Plethora Solutions Holdings Plc Regulatory News (PLE)

16 Dec 2005 07:00

Plethora Solutions Holdings PLC16 December 2005 For immediate release 16 December 2005 Plethora Solutions Holdings plc Final Analysis from a Positive Phase II Clinical Study of PSD502 for the treatment of Premature Ejaculation (PE) Plethora Solutions Holdings plc ("Plethora" or the "Company") is pleased toannounce final data from the Phase II studies of its treatment for prematureejaculation, PSD502. This report contains additional data, including secondary clinical endpoints,and follows the announcement of initial findings from the study made on 1December 2005 Key points of the final PSD502 data are: • Clinically and statistically significant increase in ejaculation latency time • PSD502 superior to placebo with respect to improvements in all secondary endpoints • Well tolerated and devoid of systemic side effects In addition to the previously reported highly significant differences betweenPSD502 and placebo with respect to increases in intravaginal ejaculation latencytime (IELT) (Table 1), PSD502 was also found to be superior to placebo on allsecondary endpoints measured. Over half of patients responded favourably to PSD502 with only approximately athird responding to placebo (Table 2). As would be expected from the overallresponse, a considerably greater number of patients also showed both a threeminute and four minute increase on PSD502 when compared to placebo. The changes observed in all other clinically validated endpoints were entirelyconsistent with clinically significant differences in IELT increase produced byPSD502 compared to placebo. PSD502 was superior to placebo with respect toejaculatory control and sexual quality of life for patients and their partners,(Tables 3 and 4 respectively). In addition, eighty-one percent of patients feltthat the PSD502 spray was easy to use. Using comparable endpoints to those used in large scale studies of oraltreatments for PE, it can be concluded that PSD502 has now been shownunequivocally to produce clinical benefit and to be superior to placebo. The study also showed a benign side effect profile (Table 5) as would beexpected due to the established, long term safety of the components. Dr Steven Powell, Chief Executive of Plethora, commented: "The final data from this Phase II study has demonstrated that PSD502 has greatpotential as a treatment for this common and distressing condition. The findingsfrom the study confirm not only its viability as a treatment for prematureejaculation but also the strong safety profile of PSD502. The subjectiveperceptions of benefit found in this study increase our confidence that men andtheir partners will find PSD502 to be an acceptable means of treating PE.Discussions continue with potential partners to take PSD502 through the nextstage of its clinical development and I look forward to updating shareholders onprogress." Table 1. Summary of the raw means for Intravaginal Ejaculation Latency Time(IELT) Variable Visit PSD502 Placebo Mean (s.e.) Mean (s.e.) IELT (minutes) Baseline 1.0 (0.27) 0.9 (0.15) End of study 4.9 (1.13) 1.6 (0.33) The change from baseline in IELT adjusted for centre and baseline was clinicallyand statistically significantly higher in the PSD502 treated group compared tothe placebo treated group (p 2 occasionsduring the treatment period above a predefined level Response level Treatment>2 IELT times of at PSD502 Placeboleast:2 minutes 55% 35%3 minutes 40% 13%4 minutes 25% 13% Table 3: Summary of the raw means for Index of Ejaculatory Control Variable Visit PSD502 Placebo Mean (s.e.) Mean (s.e.) Index of ejaculatory Baseline 2.6 (0.67) 2.7 (0.55)control (0-24)* End of study 9.6 (1.41) 5.6 (0.91) *Low responses reflect a poor outcome and high scores reflect a good outcome. Table 4: Summary of the Mean Change from baselines for Sexual QoL adjusted forbaseline and centre Variable Mean: PSD502 Placebo Sexual quality of Change from baseline, adjusted 7.9 5.4life (patients) for centre and baseline 95% confidence interval 2.7 to 13.1 0.5 to 10.3 Sexual quality of Change from baseline, adjusted 3.47 1.71life (partners) for centre and baseline 95% confidence interval -1.0 to 8.0 -2.4 to 5.8 Table 5: Treatment Related Adverse Events with an incidence of >5% Entered Reported any adverse events Patients * PartnersPSD502 26 3 0Placebo 28 0 0 *All local numbness mild (2 patients) and moderate (1 patient) No adverse event led to discontinuation from study For further information contact: Plethora Solutions Tel : 0207 269 8630Steven Powell Collins Stewart Tel : 0207 523 8350Tim Mickley Buchanan Communications Tel : 0207 466 5000Isabel Podda About Plethora: Plethora is a UK-based specialty pharmaceutical company focused on thedevelopment of products for the treatment of urological disease. The company hasproducts in clinical development for the treatment of overactive bladder, benignprostatic hyperplasia, stress urinary incontinence, interstitial cystitis andpremature ejaculation. The company is headquartered in the UK and recentlylisted on the London Stock Exchange (AIM:PLE). This information is provided by RNS The company news service from the London Stock Exchange