TILS.L Regulatory News (TILS)

20 Jun 2005 07:01

ReGen Therapeutics PLC20 June 2005 ReGen Therapeutics PLC 20th June 2005 ReGen Achieves Production Scale-Up Milestone for Colostrinin(TM) ReGen Therapeutics Plc, which has been working in collaboration with SterlingTechnology Inc.*, has now successfully defined the production process forColostrinin(TM), its proline-rich polypeptide extract of bovine colostrum, atindustrial scale. Work now continues to make this process fully compliant withthe necessary standards of GMP (Good Manufacturing Practice) with a view tomaking sufficient material to begin safety studies in the next few months.Sterling Technology is a leading provider of colostrum products for the humannutraceutical market in the USA. Mr. Percy Lomax ReGen's Chairman and Chief Executive added, "Being able todemonstrate that Colostrinin(TM) can be manufactured cost-effectively atindustrial scale is a very significant milestone for us, particularly from theperspective of potential commercial licensees. We are currently discussingpotential terms with separate partners in North America and Japan." For further information, please contact:Andrew MarshallMarshall Robinson RoeTel No 020 7960 6007 *Sterling Technology Inc is 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 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. In a 30-week clinical study it was shown that: Approximately 40% of patients on Colostrinin(TM) were stabilised or improvedafter 15 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