6 Oct 2008 07:00
6th October 2008 embargoed for 7am
ReGen Therapeutics Plc
Review of zolpidem effects after brain damage due to brain trauma, stroke and other causes, presented at 'Magic bullet' Conference
ReGen Therapeutics Plc ("ReGen" or the "Company") announces that a review of the use of zolpidem in brain dormancy was presented by Dr Ralf Clauss* at the Ehrlich II congress on 'magic bullets' in Nuremburg, Germany on Friday 3rd October.
Summarising his presentation Dr.Clauss said:
'It has now been ten years since the awakening of the first patient from his state of impaired consciousness after swallowing 10mg zolpidem. In the past decade, zolpidem has been effective in a multitude of patients with brain damage ranging from birth injury to traumatic brain injury to stroke and others. SPECT and PET scanning studies in these patients show reactivation of brain metabolism in quiescent brain regions after injury, designated functional neurodormancy. Recently MEG studies have shown that these suppressed neurodormant brain areas have a characteristic slow wave magnetic rhythm that normalises after zolpidem, but not after placebo or other sleeping drugs such as zopiclone.
Neurodormancy arises as a physiological thread that is present in a multitude of unrelated brain pathologies, most likely a basic physiological protection mechanism that is initiated after brain damage. It forms a target for zolpidem which re- activates neurodormant tissue and normalises clinical features that occur because of the suppressed neurodormant brain'.
Concluding, Dr Clauss described the preliminary results of a study that is being conducted at the University of Pretoria, South Africa and scheduled to be presented in full at the Asia Oceania Congress of Nuclear Medicine and Biology, Delhi, India, Nov, 2008.
'In this study, 40 patients with clinical and neurologically confirmed brain damage due to various causes (mainly stroke and traumatic brain injury) were investigated by brain SPECT imaging before and after zolpidem. All patients underwent non-attenuation corrected HMPAO rest/zolpidem imaging. All testing was completed within a maximum period of a week. Three experts reviewed all images, blinded to the rest and zolpidem studies. Concordance / discordance of brain SPECT and neurological assessment was assessed. The results show that 72.5% of patients demonstrated an improvement in cerebral perfusion after zolpidem which is significantly higher than the response picked up on clinical measurements only'.
Commenting on this presentation from a commercial perspective, Mr Percy Lomax ReGen's Chairman and CEO said:
'The recent trial taken together with the previous trial and so many individual reports of a beneficial effect from zolpidem in a wide range of brain damage, from birth injury to trauma, stroke and others, demonstrates that zolpidem can help a considerable number of patients with such conditions. Encouragingly the new Pretoria study suggests that the proportion responding to zolpidem could actually be higher than previously expected based on clinical measurement alone. In some patients the benefit has been profound with recoveries of speech, continence, cognitive function and limb paralysis. There has been no report of undue adverse effects other than the expected daytime sedation, moreover ReGen believes that it has found a non-sedating dose of 2.5mg in a spray form as reported at the end of a clinical trial in August 2007.
ReGen is currently negotiating to license out zolpidem, having prepared a second clinical trial to show statistical evidence of efficacy at this dose level. The Company believes that the market is worth at least $4.3bn and a licensing deal in this market could be very attractive in terms of income to ReGen'.
* Dr. Clauss is a Nuclear Medicine specialist at the Royal Surrey County Hospital, Guildford, UK and is scientific consultant to ReGen and a shareholder.
Notes to Editors:
In June, the Company announced that collaborators at Aston University, Birmingham UK had discovered new evidence of zolpidem's unique mode of action using pharmaco-magneto-encephalography (MEG) brain imaging. They found that non-functioning areas of the brain within the stroke damage area of a patient were being kept in a dormant state by excessive slow wave activity that zolpidem reversed. This effect could not be reproduced with placebo or another sedative with a similar pharmacological action called zopiclone. ReGen has filed a new patent application around this important discovery.
Recent analysis of data from ReGen's first study has established in patients with long-standing brain damage that the sublingual route of dosing is more consistent, faster in onset and more potent than existing tablets, characteristics that will greatly help patients to control the effect of dosing when they need to avoid sedation. More importantly, the trial also demonstrated that 2.5 mg sublingually was non-sedative even when repeated, and since published reports have shown 2.5mg to be an effective dose in this new indication, it established a clear demarcation between ReGen's new indication and generic sedative formulations.
Currently, and with advice from internationally respected experts in stroke rehabilitation, ReGen is planning a further, double-blind clinical trial in the UK designed to demonstrate the efficacy of repeated doses of zolpidem after stroke. This information will help to design optimal treatment regimens.
For further information, please contact:
Percy Lomax
ReGen Therapeutics Plc
Tel: 020 7153 4920
Roland Cornish/Felicity Geidt
Beaumont Cornish Limited
Tel: 020 7628 3396
David Scott/Nick Bealer
Alexander David Securities Limited
Tel: 020 7448 9820
Adrian Duffield/Jon Davies
College Hill Associates
Tel: 020 7457 2020