FDA Accept Phase II ( PSD597)

2 Mar 2006 07:00

Plethora Solutions Holdings PLC02 March 2006 For Immediate Release 2 March 2006 PLETHORA SOLUTIONS HOLDINGS PLC FDA Acceptance for Phase II Clinical Trial with PSD597 Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM : PLE) ispleased to announce that its Investigational New Drug Application (IND) has beenaccepted by the U.S. Food and Drug Administration (FDA), for the initiation of aPhase II development programme for PSD597 in interstitial cystitis (IC). As with Plethora's programmes in premature ejaculation (PE) and stressincontinence (SUI), the Phase II study is supported by encouraging positiveclinical pilot data from two studies in volunteers and IC sufferers. PSD597 willnow enter a double-blind placebo controlled study with patients recruited fromover 20 centres in the USA and Canada. The study will be initiated andrecruitment completed in 2006. PSD597 is a proprietary formulation of a marketed analgesic product and will beapplied into the bladder using a technique which will be suitable for bothout-patient clinics and home administration. The novel formulation affords newpatent protection and as the product is covered by an extensive long-term safetypackage affords a potentially fast track to market. Interstitial cystitis (IC) is a chronic syndrome characterised by bladder andpelvic pain and increased urinary frequency and urgency. The dominant symptom ofIC is chronic 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. Plethora believes that a treatment offeringsymptomatic relief of IC/CPP addresses a clear medical need and represents asignificant market opportunity. PSD597 is based on intellectual propertydeveloped by Dr Richard Henry of Queen's University in Kingston, Ontario,Canada. Dr Steven Powell, CEO of Plethora commented: "We acquired rights to PSD597 in September 2005 and we are delighted to receiveregulatory clearance so quickly enabling us to begin the next stage of clinicaldevelopment in collaboration with a number of leading centres in the USA andCanada. We look forward to updating shareholders on the progress of thisexciting new product later this year." For further information contact: Plethora Solutions Tel : 0207 269 8630Steven Powell Collins Stewart Tel : 0207 523 8350Tim Mickley Buchanan Communications Tel : 0207 466 5000Tim Anderson, Isabel Podda About Plethora: Plethora is focused on the development of products for the treatment ofurological disease. The Company has products in clinical development for thetreatment of overactive bladder, benign prostatic hyperplasia, stress urinaryincontinence, interstitial cystitis and premature ejaculation. In January 2006,Plethora acquired Minneapolis (MN) based Timm Medical Technologies Inc whichmarkets products for the treatment of erectile dysfunction (ED) to urologyclinics through a US-based speciality sales team. The Company is headquarteredin the UK and is listed on the London Stock Exchange (AIM:PLE) Furtherinformation is available at www.plethorasolutions.co.uk This information is provided by RNS The company news service from the London Stock Exchange