Guest guest Posted October 22, 2006 Report Share Posted October 22, 2006 You may have seen this before since it was first published in May. Here is a press Release from http://www.palatin.com/news/news.asp?ID=145 PALATIN TECHNOLOGIES AND KING PHARMACEUTICALS COMPLETE ENROLLMENT IN TWO PHASE IIB CLINICAL TRIALS EVALUATING BREMELANOTIDE IN PATIENTS WITH ERECTILE DYSFUNCTION CRANBURY, NJ and BRISTOL, TN — May 4, 2006 – Palatin Technologies, Inc. (AMEX: PTN) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the companies have completed enrollment in two Phase IIb clinical trials of bremelanotide in patients with erectile dysfunction (ED). Bremelanotide is a melanocortin agonist that Palatin and King are jointly developing for the treatment of both male and female sexual dysfunction. The primary objective of these two dose-ranging clinical trials is to identify safe and efficacious doses for evaluation in Phase III pivotal trials slated to begin in the first quarter of 2007. Dr. Trevor Hallam, Executive Vice President, Research and Development of Palatin, stated, “Together with our colleagues at King, we are very pleased to achieve this significant milestone for these two critically important clinical trials. The data from these two studies should allow the companies to develop a robust Phase III pivotal trial program for consideration by the U.S. Food and Drug Administration.â€Clinical Trial DetailsThe two Phase IIb clinical trials are double-blind, placebo-controlled trials that entail a one month run-in period and a three month treatment period. The primary endpoint for both studies is the change in the Erectile Function domain of the International Index of Erectile Function from baseline at the end of the three month treatment period. The first Phase IIb clinical trial is evaluating the safety and efficacy of bremelanotide in approximately 560 non-diabetic patients suffering from mild to severe ED. The second clinical trial is similarly evaluating approximately 265 diabetic patients also suffering from mild to severe ED. About BremelanotideBremelanotide is the first compound in a new drug class called melanocortin receptor agonists under development to treat sexual dysfunction. This new chemical entity is being evaluated in Phase IIb clinical trials studying the efficacy and safety profile of varying doses of this novel compound in men experiencing ED and women experiencing female sexual dysfunction (FSD). The mechanism of action of bremelanotide may offer important benefits over currently available products for the treatment of ED because it acts on the pathway that controls sexual function without acting directly on the vascular system. Clinical data indicates that bremelanotide may be effective in treating a broad range of patients suffering from ED. The nasal formulation of bremelanotide currently under development is as convenient as oral treatments, is more patient-friendly than invasive treatments for ED, such as injections and trans-urethral pellets, and appears to result in a rapid onset of action.Although the current ED market is primarily served by PDE-5 inhibitors which target the vascular system, a substantial unmet medical need for alternative sexual dysfunction therapies exists. Many patients are contraindicated for, or non-responsive to, PDE-5 inhibitors. In addition, current literature indicates that about one half of all patients who receive an initial prescription for a PDE-5 inhibitor do not renew the prescription due chiefly to adverse side effects, drug interaction issues, and/or the lack of an acceptable level of responsiveness. I wish you all the bestAubrey Quote Link to comment Share on other sites More sharing options...
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