24/10/2002
ReGen Therapeutics Plc (‘ReGen’ or ‘the Company’) is today presenting preliminary results from its ongoing work to identify the mode of action of Colostrinin™, its potential therapy for Alzheimer’s disease (AD), at the 18th International Conference on Alzheimer’s disease in Barcelona, Spain.
ReGen is particularly encouraged by the results of this research according to Chairman Percy Lomax who also commented ‘For some time we have suspected that Colostrinin™ is a powerful antioxidant, which may at least partially explain the results we have seen in past clinical studies. The work conducted in collaboration with University of Texas Medical Branch has begun to add solid scientific evidence to support the earlier hypotheses and will further strengthen the Company’s position in its future dealings with potential development partners.’
ReGen reported in July 2002 that Colostrinin™ had shown clinical efficacy and was well-tolerated in a placebo controlled study in subjects with either mild or moderate AD. The new data presented today by Dr Marian Kruzel*, one of the Company’s scientific advisers, offers a significant insight into how Colostrinin™ may achieve its clinical effect.
Accumulating evidence implicates oxidative stress in the pathogenesis of several neurodegenerative diseases, including AD. Increased lipid peroxidation, decreased levels of polyunsaturated fatty acids, and increased levels of 4-hydroxynonenal (4HNE), F(2)-isoprostanes, and F(4)-neuroprostanes (highly reactive molecules produced by the generation of free radicals and capable of damaging important cellular components) are present in the brain of AD sufferers.
In vitro data presented today show that Colostrinin™ reduces the abundance of 4HNE-protein adducts, reduces intracellular levels of reactive oxygen species, inhibits 4HNE-mediated glutathione (GSH) depletion (important for maintenance of cellular red-ox status, metabolism and enzyme regulation) and inhibits 4HNE-induced activation of p53 protein and c-Jun NH2-terminal kinase enzymes (both involved in the process of apoptosis – programmed cell death).
Commenting on the work, Dr Kruzel said ‘The findings suggest that Colostrinin™ can down-regulate 4HNE mediated lipid peroxidation and its product-induced signalling that leads to pathological changes at the cellular and organ level. These results may help to explain the clinical benefits of Colostrinin™, as seen in the recently completed clinical study in Alzheimer’s disease patients, and suggest potential applications in other diseases which are mediated by reactive oxygen species. Further research to investigate these preliminary findings is continuing’.
* This research has been conducted as part of ReGen’s ongoing collaboration with the University of Texas Medical Branch, Galveston, Texas, USA and has been performed by Dr Istvan Boldogh at the Department of Microbiology and Immunology.
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 neutraceutical 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.
Alzheimer’s disease 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 dramatic increase in the number of people living to the age of 80 years and beyond by the middle of this 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 2050.
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 has been 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 treatments is estimated to be worth at least US$5 billion.
The Company estimates that the cost of treatment with Colostrinin™ will be competitive with existing therapies.