To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Study Shows Invicorp Nearly 70% Effective In Treating Impotence URL: http://www.pslgroup.com/dg/29DBE.htm Doctor's Guide May 28, 1997
NEW YORK, May 28, 1997 -- A recently concluded clinical study has shown that a new drug therapy for treating erectile dysfunction (ED), or impotence, Invicorp(TM) was nearly 70 percent effective in treating patients with pharmaco-resistant erectile dysfunction. The therapy, developed by Senetek PLC, is a unique neurotransmitter combination-drug therapy administered with a proprietary state-of-the-art autoinjector. The patients in the study were consecutive erectile clinic attenders who had previously failed therapy with intracavernosal 20 mg of prostaglandin E1 (PGE1), also known as alprostadil -- currently the only regulatory-approved intracavernosal drug therapy available in the marketplace for treating male patients with organic erectile dysfunction (impotence) -- and 30 mg of papaverine in combination with 1mg of phentolamine mesylate. Forty-seven of the 70 patients achieved erections suitable for sexual intercourse, initially under clinical supervision and subsequently during home use of Invicorp. The primary minor side effect associated with use of Invicorp was transient facial flushing in 37 /70 patients (53 percent). None of the patients who were administered Invicorp reported priapism or other serious adverse events. Wallace Dinsmore, M.D., of the Department of Genito Urinary Medicine at Royal Victoria Hospital, Belfast, Northern Ireland, conducted the study, and will be presenting his clinical data at the "2nd Meeting of the European Society for Impotence Research (ESIR)" in Madrid, Spain, October 1-4, 1997. Last month Senetek PLC announced that it filed a Product Licensing Application (PLA) with the United Kingdom's Medicines Control Agency (MCA) seeking approval to market Invicorp to treat moderate-to-severe, organic-based erectile dysfunction (ED) in males. The PLA submission included data from Phase III clinical trials involving more than 700 men among eight sites in the United Kingdom. The data from the pivotal studies suggested that Invicorp was 81 percent effective in treating male patients with organic-based ED -- patients who previously could not function sexually -- enabling them to have an erection suitable for intercourse. Of particular note involving the pivotal studies: 59 percent of the patients treated successfuly with Invicorp had previously been treated with alternative pharmacotherapies, including prostaglandin (PGE1), papaverine and yohimbine, but had withdrawn from treatment either due to lack of effectiveness (45 percent) or side effects or other reasons (55 percent). Eighty-two percent responded successfully to Invicorp, whereas previous pharmacotherapy had failed to be satisfactory. The primary side effect associated with Invicorp was short-term facial flushing. Invicorp is an injectable formulation of vasoactive intestinal polypeptide (VIP) in combination with the adrenergic drug phentolamine. VIP, in combination with phentolamine and sexual stimulation, is expected to provide a new and effective alternative for ED patients that is essentially free of the troublesome side effects and cumbersome delivery methods limiting the use of other pharmacologic preparations. Invicorp can be delivered using Senetek's novel and patented Auto Injector -- which renders the self-injection process exceptionally easy and unobtrusive to perform and helps ensure accurate, safe delivery of medication. Senetek PLC is a biotechnology company providing technologies and solutions for aging-related health problems. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.