Plethora Solutions Holdings Plc Regulatory News (PLE)

6 Sep 2007 07:01

Plethora Solutions Holdings PLC06 September 2007 For Immediate Release 6th September 2007 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update PSD597 for interstitial cystitis: Positive outcome for Phase II study in an areaof significant unmet medical need •Statistically and clinically significant improvement in symptoms•Treatment effect sustained beyond dosing•Drug safe and well tolerated Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disorders,is pleased to announce a positive outcome for a Phase II clinical study ofPSD597 for the treatment of interstitial cystitis and painful bladder syndrome(IC/PBS). IC is a chronic urological disorder that predominantly afflicts young and middleaged women. The condition is characterised by bladder pain, urinary frequencyand urgency without an identifiable cause and the intensity of the conditionranges from inconvenience to all pervasive and socially debilitating. In itsmost severe form, quality of life with IC can be worse than end stage renaldisease(1). In a 2006 report(2), IC prevalence was reported as a global patientpopulation of 16 million with 6.4 million patients in the US alone. Currenttreatments for IC/PBS are limited in their effectiveness in reducing pain andtypically have a short duration of effect. The Plethora study was a double-blind placebo controlled study with 102 patientsrecruited from 22 centres in the USA and Canada. The objectives were to showboth immediate and sustained relief of the symptoms of interstitial cystitis. Apreliminary analysis of the data indicates that patients treated with PSD597experienced a statistically significant improvement (p< 0.01) in their symptomsas measured by the primary endpoint of Global Response Assessment (GRA). GRA isa well recognised parameter used by clinical practitioners treating IC patientsand is a standard measure of the patient's response to treatment (includingchanges in pain, urinary frequency and urgency). These results are furthersupported by the secondary endpoints, including symptom and problem indices.Importantly, the treatment effect was maintained for several weeks and the drugwas safe and well tolerated and devoid of systemic side effects oftenexperienced with oral drug administration. The blinded study was followed by avoluntary, open label study to gather further information on the longer termtreatment effect. This open label extension recruited from both the treatmentand placebo arms of the blinded study. Significantly, 86% of patients whocompleted the double-blind placebo controlled study elected to remain in theopen label study indicating strong support for this novel treatment. Initialfindings from the open label study suggest that the treatment effect wassustained. Full data from the blinded and open label studies will be availablelater in the year. PSD597 is delivered into the bladder using a technique suitable for bothout-patient clinics and home administration. The proprietary formulation of thedrug 'protects' the drug in the hostile environment of the bladder to ensurethat the drug remains in the optimal chemical form for transport across thebladder wall to its site of action. The Principal Investigator, Professor Curtis Nickel, Dept of Urology, Queen'sUniversity, Kingston, Ontario commented: "Patients suffering from interstitial cystitis/painful bladder syndrome (IC/PBS)and physicians managing this chronic debilitating condition have becomediscouraged as one potential beneficial therapy after another has failed to showsignificant clinical efficacy when subjected to rigorous scientific scrutiny.The results from this well designed, randomised, placebo controlled studyevaluating the safety and efficacy of PSD597, which showed very encouragingstatistically and clinically significant improvement with PSD597 compared toplacebo, may change this pessimism. This study definitely shows that PSD597 iseffective for the acute treatment of the pain and voiding symptoms of IC/PBS andwill prove to be of significant benefit in treating flares and exacerbations ofthe condition. Patients and physicians now have a right to be encouraged that anew therapy holds promise for the future." Dr Mike Wyllie, CSO of Plethora, commented: "After the success of PSD502 in its Phase II study, the positive data from thissuccessful study provide further validation of the Plethora model where marketedproducts are reformulated in a novel way and fast-tracked into new therapeuticareas. Not surprisingly, given the size of the commercial opportunity forPSD597, there is considerable interest from pharmaceutical companies in theoutcome of this study. Discussions will now be initiated with regulatoryauthorities to confirm the requirements for the remaining component of theregistration programme for this product. We look forward to updatingshareholders as this development programme and associated partnering discussionsadvance." (1) Held, PJ et al; Epidemiology of interstitial cystitis. Hanno, PM. Interstitial Cystitis. 29 - 48. 1990, London, Springer-Verlag(2) Source: Datamonitor Report, "Interstitial Cystitis - Few Treatments, Poor Outcomes", 04.2006 -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. In January 2006, Plethora acquired Minneapolis (Mn)based Timm Medical Technologies Inc which markets products for the treatment oferectile dysfunction (ED) to urology clinics through a US-based specialty salesteam. The Company is headquartered in the UK and is listed on the London StockExchange (AIM:PLE) Further information is available atwww.plethorasolutions.co.uk This information is provided by RNS The company news service from the London Stock Exchange