Plethora Solutions Holdings Plc Regulatory News (PLE)

19 Dec 2007 07:01

Plethora Solutions Holdings PLC19 December 2007 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update - PSD502 for Premature Ejaculation PSD502 - European Phase III underway Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disorders,is pleased to announce it has now received regulatory approval to start a phaseIII study of PSD502 for the treatment of premature ejaculation in Europe. Thisfollows its recent announcement of the initiation of the phase III programme forPSD502 in the USA (30.10.2007). PSD502 is a proprietary formulation of two marketed drugs, lidocaine andprilocaine, dispensed by a metered dose aerosol developed for the treatment ofpremature ejaculation, a disorder affecting up to 30% of men in Europe and theUSA. There are currently no approved treatments for premature ejaculation.PSD502 is applied locally "on demand" and is effective within five minutes.PSD502 has a good safety profile with minimal partner transfer, eliminating therequirement to use a condom. In recently published results from a Phase IIstudy, PSD502 was shown to increase ejaculation latency time significantly whencompared with placebo (Dinsmore, W et al BJU Int 2007; 99: 369-35). In May 2007 Plethora licensed PSD502 to Sciele Pharma, Inc. for the prematureejaculation indication in the US while retaining co-promotion rights to the USurologist market. Study details: There are two pivotal studies running in parallel, one in North America and onein 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. TheEuropean study is expected to recruit 270 patients across 36 centres. Dr Steven Powell, CEO of Plethora, commented: "We are pleased to be starting phase III recruitment in Europe. This will helptowards meeting our goal of completing the study before the end of 2008." -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