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Research Update

25 Aug 2006 07:00

ReGen Therapeutics PLC25 August 2006 Embargoed for 7am 25 August 2006 Research Update In-vitro study shows ReGen's ColostrininTM to have anti-ageing and anti-cancerpotential The Directors of ReGen Therapeutics Plc ('ReGen') are pleased to announce that areport published today 25th August commissioned by ReGen has indicated thatColostrininTM could have anti-ageing and anti-cancer potential. Developmentsare still at an early stage. To read the full report please go towww.regentherapeutics.com. Some of the highlights of the report are as follows: A study undertaken by Dr Istvan Boldogh at the University of Texas MedicalBranch* has indicated that ColostrininTM, ReGen's compound, may have an impacton the ageing process and the development of cancer in addition to its knowntherapeutic qualities in respect of Alzheimer's disease. The full results of an in-vitro study showing that ColostrininTM reduces thespontaneous or induced mutation frequency in the DNA of cells has been publishedin the Journal of Experimental Therapeutics and Oncology. As such DNA damage isimplicated in the general process of ageing and ultimately the development ofcancer, this study suggests that ColostrininTM may have potential in theprevention of both processes. The study, which was performed in both Hamster and Human cells, looked at theimpact of ColostrininTM on the frequency of defined DNA mutations in these cellsas it occurs naturally and when induced by various known chemical or physicalagents. In cells stressed oxidatively, ColostrininTM reduced the frequency of mutationinduced by reactive oxygen species (ROS) to nearly background levels in adose-dependent manner. Likewise, ColostrininTM, at the dose level indicated inthe report, reduced the frequency of mutation caused by two mutagenic agents,methyl methane sulphonate and mitomycin-C, the latter often used in cancerchemotherapy. Notably ColostrininTM decreased UVA and UVB radiation inducedmutation frequency. The latter finding is of particular interest because thesedamaging radiations are a natural part of sunlight. UVA radiation plays a rolein the induction of malignant melanoma and UVB radiation is the primary cause ofsquamous cell carcinomas. Commenting on the findings, Dr. Istvan Boldogh, Department of Microbiology andImmunology at UTMB*, Galveston, Texas, USA, the study's principal investigatorsaid: 'Taken together, these results suggest that the antimutagenic properties ofColostrininTM are achieved via multiple mechanisms - by decreasing intracellularlevels of ROS and so preventing DNA damage and by increasing the efficiency ofnatural DNA repair mechanisms. These results are highly significant becausenatural compounds that can prevent or reduce the damage caused by such genotoxicagents when either produced by the body itself or mediated via environmentalexposures are of great interest from the perspective of public health.' Commenting on the study, Percy Lomax, Chairman and Chief Executive Officer,said: 'These new findings are particularly exciting and are part of the ongoingdevelopment of ReGen's compound, ColostrininTM. Firstly, they give yet furtherrationale to the marketing of ColostrininTM as a nutritional supplement in theageing population, as intended through our recent deal with Metagenics**.Secondly, it gives further scientific backing to the development of compounds,based on the active ingredients within ColostrininTM, as pharmaceuticalcompounds for use in specific disease conditions and suggests we may extend thedisease indications we are currently exploring.' * ReGen has a sponsored research agreement with the University of Texas MedicalBranch, Galveston, Texas, USA. **On 13/7/2006 ReGen announced that it had entered into an exclusive licenceagreement with Metagenics, Inc. for the commercialisation of ReGen'sColostrininTM as a human nutraceutical in North America. Headquartered in SanClemente, California, Metagenics is a leading developer, manufacturer andmarketer of nutraceuticals, dedicated to researching and evaluating the effectsof natural ingredients on genetic expression and protein activity. For further information, please contact:Andrew MarshallGreycoat Communications0207 960 6007 NOTES TO EDITORS Background ReGen's principal activity is the development of a potential therapy forAlzheimer's disease and also the development of nutraceutical uses forColostrininTM. Alzheimer's disease is a progressive, neurodegenerative and ultimately fataldisease that slowly destroys the brain. Symptoms of Alzheimer's disease includeprogressive impairment of cognitive function including memory loss, inability tothink abstractly, loss of language function, attention deficit and associateddepression, anxiety and agitation. Eventually Alzheimer's disease sufferers losethe ability to take care of themselves and must be looked after either by familyor in residential care homes and hospitals. Ultimately, sufferers become lessresistant to infections and other illnesses, which often become the actual causeof death. In a 30 week clinical study, reported in the peer reviewed Journal ofAlzheimer's Disease in 2004, it was shown that: • More than 40% of patients on ColostrininTM 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, and 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 Adverse Events or safety concerns were observed during the trial. 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