Plethora Solutions Holdings Plc Regulatory News (PLE)

5 Feb 2008 07:00

Plethora Solutions Holdings PLC05 February 2008 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update Positive clinical data from PSD506 incontinence study. • Indication of clinical efficacy at doses equal to or greater than 20mg • Drug well tolerated with no evidence of dry mouth Plethora Solutions Holdings PLC ("Plethora", AIM: PLE), the specialist developerof products for the treatment and management of urological disorders, is pleasedto announce preliminary analysis of results from patients with unstable bladdercontractions. This dose escalation study has shown that PSD506, a potentialnovel drug treatment for overactive bladder or urge urinary incontinence (UUI),is effective at doses equal to or greater than 20mg. PSD506 is a novel M2/M3 muscarinic receptor subtype-selective antagonist for thetreatment of UUI in women and potentially UUI and Lower Urinary Tract Symptoms(LUTS) in men. PSD506 represents the first of a new generation of thisantimuscarinic drug class. PSD506 works by selective and potent antagonism oftwo receptors important for mediating over-excitability of the human bladder, M2and M3 muscarinic cholinoceptors. PSD506 has the potential to improve theinhibition of hyperactivity in urological tissues, while sparing commonantimuscarinic side-effects of dry mouth, gastrointestinal disturbance anddizziness/ confusion, which are observed with current therapies in the class.Plethora licensed exclusive rights to PSD506 from F. Hoffmann-La Roche Ltd. Antimuscarinic drugs are the mainstay of the management of UUI. Although membersof this drug class can be highly effective, they are poorly tolerated due to thecompliance-limiting side effect of dry mouth, which in some cases can result inpatients not being able to speak nor swallow. PSD506 is a member of this classbut has a different pharmacological profile from established agents and waspredicted to offer an improved clinical profile. Prior to this study, PSD506 wasknown to be well tolerated. These new data demonstrate for the first time thatthe drug is well tolerated at doses that will produce clinical benefit. Theclinical benefit is being explored in additional studies. This dose escalation study has been completed measuring the impact of PSD506 onunstable bladder contractions in patients. In the study conducted by ProfessorMike Craggs within the Nephro Urology Clinical Trials Unit (NUCT) in London, thedrug has been found to be effective at doses greater than or equal to 20mg.Consistent with previous studies the drug was well tolerated and in particularthere was no dry mouth. Dr Mike Wyllie, Plethora CSO commented "PSD506 occupies a unique position in thePlethora portfolio as it is our only novel chemical entity (NCE). This study,providing evidence of efficacy for the first time, justifies our commitment toour ongoing activities in both UUI and LUTS. The fact that little dry mouth hasbeen seen in close to 200 volunteers and patients provides evidence of a majorpoint of clinical differentiation over marketed antimuscarinic agents". UUI is characterised by an unpredictable, frequent and sudden need to urinate,which may or may not result in the leaking or gushing of urine. It is estimatedthat approximately 7 million women in North America, France, Germany, Italy,Spain and the United Kingdom experience moderate to severe UUI and a further 10million suffer from moderate to severe mixed incontinence. In addition it isestimated that more than 45 million men (40-79 yrs) will experience moderate tosevere LUTS in North America and Western Europe. There is a significant unmetneed for effective well tolerated treatments for these conditions. NUCT Medical Director, Dr Brian Leaker, stated "As would be expected in thistype of study, the effects of PSD506 were dose related, with the threshold forefficacy being 20 mg and a full clinical effect being apparent at 40mg.Consistent with the earlier clinical work, all doses were well tolerated and inparticular there was no evidence of dry mouth. This coupled with good efficacycould be a key point of differentiation." -Ends- For further information contact: Plethora Solutions Tel: 020 3077 5400Steven Powell City/Financial Enquiries Tel: 020 7379 5151MaitlandBrian Hudspith/Liz Morley Scientific/Trade Press Enquiries Tel: 020 7861 3838De Facto CommunicationsRichard Anderson About Plethora: Plethora is focused on the development and marketing of products for thetreatment of urological disorders. The Company has products in clinicaldevelopment for the treatment of overactive bladder, stress urinaryincontinence, interstitial cystitis, gynaecological pain, erectile dysfunctionand premature ejaculation. Plethora has a US subsidiary, Timm MedicalTechnologies Inc, which markets products for the treatment of erectiledysfunction (ED) to urology clinics through a national US specialty sales team.The Company is headquartered in the UK and is listed on the London StockExchange (AIM:LSE). Further information is available atwww.plethorasolutions.co.uk. This information is provided by RNS The company news service from the London Stock Exchange