ReGen announces publication showing reversal of effects of severe brain injury
by zolpidem
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.