TILS.L Regulatory News (TILS)

9 May 2006 10:51

ReGen Therapeutics PLC09 May 2006 9 May 2006 ReGen Starts Safety Studies with Industrial Scale Bovine ColostrininTM toSupport its Commercialisation as a Nutraceutical Having now achieved the production of ColostrininTM at industrial scale ReGenTherapeutics Plc ("ReGen"), announces that it is starting formal safety studies*with ColostrininTM its proline-rich polypeptide extract of bovine colostrum**.While there have been no safety concerns associated with the use ofColostrininTM in previously conducted safety or clinical studies, this is a keymilestone for ReGen as these earlier studies used ColostrininTM made with asmall-scale process and using ovine rather than bovine colostrum. In parallelwith the safety programme, work continues to complete the incorporation of GoodManufacturing Practise (GMP) into the production process. Commenting, Mr. Percy Lomax ReGen's Chairman and Chief Executive said, 'Beingable to demonstrate that the version of ColostrininTM that we are proposing tosell commercially as a nutraceutical is as safe and effective as that used inour previous experimental and clinical studies is crucial to clinching a dealwith a marketing partner. We have recently shown that our bovine new processmaterial has the same physical characteristics and potency as the original ovinematerial. With the imminent start of definitive safety studies and theircompletion in due course, the conclusion of a commercial deal and the eventualmarketing of ColostrininTM moves a great deal closer'. ReGen are currently discussing the commercial licensing of ColostrininTM for useas a human nutraceutical with separate partners in North America, Japan andother regions of the World. For further information, please contact:Andrew MarshallGreycoat CommunicationsTel No 020 7960 6007 * These studies are being conducted for ReGen by a well known contract researchorganisation based in the USA. ** ColostrininTM is being manufactured for ReGen by Sterling Technology Inc. anexperienced processor of colostrum products based in Brookings, South Dakota,USA. Note 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 it was shown that: Approximately 40% of patients on ColostrininTM were stabilised or improved after15 weeks of therapy, based on an Analysis of Overall Response. 33% of patients continued to show stabilisation or improvement after 30 weeks oftreatment, although levels of benefit were slightly higher at the 15-week stageof 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 duringthe trial This information is provided by RNS The company news service from the London Stock Exchange