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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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