08/07/2002
ReGen Therapeutics Plc is pleased to announce that results from the final open label phase of its trial of Colostrinin™ in the treatment of Alzheimer’s disease reinforce the findings from the first placebo controlled phase of the trial. As a result, the Company intends to continue its development programme for Colostrinin™.
In the final phase of the trial, all participating patients received Colostrinin™ for a 15-week period. This phase followed the conclusion of the initial 15-week placebo- controlled phase of the trial, which showed that significant clinical benefits appear to have been derived from the Colostrinin™ treatment.
The 30-week trial data demonstrates 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
ReGen considers the data from the trial to be very positive, confirming the findings of earlier pilot studies in Poland and supporting its view that Colostrinin™ is a potentially effective treatment for Alzheimer’s disease. The Company will therefore continue its development programme, in preparation for the next stage of clinical testing. The programme will now also include an investigation into whether the effects of the product can be further enhanced by varying the dosing regimen. ReGen is currently in discussions with a number of parties in relation to securing sufficient funding for this next stage of development.
Executive Chairman, Percy Lomax, said:-
‘We are delighted that the overall trial data has confirmed earlier indications that Colostrinin™ is potentially a safe and effective treatment for Alzheimer’s disease and are continuing our work to prepare for future clinical studies.
We are also continuing to discuss our development plans with several potential partners.’
For further information please contact:
Percy Lomax, Chairman
Mike Harvey, Chief Executive Officer
REGEN THERAPEUTICS PLC
Tel No: + 44 (0) 20 7907 0910
Lisa Baderoon
BUCHANAN COMMUNICATIONS
Tel No: + 44 (0) 20 7466 5000
NOTES TO EDITORS
Background
Regen’s principal activity is the development of a therapy for Alzheimer’s disease.
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, they become less resistant to infections and other illnesses, which are often the actual cause of death.
The Company’s therapy which it 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 of 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 have shown Colostrinin to have good therapeutic effect, with a significant percentage of Alzheimer’s disease patients treated showing stabilisation, and, in some cases, signs of improvement over a period of several years.
The Alzheimer’s disease ‘timebomb’ and the cost of caring Alzheimer’s disease, or pre-senile dementia, is characterised by gradual onset with a progressive loss of memory and cognitive function, resulting from the degeneration of neurones in the brain. The European Dementia Consortium states that Alzheimer’s disease occurs in 3.1% of 70-79 year olds.
It is currently estimated that there are already over ten million Alzheimer’s disease suffers in the USA, Europe and Japan. Demographic trends predict a dramatis increase in the number of people living to the age of 80 years and beyond by the middle of the twenty first century. On the basis of current estimates of the incidence of Alzheimer’s disease in the population, the number of suffers globally could well increase significantly. Taking in to account demographic changes in Japan, other Asian countries and the Americas, the global figure for Alzheimer’s disease patients may exceed 100 million by the middle of this century.
According to the Alzheimer’s Association, Alzheimer’s disease in the USA is the third most expensive disease after heart disease and cancer in terms of the cost to society, and is estimated to cost more than US$100 billion annually, with a lifetime cost-per-patient of over US$170,000.
The world market for Alzheimer’s disease treatment is estimated to be worth US$5 billion.
The Company estimates that the cost of treatment with Colostrinin will be competitive with existing therapies.