Adocia announced today the initiation of a clinical Phase III study in India of BioChaperone PDGF-BB, the company’s innovative formulation of Platelet Derived Growth Factor (PDGF-BB) for the treatment of diabetic foot ulcers. This follows the approval given by the Drug Controller General of India (DCGI) on August 22nd, 2014. The dossier for this clinical trial was filed in September 2012, but the processing of the application had been delayed by the internal reorganization of the Indian regulatory agency.
This Phase III clinical trial is designed to confirm on a large population the efficacy of BioChaperone PDGF-BB spray to treat diabetic foot ulcer. Its results are expected to be used to support registration and market approval in India and in several other emerging countries. This double- blind, multicenter study will enroll 252 diabetic patients with a chronic foot ulcer. The main efficacy endpoint is complete wound closure after a maximum 20 weeks of treatment. Secondary efficacy criteria include wound closure at 10 weeks and the rate of reoccurrence three months after closure.