First UK Clinical Trial Site Open for Recruitment of Diabetic Patients with Chronic Limb-Threatening Ischemia Using Novel Patient-Specific Regenerative Cell Therapy

London, UK, 4 December 2019: The first UK clinical trial site for the treatment of diabetic patients with chronic limb-threatening ischemia (CLI) using a novel patient-specific regenerative therapy has opened for patient recruitment at the University Hospital of Wales in Cardiff. The site will be evaluating REXGENERO’s REX-001 in two Phase III trials, codenamed the SALAMANDER trials. The trials are being led by Mr Ian Williams, a Consultant Vascular Surgeon and the Principal Investigator at the site.

The University Hospital of Wales is participating in the 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 has been working in collaboration with the Cardiff & Vale University Health Board to progress the initiation of the two SALAMANDER trials and is planning to activate new clinical trial sites in the Midlands in England shortly.

CLI is a chronic disease and the most serious form of peripheral arterial disease (PAD), a common condition in which a build-up of fatty deposits in the arteries reduces the blood flow to the legs and feet. CLI is characterized by chronic ischemic at-rest pain, ulcers or gangrene in one or both legs. CLI is a common condition in Europe and the United States affecting 1-1.5% of the population aged over 40¹. It represents an area of high unmet medical need as there are currently no approved therapies that successfully treat the CLI patient population. Patients with CLI have a very negative prognosis. A year after initial diagnosis, around 12% of patients have had an amputation. Five years after diagnosis the situation is even worse with mortality at 50%, rising to 70% after ten years².

REX-001 represents a new class of regenerative medicines. It 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 4 days after collection of bone marrow cells.

Ian Williams, Consultant Vascular Surgeon and Principal Investigator commented, “Chronic limb-threatening ischemia is a serious disease with severe consequences and limited treatment options. There is a high unmet need for novel and innovative therapies – such as REX-001 – that have the potential to be a highly effective treatment and to reduce amputation and mortality rates amongst the patient population.”

Rexgenero, the company pioneering the development of REX-001, says that the experimental product has already demonstrated efficacy in Phase I/II studies. In the Phase II clinical trial, 82% of patients with non-healing ischemic ulcers were healed within the first 12 months after a single administration dose of REX-001.

Joe Dupere, CEO of Rexgenero added, “Treating our first patient with REX-001 in the UK represents an important milestone for our Phase III program 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.”

Rexgenero is planning 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. In addition to the trial sites in the UK, Rexgenero is also recruiting patients for both trials at sites in Spain, Austria, Portugal, Poland, Hungary, the Netherlands and the Czech Republic.

For more information about the REX-001 Phase III SALAMANDER trials, and how to participate, please visit the clinical trial website.

References

1. Sigvant et al. A population-based study of peripheral arterial disease prevalence with special focus on critical limb ischemia and sex differences. J. Vasc. Surg. 45, 1185-1190 (2007).

Varu, V. N. et al. Critical limb ischemia. J. Vasc. Surg. 51, 230–241 (2010).