09/11/2009
ReGen Therapeutics Plc “ReGen” or “the Company” is pleased to announce further positive news concerning its ‘Zolpidem Project’.
Final results of a study using SPECT scanning have shown that zolpidem significantly improves the cognitive and motor performance of subjects with brain damage. The results of this study, conducted in Pretoria, South Africa will be presented by Dr. Ralf Clauss* at the 4th International Congress on Brain and Behaviour, 3-6 December 2009 in Thessaloniki, Greece. A manuscript of this study has also been accepted for publication in a peer-reviewed specialist journal and will appear in print over the next few months.
Commenting on the study Dr.Clauss said, “This prospective study add further evidence to the numerous previous reports that zolpidem is clinically effective in patients with established brain damage. The fact that around 50% of subjects receiving a 10mg zolpidem tablet daily experienced sedation confirms that a lower, flexible formulation is required to optimise efficacy in individual subjects”. The Company estimates that the market for products exploiting this new use could be worth at least $4.3bn. Further studies are being planned for 2010, currently, ReGen is seeking to find a co-development/licensing partner or grant assistance to bring this new patented use and appropriate novel formulations to market. A detailed abstract of the study appears below.
Abstract:
23 of 41 consecutive adult patients, at least 6 months after brain damage were selected as neurologically disabled patients after scoring less than 100/100 on the Barthel Index. Causes of brain damage included stroke (12 subjects), traumatic brain injury (7 subjects), anaphylaxis (2 subjects), drug overdose (1 subject) and birth injury (1 subject). The selected 23 patients had a baseline SPECT scan before starting daily zolpidem therapy and a second within two weeks of therapy, performed 1 hour after receiving 10 mg oral zolpidem. Scans were designated as improved when at least two of three independent assessors detected improvement after zolpidem. The rest were designated non-improved.
After four months of daily zolpidem therapy, the clinical condition of subjects was rated on the Tinetti Falls Efficacy Scale (TFES) before and after zolpidem. The TFES ratings of all subjects and scan improvers and non-improvers were compared statistically.
Mean overall improvement after zolpidem on TFES was 11.3%, from 73.4/100 (SD 25.4) to 62.1/100 (SD 28.8) (p=0.0006). 10/ 23 (43%) improved on SPECT scan after zolpidem. Their mean TFES improvement was 19.4% (SD 16.75) compared with 5.08% (SD 5.17) in 13/23 non improvers (p=0.0081).
* Dr. Clauss is a Nuclear Medicine specialist at the Royal Surrey County Hospital, Guildford, UK and is scientific consultant to ReGen.
Notes to Editors:
In June 2008, ReGen Therapeutics Plc 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.
Analysis of data from a previous clinical study conducted in patients with long-standing brain damage by ReGen established 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.
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