TILS.L Regulatory News (TILS)

22 May 2006 11:11

ReGen Therapeutics PLC22 May 2006 ReGen announces publication showing reversal of effects of severe brain injuryby zolpidem ReGen Therapeutics Plc ('ReGen' or 'the Company') is developing an important newuse for zolpidem, a long-established and safe treatment for insomnia. Today the Company announces the publication of an article in volume 21 pages 23- 28 of the journal Neurorehabilitation (Clauss, R P and Nel, W H)* showing thatthe 'arousal' effect of zolpidem in three subjects in a permanent vegetativestate resulting from brain damage is maintained after daily treatment over aperiod of up to six years. The publication states that the new use was firstseen in a thirty-year old man who was mute, incontinent and in permanent spasmafter a severe traffic accident three years earlier. When given zolpidem forrestlessness one night he was able to communicate verbally, spasms relaxed andhe recognised people around him for the first time since the accident. Theeffect lasted while zolpidem remained in the body and has been repeated withgradually improving effect for six years since the first dose. The three subjects referred to in the publication, two motor vehicle accidentpatients and one near drowning patient, all of them in the permanent vegetativestate for at least three years, were rated using well-accepted debility scalesbefore and after daily treatment with zolpidem. Long-term response was monitoredfor between three and six years. All patients were aroused transiently everymorning after zolpidem. Drug efficacy did not decrease and there were no sideeffects after up to six years daily use. Brain scans known as SPECT have also been carried out to show which braintissues were functioning and they showed that dormant areas of the brain becameactive while zolpidem remained in the body. The change coincided with theclinical improvements. Hitherto the dormant areas were considered irreversiblydamaged. A significant number of patients has now been treated by Dr Nel with beneficialeffects after strokes, birth injury and Bell's palsy. The clinical effect isgenerally proportional to the size and position of the dormant area andcorrelates with predicted drug levels in the brain/plasma. Commenting, Percy Lomax, ReGen Chairman and Chief Executive said "It isencouraging that the effect is so beneficial to patients, that it is maintainedover a long period and that the drug is well tolerated. Sleepiness appears to bethe main if not sole disadvantage, but we believe that can be minimised toacceptable levels with new formulations. With this in mind, ReGen is now undertaking a Phase IIa 'clinical proof ofconcept' study in South Africa in known zolpidem responders led by oursubsidiary Guildford Clinical Pharmacology Unit Ltd. This study will compare anew formulation with an existing tablet formulation, hoping to achieve efficacybut without sedation. The results will be used to find a commercial partner tocomplete formulation, clinical development and marketing." Given that stroke alone is the largest single cause of severe disability inEngland and Wales, with over 250,000 people being affected at any one time, theCompany believes that zolpidem represents a significant medical and commercialopportunity. ReGen estimates suggest that the total potential world market forzolpidem in this new use is around $4.3bn per annum. * Since writing this research Drs Clauss and Nel have become consultants andshareholders of ReGen as a result of the acquisition of Sciencom Limited on 14February 2006. For more information, please contact: Andrew Marshall Greycoat Communications Tel No 020 7960 6007 Mobile: 07785 297111 This information is provided by RNS The company news service from the London Stock Exchange