatic lower extremity
amputations in the western world. Foot complications are the most
frequent reason for hospitalisation in patients with diabetes and
account for up to 25% of all diabetic admissions in North America
and UK. The majority of diabetic foot complications begin with the
formation of skin ulcers. Early clinical intervention combined with
appropriate treatment of these ulcers may prevent up to 85% of
amputations.
ICX-PRO consists of human dermal fibroblasts (HDFs) embedded in
a fibrin gel. HDFs are cells which are responsible for and
orchestrate the wound healing process and which may be absent or
dysfunctional in chronic wounds.
About Intercytex:
Intercytex is an emerging healthcare company developing cell
therapy products for the woundcare and aesthetic medicine markets.
It is using its proprietary expertise in cell therapy to develop
products that harness the innate ability of human cells to
regenerate and repair the body.
Intercytex has four products in development: ICX-PRO, to
stimulate active repair in chronic wounds in Phase III trials for
VLUs and Phase II for DFUs; ICX-SKN, being developed as a durable
and robust skin replacement, due to start Phase I trials later this
year; ICX-RHY, a facial rejuvenation product which has completed a
Phase I clinical trial and ICX-TRC, a hair regeneration product
shortly to enter Phase II clinical trials.
Intercytex commenced operations in 2000 and currently employs
around 70 staff. In addition to its head office in Cambridge, UK,
it has a GMP clinical production facility plus research and
development laboratories in Manchester, UK. Additional laboratories
are located in Boston, USA.
Intercytex’ shares were admitted for trading on the
Alternative Investment Market of the London Stock Exchange on 1
February 2006 under the ticker symbol ICX.L.
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