31/10/2007
ReGen Therapeutics Plc (‘ReGen’) use of zolpidem as a brain dormancy reversal treatment for patients with debilities as a consequence of brain damage is being featured in a BBC 1 television documentary to be screened in a 50 minute programme on Wednesday 31 October at 10.40 pm, entitled The Waking Pill.
According to the BBC programme listings, the documentary, part of the One Life series, looks at treatment possibilities for people with long-term impaired consciousness and features the Britons Joanne Douglas and Amy Pickard whose families journey to South Africa to investigate the positive findings with zolpidem for themselves.
There are a number of well-documented cases of zolpidem being used to improve the 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 be ambulant patients.
ReGen’s thesis is that zolpidem can reverse ‘dormancy’ at sites removed from a primary site of brain damage (e.g. stroke, head trauma, viral infection, near-drowning). This thesis is derived from observations of open case clinical studies in over 200 patients. Where those functions controlled by the dormant brain 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 confirmed that its 2.5mg novel formulation of zolpidem is non-sedating when used on conscious, fully perceptive, ambulant patients having various debilities as a consequence of brain damage. It was performed in collaboration with ReGen’s subsidiary, Guildford Clinical Pharmacology Unit Limited and investigators at the 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 of zolpidem in reversing brain dormancy. These discussions are ongoing and involve a significant number of outside experts in this field. At the same time ReGen is continuing its scientific investigations into the way zolpidem works in this situation.
Should this trial, which is scheduled to start in 2008, be successful ReGen will look for a licensing partner. ReGen currently estimates the market for this product at $4.3 billion.
Notes to Editors:
The recently completed ReGen 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 preliminary signs of efficacy.
The study showed that a 2.5mg spray was no more sedative than a placebo, 10mg and 5mg sprays induced sedation in a dose responsive manner and 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.
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. In addition ReGen believes its intellectual position will be further bolstered by a novel formulation of zolpidem.
ReGen also reminds Editors that Metagenics Inc. launched ReGen’s lead product ColostrininTM as CogniSureTM in the USA in the nutraceutical professional channel on 1 October 2007.
For further information:
Percy Lomax
ReGen Therapeutics Plc
Tel No 020 7153 4920
Andrew Marshall
Greycoat Communications
Tel No 020 7960 6007
Mobile 07785 297111
Roland Cornish/Felicity Geidt
Beaumont Cornish Limited
Tel No 020 7628 3396