Plethora Solutions Holdings Plc Regulatory News (PLE)

26 Jul 2005 07:00

Plethora Solutions Holdings PLC26 July 2005 For Immediate Release 26 July 2005 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update PSD502 - Topical analgesic spray Clinical Study for use in plastic surgery/burns Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM : PLE), aUK-based speciality pharmaceutical company is pleased to announce that it isinitiating a Proof of Principle clinical study for PSD502 as a treatment forpain associated with burns, and with painful surgical procedures such as donorskin grafting. PSD502 is a topical spray which is currently undergoing Clinical Development forpatients with Premature Ejaculation. While the focus of Plethora remains on thedevelopment of drugs for the treatment of urological diseases, the company aimsto maximise the potential of its existing intellectual property. The company, inworking together with a series of focus groups, has recognised a significantcommercial opportunity for secondary use of PSD502 in the treatment of painfulconditions affecting mucous membranes or non-intact skin. An estimated 250,000 people are burnt each year in the UK alone. Of these175,000 attend accident and emergency departments and 13,000 of these 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, such as PSD502, could providerapid and effective pain relief in these and other painful superficial wounds.The use of PSD502 as a metered dose aerosol will afford the patient andphysician the potential for a fully flexible on-demand means of titrating thedose to meet the patients' needs. No other treatment is licensed for thiscondition. Plethora is collaborating with two of the largest UK burns units; WythenshaweHospital, Manchester and Broomfield Hospital, Chelmsford. Proof of Principlestudies of PSD502 are planned with both these Centres of Excellence. Dr De Mello, Director of Day Case Surgery at The Wythenshawe Burns Unit, iscurrently performing a preliminary patient pain evaluation in preparation for aProof of Principle study of PSD502. Plethora hopes to report on the outcome ofthis study in 2006. Mr Ken Dunn, Consultant Burns and Plastic Surgeon and Head of the Burns Unit,Wythenshawe Hospital, Manchester, commented: "Burns and donor skin grafting continues to be associated with significant painand there is a high clinical need for an effective, safe treatment for pain.PSD502, as a concentrated mixture of two clinically proven, highly effectivelocal anaesthetic agents, should be a very useful treatment for patientssuffering from burns or for patients who require certain painful surgicalprocedures". Mr Peter Dziewulski, Head of Unit, and Mr Bruce Philp, both Consultant Burns andPlastic Surgeons at Broomfield Hospital, Chelmsford commented: "Due to the rapid onset of action and ease of administration, PSD502 shouldprovide much needed immediate pain relief for patients suffering from acuteburns" Steven Powell, CEO of Plethora, said: "Pain management is a critical issue for doctors treating burns and skin graftpatients. We are delighted that the teams at Wythenshawe and Broomfield haveagreed to help us accelerate the preliminary stage of the clinical developmentof this product. If these studies prove successful we will look to license thisproduct on to a pharmaceutical partner with development and marketing expertisein this clinical indication" For further information contact: Steven PowellPlethora Solutions Tel : 0207 269 8630 Tim MickleyCollins Stewart Tel : 0207 523 8350 Tim Anderson, Isabel PoddaBuchanan Communications Tel : 0207 466 5000 About Plethora: Plethora is a UK-based speciality pharmaceutical company focused on thedevelopment of products for the treatment of urological disease. The company hasproducts in clinical development for the treatment of overactive bladder, benignprostatic hyperplasia, stress urinary incontinence and premature ejaculation.The company is headquartered in London, UK and is listed on the AlternativeInvestment Market (AIM) of the London Stock Exchange. (AIM:PLE) This information is provided by RNS The company news service from the London Stock Exchange