Plethora Solutions Holdings Plc Regulatory News (PLE)

6 Dec 2007 07:00

Plethora Solutions Holdings PLC06 December 2007 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update - PSD508 for dysmenorrhoea Phase IIb trial initiated, first patients recruited Plethora Solutions Holdings PLC ("Plethora", AIM: PLE), the specialist developerof products for the treatment and management of urological disorders, is pleasedto announce that the first patients have been recruited into a Phase IIb studyin dysmenorrhoea (period/menstrual pain). PSD508 is a well characterised non-steroidal anti-inflammatory (NSAID) which isadministered intra-vaginally utilising proprietary technology which Plethoralicensed from Metris Therapeutics Limited in 2006. This novel approach has thepotential benefit of allowing women to access a convenient "on-demand" treatmentcontaining an NSAID whilst minimising systemic exposure to the drug. It shouldallow higher doses of drug than might otherwise have been delivered orally; thusproviding rapid, local pain relief and minimal systemic and compliance-limitinggastro-intestinal side effects, which would otherwise be associated withexposure to orally administered NSAIDs. Dysmenorrhoea is a painful, often incapacitating, menstrual cramp which afflictsaround 50% of women of reproductive age and is one of the leading causes ofabsenteeism from work and school. Standard treatments include orallyadministered non-steroidal anti-inflammatory drugs, pain-killers and hormonetherapy to bring about symptomatic relief. Study details The study is a double-blind, placebo-controlled, multiple-dose, crossover proofof concept study which compares the efficacy of vaginally delivered PSD508 tothat of oral NSAID and placebo in relieving menstrual-related pain. This studywill take place across three consecutive menstrual cycles, allowing the trial totake place in the shortest possible time frame. The study will also evaluate thesafety and tolerability of PSD508. Up to 90 women will be recruited in Europe.Regulatory approval for this study has been achieved and the first patientsrecruited. Dr Steven Powell, CEO of Plethora, commented: "Plethora has reported significant progress this quarter. The initiation of thisstudy is a major step in the development of PSD508 and enables us to progressdiscussion with potential partners. In addition, this meets our commitment toinitiate clinical studies with this novel delivery system by end of 2007." -Ends- For further information contact: Plethora Solutions Tel : 020 7269 8630Steven Powell City/Financial Enquiries Tel: 020 7379 5151MaitlandBrian Hudspith/Liz Morley Scientific/Trade Press Enquiries Tel: 020 7861 3838De Facto CommunicationsRichard Anderson About Plethora: Plethora is focused on the development and marketing of products for thetreatment of urological disorders. The Company has products in clinicaldevelopment for the treatment of overactive bladder, stress urinaryincontinence, interstitial cystitis, gynaecological pain, erectile dysfunctionand premature ejaculation. Plethora has a US subsidiary, Timm MedicalTechnologies Inc, which markets products for the treatment of erectiledysfunction (ED) to urology clinics through a national US specialty sales team.The Company is headquartered in the UK and is listed on the London StockExchange (AIM:LSE). Further information is available atwww.plethorasolutions.co.uk. This information is provided by RNS The company news service from the London Stock Exchange