Intercytex - Year-end clinical trial update

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 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 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 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.”