The University Hospital of Wales is the first UK trial site for the treatment of diabetic patients with chronic limb-threatening ischemia (CLI) using a novel patient-specific regenerative therapy. The site is recruiting patients for the study that is evaluating Rexgenero’s REX-001 in two Phase II trials, codenamed the SALEMANDER trials. Led by Ian Williams, a vascular surgeon and the principal investigator at the site.
A UK Consortium
University Hospital of Wales is participating in these trials through a consortium, the Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC), part of the Advanced Therapy Treatment Centre Network (ATTC) which aims to bring pioneering advanced therapy medicinal products (ATMPs) to patients. The MW-ATTC, in collaboration with the Cardiff and Vale University Health Board, has sought to progress the initiation of the two SALAMANDER trials and plans on activating new clinical trial sites in the Midlands in England soon reports Vascular News.
What is REX-001?
A new class of regenerative medicine, REX-001 is an autologous cell therapy manufactured using the patient’s own bone marrow and consists of immune cells (lymphocytes, monocytes and granulocytes) and progenitor cells involved in immune modulation and tissue regeneration. It is administered as a single dose within four data post collection of bone marrow cells.
The Sponsor Plans
Sponsor Rexgenero seek to treat a total of 60 patients with CLI and rest pain and 78 patients with CLI and non-healing ischemic ulcers in two independent Phase III SALAMANDER trials in approximately 25 hospitals across Europe. Other sites include ones in Spain, Austria, Portugal, Poland, Hungary, The Netherlands and the Czech Republic.
Who is Rexgenero?
Founded in 2015, UK-based Rexgenero has raised approximately $15.3 million in venture capital funds. Rexgenero is a clinical-stage regenerative medicine company developing advanced cell-based therapies with a focus on serious diseases with unmet medical needs, such as Critical Limb Ischemia (CLI). The Company’s lead candidate REX-001 is a highly innovative autologous cell therapy that is being studied in a Phase III clinical program in patients with CLI with diabetes, a poorly treated disease with a high risk of amputation and death. REX-001 has shown to be effective in Phase I/II and Phase II trials, alleviating CLI in the majority of patients by reducing pain, alleviating ulcers, increasing mobility, improving sleep and reducing the need for amputation. Rexgenero is developing REX-001 in a range of indications and, pending approval, intends to launch and market this specialty product in major territories. Rexgenero draws on an exceptional understanding of the fundamental science of cell therapies developed by the Andalusian Health Authority (Servicio Andaluz de Salud) and Andalusian Initiative of Advanced Therapies.
Ian Williams, Vascular SurgeonSource: Vascular News