TILS.L Regulatory News (TILS)

15 May 2007 12:00

ReGen Therapeutics PLC15 May 2007 AGM STATEMENT At today's AGM of ReGen Therapeutics Plc ("ReGen") the Company's Chairman andChief Executive Officer Percy Lomax will comment as follows in relation to theCompany's activities in what he described as a pivotal year for the Company: COLOSTRININ(TM) US LAUNCH UPDATE: ReGen and its North American licensee Metagenics Inc, have stated that severalimportant conditions of their agreement have now been satisfied. Namely, agreedtoxicology testing on ColostrininTM has been completed to mutual satisfactionand Metagenics has inspected the manufacturing facilities of ReGen's suppliersand has found these to be acceptable for commercial production. The twocompanies continue to work together to achieve the launch of the product tohealthcare practitioners in the US during the last quarter of 2007. Furtherdetails in relation to product marketing are considered commerciallyconfidential. Percy Lomax said, 'The anticipated launch of ColostrininTM as the product ofReGen research will be the culmination of a long period of scientific andcommercial development. We believe that it will be potentially of greatcommercial significance to the ReGen group'. Jeff Katke, Chairman and Chief Executive Officer of Metagenics, added, 'We tooare very pleased to be close to introducing ColostrininTM in the US as we see itas an important part of our science-based neurological product line and believeit will help to maintain the health of the ageing population'. ZOLPIDEM: The Clinical trial in South Africa is progressing very well. Despite someunexpected bureaucratic delays patient recruitment has recently proceeded apace.Clinical work is now expected to be completed by the end of June 2007. Although conclusions on efficacy and sedation must await the completion ofdosing and unblinding of the trial, at present it is possible to say that nosafety concerns have been seen and that the spray formulation has been shown towork faster than tablets. This latter observation is important because it meansthat with such a formulation ReGen believes it will be easier for patients tosteer a narrow course between effect and sedation. ReGen expects to be able to announce the full results of the trial in August2007. In response to reported comments on its patent position ReGen confirms that itis applying for a 'use' patent for zolpidem which has been granted in SouthAfrica and is in examination in other markets. ReGen also reports that a documentary was screened on the Discovery Channel inthe UK about ReGen's use of zolpidem in brain dormancy and that participation infurther documentaries is being considered. COLOSTRININ(TM) PEPTIDE EVALUATION: ReGen has now fully characterised the peptides in bovine ColostrininTM and arecurrently in the process of assessing the activity of a selection of syntheticproline-rich peptides in various in-vitro models predictive of activity inneurodegenerative diseases. ReGen believes that it is encouraging that in modelsof neuroprotection preliminary data have suggested that some of these structuresare very active and others are less so, offering the prospect that astructure-activity relationship exists. Once full data from these studies is available (expected during Q4 2007) itremains the intention of the Company to investigate further this relationship bytesting some of the more promising structures and chemical modifications of themin more exacting in-vitro and in-vivo models. It is hoped that this process willlead to the identification of a pre-clinical candidate that could be the subjectof a licensing deal with a pharmaceutical partner. COLOSTRININ(TM) VET STUDY: ReGen is pleased to report that studies to evaluate the potential use ofColostrininTM to treat possible cognitive impairment in aged dogs and cats arescheduled to start at the beginning of June 2007. These studies will beperformed in parallel by a well-respected UK veterinarian, Dr Nick Mills, at hisveterinary clinics in Kent, UK. Results are currently expected during November2007. GUILDFORD CLINICAL PHARMACOLOGY UNIT LIMITED: External orders for GCPUL are lower than at the same stage as last year, butGCPUL continues to make a significant contribution to the zolpidem study. For further information, please contact: Andrew MarshallGreycoat CommunicationsTel: 020 7960 6007Mobile: 07785 297111 This information is provided by RNS The company news service from the London Stock Exchange