Rexgenero cleared to continue Phase III trial of REX-001

Privately-held UK regenerative medicine company Rexgenero today announced 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. The study is testing Rexgenero’s lead candidate REX-001 in diabetic patients with critical limb-threatening ischemia (CLI).

“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,” said Rexgenero’s chief medical officer Gilbert Wagener, who joined the company in July this year. Dr Wagener added: “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.”

Area of high unmet medical need