Data from Pharmawand - Curated by EPG Health - Date added 27 January 2018
Rexgenero Ltd, a clinical-stage regenerative medicine company developing advanced cell-based therapies with a focus on Critical Limb Ischemia (CLI), announces the treatment of its first patient in a Phase III programme evaluating the Company’s lead product, REX 001, in patients with Critical Limb Ischemia (CLI) and Diabetes Mellitus (DM).
Rexgenero is conducting two pivotal, placebo-controlled, double-blind, adaptive Phase III trials in patients with CLI and DM. The Phase III study in patients with Rutherford stage 4 CLI will assess the efficacy and safety of REX 001 with a primary endpoint of complete relief of ischemic rest pain. The Phase III study in patients with Rutherford stage 5 CLI will assess the efficacy and safety with a primary endpoint of complete ulcer healing. Amputation-free survival is included as a secondary endpoint in both studies.
The designs of both trials, including the patient population and primary endpoints, have been fully endorsed by the European Medicines Agency (EMA). The primary endpoints are the most clinically relevant to patients and physicians, are correlated to the improved clinical condition of patients and are expected to increase the probability of success. The Company plans to enroll a total of 138 patients at approximately 35 clinical sites in Europe with first interim results expected in circa 18 months’ time and full data in 2020.