Plethora Solutions Holdings Plc Regulatory News (PLE)

24 Apr 2008 07:00

Plethora Solutions Holdings PLC24 April 2008 Embargoed Release: 07:00hrs Thursday 24 April 2008 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update - PSD508 for Dysmenorrhoea Completion of Recruitment in Phase IIb trial Plethora Solutions Holdings plc ("Plethora", AIM: PLE), the specialist developerof products for the treatment and management of urological disorders, is pleasedto announce the completion of patient recruitment into a Phase IIb study indysmenorrhoea, which is a painful and often incapacitating menstrual cramp whichafflicts over 50% of women of reproductive age and is one of the leading causesof absenteeism from work and school. Standard treatments include orallyadministered non-steroidal anti-inflammatory (NSAID) drugs, pain-killers andhormone therapy to bring about symptomatic relief. PSD508 is a proprietary delivery form of a well characterised NSAID, which isadministered intra-vaginally utilising technology which Plethora licensed fromMetris Therapeutics Limited in 2006. This novel approach has the potentialbenefit of allowing women to access a convenient "on-demand" treatmentcontaining an NSAID while minimising systemic exposure to the drug and therebylowering the risk of side effects which limit the usefulness of existingtherapies. Although the technology is being evaluated in dysmenorrhoea, it mayhave much wider utility in the treatment of uro-gynaecological disorders wherethere is little or no effective therapy, e.g. endometriosis and dyspareunia. Study details The study was designed to confirm an earlier proof of concept study. It is a 'gold standard' double-blind, placebo-controlled, multiple-dose crossover studycomparing the efficacy of intra-vaginally delivered PSD508 to that of oral NSAIDand placebo in relieving menstrual-associated pain. This study is taking placeacross three consecutive menstrual cycles, allowing the trial to be completed inthe shortest possible time frame. The study will also add to the extensiveexisting clinical data on the safety and tolerability of PSD508. A total of 159patients have been enrolled into the study at 3 centres in the UK. Dr. Mike Wyllie, CSO of Plethora, commented: "This study was initiated in December 2007 and the ease with which we haverecruited and enrolled patients is indicative of the large patient populationwhich is poorly served by existing treatment options and it is also a measure ofthe acceptability of this product as a patient-friendly drug delivery platform.The conclusion of this study, when the outcome is reported in full later thisyear, will also end our period of significant investment in Phase II studies inour women's health portfolio. These include PSD503 for the treatment of stressurinary incontinence, PSD506 for overactive bladder and PSD597 for the treatmentof interstitial cystitis; all of which are now the subject of early stagelicensing discussions." For further information contact: Plethora Solutions Tel : 020 3077 5406Steven Powell Hansard Group Tel: 020 7245 1100Adam Reynolds/John Bick 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