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Biotech / Medical : ICOS Corporation -- Ignore unavailable to you. Want to Upgrade?

To: SemiBull who wrote (1013)	11/3/2003 8:02:51 PM
From: SemiBull	Read Replies (1) \| Respond to of 1139

Palatin anti-impotence drug shows promise in trial Monday November 3, 5:34 pm ET By Bill Berkrot NEW YORK, Nov 3 (Reuters) - An experimental anti-impotence nasal spray that works on the most complex of sexual organs -- the brain -- achieved its primary goals in a mid-stage clinical trial, Palatin Technologies Inc. (AMEX:PTN - News) said on Monday. In a safety and efficacy study of its PT-141 drug for erectile dysfunction, Palatin reported statistically significant improvement in erections across all four dosing levels tested, with no cardiovascular side effects, the tiny Cranbury, New Jersey-based company said. Results of the month-long study, which involved 271 patients with mild to severe erectile dysfunction who had previously responded well to Viagra, were presented Saturday night at a medical conference in Los Angeles. "The clinical results here indicate that there is no reason why we can't move this drug forward and get it approved," Palatin Chief Executive Carl Spana told Reuters. The trial gave patients either a placebo or the Palatin drug at 5-milligram, 10-mg, 15-mg or 20-mg doses. The one piece of apparently negative news to come out of the study was that about 12 percent of patients discontinued use of the drug due to adverse side effects. About 60 percent of the discontinuations were due to gastrointestinal problems, and those were limited to patients taking the two higher doses, the company said. Virtually none of the dropouts were taking the two lower doses. Palatin said in its next mid-stage, or Phase 2, trial it will eliminate the 20-mg dose. Shares of Palatin fell 85 cents, or 19.8 percent, to close at $3.45 on the American Stock Exchange. MARKET ENTRY SEEN DISTANT Even with no unforeseen hitches in what Spana called "a very clear path to approval," it will be late 2007 or early 2008 before Viagra and its similar competitors face a challenge from this new class of drug, the company predicted. Spana said Palatin has sufficient cash to fund its research and development "well into next year" and is already in talks with potential marketing partners in the drug industry. Pfizer Inc.'s (NYSE:PFE - News) Viagra and its new competitors -- Levitra from Bayer AG (XETRA:BAYG.DE - News) and GlaxoSmithKline (London:GSK.L - News) and Cialis from Eli Lilly and Co. (NYSE:LLY - News) and Icos Corp. (NasdaqNM:ICOS - News) -- are known as PDE-5 inhibitors and all work by blocking the enzyme that shuts down blood flow into the penis, which helps to maintain an erection. Palatin's drug helps initiate erection by stimulating nerves in the hypothalamus portion of the brain, which signals blood to flow into the penis. "There's no doubt it's an effective drug," said Dr. Myron Murdock, a principal investigator in the Palatin trial. He said one advantage over Viagra and similar drugs is that patients who are on nitrates or nitroglycerine will be able to take the Palatin drug. There are about 9 million American men who take those types of heart medication who cannot use PDE-5 inhibitors, according to Murdock. Dr. Irwin Goldstein, director of the Center for Sexual Medicine at Boston University School of Medicine, welcomed any new research into the field of sexual medicine, but said PDE-5 inhibitors had set the bar very high for any alternatives. "This is a class that is dramatically safe and effective," Goldstein said of Viagra and its similar rivals. Patients on average reported that PT-141 was effective for about eight to 10 hours -- about twice the window of opportunity from Viagra, but far less than Cialis, the so-called "weekend" drug that has been shown to work for up to 36 hours. Goldstein said any new drug would have to be proven to be as safe and effective as the PDE-5 inhibitors. "That's a huge hurdle," he said.