Intercytex announces successful Phase II results and commences Phase III trials for ICX-PRO – its novel wound-healing product
8th August 2005
Cambridge, UK, 8 August 2005 - Intercytex, the cell therapy company developing products for the advanced woundcare and aesthetic medicine markets, today announces successful Phase II results for ICX-PRO, its novel woundcare product which has now entered a multi-centre Phase III clinical trial.
ICX-PRO is a topical woundcare product designed to actively stimulate repair in persistent chronic wounds including venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). It comprises active, allogeneic, human dermal fibroblasts – the cells that are responsible for the wound healing process - in a human fibrin-based gel, which is applied to the wound at regular intervals until complete healing of the wound has occurred.
The randomised Phase IIb efficacy trial was performed on patients who had suffered from a VLU for at least six months and which had not responded to the current “gold standard” treatment - four-layer compression bandaging. The final data indicated that 75% of patients who received ICX-PRO showed a measurable reduction in wound size and 44% of patients (treated with the higher dose being used in the Phase III study) achieved complete closure. No patient safety concerns were observed during the Phase IIb study.
Mr Stephen Blair, Consultant Vascular Surgeon at Wirral Hospital Trust, Chief Investigator in the UK for the Phase III study, said: “We are very encouraged that the final data from the Phase IIb trial has confirmed our perception of the clinical benefits of ICX-PRO and we are extremely pleased to be participating in the Phase III trial.”
The FDA has approved a blinded, randomised, multi-centre Phase III trial for ICX-PRO. Around 200 patients suffering from VLUs of at least three months duration that have been non-responsive to conventional therapy will take part in the trial. Approximately half the patients will have active product, a quarter will have a placebo consisting of fibrin gel with no cells and a quarter will receive four-layer compression bandaging. The endpoint will be to show an incidence of 100% wound closure at 12 weeks. Results of the trial are expected by the end of 2006.
“We are very excited about commencing this Phase III trial for ICX-PRO,” said Nick Higgins, Intercytex’ Chief Executive Officer. “ICX-PRO has already shown great potential in the clinic for treating venous leg ulcers, a highly distressing and debilitating condition which is underserved by the current products on the market.”
