Plethora Solutions Holdings Plc Regulatory News (PLE)

29 Nov 2007 07:01

Plethora Solutions Holdings PLC29 November 2007 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update Positive Phase II clinical data for PSD503 in the treatment of stress urinaryincontinence • 44% improvement in primary efficacy endpoint of pad weight vs placebo• Drug safe and well tolerated with no evidence of blood pressure elevation Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disorders,is pleased to announce that preliminary analysis of Phase II data has confirmeda positive clinical effect and safety of PSD503 as a front-line therapy forstress urinary incontinence (SUI). 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 over half of all femaleincontinence sufferers and is the most frequently reported type of incontinencein women under 50. This equates to a potential treatment population of 23million women in North America, France, Germany, Italy, Spain and the UK whosuffer from mild to moderate SUI. The condition can have a significant negativeimpact on quality of life and there is, as yet, no drug with global approval forthe treatment of the condition. PSD503 is a metered dose, topical gel formulation of phenylephrine, which is amember of a class of drugs called alpha-adrenergic agonists which have a longhistory of clinical use as both systemic and topical agents for appetitesuppression and nasal decongestants. There has also been previously reportedevidence that alpha agonists can reduce the symptoms of SUI. However, they havealso been associated with side effects including agitation, tremor, respiratorydifficulty and particularly hypertension and cardiac arrhythmias that wouldpreclude their use as oral agents for the long term treatment of SUI. PSD503 hasbeen developed specifically as a locally administered formulation of an alphaagonist which would achieve target organ selectivity and provide effectivesymptom improvement in the absence of obtrusive side effects. This preliminary analysis, in 12 patients, of the double-blind, crossoverplacebo controlled study shows that PSD503 produced a 44% overall reduction inleakage (as measured from pad weight), whereas placebo was largely withouteffect (11% increase in pad weight). Improvement with PSD503, beyond that ofplacebo, was reported in 50% of the women with stress incontinence whichrepresents a good responder rate for a urological condition such as incontinenceor benign prostatic hyperplasia (BPH). In addition, the cardiovascular sideeffect profiles of placebo and PSD503 are indistinguishable, with no evidence ofblood pressure elevation in any subject. Consistent with this finding, only verylow systemic plasma concentrations of phenylephrine are found. These data are consistent with an earlier Plethora open label study conducted at the Institute of Urology in London, which demonstrated that, at this dose, PSD503 can have an effect on urethral resistance and overall urodynamic parameters. The purpose of this Phase II study was to further quantify the magnitude of the improvement achieved with PSD503 and these results add support to the commercial potential of this development product. Dr Steven Powell, CEO of Plethora, commented: "These data further confirm the potential for PSD503 to meet a poorly metmedical need in the treatment of stress urinary incontinence. They also addsubstantially to the package of data required for successful out-licensing.Potential licensing partners have expressed an interest in this programmealready and, with this data, we look forward to advancing these discussions. "After the successes in Phase II with PSD502 and PSD597, these results forPSD503 further validate the Plethora model in which marketed products arereformulated in a novel way to minimise systemic exposure and fast-tracked intonew therapeutic areas." -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 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