7 Nov 2008 07:00
| For Immediate Release | 7th November 2008 |
PLETHORA SOLUTIONS HOLDINGS PLC
Clinical Update - PSD502 for Premature Ejaculation
Positive Outcomes from European Phase III Pivotal Trial
Statistically and Clinically Significant Increase in
All Three Co-primary Endpoints
Well Tolerated and Devoid of Systemic Side Effects
Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM: PLE), the specialist developer of products for the treatment and management of urological disorders, announces that its European Phase III double-blind placebo controlled study of PSD502 for the treatment of premature ejaculation (PE) has met its three co-primary endpoints of Intra-vaginal Ejaculation Latency Time ('IELT') and Index of Premature Ejaculation ('IPE'; Ejaculatory Control and Sexual Satisfaction domains).
The successful European study is one of two pivotal Phase III studies running in parallel with identical protocols. The second Phase III study is being conducted in North America and is expected to complete in the first half of 2009. Once the results from the US Phase III study become available, data from the two studies will be combined for submission for regulatory approval in the USA and Europe.
European and US Phase III Study Details:
Each Phase III study is a multi-centre, randomised, double blind, placebo-controlled efficacy study and the programme is expected to recruit a total of 540 patients across the two studies. Patients are treated for a 12 week period with an optional open label phase of up to 9 months.
The European study was conducted with 300 randomised patients across 32 investigational centres in 4 countries across Europe. Of these, 265 patients also entered the optional 9 month open label study.
European Phase III Study Outcome:
Initial analyses show that PSD502 produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints. The intravaginal ejaculation latency time (IELT) geometric mean for PSD502 was 4 minutes compared to 1 (one) minute in placebo (p There was a 7 point difference between PSD502 and placebo in the IPE domain for Ejaculatory Control (p difference between PSD502 and placebo in the IPE domain for Sexual Satisfaction (pin a 16 point range is considered clinically significant.
There were no serious adverse events and only 2.6% of patients reported treatment-related adverse events in the PSD502 group compared with 1% in the placebo. PSD502 was well tolerated and there were no systemic adverse events.
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 between 25% and 30% of men in Europe and the USA. There are currently no approved pharmaceutical 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.
In May 2007, Plethora signed an exclusive license agreement with Sciele Pharma, Inc to market PSD502 for premature ejaculation in the USA while retaining the option to co-promote the product to the US urologist market. Licensing discussions are ongoing with a number of potential partners for PSD502 outside of the USA.
Dr Mike Wyllie, CSO of Plethora, said:
"We are clearly delighted with these highly significant results from the European Phase III clinical study and now await the final results from the US study in the first half of 2009. We already have a partner for the US market and will now move ahead with our discussions with prospective partners across other territories."
-Ends-
For further information contact:
| Plethora Solutions Steven Powell | Tel : 020 3077 5400 |
| FinnCap Geoff Nash | Tel: 020 7600 1658 |
| Hansard Group Adam Reynolds/John Bick | Tel: 020 7245 1100 |
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 US national sales operation. 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.