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| |  WMIR: Investigational Drug, Cialis (IC351), Reported To Improve Erections INDIANAPOLIS, IN -- November 28, 2000 -- Data from a large Phase II clinical trial show that up to 88 percent of men taking an investigational oral treatment for erectile dysfunction (ED) -- Cialis™ (IC351), a new- generation phosphodiesterase type 5 (PDE5) inhibitor -- reported improved erections relative to placebo. These findings, presented at the 9th World Meeting on Impotence Research in Perth, Australia, show that Cialis increased the percentage of successful and satisfying intercourse attempts for both men and their partners. "Cialis is a potent and highly selective PDE5 inhibitor that was well tolerated at a range of doses in this study, with mild to moderate side effects reported that diminished over time," said Dr. Gerald Brock of St. Joseph's Health Centre, Department of Urology, Ontario, Canada. "It may provide a promising therapeutic option to help men improve their sexual function." Dr. Brock, a leading researcher in erectile dysfunction, presented Phase II data from a clinical study that examined the safety and efficacy of on-demand Cialis treatment in 212 men with mild-to-severe ED. Men were randomized to receive either placebo or Cialis at doses up to 25 mg over an eight-week period. Up to 88 percent of men taking Cialis reported significantly improved erections compared with 28 percent of those taking placebo. "What is important about this study was that Cialis was studied in a broad group of men with erectile dysfunction," said Dr. Brock. "We saw improved results in men suffering from erectile dysfunction of varying severity and causes, such as diabetes, and importantly we did not see serious side effects." The results presented at this meeting confirm the results of two previous Phase II multi-center placebo-controlled trials. In these studies, different doses of Cialis and different dosing regimens were examined. These studies demonstrate consistent, statistically significant improvement in erectile function. Collectively these studies enrolled nearly 700 men with ED of varying severity and causes. The most frequent treatment-related adverse events reported were headache, myalgia (muscle pain), dyspepsia (stomach upset following meals) and back pain. These events were dose-related, generally mild-to-moderate, and tended to abate with continued treatment. A global Phase III investigational clinical program for Cialis is currently underway. To evaluate Cialis' effect versus placebo, researchers compared baseline scores from the International Index of Erectile Function (IIEF) questionnaire and sexual encounter profile (SEP) diaries of ED sufferers and their partners. These measurements determine the ability of men to obtain and maintain an erection in order to have satisfying intercourse and achieve orgasm. Data obtained from SEP diaries showed increased reports from both men and their partners of successful and satisfying intercourse attempts. Erectile dysfunction is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. It affects an estimated 70 million men and their partners worldwide with many cases caused by physical conditions, including various cardiovascular diseases and diabetes. Additionally, results from comparative in-vitro (test tube) research were presented at this meeting, with results suggesting that Cialis was more selective than sildenafil at targeting PDE5 receptor sites. PDE5 is an important enzyme involved in controlling blood flow to the penis. When PDE5 is inhibited, natural sexual stimuli produce a more pronounced effect, facilitating the ability of men with ED to attain and maintain an erection. This research showed that Cialis affected the PDE5 receptor sites without interfering appreciably with the actions of other known PDEs that play essential roles in the action of cells in different parts of the body (for example, those found is various organs and tissues such as the brain, heart, kidney or eyes). "This selectivity research suggests that you would need approximately 700 times more Cialis to inhibit the action of PDE6, the phosphodiesterase found in the retina of the eye, than would be needed to inhibit PDE5 to a similar extent," said Dr. Brock.
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