Plethora Solutions Holdings Plc Regulatory News (PLE)

30 Oct 2007 07:01

Plethora Solutions Holdings PLC30 October 2007 Clinical Update - PSD502 for Premature Ejaculation PSD502 advances into final stage of development Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disorders,has initiated the Phase III programme for PSD502 in the USA for the treatment ofpremature ejaculation, marking the final stage of the clinical development forthis product. PSD502 is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the USA and for which there is no approved treatment. The product is applied locallywhen needed (often referred to as "on demand" therapy) and is effective within five minutes. Other key advantages of the product are a good safety profile, minimal partner transfer, eliminating the need to use a condom for protection from the product and the potential for the dose to be self-titrated or adjusted under physician direction. The product was shown to increase ejaculation latency time substantially when compared with placebo in a multi-centre Phase IIstudy. This data has been published recently in BJU International (Dinsmore W etal 2007, BJU Int 99: 369-35). In May 2007 Plethora licensed PSD502 to Sciele Pharma, Inc. for the premature ejaculation indication in the US while retaining co-promotion rights to the US #urologist market. Study Details: The company intends to run the two pivotal studies in parallel, one in the USAand one in Europe. Each will be a multi-centre, randomised, double blind,placebo-controlled efficacy study recruiting a total of 540 patients across bothstudies. Patients will be treated for a 12 week period with an optional 5 monthopen label phase. The primary endpoints will be Intra-vaginal EjaculationLatency Time (IVELT), sexual satisfaction and ejaculatory control. Secondaryendpoints will include Sexual Quality of Life and partner satisfaction. Thestudy design and powering, agreed with both US and EU regulatory authorities,will employ validated patient reported outcomes (PROs). The two studies willrecruit patients in 36 centres in Europe and 38 in the USA and Canada, includingalmost all North American opinion leaders. It has also been agreed with theregulators that 1-year open label extensions to the studies are not required andthis will reduce time to study closure considerably. Steven Powell, Plethora CEO, commented: "We are pleased to be advancing PSD502 into the final stage of clinicaldevelopment for the treatment of premature ejaculation. If patient recruitmentproceeds as planned, we would expect to see headline data towards the end of2008 which will be a major milestone in the life of both this product andPlethora". Patrick Fourteau, President and CEO of Sciele Pharma commented: "We are pleased with the excellent progress Plethora has made with thedevelopment of PSD502, initiating the Phase III pivotal trials within ourpreviously announced timelines. PSD502 for premature ejaculation addresses anunmet medical need that affects a significant number of adult males in all agegroups." -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