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Intercytex announces world first in skin repair using laboratory-manufactured human skin

First artificial living skin graft to demonstrate full, consistent wound integration and persistence represents important landmark in regenerative medicine

Cambridge, UK: Intercytex Group plc, the cell therapy company focused on aesthetic medicine and tissue repair, announces today a clinical breakthrough in regenerative medicine following the conclusion of a clinical trial in which laboratory-made living human skin has been fully and consistently integrated into the human body for the first time. ICX-SKN contrasts with all other living skin graft alternatives which biodegrade in situ after a matter of weeks.

In the trial (which is published today in the July issue of Regenerative Medicine, available now for online viewing at www.futuremedicine.com), a full-thickness skin sample was excised from the upper arm of six volunteers and replaced with Intercytex' skin graft replacement product, ICX-SKN. After 28 days both visual and histological analysis showed that in all volunteers the ICX-SKN grafts were rapidly vascularised and overgrown with the hosts' own cells, resulting in a fully integrated skin graft that had closed and healed the wound site.

ICX-SKN comprises a collagen-based matrix produced by the same skin cells - human fibroblasts - that are responsible for laying down the collagen in natural skin. The fibroblasts weave a collagen structure which mimics that found in skin and which shares many of the structural attributes of skin. Intercytex' scientists believe that the combination of living human fibroblasts in a human fibroblast-produced matrix underpins the integration and acceptance of ICX-SKN by the host skin. To date, other living regenerative medicine skin constructs have degraded too quickly to act as skin grafts when implanted in the human body.

In certain wounds and burns the use of skin grafts taken from a different part of the patient's own body is the optimal treatment to obtain wound closure. However, their use is avoided wherever possible because skin grafting itself is a painful and traumatic process that creates an additional wound. ICXSKN represents a potential alternative which could be of enormous benefit to patients and physicians.

The next stage of clinical development will involve application of ICX-SKN to larger wounds with a view to generating data that would enable rapid progress to pivotal trials and granting of a marketing licence.

Dr Paul Kemp, Intercytex' Founder, Chief Scientific Officer and senior author of the paper, said:
'Intercytex intends to develop a range of cell-based implants that can regenerate lost tissue and this research is an important milestone in the pursuit of that objective. For regenerative medicine to fulfil its promise, scientists need to develop cellular implants that are accepted and integrated into the human body. So far this has proved elusive but today's research shows, for the first time, that it can be achieved."

Dr Stephen L Minger, Director, Stem Cell Biology Laboratory, Wolfson Centre for Age Related Diseases, King's College London and an acknowledged world expert in regenerative medicine, commented: 'I think these results are a real breakthrough in the field of wound healing and regenerative medicine in general. To have an off-the-shelf skin replacement product that can be used in large numbers of patients will revolutionise the treatment of burned and skin damaged patients."

Mr Ken Dunn, Consultant burns and plastic surgeon at University Hospital of South Manchester, said: "Surgeons have long had a need for a skin graft replacement. The data described in this paper offer real promise to provide surgeons with a product that could be used 'off-the-shelf'to help to heal patients."

A recent U.S. DHSS report states that regenerative medicine is in 'the vanguard of 21st century healthcare" with a 'worldwide market for regenerative medicine conservatively estimated to be $500 billion by 2010". However, the field has been limited by an inability to create tissues in the laboratory that are recognised as natural and can be fully integrated into the body.

The full text of this article is available from the publishers. Please e-mail s.boisseau@futuremedicine.com to request access

Intercytex is a cell therapy company which is focused on aesthetic medicine and tissue repair. 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, designed to stimulate active repair in chronic wounds -in a Phase III trial
• Vavelta, a facial rejuvenation product to be launched in the second half of 2007
• ICX-SKN, being developed as a durable and robust skin replacement - recently completed a Phase I trial
• ICX-TRC, a hair regeneration product - in a Phase II trial

All Intercytex' products are derived from unmodified human cells.

Intercytex commenced operations in 2000 and currently employs around 75 staff. In addition to its head office in Cambridge, UK, it has a GMP clinical production facility with research and development laboratories in Manchester, UK. Additional laboratories are located in Boston, USA.

Intercytex' shares trade on AIM, a market of the London Stock Exchange, under the ticker symbol ICX.L.

Additional information on the Company can be found at www.intercytex.com

Statements contained within this press release may contain forward-looking information or statements with respect to the financial condition, results of operations and business achievements/performance of Intercytex and certain of the plans and objectives of management of Intercytex with respect thereto. By their nature, forward-looking statements involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', 'continue' or similar expressions. A number of factors, including the satisfactory progress of research and development, could cause Intercytex'actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements. Forward projections reflect management's best estimates based on information available at the time of issue and are not a guarantee of future performance. Other than as required by applicable law, Intercytex does not undertake any obligation to update or revise any forward-looking information or statements to reflect events or circumstances after the date of this release.

The term "Intercytex" refers to Intercytex Group plc and its subsidiary undertakings.