Clinical Update PSD597

8 Oct 2007 07:00

Plethora Solutions Holdings PLC08 October 2007 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update Full analysis of Phase II clinical results confirm PSD597 is an effective, safeand rapidly acting treatment for patients suffering from interstitial cystitis/painful bladder syndrome • Significant improvement in both Primary and Secondary efficacy endpoints• Both immediate and sustained clinical benefit confirmed• 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 further results and analysis of a Phase II clinical studyof PSD597 in the treatment of interstitial cystitis and painful bladder syndrome(IC/PBS). The full analysis confirms and extends the initial positive outcomesannounced on 6 September 2007. IC is a chronic urological disorder that afflicts young and middle aged womenespecially. The condition is characterised by bladder pain, urinary frequencyand urgency. Symptoms may be severe, to the point that pain and associatedcomplaints come to dominate the sufferer's life. In a 2006 report(1) a globalpatient population of 16 million with IC was reported with a prevalence of 6.4million patients in the USA alone. Current treatments for IC/PBS are of limitedeffectiveness and any improvement is typically of short duration. Trial Protocol The Plethora study was a randomized, double-blind, placebo controlled trial intowhich 102 patients were recruited in 22 centres in the USA and Canada. Bladderpain was required for patient enrolment, but the entry criteria were otherwisewidely drawn so that a broad and representative group of patients might enter.The immediate and prolonged effects of a course of PSD597 treatment wereinvestigated. Results - clear and substantial improvements in GRA, the primary endpoint Patients who received PSD597 showed clear and substantial improvements in theprimary endpoint measure, Global Response Assessment (GRA), a patient-ratedscale of improvement in bladder symptoms which is now an international standardin IC/PBS trials. At Day 8, 15 patients (30%) in the 'intent-to-treat'population reported moderate or marked improvement after PSD597 treatmentcompared with only 5 patients (10%) randomized to placebo (p=0.012);improvements in the two groups at Day 15 were 24% and 12% respectively (p=0.102). Analysing the response across all GRA categories, the difference withPSD597 treatment at Day 15 was highly significantly different from placebo (p=0.005). These positiveresults were replicated across all secondary endpoints with improvementsreported in bladder pain, urinary frequency and urgency, whether assessed asindividual symptoms or combined into widely-accepted symptom and problemindices. The O'Leary-Sant Interstitial Cystitis Symptom Index and InterstitialCystitis Problem Index each improved following treatment with PSD597 (p=0.041, p < 0.001 at Day 8, respectively, comparing PSD597 and placebo treatment groups; p=0.12, p=0.038 comparing the two treatments at Day 15). PSD597 was well tolerated, appeared safe, and was devoid of systemic side effects oftenexperienced with oral drugs. Voluntary Open Label Study - 86% of patients elected to receive second treatment The drug effect was confirmed in an extension to the study. In this voluntarypart of the trial, patients who completed the double-blind placebo controlledphase were offered the choice of open label treatment with PSD597 for 5 daysfrom Day 15. Notably, 86% of patients elected to receive a second treatment.This provides direct evidence of treatment acceptability and the lack ofalternative treatment options. Treatment was again well tolerated and safe. AtDay 22, 63% of those patients who had received PSD597 in the double-blind studyphase reported moderate or marked improvement in Global Response Assessmentafter the second treatment; of the patients who previously were randomized toplacebo, 44% now responded to active treatment. By Day 29, GRA response rateswere still maintained at 56% and 39% in the two groups. The results complementthose seen in the initial double-blind study phase and, together, they suggestthat the benefits of PSD597 are sustained for a considerable period aftertreatment and, secondly, confirm that clinical benefit can be increased withrepeated PSD597. Dr. Mike Wyllie, CSO of Plethora, commented: "These full results confirm and extend previous findings and show that PSD597offers a simple, effective treatment for patients suffering from interstitialcystitis. These longer term studies confirm that the product produces rapid andeffective relief of symptoms and that the effect is maintained over severalweeks. Dialogue will now be initiated with regulatory authorities to define thephase III programme required for registration in parallel with discussions withpotential licensing partners." (1) 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