|
Intercytex Group plc today provides a year-end update to investors on its clinical trial programmes
CAMBRIDGE, UK | December 18, 2007 | Intercytex Group plc (LSE: ICX), the regenerative medicine company developing innovative products to restore skin and hair, today provides a year-end update to investors on its clinical trial programmes.
ICX-SKN, which mimics the structure of natural skin, is intended as a skin graft replacement.
In a Phase I trial in 6 subjects earlier in the year ICX-SKN was applied to a full thickness wound site. 28 days later both visual and histological analysis showed that in all volunteers the ICX-SKN grafts were rapidly vascularised and overgrown with the hosts' own cells, resulting in a fully integrated skin graft that had closed and healed the wound site. This remarkable result contrasts with all other living skin graft alternatives which biodegrade in situ after a matter of weeks.
A further 6 subjects have now been treated in an extension of the trial and followed up for 28 days. Visual examination of the wound site confirms good healing of the wound in a similar manner to the earlier trial.
The progress of these subjects will be monitored out to 3 and 6 months to track the longer term efficacy of the treatment.
ICX-PRO
ICX-PRO is being developed as a second generation cell therapy to stimulate wound healing and closure in chronic wounds. It has a number of clear advantages over existing cell therapy products the sales of which have been growing rapidly in recent years.
Recruitment to the pivotal Phase III trial for use of ICX-PRO in venous leg ulcers is expected to reach around 320 randomised patients by the end of December. This is a multi-centre study currently being performed in the USA, UK and Canada. In total it is planned to recruit 396 patients to the trial. Clinical trial sites in Germany have taken longer to open than anticipated and as a direct consequence it is now expected that enrolment into this trial will be completed in Q2/2008 rather than Q1/2008 as previously estimated.
ICX-TRC
ICX-TRC is a novel hair regeneration product. It consists of a suspension of autologous dermal papilla (DP) cells. These cells are able to stimulate the generation of new hairs when injected into the scalp in close proximity to the epithelial cells which generate the hair.
In September this year we announced the first results from the current Phase II trial. In the sub-group of subjects (5 in total) whose scalp was pre-stimulated at the time of injection all subjects showed substantial and visible increased hair counts at 6 and/or 12 weeks (13-105%). We believe this increased hair production is attributable to the interaction between the injected DP cells and the stimulated resident hair producing cells.
A further 5 subjects have now been treated with ICX-TRC using the pre-stimulation technique with 2 more expected in January. By the end of March 2008 we expect to announce preliminary 12 week data on up to 16 subjects in total and preliminary 24 week data on up to 10 subjects.
VAVELTA®
VAVELTA is a cell therapy approach to facial rejuvenation and scar remodelling. It comprises a suspension of fibroblasts in a cell storage medium, for injection into the skin. It is intended to repopulate the skin with active young fibroblasts, replacing those lost by ageing and supplementing the function of older, less productive cells.
In the Phase II dose ranging trial in nasolabial folds being carried out by Professor Nick Lowe, all 16 subjects have been treated with a high and low dose. We expect to announce preliminary 12 week data on all subjects and preliminary 24 week data on 7 subjects by the end of March 2008. In September we reported data on the first 6 subjects who had been treated with a low dose; at 12 weeks, the earliest time point at which a response was expected, the average satisfaction scores for the treatment as assessed separately by both subjects and the investigator on a scale of 1-10 (10 being the highest), was over 8. In addition, the investigator measured a noticeable improvement in wrinkle severity in all subjects.
We are also investigating the use of VAVELTA in acne scarring in a study being conducted by Dr David Eccleston; all 10 subjects have received their first treatment with 5 having received the second of the 2 planned treatments. The remaining 5 will have their second treatment in January. We expect to announce preliminary 12 week data on all subjects and some 24 week data by the end of March 2008.
Our third Phase II trial of VAVELTA, looking at burns scars (including contractures), is on track (subject to regulatory approvals) to commence in Q1 2008.
The pre-commercialisation evaluation of VAVELTA is proceeding well with 12 subjects already treated. An update on the commercialisation of VAVELTA will be made at our preliminary results in March next year.
Nick Higgins, CEO commented: “We have made strong progress across our clinical development pipeline during 2007 with positive clinical efficacy data being generated on all our products in the portfolio. With significant newsflow in the first half of 2008, Intercytex is well positioned to capitalise on the rapidly emerging field of regenerative medicine.”
Enquiries
For more information, contact:
Intercytex Group plc
Nick Higgins, Chief Executive Tel: 0161 904 4500
Richard Moulson, Chief Financial Officer Tel: 0161 904 4500
Financial Dynamics
David Yates Tel: 0207 269 7156
Piper Jaffray
David Rasouly Tel: 0203 142 8700
Notes for Editors
Intercytex is a leading 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:
-- ICX-PRO, designed to stimulate active repair in chronic wounds - in a Phase III trial for VLUs and a Phase II trial for DFUs
-- ICX-SKN, being developed as a durable and robust skin replacement – in a Phase I extension trial
-- VAVELTA®, a facial rejuvenation product already introduced to the UK market
-- 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 75 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, USA.
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.
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.
SOURCE: Intercytex Group plc |
