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Results for the year ended 31 December 2008


26th March 2009

--Intercytex reports results and data from VAVELTA® and ICX-TRC studies--

Intercytex Group plc (LSE: ICX), a developer of regenerative medicine products, today announces its results for the year ended 31 December 2008.  The Company also reports new clinical data on its regenerative medicine products; VAVELTA® and ICX-TRC.

On 20 February 2009, Intercytex announced that following the decision to discontinue the development of Cyzact®, the Board has determined to evaluate all strategic options for the Company. Options being considered include the possible merger or sale of the business.

PRODUCT SUMMARY

VAVELTA® - natural repair for damaged skin

  • VAVELTA®  made commercially available to small group of UK specialists from June 2008
  • Over 120 patients treated by Clinical Practice Group (CPG) since launch and CPG now expanded to 16 clinics
  • Positive final data from two Phase II trials of VAVELTA® presented at the FACE congress in June 2008
  • Announced today eight Epidermolysis Bullosa patients treated with VAVELTA®. Remarkable and rapid healing responses seen in all of the five patients evaluable to date
  • Phase II trial for burns scars (including contractures) on hold to refocus resources

SHEF-1 - age-related macular degeneration

  • Preclinical development programme obtained via the acquisition of Axordia in December 2008
  • SHEF-1 licensed to The London Project to Cure Blindness for treatment of age-related macular degeneration, the leading cause of blindness in the elderly
  • Development fully funded by The London Project to Cure Blindness

ICX-TRC - hair regeneration

  • Positive data from Phase II trial announced today - increase in hair count in the majority of  evaluable subjects observed at 48 weeks

ICX-SKN - skin grafts for acute wounds

  • Phase I study in excisions showed integration of graft in all 12 patients persisting for up to 6 months 
  • Product being reformulated for burns application as part of the AFIRM grant award

Cyzact® - chronic wounds

  • Cyzact® discontinued after failure of Phase III venous leg ulcer trial in February 2009

CORPORATE AND FINANCIAL SUMMARY

  • Loss before tax for the year slightly reduced at £11.53m (2007: £11.63m)
  • Cash and cash equivalents and liquid investments at 31 December 2008 of £4.86m (2007: £12.50m)
  • Placing of new shares in September 2008 raised £2.75m gross
  • Awarded US$1.5m over 5 years from US Armed Forces Institute of Regenerative Medicine (AFIRM) to support development of ICX-SKN for burns
  • Awarded grant from the Technology Strategy Board of £285k over 3 years to assist with development of strategies for preservation and storage of cell therapy products
  • Acquisition of embryonic stem cell company Axordia Limited (Axordia) for £1.68m in shares in December 2008
  • Restructuring announced in January 2009 to significantly reduce cash burn
  • Strategic review announced on 20 February 2009.  The Board continues to explore options to maximise shareholder value, and the Company is now in discussions with a number of parties which may or may not lead to an offer being made for the Company

BOARD

  • Appointment of Max Herrmann ACA as Chief Financial Officer replacing Richard Moulson
  • Appointment of Lee Woodward ACA as Company Secretary and Financial Controller (previously Financial Controller)

Nick Higgins, CEO of Intercytex, commented: “Following the discontinuation of development of Cyzact, all our efforts are focused on maximising the value of the rest of our broad portfolio of highly innovative regenerative medicine products. Vavelta® continues to gain patient and clinician acceptance with more than 120 people having now been treated in a commercial setting. Today we have announced promising results from use of Vavelta in the devastating skin condition epidermolysis bullosa, and final Phase II results of ICX-TRC which have demonstrated good hair regeneration. The recent acquisition of Axordia has provided Intercytex 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 a significant portfolio of regenerative medicine products.”

Enquiries

For more information, contact:

Intercytex Group plc  
Nick Higgins, Chief Executive Tel:      0161 904 4500
Max Herrmann, Chief Financial Officer Tel:      0161 904 4500
   
Financial Dynamics  

Jonathan Birt

Tel:      0207 269 7205
Emma Thompson Tel:      0207 269 7182
   

Piper Jaffray Ltd

 
Will Carnwath Tel:      0203 142 8700

Notes for Editors

Intercytex is a regenerative medicine company developing innovative products to restore skin and hair. Intercytex is using its fully integrated cell technology platform to develop products that harness the innate ability of human cells to regenerate and repair the body.

Intercytex has four products in development:

  • 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-TRC, a hair regeneration product. Phase II trial completed
  • ICX-SKN, being developed as a skin graft replacement for burns and acute wounds, Phase I trials completed

Intercytex commenced operations in 2000 and currently employs around 50 staff. In addition to its head office in Cambridge, UK, it has GMP compliant clinical production facility plus research and development laboratories in Manchester, UK. Additional laboratories are located in Boston, US and Sheffield, UK.

Intercytex’ shares trade on the Alternative Investment 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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