London, UK, 25th January 2018: Rexgenero Ltd, a clinical-stage regenerative medicine company developing advanced cell-based therapies with a focus on Critical Limb Ischemia (CLI), today 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).
REX-001 is a novel autologous cell therapy that has been shown to stimulate the growth of new blood vessels to restore blood supply to the limb, alleviate symptoms and improve quality of life of patients with CLI.
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 enrol 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.
Joe Dupere, Rexgenero’s CEO, commented, “We are extremely pleased to announce the first patient infusion in our Phase III programme with REX-001, which if successful could significantly improve the treatment of patients with CLI. The programme has been designed following advice from the EMA and in close collaboration with our Scientific Advisory Board. CLI is a medical condition with a clear need for new improved treatment options. Our goal is to bring innovative cell, gene and tissue therapies to the market addressing high unmet needs which cannot be treated with available therapies. We believe that REX-001 has the potential to be one of the first effective cell therapy products available for patients with CLI.”
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