Positive Ph II results for Modex' EpiDex

Switzerland's Modex Therapeutics has revealed positive final resultsfrom a Phase II trial with its skin replacement product EpiDex. These results, it says, confirm those announced in June and further support the observations of dermatologists in Switzerland and Germany, where EpiDex is already being sold for the treatment of hard-to-heal chronic skin ulcers.

The trial compared EpiDex with the surgical split-thickness mesh graft currently regarded as the gold standard for the treatment of such ulcers. It was conducted at 12 centers in Europe and assessed results from 77 evaluable patients. No other cell-based wound-healing product has ever been directly compared in this way in a clinical trial, the company said.

The results showed that, at 12 weeks, EpiDex was as effective as the surgical procedure of split-skin mesh grafting. Also, 73% of all patients who received EpiDex showed a significant reduction in skin ulcer surface area, compared with 72% in all split-skin mesh-grafted patients. The product was well tolerated and safe, and investigators reported no unexpected safety concerns.