Press Releases

Phase III results of Cyzact® fail to meet primary endpoint

Intercytex Group plc (LSE: ICX) (“Intercytex” or “the Company”) announces that the Phase III study of Cyzact® for the treatment of venous leg ulcers has failed to meet its primary endpoint. The primary endpoint was demonstration of a statistically significant (p<0.05) increase in complete wound closure at up to 12 weeks compared to four layer compression bandaging alone.

The 396-patient Phase III trial was conducted in the US, the UK and Canada. The three arm study involved all patients receiving four layer compression bandaging (the current standard of care for venous leg ulcers) with either Cyzact® (n=196), vehicle (a fibrin disc with no cells, n=100) or standard of care alone (n=100). The primary endpoint of the study was the incidence of complete wound closure at up to 12 weeks for the Cyzact® arm of the study versus the standard of care arm.

No statistically significant difference was seen between any of the groups. Data from the secondary endpoints of the trial have yet to be collated. Apart from completing the data analysis, no further work on Cyzact® is planned in any indication.

In the light of this disappointing result the Board has determined to review all strategic options for the Company.

Nick Higgins, Intercytex’ Chief Executive Officer, said: "The results of the Phase III study of Cyzact® in the treatment of venous leg ulcers are disappointing, given the encouraging results of earlier studies. Based on these results we have decided to end further development work on Cyzact®. However, our pipeline of other products remains robust. Feedback from clinicians using Vavelta® gives us increasing confidence in its potential in aesthetics and regenerative medicine. In addition, final Phase II results of ICX-TRC in hair regeneration are expected by the end of Q1 2009. The recent acquisition of Axordia also provides us with world class stem cell technology and a leading collaboration with the London Project to Cure Blindness. With ICX-SKN, our skin graft replacement for burns and acute wounds, fully funded by the US Armed Forces Institute of Regenerative Medicine (AFIRM), we have an exciting portfolio of regenerative medicine products.”

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Notes for Editors

Intercytex is a developer of regenerative medicine products. Intercytex uses its fully integrated cell technology platform to develop living, human cell-based products, at commercially viable scale in attractive markets.
Intercytex has four programmes:

• VAVELTA®, a skin repair and rejuvenation product intended to improve the feel, function and appearance of skin damaged by scarring and the aging process, and available from a number of accredited centres in the UK
• SHEF-1, development of a stem cell line suitable for differentiation into RPE cells, being carried out in collaboration with the London Project to Cure Blindness
• ICX-SKN, being developed as a skin graft replacement for burns and acute wounds, Phase I trials completed
• ICX-TRC, a hair regeneration product, in a Phase II trial.

Intercytex commenced operations in 2000. 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.

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