cyzact® - chronic wound repair

cyzact® is a topical woundcare product designed to stimulate active repair and closure in persistent chronic wounds. It comprises active, allogeneic human dermal fibroblasts embedded in a human  fibrin gel matrix which is applied to the wound at regular intervals until healing has occurred.

In February 2009, Intercytex announced that the Phase III study of cyzact® for the treatment of venous leg ulcers had failed to meet its primary endpoint.  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. As a result no further work on cyzact® is planned in any indication.