Plethora Solutions Holdings Plc Regulatory News (PLE)

30 Sep 2008 07:00



Embargoed Release: 07:00hrs Tuesday 30th September 2008

PLETHORA SOLUTIONS HOLDINGS PLC

Clinical Update - PSD502 for Premature Ejaculation

Completion of European Phase III Trial

Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialist developer of products for the treatment and management of urological disorders, is pleased to announce the completion this week of the European Phase III study of PSD502 for the treatment of premature ejaculation in Europe. The study was initiated in December 2007 and results from the blinded study are expected in the final quarter of 2008.

In recently published results from a Phase II study, PSD502 was shown to increase ejaculation latency time significantly when compared with placebo (Dinsmore W et al BJU Int 2007; 99: 369-35).

Study details:

There are two pivotal Phase III studies running in parallel, one in North America and one in Europe. Each is a multi-centre, randomised, double blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. 275 patients will have completed the blinded phase of the study across 32 investigational centres in 4 countries across Europe. Of these, 265 patients have entered an optional 5 month open label study.

Recruitment in the equivalent study in the US is ongoing and data from the two studies will be combined for submission for regulatory approval in the US and Europe in the first half of 2009.

In May 2007, Plethora signed an exclusive license agreement with Sciele Pharma, Inc to market PSD502 for premature ejaculation in the USA.

Dr Mike Wyllie, CSO of Plethora, commented:

"We are delighted to have completed this arm of the Phase III study. The willingness of patients to enter the open-label study is most encouraging, as is the low drop out rate throughout the trial. The speed at which recruitment was completed, given the stringent entry criteria, confirms both the number of PE patients in the general population and their willingness to seek treatment."

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About Plethora:

Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company has products in clinical development for the treatment of overactive bladder, stress urinary incontinence, interstitial cystitis, gynaecological pain, erectile dysfunction and premature ejaculation. Plethora has a US subsidiary, Timm Medical Technologies Inc, which markets products for the treatment of erectile dysfunction (ED) to urology clinics through a national US specialty sales team. The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM:PLE). Further information is available at www.plethorasolutions.co.uk.