TILS.L Regulatory News (TILS)

5 Feb 2007 07:01

ReGen Therapeutics PLC05 February 2007 STUDAY SHOWING THAT REGEN'S COLOSTRININ(TM) INCREASES LIFE-SPAN AND NEUROLOGICALPERFORMANCE IN MICE TO BE PRESENTED AT ALZHEIMER'S DISEASE CONFERENCE ReGen Therapeutics Plc ('ReGen' or the 'Company') announces that the results ofan in-vivo study showing that Colostrinin(TM) increases the lifespan andimproves the neurological performance of inbred mice predisposed to prematureageing have been accepted for presentation at the 8th International Conferenceof Alzheimer's and Parkinson's Diseases in Salzburg Austria March 14th-18th2007*. Commenting on the findings, Dr. Istvan Boldogh, Principal Investigator andProfessor at the Department of Microbiology and Immunology at UTMB**, Galveston,Texas, USA, said: "In this study, we investigated the effects of oral administration ofColostrinin(TM) on the life-span and various behaviour characteristics in micepredisposed to premature ageing. Our results showed that Colostrinin(TM) indeedprolongs life-span and improved age-associated locomotion, motor coordinationand learning/memory capacities. Moreover, the increase in life-span and improvedneurological performance correlates well with reduced levels of oxidative stressmarkers measured in various organs including the brain and liver. These resultssupport the view that Colostrinin(TM) has potential utility in the management ofage-related neurodegenerative diseases and improvement in the quality of life ofelderly individuals. These in-vivo results are entirely consistent with in-vitroresults that we have previously presented*** and will soon be published in thejournal of Neuropeptides". Commenting on the study, Percy Lomax, Executive Chairman, said, " In developingour nutraceutical product, Colostrinin(TM), we are looking to help improvepeoples' quality of life. This study shows that with respect to ageing andneurological functions we may be able to do that. Together with our previouslypublished studies on Colostrinin(TM), in particular our clinical study inindividuals with Alzheimer's disease, we have some positive science with whichto support the anticipated launch of Colostrinin(TM) as a nutraceutical later this year, initially through our North American licensee, Metagenics Inc.". A copy of the poster will be added to the ReGen website(www.regentherapeutics.com) once it has been presented. * 2007 Alzheimer's and Parkinson's Diseases: Progress and New Perspectives. ** ReGen has a sponsored research agreement with the University of Texas MedicalBranch, Galveston, Texas, USA. **\* These findings were presented as a poster at the 21st InternationalConference of Alzheimer's Disease International Istanbul, Turkey 28 September to1 October, 2005. A press release issued on 28/9/2005 and a copy of the poster isavailable via the ReGen website 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 forColostrinin(TM). 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. Clinical Data: 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 Colostrinin(TM) 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 Oxidative Stress: Continuous low levels of oxidative damage (induced by oxidative stress) to cellsplay a pivotal role in the pathogenesis of age-associated neurodegenerativediseases such as Alzheimer's, Parkinson's disease and other disorders of thecentral nervous system. The sources of oxidative stress manifested by theproduction of reactive oxygen species (ROS) are mitochondria and are,themselves, targets of ROS attack. Mitochondria are key organelles involved inenergy production and the generation of secondary messenger molecules, which, inturn, regulate cells, and also control the process of apoptosis (programmed celldeath). Metagenics Inc: In July 2006 ReGen announced that it had entered into an exclusive licenceagreement with Metagenics, Inc. for the commercialisation of Colostrinin(TM) as a human nutraceutical in North America. With headquarters in San Clemente, California, Metagenics is a leadingdeveloper, manufacturer and marketer of science-based nutraceuticals and medicalfoods sold to healthcare practitioners worldwide. It is dedicated to researchingand evaluating the effects of natural ingredients on genetic expression andprotein activity. The company has manufacturing and research facilities locatedin Gig Harbor, Washington, including its MetaProteomics(R) NutrigenomicsResearch Center and its Functional Medicine Research Center for human clinicalresearch. Metagenics holds multiple proprietary formula patents and producesover 400 research-based products to optimise health. Metagenics demonstrates itscommitment to purity and quality through its certifications for GoodManufacturing Practices (GMP) from the National Nutritional Foods Association,NSF International, and the Therapeutic Goods Administration of Australia. Thecompany has over 30,000 healthcare practitioners promoting its products in theNorth American markets alone (www.metagenics.com). Under the terms of the licence agreement, ReGen will produce bulk Colostrininfor delivery to Metagenics, who will carry out the final stages of productionand will arrange for marketing, distribution and sale of the final product. Bothparties are currently working closely together to establish the bestcommercialisation strategy for the North American market. The Agreement initially provides Metagenics with the exclusive right to marketColostrinin via healthcare professionals with an option to extend exclusivityinto the retail channels, such as drugstores and supermarkets at a later date,within six months of the products first launch. The Agreement is conditional on,amongst other things, satisfactory completion of toxicology testing onColostrinin and of due diligence by Metagenics on the Colostrinin manufacturingfacilities. The toxicology programme is ongoing. Once the results are known andthe other conditions of the licence agreement have been met, the requisite U.S.regulatory filings will be made. Alzheimer's and Parkinson's Diseases: Progress and New Perspectives: This international conference is under the auspices of the Austrian AlzheimerSociety, the Austrian Neurological Society and the Austrian Parkinson's Society. This meeting follows the highly successful 7th AD/PD Conference that took placein 2005 in Sorrento, Italy and hosted nearly 1,500 participants. The abstractsof the conference will be published as a supplement to the NeurodegenerativeDiseases Journal (NDD) published by S Karger AG and that the proceedings will bepublished as a separate volume of the Neurodegenerative Diseases Journal. This information is provided by RNS The company news service from the London Stock Exchange