Study confirms Zolpidem effect in brain damage
(Thomson Reuters ONE) - Study Confirming Zolpidem Effect in Brain Damage Accepted forPresentation at Clinical Conference.9/11/09ReGen Therapeutics Plc "ReGen" or "the Company" is pleased toannounce further positive news concerning its 'Zolpidem Project'.Final results of a study using SPECT scanning have shown thatzolpidem significantly improves the cognitive and motor performanceof subjects with brain damage. The results of this study, conductedin Pretoria, South Africa will be presented by Dr. Ralf Clauss* atthe 4th International Congress on Brain and Behaviour, 3-6 December2009 in Thessaloniki, Greece. A manuscript of this study has alsobeen accepted for publication in a peer-reviewed specialist journaland will appear in print over the next few months.Commenting on the study Dr.Clauss said, "This prospective study addsfurther evidence to the numerous previous reports that zolpidem isclinically effective in patients with established brain damage. Thefact that around 50% of subjects receiving a 10mg zolpidem tabletdaily experienced sedation confirms that a lower, flexibleformulation is required to optimise efficacy in individual subjects".The Company estimates that the market for products exploiting thisnew use could be worth at least $4.3bn. Further studies are beingplanned for 2010, currently, ReGen is seeking to find aco-development/licensing partner or grant assistance to bring thisnew 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 braindamage were selected as neurologically disabled patients afterscoring less than 100/100 on the Barthel Index. Causes of braindamage included stroke (12 subjects), traumatic brain injury (7subjects), anaphylaxis (2 subjects), drug overdose (1 subject) andbirth injury (1 subject). The selected 23 patients had a baselineSPECT scan before starting daily zolpidem therapy and a second withintwo weeks of therapy, performed 1 hour after receiving 10 mg oralzolpidem. Scans were designated as improved when at least two ofthree independent assessors detected improvement after zolpidem. Therest were designated non-improved.After four months of daily zolpidem therapy, the clinical conditionof subjects was rated on the Tinetti Falls Efficacy Scale (TFES)before and after zolpidem. The TFES ratings of all subjects and scanimprovers and non-improvers were compared statistically.Mean overall improvement after zolpidem on TFES was 11.3%, from73.4/100 (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 improvementwas 19.4% (SD 16.75) compared with 5.08% (SD 5.17) in 13/23 nonimprovers (p=0.0081).* Dr. Clauss is a Nuclear Medicine specialist at the Royal SurreyCounty Hospital, Guildford, UK and is scientific consultant to ReGen.Notes to Editors:In June 2008, ReGen Therapeutics Plc announced that collaborators atAston University, Birmingham UK had discovered new evidence ofzolpidem's unique mode of action usingpharmaco-magneto-encephalography (MEG) brain imaging. They found thatnon-functioning areas of the brain within the stroke damage area of apatient were being kept in a dormant state by excessive slow waveactivity that zolpidem reversed. This effect could not be reproducedwith placebo or another sedative with a similar pharmacologicalaction called zopiclone. ReGen has filed a new patent applicationaround this important discovery.Analysis of data from a previous clinical study conducted in patientswith long-standing brain damage by ReGen established that thesublingual route of dosing is more consistent, faster in onset andmore potent than existing tablets, characteristics that will greatlyhelp patients to control the effect of dosing when they need to avoidsedation. More importantly, the trial also demonstrated that 2.5 mgsublingually was non-sedative even when repeated, and since publishedreports have shown 2.5mg to be an effective dose in this newindication, it established a clear demarcation between ReGen's newindication and generic sedative formulations.For further information, please contact:Percy LomaxReGen Therapeutics PlcTel: 020 7153 4920Roland Cornish/Felicity GeidtBeaumont Cornish LimitedTel: 020 7628 3396David Scott/Nick BealerAlexander David Securities LimitedTel: 020 7448 9820This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 09.11.2009 - 08:00 Uhr
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