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Tuesday, February 7, 2012

Intercytex plc: Preliminary results for the year ended 31 December 2008

--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® - ch ronic 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.”

 



Published: 26th Mar 2009 - 09:55:48
Modified: 26th Mar 2009 - 09:56:34

 
 

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