PSD502 Clinical Trial Data

1 Dec 2005 07:00

Plethora Solutions Holdings PLC01 December 2005 For immediate release 1 December 2005 PLETHORA SOLUTIONS HOLDINGS PLC Positive Phase II Clinical Study of PSD502 for the treatment of PE • Statistically significant increase in ejaculation latency time • Well tolerated and devoid of side effects Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM : PLE), acompany focused on the development of products for the treatment of urologicaldisorders, is pleased to announce a positive outcome for the Phase II clinicalstudy of PSD502 for the treatment of premature ejaculation ("PE"). Thepotential market for PE drugs has been estimated by major pharmaceuticalcompanies to be $5 billion per annum with no clinically approved product beingavailable for the treatment of this condition. Plethora has conducted a "gold standard", double-blind, placebo-controlled trialin eight centres across Europe and evaluated the effect of the product onejaculation latency time and subject/partner satisfaction following theapplication of PSD502 prior to sexual intercourse. Initial analysis shows that PSD502 produced a statistically significant increasefrom baseline in the primary study endpoint of intravaginal ejaculatory latencytime (IELT) of 3.7 minutes whereas placebo increased latency by 0.9 minutes (p