Plethora Solutions Holdings Plc Regulatory News (PLE)

8 Feb 2007 07:01

Plethora Solutions Holdings PLC08 February 2007 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Programme Extension - Plethora initiates parallel study for PSD597 as analgesic therapy in urogynaecological procedures. Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disorders,announces the initiation of a new clinical programme in an additional clinicalindication for PSD597, a novel therapy under development for the treatment ofinterstitial cystitis and painful bladder syndrome (IC/PBS). Following positive feedback from the clinical centres involved in its existingIC study, Plethora has, in parallel, initiated a second study to demonstrateefficacy of the product as an analgesic therapy in urogynaecological proceduressuch as cystoscopy and bladder biopsy. These procedures are often performedcurrently in the absence of any analgesic agent. As a result of its fast onsetof action, PSD597 may bring immediate pain relief to these patients during thisshort procedure. It has been estimated that at least 62,000 Americans undergo abladder biopsy each year to confirm the presence of bladder cancer, while over150,000 women undergo hydrodistension procedures for IC/PBS. Recruitment isalready under way in five centres in this second PSD597 study, which isscheduled to report in the first half of 2007. PSD597 is currently undergoing a Phase II clinical study in North America todemonstrate its efficacy in the treatment of interstitial cystitis; a chronicsyndrome characterised by bladder pain and increased urinary frequency andurgency. A self-reported survey of American households indicated that almost 1%of women had received a diagnosis of IC/PBS suggesting that there are at least900,000 female sufferers in the USA alone. Current treatments for IC/PBS arelimited in their effectiveness. The objective of the ongoing clinical programmeis to provide additional confirmation of the findings from two pilot studies inwhich PSD597 was shown to provide immediate, effective and long-acting symptomrelief in these major, poorly-controlled, debilitating conditions. Recruitmentin this current Phase II study is on track to report results in the first halfof the year. Professor Alvaro Morales of Queens University, Ontario, Canada commented:"Based on the degree of benefit and duration of clinical effect emerging in thecurrent IC study together with the results of the previous two previous studies,PSD 597 could be of considerable benefit to patients suffering not only fromchronic IC and bladder pain but also in this second area of un-met clinical need". Dr Steven Powell, Plethora CEO, concluded:"Existing, published clinical data for the efficacy of PSD597 in the treatmentof IC is promising and we have already received a strong level of interest inthis product from potential partners. The development path for the new,additional indication is short as the product would be used in an acute settingwith no long term safety issues. We may therefore be in a position to considerretaining marketing rights to the second indication whilst continuing partneringdiscussions around the primary, IC/PBS indication". -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 3838DeFacto 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 and prematureejaculation. In January 2006, Plethora acquired Minneapolis (Mn) based TimmMedical Technologies Inc which markets products for the treatment of erectiledysfunction (ED) to urology clinics through a US-based specialty sales team. TheCompany is headquartered in the UK and is listed on the London Stock Exchange(AIM:PLE) Further information is available at www.plethorasolutions.co.uk This information is provided by RNS The company news service from the London Stock Exchange