15/05/2007
At today’s AGM of ReGen Therapeutics Plc (‘ReGen’) the Company’s Chairman and Chief Executive Officer Percy Lomax will comment as follows in relation to the Company’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 several important conditions of their agreement have now been satisfied. Namely, agreed toxicology testing on ColostrininTM has been completed to mutual satisfaction and Metagenics has inspected the manufacturing facilities of ReGen’s suppliers and has found these to be acceptable for commercial production. The two companies continue to work together to achieve the launch of the product to healthcare practitioners in the US during the last quarter of 2007. Further details in relation to product marketing are considered commercially confidential.
Percy Lomax said, ‘The anticipated launch of ColostrininTM as the product of ReGen research will be the culmination of a long period of scientific and commercial development. We believe that it will be potentially of great commercial significance to the ReGen group’.
Jeff Katke, Chairman and Chief Executive Officer of Metagenics, added, ‘We too are very pleased to be close to introducing ColostrininTM in the US as we see it as an important part of our science-based neurological product line and believe it will help to maintain the health of the ageing population’.
ZOLPIDEM:
The Clinical trial in South Africa is progressing very well. Despite some unexpected 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 of dosing and unblinding of the trial, at present it is possible to say that no safety concerns have been seen and that the spray formulation has been shown to work faster than tablets. This latter observation is important because it means that with such a formulation ReGen believes it will be easier for patients to steer a narrow course between effect and sedation.
ReGen expects to be able to announce the full results of the trial in August 2007.
In response to reported comments on its patent position ReGen confirms that it is applying for a ‘use’ patent for zolpidem which has been granted in South Africa and is in examination in other markets.
ReGen also reports that a documentary was screened on the Discovery Channel in the UK about ReGen’s use of zolpidem in brain dormancy and that participation in further documentaries is being considered.
COLOSTRININ(TM) PEPTIDE EVALUATION:
ReGen has now fully characterised the peptides in bovine ColostrininTM and are currently in the process of assessing the activity of a selection of synthetic proline-rich peptides in various in-vitro models predictive of activity in neurodegenerative diseases. ReGen believes that it is encouraging that in models of neuroprotection preliminary data have suggested that some of these structures are very active and others are less so, offering the prospect that a structure-activity relationship exists.
Once full data from these studies is available (expected during Q4 2007) it remains the intention of the Company to investigate further this relationship by testing some of the more promising structures and chemical modifications of them in more exacting in-vitro and in-vivo models. It is hoped that this process will lead to the identification of a pre-clinical candidate that could be the subject of a licensing deal with a pharmaceutical partner.
COLOSTRININ(TM) VET STUDY:
ReGen is pleased to report that studies to evaluate the potential use of ColostrininTM to treat possible cognitive impairment in aged dogs and cats are scheduled to start at the beginning of June 2007. These studies will be performed in parallel by a well-respected UK veterinarian, Dr Nick Mills, at his veterinary clinics in Kent, UK. Results are currently expected during November 2007.
GUILDFORD CLINICAL PHARMACOLOGY UNIT LIMITED:
External orders for GCPUL are lower than at the same stage as last year, but GCPUL continues to make a significant contribution to the zolpidem study.
For further information, please contact:
Andrew Marshall
Greycoat Communications
Tel: 020 7960 6007
Mobile: 07785 297111