Vavelta: Phase II Data Presented at Face and Commercial SalesCommenced
CAMBRIDGE, England, July 3, 2008-Intercytex Group plc (LSE: ICX) the leading developer of regenerative medicine products to restore skin and hair, today announces that positive 6 month follow-up data from two Phase II trials of VAVELTA, its cell therapy product for damaged skin, were presented at the FACE congress on 28th June, 2008.
The first Phase II clinical trial, focused on nasolabial folds, was conducted at the Cranley Clinic for Dermatology in London with Professor Nicholas Lowe MD FRCP. In this trial 6 subjects received a low dose of product. A second group of 10 subjects was then injected with a higher dose. All subjects were followed out to 6 months post-treatment with the following results:
* The average satisfaction scores for both groups at 6 months for the treatment as assessed separately by both subjects and the investigator on a scale of 1-10 (10 being the highest), were 7.8 and 7.6 respectively. In addition, the investigator measured an improvement in wrinkle severity in 12 (75%) subjects * No serious adverse events have been observed and the product has been well tolerated
The second Phase II study involved the use of the product in acne scarring in a study conducted by Dr David Eccleston MB ChB, at the MediZen Clinic in Birmingham. Subjects were followed out to 6 months post-treatment with the following results:
* The average satisfaction scores for the treatment at 6 months as assessed separately by both subjects and the investigator on a scale of 1 -10 (10 being the highest) were 6.8 and 6.3 respectively * No serious adverse events have been observed and the product has been well tolerated
Treatment has commenced in a third Phase II trial investigating use of the product for burns scars (including contractures). It is intended to recruit up to 30 patients in this open label study.
Over the last 9 months a Clinical Practice Group (CPG) of 5 specialist clinicians has been conducting field evaluations in a commercial setting. To date, over 30 patients have been treated for a variety of different skin imperfections including acne scarring and wrinkle reduction. Feedback from clinicians and patients on the product has been sufficiently positive that commercial sales have now commenced through a limited number of accredited centres in the UK.
Nick Higgins, CEO of Intercytex, commented: "We have made very substantial progress with VAVELTA® over the last 12 months. Since introducing the product in 2007 we have completed two clinical trials, begun a third trial and treated over 30 patients in a commercial setting. We are encouraged by the high satisfaction scores achieved and from the very favourable reaction from aesthetic specialists."
For more information, contact:
Intercytex Group plc Nick Higgins, Chief Executive Tel: 0161 904 4500 Richard Moulson, Chief Financial Tel: 0161 904 Officer 4500
Financial Dynamics David Yates Tel: 0207 269 7156 Lara Mott Tel: 0207 269 7182 Piper Jaffray Ltd Will Carnwath Tel: 0203 142 8700
Notes for Editors
FACE (the Facial Aesthetic Conference and Exhibition), held in London, is the largest medical aesthetic conference in the UK, aimed at practitioners and clinics providing predominantly non-surgical medical aesthetic treatments.
Intercytex is the leading developer of regenerative medicine products to restore skin and hair. 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 products in development:
* ICX-PRO (Cyzact®), designed to stimulate active repair in chronic wounds - in a Phase III trial for venous leg ulcers and a Phase II trial for diabetic foot ulcers * ICX-SKN, being developed as a skin graft replacement - in a Phase I extension trial * VAVELTA®, a facial rejuvenation and skin damage repair product in Phase II efficacy trials * 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 80 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.
Intercytex' shares trade on the Alternative Investment Market of the London Stock Exchange under the ticker symbol ICX.L and on the Open Market and the Xetra trading platform of the Frankfurt Stock Exchange under the symbol IGJ.F.
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.
Posted: July 2008