Rexgenero has opened the first site in the UK to enrol diabetic patients with chronic limb-threatening ischemia (CLI) for the Phase III SALAMANDER studies of REX-001.
The site at the University Hospital of Wales is participating via the Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC) consortium, which is part of the Advanced Therapy Treatment Centre Network (ATTC).
In alliance with the Cardiff & Vale University health board, the MW-ATTC intends to advance the SALAMANDER trials and activate new sites in the country.
REX-001 is an autologous regenerative cell therapy made with the patient’s bone marrow. It comprises immune cells and progenitor cells associated with immune modulation and tissue regeneration.
The therapy is given as a single dose within four days of the collection of bone marrow cells.
In a previous Phase II trial, a single REX-001 dose led to the healing of ischemic ulcers in 82% of patients within the initial 12 months.
The SALAMANDER trials will recruit a total of 60 patients suffering from CLI and rest pain and 78 CLI patients with non-healing ischemic ulcers at 25 hospitals across Europe.
Apart from the UK, the company will enrol patients in the Netherlands, Austria, Poland, Hungary, Czech Republic, Spain and Portugal.
Rexgenero CEO Joe Dupere said: “Treating our first patient with REX-001 in the UK will be an important milestone for our Phase III programme in diabetic patients with chronic-limb threatening ischemia, a severe condition with high unmet need.
“With clinical trial sites and manufacturing bases now open across multiple countries in Europe, we are one step closer to completion of the Phase III studies and potential regulatory and market approval for an innovative and much-needed product.”
Results from the Phase III SALAMANDER studies are set to be available in 2021.