Plethora Solutions Holdings Plc Regulatory News (PLE)

19 Jun 2008 07:00



PLETHORA SOLUTIONS HOLDINGS PLC

Clinical Update - PSD502 for Premature Ejaculation

Completion of Recruitment for 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 of recruitment into the European arm of a Phase III study of PSD502 for the treatment of premature ejaculation in Europe. The study was initiated in December 2007 and results are expected before the end of 2008.

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 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 the requirement to use a condom. 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: 369-375).

Study details:

There are two pivotal 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. In the European arm, 333 patients have been recruited by 32 investigational centres in 4 countries across Europe. Patients are being treated for a 12 week period with an optional 5 month open label phase. The primary endpoints will be Intra-vaginal Ejaculation Latency Time (IVELT), sexual satisfaction and ejaculatory control. Secondary endpoints will include Sexual Quality of Life and Partner Satisfaction. 

Dr Mike Wyllie, CSO of Plethora, commented:

"We are delighted to have completed recruitment into this key Phase III study on time and within budget. The ease of recruitment into the study is once again indicative of the large available patient population and the support which exists for this product amongst urologists and primary care physicians across Europe. We expect to report in full on the outcome of this study towards the end of the year."

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