Clinical Update PSD597 for IC

25 Jun 2007 07:01

Plethora Solutions Holdings PLC25 June 2007 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update - PSD597 for interstitial cystitis Completion of Recruitment in PSD597 Clinical Study Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disordersis pleased to announce the completion of patient recruitment into its Phase IIclinical study of PSD597 for the treatment of interstitial cystitis (IC). Thestudy is a double-blind placebo controlled study with patients recruited fromover 20 centres in the USA and Canada. The objective of the study is to confirmboth immediate and sustained relief of the symptoms of interstitial cystitis.The outcome of the trial will be known later in 2007. Plethora has previously reported encouraging clinical pilot data from twostudies in both volunteers and IC sufferers which demonstrated that PSD597immediately and effectively reduced the pain of interstitial cystitis. Thiseffect was maintained for a considerable period of time thereafter in theabsence of obtrusive side effects. PSD597 is a proprietary formulation of a marketed analgesic product which isapplied into the bladder using a technique suitable for both out-patient clinicsand home administration. The proprietary formulation affords new patentprotection and the product is covered by an extensive existing long-term safetypackage that provides a potential fast track to market. Interstitial cystitis (IC) is a chronic, debilitating condition characterised bybladder and pelvic pain and increased urinary frequency and urgency which has amajor impact on patient quality of life. IC is consistently associated withchronic pelvic pain (CPP). A UK study of almost 25,000 women found theprevalence of CPP to be 38%, which is comparable to the reported prevalence ofmigraine (37%) and back pain (41%). Current treatments for IC and CPP arelimited in their effectiveness. A second PSD597 trial to explore the potential benefits of the product providingpain relief during the many hundreds of thousands of minor urological surgicalprocedures performed every year is also nearing full enrolment and will alsoreport later in 2007. Dr Steven Powell, CEO of Plethora commented: "Interstitial Cystitis is an area where there are limited effective treatmentoptions despite the large number of patients who are affected by the diseaseeither on a regular or sporadic basis. We believe that PSD597 has potential toaddress a clear medical need and represents a significant market opportunity. Welook forward to updating shareholders on the progress of this exciting newproduct later this year." -Ends- For further information contact: Plethora Solutions Tel : 020 7269 8630Steven Powell City/Financial Enquiries Tel: 020 7379 5151MaitlandBrian Hudspith/Liz Morley Scientific/Trade Press Enquiries Tel: 020 7861 3838DeFacto 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. In January 2006, Plethora acquired Minneapolis (Mn)based Timm Medical Technologies Inc which markets products for the treatment oferectile dysfunction (ED) to urology clinics through a US-based specialty salesteam. The Company is headquartered in the UK and is listed on the London StockExchange (AIM:PLE) Further information is available atwww.plethorasolutions.co.uk This information is provided by RNS The company news service from the London Stock Exchange