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02-Jun-2019

First Czech Republic Diabetic Patient with Critical Limb Ischaemia Treated with Novel Regenerative Therapy by Associate Professor Václav Procházka at University Hospital Ostrava

Phase III SALAMANDER Trial of Rexgenero’s REX-001 Open and Recruiting

London, UK, 29 May 2019: The first diabetic patient in the Czech Republic with a potentially life-threatening cardiovascular disease, called critical limb ischaemia (CLI), has been treated with REX-001, a novel regenerative therapy, in the SALAMANDER clinical trial being undertaken by Associate Professor Václav Procházka, the Principal Investigator at University Hospital Ostrava and an international expert in CLI.

CLI is a caused by a severe blockage in the arteries of the lower limbs, which markedly reduces blood flow, and is a serious form of peripheral arterial disease (PAD). Caused by atherosclerosis, PAD is the hardening and narrowing of the arteries over time due to the build-up of fatty deposits called plaque.

CLI is a common condition in Europe and the United States affecting 1-1.5% of the population aged over 40, with an estimated prevalence of 21,000-28,000 in the Czech Republic1,2,3,4.

The most prominent features of CLI are severe pain in the feet and legs while a person is resting, and non-healing sores on the feet or legs. Half of all patients with CLI are diabetics5. Left untreated, the complications of CLI may result in gangrene, amputation of the affected limb or even death. The global amputation rate is estimated at 25% within one year of diagnosis but varies according to the severity of the condition, with rates of 11% in patients with superficial ulcers and up to 83% in patients with gangrene6,7.

REX-001 is one of a new class of regenerative medicines: it is a so-called autologous cell therapy manufactured using the patient’s own bone marrow and contains 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.

The University Hospital Ostrava is the first Hospital in the Czech Republic to recruit patients for the Phase III SALAMANDER trial for the treatment of ischemic ulcers in patients with CLI and diabetes. The clinical trials have been given the name SALAMANDER in reference to the amphibian’s ability to regenerate its tail and limbs.

Associate Professor Václav Procházka, an international expert in CLI and the Principal Investigator at University Hospital Ostrava commented, “Every day I see patients with CLI who suffer from leg ulcers, pain at rest and in general have a very poor quality of life. There are limited treatment options available, so these patients are in desperate need and cell therapies such as REX-001 offer great potential.”

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

Karen Reitsma, Vice President, Clinical and Regulatory Development, of Rexgenero commented, “It is great news to have treated the first patient in the Czech Republic for our Phase III SALAMANDER trials. University Hospital Ostrava is our 14th clinical trial site in Europe open and actively recruiting patients with several other new sites gearing up to start recruitment shortly.”

Joe Dupere, CEO of Rexgenero added, “Treating our first patient with REX-001 in the Czech Republic represents an important milestone as we ramp up patient recruitment across Europe for our Phase III program in diabetic patients with CLI. It is a privilege to be working with Associate Professor Procházka in Ostrava, whose extensive knowledge of this specialist area will be invaluable for the development of REX-001.”

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 30 hospitals across Europe. In addition to this trial site in Ostrava in the Czech Republic, Rexgenero is also recruiting patients for both trials at sites in Spain, Austria, Portugal, Poland, Hungary and The Netherlands.

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

References
1. Nehler et al. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. Journal of Vascular Surgery (2014), 60:3, 686-695
2. Criqui et al. The epidemiology of peripheral artery disease: importance of identifying the population at risk. Vasc. Med. (1997). 2: 221-226
3. Sigvant et al. A population-based study of peripheral arterial disease prevalence with special focus on critical limb ischemia and sex differences. Journal of Vascular Surgery (2007), 45:6, 1185-1190
4. Maylar et al. Recent trends in morbidity and in-hospital outcomes of in-patients with peripheral arterial disease: a nationwide population-based analysis. European Heart Journal (2013), 34, 2706–2714
5. Norgren et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Journal of Vascular Surgery (2007) Jan;45 Suppl S:S5-67
6. Baser et al. Prevalence, Incidence, and Outcomes of Critical Limb Ischemia in the US Medicare Population. Vascular Disease Management (2013). 10(2)
7. Stocki et al. Costs of Lower Extremity Ulcers Among Patients with Diabetes. Diabetes Care (2004), 27: 2129-2134

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Last Updated: 03-Jun-2019