Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix partner NHS Blood and Transplant initiates pilot trial in the area of dermatology

Pilot trial to use skin grafts decellularised using dCELL® technology

YORK, 16 December, 2010 - Tissue Regenix, the RegenMed company focused on the development and commercialisation of acellular tissue replacement products to address the chronic global shortfalls in donor tissue availability, announces that its partner, NHS Blood and Transplant (NHSBT), has initiated a pilot study to evaluate the use of decellularised human donor skin grafts (dCELL® Human Dermis) in the treatment of chronic, non-healing wounds, utilising Tissue Regenix's proprietary dCELL® technology.

The pilot study will be comprised of 20 patients with existing chronic wounds. Patients will be monitored over a 42-day period in order to assess the effectiveness of dCELL® Human Dermis in improving the closure of chronic wounds. The pilot study is designed to investigate the responsiveness of chronic wounds to determine the size of a larger, multi-centred study. Patients will continue to be monitored for up to six months following completion of the pilot study. The study, led by Mr Ardeshir Bayat, a NIHR clinician scientist in the field of plastic and reconstructive surgery with international expertise in wound healing research, will be carried out at the University Hospital of South Manchester (UHSM). The initial pilot study will be largely funded by the NHSBT.

Chronic wounds are caused by a number of factors with over 90% due to varicose ulcers, pressure sores and diabetic ulcers. Up to 5% of people over the age of 65 suffer chronic wounds with numbers increasing as aging Western populations and the incidence of cardiovascular disease factors, such as diabetes and smoking, result in the rising incidence of chronic wound formation. The treatment of chronic wounds represents a significant annual burden on healthcare systems, costing the NHS alone over £1 billion per annum.

NHSBT is responsible for the provision of a safe and reliable supply of blood and organs, and the majority of therapeutic tissue grafts within England and North Wales. NHSBT has an agreement whereby they have the right to carry out pre-clinical and clinical evaluations using Tissue Regenix's dCELL® technology for development purposes and the manufacture of human tissue derived clinical products for use by the NHS. Tissue Regenix has the exclusive commercialisation rights to all data generated from the NHSBT trials. The partnership with NHSBT will significantly shorten the timelines for getting approval for dermatology products while keeping costs associated with clinical trials to a minimum.

Mr Ardeshir Bayat, chief investigator based at the University of Manchester and UHSM, said: "We are very excited by the prospect of this work. This new technology has the potential to help many patients with long term, chronic wounds. Our experience of running trials means that NHSBT should be able to use good clinical data to support the use of these new tissues across the NHS."

Antony Odell, Tissue Regenix's Managing Director, said: "We are very pleased that our partner NHSBT has elected to conduct these trials using Tissue Regenix's dCELL® technology. This use of our proprietary technology platform provides us with the opportunity to broaden our pursuit of target indications at minimum cost to the company. We believe that these trials can produce promising data and new intellectual property for Tissue Regenix."

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About Tissue Regenix

Tissue Regenix, the RegenMed Company, was incorporated in May 2006 to commercialise the academic research of Professor Eileen Ingham and Professor John Fisher from the University of Leeds in the field of tissue decellularisation. Its dCELL® Technology comprises a patented process which removes cells and other components from human and animal tissue allowing it to be used without anti-rejection drugs to replace worn out or diseased body parts.

About dCELL® Technology

The process comprised within the dCELL® Technology involves the production of biological scaffolds created by taking a piece of human or animal tissue that is equivalent to the diseased or damaged body part which is being replaced, treating such tissue with a series of gentle chemical washes and then sterilising it. The end product is a scaffold which can be stored under normal conditions at room temperature like any synthetic medical device and, when it is implanted into the body, it repopulates with the patient's own cells using natural biological repair mechanisms.

Tissue Regenix's strategy is to continue to use its core dCELL® Technology as a platform to develop a range of products using the established medical device regulatory pathway to deliver solutions to unmet clinical needs. The three priority markets for the application of the technology are: Vascular (e.g. Vascular Patches); Cardiac (e.g. Heart Valves); and Orthopaedics (e.g. Meniscus).