07/12/2006
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 dosing subjects in a clinical study designed to explore the effects of zolpidem in people 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, can normalise areas of brain dormancy secondary to a primary lesion in brain damage conditions e.g. stroke, traumatic brain injury, vascular dementia and Bell’s palsy.
The study is a double-blind, Phase IIa ‘clinical proof of concept’ study in known zolpidem responders being performed in collaboration with ReGen’s subsidiary, Guildford Clinical Pharmacology Unit Ltd., UK and investigators at the Walko Medical Centre in Springs, South Africa where the ‘antidormancy’ effect of zolpidem was first discovered. This study will compare various doses of 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 in patients in a Persistent Vegetative State (PVS) ReGen would state that no patients in this trial are in a PVS state and all are ambulant. Full results
from 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 have been the restoration of consciousness, swallowing, co-ordination and motor function after stroke and traumatic brain injury. This reversal of dormancy has been visualised by SPECT brain scanning on dosing with zolpidem. Work is ongoing to clarify the basis of this activity.
The clinical effect is generally proportional to the size and position of the dormant area and correlates with drug levels in the brain/plasma. Whilst to date these effects have been achieved with existing formulations these are less than ideal for the new use, with sedation as a significant limiting factor.
Commenting, Percy Lomax, ReGen Chairman and Chief Executive said ‘We are pleased that we are now able to get this study underway. In addition to objectively confirming the effects of zolpidem in a clinical trial setting, we hope it will show that new, low dose formulations have an anti-dormancy effect but in the absence of sedation. If this is the case this will support the development of several new formulations that we hope will allow the full benefits of zolpidem to be delivered to patients’.
For more information, please contact:
Andrew Marshall
Greycoat Communications
Tel: 020 7960 6007
Mobile: 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 a primary site of brain damage (e.g. stroke, head trauma, viral infection, near-drowning). This thesis is derived from observations of open case clinical studies in over 150 patients.
Thus, where those functions controlled by the dormant brain areas have been normalised 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, among other things, the precise mode of action of zolpidem in this situation. ReGen filed 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 reduction in dosage would mean a reduction in sedation, but continue the therapeutic efficacy. The trial is also intended to include the use of a novel orobuccal spray.
ReGen wishes to stress that it believes the overwhelming market for this drug is for ambulant patients and whilst it has a use in PVS this is not the main direct audience.
Further ReGen wishes to state it does not consider it to be its place to enter into the medical ethics debate about the use of zolpidem in PVS patients. What ReGen is working on is a reversal of brain dormancy. The licensing of any drug is the responsibility of the Health Authority and its use is within the doctor patient relationship and ReGen will make no comment on that.