Press Releases

Intercytex Group plc - Clarification of regulatory status of ICX-RHY

Intercytex Group plc (LSE: ICX) announces that the UK Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s drug and device licensing authority, has confirmed that ICX-RHY, the Company’s cell therapy product for facial rejuvenation, will fall under the proposed definition of a Tissue Engineered product once the draft EC Regulation on advanced therapy medicinal products becomes effective.

The MHRA also confirmed that, pending implementation of this Regulation, the supply or sale of ICX-RHY would not be subject to the licensing and other provisions of The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 or The Medicines Act 1968. Accordingly, Intercytex plans to make ICX-RHY available in the UK market when convincing safety and efficacy data are available.

Intercytex is currently conducting a Phase I safety trial of ICX-RHY and is planning to start a Phase II trial in the middle of the year.

ICX-RHY has been conceived as a cell therapy approach to the long term rejuvenation of rhytids (wrinkles) and other skin blemishes such as scarring. It comprises a suspension of allogeneic human dermal fibroblasts which are injected into the dermis of the skin to provide a source of young collagen-secreting cells.

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Notes for Editors

Intercytex is an emerging healthcare company developing and commercialising cell therapy products for the woundcare and aesthetic medicine markets. Intercytex 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 in two business areas:

• Woundcare
  • ICX-PRO, designed to stimulate active repair in chronic wounds - in a Phase III trial.
  • ICX-SKN, being developed as a durable and robust skin replacement - due to start a Phase I trial during 2006.

• Aesthetic medicine
  • ICX-TRC, a hair regeneration product - due to commence Phase II trials in mid-2006.
  • ICX-RHY, a facial rejuvenation product - in a Phase I trial.

All Intercytex’ products are derived from unmodified, human cells.

Intercytex commenced operations in 2000 and currently employs around 65 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 were admitted for trading on the Alternative Investment Market of the London Stock Exchange on 1 February 2006 under the ticker symbol ICX.L.

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.