Plethora Solutions Holdings Plc Regulatory News (PLE)

8 Dec 2008 07:00



Embargoed Release: Monday 8 December 2008

Plethora Solutions Holdings plc

("Plethora" or "the Company")

Clinical Update: Final analysis - PSD502 for Premature Ejaculation

All Primary and Secondary Endpoints Met in Phase III Pivotal Trial

Both Patient and Partner Satisfaction Increased Significantly

86% of Patients Rated the Treatment as Positive

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 the final analysis of its European Phase III double-blind placebo controlled study of PSD502 for the treatment of premature ejaculation (PE). PSD502 has met not only its three co-primary endpoints of Intra-vaginal Ejaculation Latency Time ('IELT') and Index of Premature Ejaculation ('IPE'; Ejaculatory Control and Sexual Satisfaction domains) but also all secondary endpoints.

The successful European study is one of two pivotal Phase III studies conducted in parallel with identical protocols. The second Phase III study is expected to complete in the first half of 2009. Data from the two studies will be combined for submission for regulatory approval in the USA and Europe.

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, 268 patients have now been entered into the optional 9 month open label study.

European Phase III Study Outcome:

Final analyses confirmed not only that PSD502 produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints but also in all secondary endpoints. The intravaginal ejaculation latency time (IELT) for PSD502 was 4 minutes compared to 1 (one) minute in placebo (p There was a 7 point difference between PSD502 and placebo in Ejaculatory Control (p difference between PSD502 and placebo in Sexual Satisfaction (pin a 16 point range is considered clinically significant. There was a 3 point difference between PSD502 and placebo in the IPE domain for distress (p.

91% of patients who received PSD502 achieved an IELT of greater than 1 minute and 75% achieved an IELT of >2 minutes following treatment. This compared to only 54% and 22% of placebo patients, respectively. Both endpoints were highly clinically and statistically significant (p.

There was a highly statistically significant (p improvement in scores for all four secondary endpoints; that is Control, Distress, Satisfaction and Interpersonal Difficulty in the PSD502 group, compared to placebo. Importantly, both patients and partners benefited from the treatment.

The number of patients in the PSD502 group who rated the quality of their orgasm as good or very good increased from 20% at baseline to 62% after treatment. In comparison, the number of placebo-treated patients with this rating decreased from 21% to 19%.

The study treatment was rated positively by 86% of patients who received PSD502 compared to 34% of placebo patients.

The Principal Investigator in the study, Prof Wallace Dinsmore, Royal Victoria Hospital, Belfast commented: 

"These results are as impressive as those observed with the phosphodiesterase inhibitors (PDEi) in erectile dysfunction at an equivalent stage of development. The positive impact of PSD502 on both patients and their partners could save many relationships".

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. Of these adverse events, only one patient who received PSD502 (0.5%) reported temporary numbness of the penis which was described as mild. 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 reported to affect between 25% and 30% of men in Europe and the USA. There are currently no approved pharmaceutical treatments for premature ejaculation.

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:

"These new data confirm and extend our initial highly encouraging analyses. We now await the final results from the US study in the first half of 2009. These highly significant results have expedited our licensing discussions for territories 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 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.