Intercytex: Phase III results of Cyzact fail to meet primary endpoint

Intercytex Group plc (LSE: ICX) (“Intercytex” or “the Company”) announces that the Phase III study of Cyzact® for the treatment of venous leg ulcers has failed to meet its primary endpoint. The primary endpoint was demonstration of a statistically significant (p<0.05) increase in complete wound closure at up to 12 weeks compared to four layer compression bandaging alone.

The 396-patient Phase III trial was conducted in the US, the UK and Canada. The three arm study involved all patients receiving four layer compression bandaging (the current standard of care for venous leg ulcers) with either Cyzact® (n=196), vehicle (a fibrin disc with no cells, n=100) or standard of care alone (n=100). The primary endpoint of the study was the incidence of complete wound closure at up to 12 weeks for the Cyzact® arm of the study versus the standard of care arm.

No statistically significant difference was seen between any of the groups. Data from the secondary endpoints of the trial have yet to be collated. Apart from completing the data analysis, no further work on Cyzact® is planned in any indication.

In the light of this disappointing result the Board has determined to review all strategic options for the Company.

Nick Higgins, Intercytex’ Chief Executive Officer, said: "The results of the Phase III study of Cyzact® in the treatment of venous leg ulcers are disappointing, given the encouraging results of earlier studies. Based on these results we have decided to end further development work on Cyzact®. However, our pipeline of other products remains robust. Feedback from clinicians using Vavelta® gives us increasing confidence in its potential in aesthetics and regenerative medicine. In addition, final Phase II results of ICX-TRC in hair regeneration are expected by the end of Q1 2009. The recent acquisition of Axordia also provides us 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 an exciting portfolio of regenerative medicine products.”