Rexgenero Announces Positive Outcome of Independent Data Monitoring Committee Meeting for Phase III Trial for Diabetic Patients with Critical Limb-Threatening Ischaemia
- REX-001 is an autologous cell-based product intended to treat critical limb-threatening ischaemia in diabetic patients
- Independent Data Monitoring Committee recommended continuing on-going phase III trial unchanged based on the evaluation of safety and tolerability data of REX-001
- Patient enrolment ongoing; visit the website → https://www.cli-treatment.com/en/home
- An interim analysis of the ongoing phase III trial is planned for Q2 2022; results for the primary endpoint are expected in the Q2 2023
London, UK, 26 October 2020: Rexgenero, a regenerative medicine company developing advanced cell therapies to treat critical limb-threatening ischaemia (CLI), today announces that the Independent Data Monitoring Committee (IDMC) for its REX-001 phase III clinical trial recently met to review patient safety and tolerability data from the initial 22 subjects. Based on this review, the IDMC unanimously agreed to continue the trial unchanged due to no significant safety concerns.
“We are pleased to receive the IDMCs recommendation that our REX-001 phase III clinical study should continue without any protocol modifications. This achievement is an important milestone
reflecting the safety profile of REX-001 in treating diabetic patients with critical limb-threatening ischaemia, a severe condition with high unmet need,” Gilbert Wagener, Senior Vice President,
Chief Medical Officer at Rexgenero, said: “We thank our team and study investigators for their efforts in running the study, and the IDMC members for their supervision and thoughtful review of the
patient data. Despite the unprecedented challenges of the COVID-19 pandemic, we believe we are back on track in terms of patient recruitment and moving the REX-001 phase III trial forward.”
CLI is the most serious form of chronic peripheral artery disease, in which severe obstruction of the arteries, as a result of plaque formation, markedly reduce blood flow to the extremities, mainly to the legs and feet. CLI may occur in one or both legs and it is characterized by excruciating pain at-rest, often including ulcers which may become gangrenous requiring amputation of the limb. The condition represents an area of high unmet medical need with very limited treatment options currently on the market, highlighting the importance of Rexgenero’s pipeline.
REX-001 consists of bone marrow-derived white blood cells extracted from the patient (autologous) and has shown efficacy in 80% of patients in early phase clinical studies. The phase III study is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with diabetes and Rutherford Category 5 CLI. Patients are randomized in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.