Patent Granted 2002

17/10/2002

Regen Therapeutics announces grant of patent on use of Colostrinin™ as a dietary supplement

ReGen Therapeutics Plc (‘ReGen’ or the ‘Company’), a company whose product Colostrinin™ has recently shown efficacy as a potential treatment for Alzheimer’s disease, announces that its subsidiary company, ReGen Biotech Ltd, has been granted a patent by the United Kingdom Patent Office.

The new patent covers the use of Colostrinin™, in combination with other materials, as a dietary supplement and is granted at a time when the Company is actively examining the potential for a neutraceutical version of Colostrinin™.
In particular ReGen is currently considering whether the new formulation could be developed in parallel with the continued development of the product as a pharmaceutical formulation for the treatment of Alzheimer’s disease.

The grant of this patent further strengthens ReGen’s intellectual property portfolio, which already consists of three granted patents, relating to the use of Colostrinin™ to treat Alzheimer’s disease and other similar disease conditions. In addition, the Company has filed a number of patent applications to support various other claims, which are currently proceeding through the evaluation process.

Commenting on this latest news, Chairman Percy Lomax said ‘The grant of a patent on use as a dietary supplement further demonstrates and underlines the potentially diverse applications for Colostrinin™. Whilst the main thrust of the Company remains the development of a pharmaceutical product to treat Alzheimer’s disease, we are continuing to examine the potential for a secondary product line, particularly in the neutraceutical sector. We are most encouraged by this latest piece of good news.’

For further information, please contact:

Andrew Marshall
Marshall Robinson Roe
Tel No: 020 7489 2033

NOTES TO EDITORS

Background

ReGen’s principal activity is the development of a potential therapy for Alzheimer’s disease and also the development of neutraceutal uses for Colostrinin™.

Alzheimer’s disease is a progressive, neurodegenerative and ultimately fatal disease that slowly destroys the brain. Symptoms of Alzheimer’s disease include progressive impairment of cognitive function including memory loss, inability to think abstractly, loss of language function, attention deficit and associated depression, anxiety and agitation. Eventually Alzheimer’s disease sufferers lose the ability to take care of themselves and must be looked after either by family or in residential care homes and hospitals. Ultimately, sufferers become less resistant to infections and other illnesses, which often become the actual cause of death.

The therapy which the Company is developing for Alzheimer’s disease is based on Colostrinin™, which is the name used by the Company for a natural product first isolated by scientists at the Ludwik Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences, in Poland (the ”Polish Institute”). Initial limited clinical trials conducted in Poland by the Polish Institute showed Colostrinin™ to have a good therapeutic effect, with a significant percentage of treated Alzheimer’s disease patients showing stabilisation, and, in some cases, signs of improvement over a period of several years.

Recently (8 July 2002), in a 30 week clinical study it was shown that:

• Approximately 40% of patients on Colostrinin™ were stabilised or improved after 15 weeks of therapy, based on an Analysis of Overall Response

• 33% of patients continued to show stabilisation or improvement after 30 weeks of treatment, although levels of benefit were slightly higher at the 15-week stage of the trial

• Efficacy demonstrated in both mild and moderate symptom groups, with greatest effects seen in earlier stages of the disease

• No drug-related Serious Adverse Events or safety concerns were observed during the trial

The Company is now continuing its Colostrinin™ development programme, in preparation for the next stage of clinical testing. The programme will now also include an investigation into whether the beneficial effects of the product can be further enhanced by varying the dosing regimen.