Press Releases

Intercytex announces successful Phase II results and commences Phase III trials for ICX-PRO – its novel wound-healing product

Cambridge, UK, 8 August 2005 - Intercytex, the cell therapy company developing products for the advanced woundcare and aesthetic medicine markets, today announces successful Phase II results for ICX-PRO, its novel woundcare product which has now entered a multi-centre Phase III clinical trial.

ICX-PRO is a topical woundcare product designed to actively stimulate repair in persistent chronic wounds including venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). It comprises active, allogeneic, human dermal fibroblasts – the cells that are responsible for the wound healing process - in a human fibrin-based gel, which is applied to the wound at regular intervals until complete healing of the wound has occurred.

The randomised Phase IIb efficacy trial was performed on patients who had suffered from a VLU for at least six months and which had not responded to the current “gold standard” treatment - four-layer compression bandaging. The final data indicated that 85% of patients (treated with the higher dose of ICX-PRO being used in the Phase III study) showed a measurable reduction in wound size. In addition 41% of patients with baseline wounds of up to 20cm² in size achieved complete wound closure during the study period. No patient safety concerns were observed during the Phase IIb study.

Mr Stephen Blair, Consultant Vascular Surgeon at Wirral Hospital Trust, Chief Investigator in the UK for the Phase III study, said: “We are very encouraged that the final data from the Phase IIb trial has confirmed our perception of the clinical benefits of ICX-PRO and we are extremely pleased to be participating in the Phase III trial.”

The FDA has approved a blinded, randomised, multi-centre Phase III trial for ICX-PRO. Around 200 patients suffering from VLUs of at least three months duration that have been non-responsive to conventional therapy will take part in the trial. Approximately half the patients will have active product, a quarter will have a placebo consisting of fibrin gel with no cells and a quarter will receive four-layer compression bandaging. The endpoint will be to show an incidence of 100% wound closure at 12 weeks. Results of the trial are expected by the end of 2006.

“We are very excited about commencing this Phase III trial for ICX-PRO,” said Nick Higgins, Intercytex’ Chief Executive Officer. “ICX-PRO has already shown great potential in the clinic for treating venous leg ulcers, a highly distressing and debilitating condition which is underserved by the current products on the market.”

Enquiries:

Intercytex
Nick Higgins, Chief Executive Officer: +44 (0)1223 421962

Financial Dynamics
David Yates/Davina Langdale: +44 (0) 207 831 3113

For further details about Intercytex and ICX-PRO, please visit www.intercytex.com

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 two products currently in clinical development, ICX-PRO and ICX-TRC. ICX-PRO is designed to actively stimulate repair in chronic wounds and is currently in Phase III trials. ICX-TRC is a hair regeneration product in Phase I trials. A third product, ICX-SKN, is in preclinical trials being developed as a true skin replacement to overcome the need for skin graft procedures. All Intercytex’ products are derived from unmodified normal human cells.

Intercytex commenced operations in 2000 and has raised over £31 million in four private equity financing rounds. The Company has around 50 employees and is headquartered in Cambridge, UK with GMP clinical production facilities, research and development located in Manchester, UK and additional laboratories in Boston, MA.

Glossary:

Allogeneic cells: cells sourced from an unrelated donor.

Fibrin: an insoluble protein formed during normal blood clotting and which forms the essential part of a blood clot. In ICX-PRO, the fibrin-based gel matrix maintains the HDFs’ functions and it gradually degrades after it has been applied to the wound allowing the HDFs to initiate healing.

Human dermal fibroblasts or HDFs: cells which are responsible for and orchestrate the wound healing process and which may be absent or dysfunctional in chronic wounds. Allogeneic HDFs are derived from the dermis of normal human skin.

VLUs: caused by chronic venous insufficiency which is a prolonged condition of inadequate circulation often associated with partial vein blockage or valve leakage. The tissue becomes poorly nourished and fragile resulting in stasis, dermatitis and breakdown or ulceration of the surrounding tissues. Whilst the majority of VLUs can be adequately treated in the clinic with compression therapy, approximately 20% remain recalcitrant and may persist for several years.

DFUs: 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.

The prevalence of leg ulceration in the adult population is estimated at 1% - 2% equating to over 587,000 patients suffering from VLUs in the US alone. The prevalence of DFUs is estimated at over 635,000 patients in the US. This number is increasing at approximately 5% per annum due to the increased incidence of diabetes. There is estimated to be a $300-$400 million annual addressable market in the US for the treatment of chronic VLUs and DFUs.