Rexgenero receives confirmation from the EMA that the design of two confirmatory Phase III clinical trials for Rexmyelocel-T is acceptable

Rexgenero receives confirmation from the EMA that the design of two confirmatory Phase III clinical trials for Rexmyelocel-T is acceptable

London, UK. Rexgenero received a Follow-up Scientific Advice letter from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) that the design of two confirmatory double-blind placebo controlled confirmatory trials is endorsed. The CHMP supports the proposed primary endpoints as well as the possibility to increase the sample size of both trials following an interim analysis per trial at half information time (i.e. when half of the patients are evaluable for response). The EMA also confirmed that if successful, these two planned confirmatory Phase III trials (trial 1 includes patients with diabetes mellitus (DM) and critical limb ischemia (CLI) Rutherford category 4 and Trial 2 includes patients with DM and CLI Rutherford category 5 would be sufficient for marketing authorisation. The Scientific Advice is a follow-up to a previous Scientific Advice received from CHMP on 30th May 2016.