22/05/2006
ReGen Therapeutics Plc (‘ReGen’ or ‘the Company’) is developing an important new use 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 that the ‘arousal’ effect of zolpidem in three subjects in a permanent vegetative state resulting from brain damage is maintained after daily treatment over a period of up to six years. The publication states that the new use was first seen in a thirty-year old man who was mute, incontinent and in permanent spasm after a severe traffic accident three years earlier. When given zolpidem for restlessness one night he was able to communicate verbally, spasms relaxed and he recognised people around him for the first time since the accident. The effect lasted while zolpidem remained in the body and has been repeated with gradually improving effect for six years since the first dose.
The three subjects referred to in the publication, two motor vehicle accident patients and one near drowning patient, all of them in the permanent vegetative state for at least three years, were rated using well-accepted debility scales before and after daily treatment with zolpidem. Long-term response was monitored for between three and six years. All patients were aroused transiently every morning after zolpidem. Drug efficacy did not decrease and there were no side effects after up to six years daily use.
Brain scans known as SPECT have also been carried out to show which brain tissues were functioning and they showed that dormant areas of the brain became active while zolpidem remained in the body. The change coincided with the clinical improvements. Hitherto the dormant areas were considered irreversibly damaged.
A significant number of patients has now been treated by Dr Nel with beneficial effects after strokes, birth injury and Bell’s palsy. The clinical effect is generally proportional to the size and position of the dormant area and correlates with predicted drug levels in the brain/plasma.
Commenting, Percy Lomax, ReGen Chairman and Chief Executive said ‘It is encouraging that the effect is so beneficial to patients, that it is maintained over a long period and that the drug is well tolerated. Sleepiness appears to be the main if not sole disadvantage, but we believe that can be minimised to acceptable levels with new formulations.
With this in mind, ReGen is now undertaking a Phase IIa ‘clinical proof of concept’ study in South Africa in known zolpidem responders led by our subsidiary Guildford Clinical Pharmacology Unit Ltd. This study will compare a new formulation with an existing tablet formulation, hoping to achieve efficacy but without sedation. The results will be used to find a commercial partner to complete formulation, clinical development and marketing.’
Given that stroke alone is the largest single cause of severe disability in England and Wales, with over 250,000 people being affected at any one time, the Company believes that zolpidem represents a significant medical and commercial opportunity. ReGen estimates suggest that the total potential world market for zolpidem in this new use is around $4.3bn per annum.
* Since writing this research Drs Clauss and Nel have become consultants and shareholders of ReGen as a result of the acquisition of Sciencom Limited on 14 February 2006.
For more information, please contact:
Andrew Marshall
Greycoat Communications
Tel No 020 7960 6007
Mobile: 07785 297111