Plethora Solutions Holdings Plc Regulatory News (PLE)

22 Jun 2005 07:00

Plethora Solutions Holdings PLC22 June 2005 For Immediate Release 22nd June 2005 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update PSD401 - Sexual Activity Monitor (SAM) Completion of Clinical Development and Validation Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM : PLE), aUK-based speciality pharmaceutical company focused on the development ofproducts for the treatment and management of urological diseases, announces thatPSD401, a device for measurement and automated recording of ejaculation time inpatients suffering from premature ejaculation (PE), has successfully completedthe final phase of its clinical development and validation programme. Plethora has been conducting a development trial of the product in both healthyvolunteers and patients suffering from PE to establish the reproducibility,efficacy and safety of the product and the ability to discriminate betweenhealthy patients and PE sufferers. In this trial over 70 patients in fourclinical centres in the UK have used the device and the data generated has beenused to establish an algorithm to give an automated, reproducible andquantifiable recording of key data. PSD401 has already obtained CE and Kite marks and is now proceeding toregulatory submissions in the USA to obtain the equivalent 510K documentationand coding for reimbursement as a diagnostic procedure. The Company is currently in discussions with several pharmaceutical companiesinterested in utilising the product in their clinical development and marketingprogrammes for drugs for the treatment of PE. Plethora has also initiateddiscussions with potential marketing and distribution partners who will targetthe urologists, andrologists, other relevant specialists and primary carephysicians who will be responsible for the management of the large PE patientpopulation. In the expanding sexual health market, PSD401 complements Plethora's therapeuticproduct PSD502 for the treatment of PE which is currently undergoing Phase IIclinical trials. Steven Powell, CEO of Plethora, commented; "It is estimated that more than 30%of men suffer from premature ejaculation. This can be a devastating conditionfor men and their partners. Recent research by major pharmaceutical companieshas indicated that the potential market for PE drugs is $5 billion per annum.PSD401 will not only be an important aid to clinical development and marketingof PE drugs but it will ultimately also provide assistance in the diagnosis andmanagement of PE by urologists and primary care physicians. To date, althoughmajor pharmaceuticals companies are developing therapies, the only method ofmeasuring the condition and any benefit due to the drug is a patient- orpartner- operated stopwatch. "We are delighted that this phase of development has been successful with theproduct proving effective at providing quantifiable, reproducible measures ofejaculation latency in PE patients and normal healthy volunteers. The device hasbeen well received by clinical investigators, patients and volunteers involvedin the three clinical trials completed to date. This reaction frominvestigators and the quality of the data derived from these studies shouldenable us to move the product into commercialisation over the coming months. Welook forward to reporting on our progress." 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 More About PSD401 PSD401 is a diagnostic device designed for use either in urology clinics,physicians' offices or in "at home" situations to quantify ejaculation latencytime. Demand for such a system was based on market analysis of the requirementsof US physicians and US and European regulators and the knowledge that severalnew drugs for PE are in advanced stages of clinical development. Despite thelarge patient population, there is no validated technique for either diagnosingPE or assessing and comparing treatments for PE. This is an issue given thenumber of treatments for PE at various stages of clinical development and notunexpectedly regulatory authorities are applying pressure for a standardiseddiagnostic device for use in such trials. Given the need for definitive andreproducible endpoints in clinical trials, the existing approach to quantitativediagnosis of PE of a patient-operated stopwatch to measure intravaginalejaculation time (IELT) has inherent problems with compliance andreproducibility. This information is provided by RNS The company news service from the London Stock Exchange