TILS.L Regulatory News (TILS)

31 Oct 2007 09:00

ReGen Therapeutics PLC31 October 2007 REGEN THERAPEUTICS NOVEL USE OF ZOLPIDEM - BBC1 DOCUMENTARY: WEDNESDAY 31OCTOBER AT 10.40 PM ReGen Therapeutics Plc ('ReGen') use of zolpidem as a brain dormancy reversaltreatment for patients with debilities as a consequence of brain damage is beingfeatured in a BBC 1 television documentary to be screened in a 50 minuteprogramme on Wednesday 31 October at 10.40 pm, entitled The Waking Pill. According to the BBC programme listings, the documentary, part of the One Lifeseries, looks at treatment possibilities for people with long-term impairedconsciousness and features the Britons Joanne Douglas and Amy Pickard whosefamilies journey to South Africa to investigate the positive findings withzolpidem for themselves. There are a number of well-documented cases of zolpidem being used to improvethe condition of patients in what may appear to be a Persistent Vegetative State(PVS) or minimally conscious state such as Joanne and Amy. ReGen, however,believes that the main beneficiaries from zolpidem therapy are likely to beambulant patients. ReGen's thesis is that zolpidem can reverse 'dormancy' at sites removed from aprimary site of brain damage (e.g. stroke, head trauma, viral infection,near-drowning). This thesis is derived from observations of open case clinicalstudies in over 200 patients. Where those functions controlled by the dormantbrain areas have been normalised the following improvements have been seen:Aphasia (speech), general cognition and, Ataxia (limb coordination/posture),hearing, basic reflexes (swallowing and continence). ReGen recently reported (23 August 2007) on a Clinical Study, which confirmedthat its 2.5mg novel formulation of zolpidem is non-sedating when used onconscious, fully perceptive, ambulant patients having various debilities as aconsequence of brain damage. It was performed in collaboration with ReGen'ssubsidiary, Guildford Clinical Pharmacology Unit Limited and investigators atthe Walko Medical Centre in Springs, South Africa where the 'antidormancy'effect of zolpidem was first discovered. ReGen is currently discussing a further trial to establish the efficacy ofzolpidem in reversing brain dormancy. These discussions are ongoing and involvea significant number of outside experts in this field. At the same time ReGen iscontinuing its scientific investigations into the way zolpidem works in thissituation. Should this trial, which is scheduled to start in 2008, be successful ReGen willlook for a licensing partner. ReGen currently estimates the market for thisproduct at $4.3 billion. Notes to Editors: The recently completed ReGen study compared various single doses of a novelsublingual spray formulation (placebo, 2.5mg, 5mg, 10mg) with an existing tabletformulation (placebo, 10mg) in terms of the onset and degree of sedation. Italso looked for preliminary signs of efficacy. The study showed that a 2.5mg spray was no more sedative than a placebo, 10mgand 5mg sprays induced sedation in a dose responsive manner and the spray showedfaster onset of action (sedative effect) than the tablet. The 5mg spray inducedthe same peak level of sedation as the 10mg tablet - 15 minutes compared with 90minutes respectively. Further information is available on the ReGen website www.regentherapeutics.com ReGen has filed an application for a use patent for the use of zolpidem in'dormancy'. ReGen considers this to be a strong use patent as the claim of'awakening' is not covered by the initial patent which is for inducing sleep. Inaddition ReGen believes its intellectual position will be further bolstered by anovel formulation of zolpidem. ReGen also reminds Editors that Metagenics Inc. launched ReGen's lead productColostrininTM as CogniSureTM in the USA in the nutraceutical professionalchannel on 1 October 2007. For further information: Percy LomaxReGen Therapeutics PlcTel No 020 7153 4920 Andrew MarshallGreycoat CommunicationsTel No 020 7960 6007Mobile 07785 297111 Roland Cornish/Felicity GeidtBeaumont Cornish LimitedTel No 020 7628 3396 This information is provided by RNS The company news service from the London Stock Exchange