Plethora Solutions Holdings Plc Regulatory News (PLE)

12 Sep 2005 07:00

Plethora Solutions Holdings PLC12 September 2005 For immediate release 12 September 2005 PLETHORA SOLUTIONS HOLDINGS PLC Completion of Recruitment on PSD502 Phase II Clinical Study Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM : PLE) ispleased to announce the completion of patient enrolment for the Phase IIclinical study of PSD502, for the treatment of premature ejaculation (PE). Thestudy is a "gold standard" double-blind, placebo controlled trial conducted ineight centres in Europe and is investigating the effect of the product onejaculation latency time and subject/partner satisfaction following theapplication of PSD502 prior to sexual intercourse. The outcome of the trial willbe known later in the year. This Phase II trial follows on from a preliminary, open-label clinical studyconducted by investigators in Canada. In this study, reported in theInternational Journal of Impotence Research, all evaluable subjects showed anincrease in ejaculation latency time after treatment with PSD502 together withan improvement in patient and partner satisfaction. Recent research by major pharmaceutical companies has indicated that thepotential market for PE drugs is $5 billion per annum with no clinicallyapproved product available. PSD502 consists of a proprietary formulation of two marketed drugs, lidocaineand prilocaine, dispensed by a metered dose aerosol. The treatment is absorbedby the mucosal membrane-like skin of the glans-penis within five minutes, but isnot absorbed by the keratinised skin of the penis shaft, thus helping tomaintain normal penile sensation. The product has the potential advantage overoral drugs taken every day as is it applied locally when needed (often referredto as "on demand" therapy). Other key advantages of the product are a low riskof safety issues, minimal partner transfer eliminating the need to use a condomand the potential for the dose to be self titrated or adjusted under physiciandirection. Steven Powell, CEO of Plethora, commented: "This is an important milestone in terms of the development of PSD502 and forthe Company. It is estimated that more than 25% of men suffer from prematureejaculation, a higher incidence than erectile dysfunction (ED). This can be adevastating condition for men and their partners and there is currently noclinically approved treatment. With patient enrolment completed we are now accelerating discussions withpotential licensing partners for this product. We look forward to updating ourshareholders on the progress of this trial and the discussions with potentialpartners in due course. " 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 a UK-based speciality pharmaceutical company focused on thedevelopment of products for the treatment of urological disease. The company hasproducts in clinical development for the treatment of overactive bladder, benignprostatic hyperplasia, stress urinary incontinence and premature ejaculation.The company is headquartered in the UK and recently listed on the London StockExchange (AIM:PLE) This information is provided by RNS The company news service from the London Stock Exchange