Rexgenero’s cell therapy provides hope to diabetic patients with critical limb ischemiaPublished: April 24, 2019
Cell therapy company Rexgenero has presented an update on its two Phase 3 clinical trials for its lead programme REX-001 to treat critical limb ischemia in patients with diabetes.
Rexgenero is a late-stage today regenerative medicine company developing advanced cell-based therapies to treat critical limb ischemia (CLI). The update was provided by the company’s CEO Joe Dupere, at the Alliance for Regenerative Medicine (ARM)’s Cell and Gene Therapy Meeting in Barcelona.
CLI is a chronic condition whereby fat accumulation in the arteries leads to severe obstruction of the arteries restricting blood supply to leg muscles. It is characterized by chronic ischemic at-rest pain, ulcers or gangrene in one or both legs.
REX-001 is an autologous cell therapy consisting of bone marrow-derived white blood cells extracted from the patient. It contains endothelial progenitors, mesenchymal stem cells and other supporting haematopoietic stem cells to promote re-vascularisation in patients. Encouraging results from three Phase 2 trials conducted in over 100 patients had shown that the processed bone marrow could stimulate vascular regrowth and alleviate the serious symptoms of the disease including ulceration, ischemia and improve the quality of life in patients.
The current Phase 3 confirmatory trials, called as Salamander trials, is designed to assess the efficacy and safety of REX-001 and are being conducted across various countries in Europe following approval from the EMA. Approximately 60 patients with CLI and rest pain, and 78 patients with CLI and non-healing wounds will take part in this research study. The study is limited to patients with diabetes. Complete relief of ischemic rest pain and complete ulcer healing are the primary endpoints of the studies, respectively. Amputation-free survival is included as a secondary endpoint in both studies. The EMA has confirmed that positive results from these two studies would be sufficient for marketing authorization of the therapies for CLI.
Rexgenero was founded in 2015 and is headquartered in London with research and development in Spain and manufacturing operations in Spain and Frankfurt.
Source: Rexgenero Presents Update on Phase III Clinical Trials with REX-001, a Cell-based Therapy for Critical Limb Ischaemia; Press Release