TILS.L Regulatory News (TILS)

7 Dec 2006 11:00

ReGen Therapeutics PLC07 December 2006 ReGen Starts South African Zolpidem Clinical Study in Brain Damage Conditions After approval by the South African regulatory agency, ReGen Therapeutics Plc('ReGen' or 'the Company') has today announced that it has started dosingsubjects in a clinical study designed to explore the effects of zolpidem inpeople who have suffered brain damage. A significant body of 'open' clinical case observations has shown that zolpidem,a long-established drug currently marketed for the treatment of insomnia, cannormalise areas of brain dormancy secondary to a primary lesion in brain damageconditions e.g. stroke, traumatic brain injury, vascular dementia and Bell'spalsy. The study is a double-blind, Phase IIa 'clinical proof of concept' study inknown zolpidem responders being performed in collaboration with ReGen'ssubsidiary, Guildford Clinical Pharmacology Unit Ltd., UK and investigators atthe Walko Medical Centre in Springs, South Africa where the 'antidormancy'effect of zolpidem was first discovered. This study will compare various dosesof a new orobuccal spray formulation with an existing tablet formulation. In view of the current interest in the UK media in the use of zolpidem inpatients in a Persistent Vegetative State (PVS) ReGen would state that nopatients in this trial are in a PVS state and all are ambulant. Full resultsfrom this study are expected to be available around the end of March 2007. Based on over 150 case studies worldwide the clinical effects of zolpidem havebeen the restoration of consciousness, swallowing, co-ordination and motorfunction after stroke and traumatic brain injury. This reversal of dormancy hasbeen visualised by SPECT brain scanning on dosing with zolpidem. Work is ongoingto clarify the basis of this activity. The clinical effect is generally proportional to the size and position of thedormant area and correlates with drug levels in the brain/plasma. Whilst to datethese effects have been achieved with existing formulations these are less thanideal for the new use, with sedation as a significant limiting factor. Commenting, Percy Lomax, ReGen Chairman and Chief Executive said 'We are pleasedthat we are now able to get this study underway. In addition to objectivelyconfirming the effects of zolpidem in a clinical trial setting, we hope it willshow that new, low dose formulations have an anti-dormancy effect but in theabsence of sedation. If this is the case this will support the development ofseveral new formulations that we hope will allow the full benefits of zolpidemto be delivered to patients'. For more information, please contact: Andrew MarshallGreycoat CommunicationsTel: 020 7960 6007Mobile: 07785 297111 Notes to Editors: 1. Brain dormancy is an expression used to describe an area of the brain where the cells are not dead, but are not functioning normally. 2. Ambulant means patients who are able to walk around. 3. PVS means Persistent Vegetative State. Patients do not display any awareness of their surroundings and are unable to communicate. Sleep alternates with apparent wakefulness. ReGen's thesis is that zolpidem can reverse 'dormancy' at sites removed from aprimary site of brain damage (e.g. stroke, head trauma, viral infection,near-drowning). This thesis is derived from observations of open case clinicalstudies in over 150 patients. Thus, where those functions controlled by the dormant brain areas have beennormalised the following improvements have been seen: • Aphasia (speech cognition) • Dysarthria (word articulation) • General cognition and IQ • Ataxia (limb coordination/posture) • Hearing • Basic reflexes (swallowing and continence) ReGen has filed a use patent for the use of zolpidem in 'dormancy'. ReGen is now carrying out background scientific research to discover, amongother things, the precise mode of action of zolpidem in this situation. ReGenfiled in May 2006 to carry out a Phase IIa clinical trial in South Africa which,using known zolpidem responders, is intending to show whether or not a reductionin dosage would mean a reduction in sedation, but continue the therapeuticefficacy. The trial is also intended to include the use of a novel orobuccalspray. ReGen wishes to stress that it believes the overwhelming market for this drug isfor ambulant patients and whilst it has a use in PVS this is not the main directaudience. Further ReGen wishes to state it does not consider it to be its place to enterinto the medical ethics debate about the use of zolpidem in PVS patients. WhatReGen is working on is a reversal of brain dormancy. The licensing of any drugis the responsibility of the Health Authority and its use is within the doctorpatient relationship and ReGen will make no comment on that. This information is provided by RNS The company news service from the London Stock Exchange