Plethora Solutions Holdings Plc Regulatory News (PLE)

18 Feb 2009 09:24



PLETHORA SOLUTIONS HOLDINGS PLC

Clinical Update - PSD502 for Premature Ejaculation

Completion of Recruitment for Global Phase III programme 

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 of recruitment into the final part of the PSD502 registration programme for the treatment of premature ejaculation. The results from this North American study are expected mid-year 2009. A parallel European Phase III study concluded successfully in November 2008 with an outcome that was both clinically and statistically highly significant. 

Two pivotal studies have now been conducted 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. The conclusion of the North American programme represents the culmination of the global phase III programme for PSD502.

North American Study Details:

Recruitment to the final arm of the global Phase III programme has now closed. All patients have entered a 4 week screening and baseline period, with at least 240 patients expected to be randomised shortly to a 12 week double-blind treatment period followed by an optional open-label phase. The primary endpoints, as in the European study, are Intra-vaginal Ejaculation Latency Time (IELT), sexual satisfaction and ejaculatory control. Secondary endpoints include Sexual Quality of Life and partner satisfaction.

European Phase III Study Outcome:

Data from the European Phase III reported in November 2008 showed that PSD502 produced large and both clinically and statistically highly significant increases from baseline in all three co-primary study endpoints and secondary endpoints. There were no serious adverse events, the drug was well tolerated and there were no systemic adverse events.

Dr Mike Wyllie, CSO of Plethora, commented:

"This represents a major milestone in the clinical development programme of PSD502 and we expect to report on the outcome later in the year. At that time, filings for global product registration are expected to be completed."

About PSD502:

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. There are currently no approved pharmaceutical treatments for premature ejaculation in the USA.

In May 2007, Plethora signed an exclusive license agreement with Sciele Pharma, Inc to market PSD502 for premature ejaculation in the USA which was amended in February 2009 subject to a satisfactory outcome of a FDA meeting scheduled for March 2009. Licensing discussions are ongoing with a number of potential partners for PSD502 outside of the USA.

-Ends-

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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:LSE). Further information is available at www.plethorasolutions.co.uk.