Intercytex completes recruitment for Phase III trial of ICX-PRO

Intercytex Group plc (LSE: ICX) the leading developer of regenerative medicine products to restore skin and hair, today announces it has reached its target of 396 patients for enrolment to the pivotal Phase III trial of ICX-PRO in venous leg ulcers. Recruitment to the trial has therefore ceased.

The recruitment target has been achieved within the previous guidance of Q2/2008. The trial, which is being conducted in centres across the USA, Canada and UK, is believed to be the first controlled, double blind trial of a cell therapy for treatment of chronic wounds.

ICX-PRO, which has now been branded as Cyzact®, is a topical woundcare product designed to stimulate active wound healing and closure in persistent chronic wounds. It comprises active, allogeneic human dermal fibroblasts (HDFs) embedded in a human fibrin gel matrix which is applied to the wound at regular intervals until healing has occurred. The units are stored and shipped under refrigerated conditions.

ICX-PRO is a second generation product that has been specifically designed to overcome the shortcomings (storage, preparation and ease of handling) of first generation cell therapy products that have constrained their commercial success. HDFs are the principal cell type found in the human dermis and are responsible for the production of collagen and structural components of skin. It is generally considered that HDFs are responsible for many events required to effect good quality wound repair. The HDFs are trapped in the fibrin scaffold for easy delivery onto the wound bed. The matrix is rapidly broken down by enzymes found in the chronic wound fluid to release the cells from the matrix.

In March this year preliminary data were reported from a Phase II trial of ICX-PRO in diabetic foot ulcers. In this study four out of the seven patients who completed the study showed complete or almost complete closure of the wound by 24 weeks. The results of this trial were presented in a poster at the EWMA conference in Lisbon in mid-May. Data from the Phase III venous leg ulcer trial are expected to be announced around the end of Q1/2009 with filing of the BLA in the second half of that year.

Discussions are continuing with potential partners regarding distribution rights to ICX-PRO.

Nick Higgins, CEO of Intercytex, commented:

“Completion of this multinational Phase III trial will be a significant achievement for Intercytex, especially given that we are supplying all product from our manufacturing facility in Manchester. Having reached our recruitment target, we are now in the final stage of the trial and can look forward to announcing the results early next year.”