Plethora Solutions Holdings Plc Regulatory News (PLE)

20 Oct 2005 07:00

Plethora Solutions Holdings PLC20 October 2005 For immediate release 20th October 2005 PLETHORA SOLUTIONS HOLDINGS PLC Initiation of PSD503 Phase II Clinical Study Plethora Solutions Holdings plc ("Plethora" or the "Company", AIM : PLE) ispleased to announce that it has received regulatory clearance to proceed withthe Phase II clinical study of PSD503, a treatment for stress urinaryincontinence (SUI). PSD503 is a metered dose, topical gel formulation of the widely-used a-adrenoceptor agonist, phenylephrine. This drug has a long history of clinicaluse as both a systemic and topical agent. The study is a double-blind, placebo controlled, three-way cross over studydesigned to evaluate the safety and efficacy of the product. The study will beconducted in two centres in the UK; King's College Hospital in London and theBristol Urological Institute (BUI). Up to 40 subjects will be recruited into thestudy and the trial is expected to complete in the second half of next year. PSD503 has already completed a double-blind, placebo-controlled, two-waycrossover pilot study, in which 12 women with mild to moderate SUI were treatedwith the product. The study confirmed safety and tolerability with respect tocardiovascular parameters (as changes in mean arterial pressure), effect onintraurethral pressure and absence of local irritation on application to theperi-urethral mucosa. SUI is the most common form of urinary incontinence in women. It ischaracterised by urine leakage when pressure is increased in the abdominalcavity during coughing, sneezing, laughing, exercising or even sitting.Epidemiological studies indicate that SUI afflicts half of all femaleincontinence sufferers, (but only 10% of incontinent men), and is the mostfrequently reported type of incontinence diagnosed in women under 50. Thecondition can have a significant negative impact on quality of life and thereis, as yet, no drug with global approval for the treatment of the condition. Commenting on the study, Professor Linda Cardozo of King's College Hospital said"stress urinary incontinence is a very distressing condition for women for whichsurgery is usually the final solution. However, this is not suitable or evendesired by all women and therefore PSD503 could prove to be a useful additionaltreatment for women desiring conservative therapy"." Professor Paul Abrams of the BUI added "Potentially PSD503 could form the basisfor effective management of stress incontinence, a condition where there isrelatively little effective drug therapy available" Steven Powell, CEO of Plethora, commented: "This is the second of our product programmes to move into Phase IIdevelopment. SUI represents a significant commercial opportunity anddemonstrates the continuing maturation of the Plethora pipeline. We look forwardto updating shareholders on the progress of this trial 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 obstructions, stress urinary incontinence and premature ejaculation.The company is headquartered in London, UK and is listed on the London StockExchange's Alternative Investment Market (AIM:PLE). This information is provided by RNS The company news service from the London Stock Exchange