TILS.L Regulatory News (TILS)

23 Aug 2007 07:00

ReGen Therapeutics PLC23 August 2007 ReGen Therapeutics Plc ("ReGen" or "the Company") • ReGen Clinical Study confirms that a novel formulation of zolpidem is non-sedating ReGen Therapeutics Plc today announces the results of a small scale study thatis part of its clinical programme designed to explore the 'antidormancy' effectof zolpidem. This study was a double-blind, Phase IIa study in twenty conscious, fullyperceptive ambulant1 patients having various debilities as a consequence ofbrain damage. It was performed in collaboration with ReGen's subsidiary,Guildford Clinical Pharmacology Unit Ltd., UK and investigators at the WalkoMedical Centre in Springs, South Africa where the 'antidormancy' effect ofzolpidem was first discovered. The study compared various single doses of a novel sublingual spray formulation(placebo, 2.5mg, 5mg, 10mg) with an existing tablet formulation (placebo, 10mg)in terms of the onset and degree of sedation. It also looked for preliminarysigns of efficacy, although the study was small and only single doses of drugwere given. The study showed the following: €2.5mg spray regimen was no more sedative than placebo €10mg and 5mg spray regimen induced sedation in a dose responsive manner •The spray showed faster onset of action (sedative effect) than the tablet •The 5mg spray induced the same peak level of sedation as the 10mg tablet - 15 minutes compared with 90 minutes respectively. Commenting on these findings ReGen's Medical Director Dr. Andrew Sutton said,"We are delighted to have obtained such clear cut evidence that a spray isabsorbed faster and more completely than tablets because this will enablepatients to control the effect more accurately. Most importantly a dose of 2.5mgcaused no more sedation than placebo, suggesting the possibility that repeated2.5mg spray doses will show efficacy without undue sedation." Percy Lomax, ReGen Chairman and Chief Executive added "Based on these results wenow have the confidence to continue the development of novel zolpidemformulations for the treatment of brain dormancy2. We are now reviewing optionsto achieve this." Further announcements will be made in due course. For more information, please contact: Andrew MarshallGreycoat CommunicationsTel: 020 7960 6007Mobile: 07785 297111 Percy LomaxReGen Therapeutics PlcTel No 020 7153 4920 Andrew Baker/Rory Creedon/Cecil JordaanHB CorporateTel No 020 7538 1166 Notes to Editors: 1. Ambulant means patients who are able to walk around. 2. Brain dormancy is an expression used to describe an area of the brainwhere the cells are not dead, but are not functioning normally. Zolpidem was found by Dr HW Nel who is now a consultant to ReGen to produceunexpected and marked improvements in motor and cognitive deficits suffered bypatients after brain injury. However, as the tablets were designed to producesedation some 30% of his patients had to stop the medication due to heavydaytime sedative effects. 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. Thus, where those functions controlled by the dormant brain areas have beennormalised the following improvements have been seen: •Aphasia (speech cognition) •General cognition and IQ •Ataxia (limb coordination/posture) •Hearing •Basic reflexes (swallowing and continence) ReGen has filed an application for a use patent for the use of zolpidem in'dormancy'. ReGen is now carrying out background scientific research to discover, amongother things, the precise mode of action of zolpidem in this situation. ReGen wishes to stress that it believes the overwhelming market for this drug isfor ambulant1 patients and whilst it has a use in Persistent Vegetative State(PVS) this is not the main direct audience. Further ReGen wishes to confirm that it does not consider that it is for ReGento participate in the medical ethics debate about the use of zolpidem in PVSpatients. What ReGen is working on is a reversal of brain dormancy2. Thelicensing of any drug is the responsibility of the Health Authority and its useis within the doctor patient relationship and ReGen will make no comment onthat. This information is provided by RNS The company news service from the London Stock Exchange