Clinical Update

8 Aug 2006 07:01

Plethora Solutions Holdings PLC08 August 2006 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update PSD502 - Topical Analgesic Spray Clinical Study for supplementary use as front-line therapy in plastic surgery/ burns Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM : PLE), thespecialist developer of products for the treatment and management of urologicaldisorders provides an update on preliminary results from an ongoing trial ofpatients undergoing skin grafts with PSD502. PSD502 is a metered-dose analgesic spray which reported positive results from aPhase II trial for the treatment of Premature Ejaculation ("PE") in December2005. Product rights for the treatment of PE will be licensed to a marketingpartner who will complete clinical development. However, while working with keyopinion leaders, the Company recognised that an additional commercialopportunity exists for the secondary use of PSD502 in the treatment of the manypainful skin/membrane conditions where local application is possible. As PSD502contains no solvent, there is no initial stinging sensation and the metered-doseapplicator makes dose adjustment extremely easy. To exploit this opportunity, Plethora is collaborating with three clinicalcentres in the UK to evaluate the product for the effective treatment of pain inburns patients, skin graft patients and paediatric burns patients. The skingraft study is one such trial and is being conducted at one of the largestnational burns units in the UK - Wythenshawe Hospital, Manchester. Dr De Mello, Consultant in Pain Medicine at The Wythenshawe Burns Unit iscurrently performing the Proof of Principle study of PSD502 in patients whorequire skin grafting to treat burns. Patients have been treated with a singledose of PSD502 to relieve the pain at the donor skin graft site. Taking a skingraft leaves a large area of exposed nerves at the donor site - this isextremely painful despite the patients receiving background morphine analgesia. The analysis of pain relief uses validated scoring systems identical to thoseused to detect strong analgesics such as opiates. 75% of patients dosed to datehave reported no pain or minimal pain at the donor site following treatment withPSD502. In addition, as expected from a locally-applied preparation,pharmacokinetic measurements showed acceptable levels of active drug in thesystemic circulation and consequently, as anticipated from the existing,extensive safety database, the product was well-tolerated with no adversetreatment effects reported. Commenting on the trial, Dr De Mello said: "Although preliminary, these results are exciting. They suggest that thistreatment could provide rapid and effective pain relief in this area of highmedical need. The improvement in pain relief for patients who received PSD502was considerable". An estimated 250,000 people are burnt each year in the UK alone. Of those,175,000 attend accident and emergency departments, and 13,000 of those areadmitted to hospital. The incidence of burn injuries is even higher in theUnited States. Burns and donor skin grafting are associated with significantpain, usually requiring morphine. A topical spray of an effective locally actinganalgesic such as PSD502 could provide rapid and effective pain relief in theseand other painful superficial wounds. The use of PSD502 as a metered doseaerosol will afford the patient and physician the potential for a fully-flexibleon-demand means of titrating the dose to meet the patients' needs. No othertreatment is licensed for this condition. Plethora hopes to report on the full outcome of this and the other PSD502topical pain studies later in 2006. Steven Powell, CEO of Plethora Solutions, said: "While licensing discussions have progressed significantly with multiplepotential partners for PSD502 as a PE treatment in the first half of 2006, thegeneration of this preliminary data underlines the value of the PSD502 asset.Pain management is a critical issue for Doctors treating burns and skin graftpatients and a substantial medical need, which our unique formulation makes itpossible for doctors to meet. We are delighted that the Wythenshawe team hasagreed to help us accelerate the preliminary stage of the clinical developmentof this product. We look forward to providing further and more detailedinformation on the outcome of these studies as it becomes available" -Ends- For further information contact: Plethora Solutions Tel : 020 7269 8630Steven Powell Collins Stewart Tel : 020 7523 8350Tim Mickley City/Financial Enquiries Tel : 020 7379 5151Maitland CommunicationsBrian Hudspith/Liz Morley/Wendy Timmons 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, gyaecological 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 speciality sales team.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