To: Peter V who wrote (9600 ) 6/3/1998 12:22:00 PM From: gringodoc Respond to of 18691
zona: slammed also by thestreet.com today:thestreet.com (snippets): >>Zonagen (ZONA:Nasdaq) had its data on two Phase III trials of its drug Vasomax presented here by the controversial and ubiquitous Johnny Spread-Your-Seed of impotence, Dr. Irwin Goldstein, a urologist from Boston University. This time, Zonagen presented data on a different number of patients than it reported data on in a press release last year and in a recent abstract. In the presentation, Goldstein, who serves as a consultant to more than half a dozen of the anti-impotence drug makers, pronounced the drug effective and safe. But some urologists continue to be baffled at the results and the trials' parameters and investors question the safety data. << >>Dr. Ron Lewis of the Medical College of Georgia challenged Goldstein, asking for an explanation of why Vasomax would work this time, when in a previous study in Europe it was shown not to work. He also asked for an explanation of why injectable phentolamine as a single agent didn't improve erections, but oral Vasomax did. Doctors also made the point at the presentation that Zonagen tested a population of patients with relatively mild impotence, which has been a common criticism of the trials that short-sellers have made about the company's trials. "I don't understand," said Dr. Lewis to TSC. "I don't know how with the injectable drug, you would not get an erection, but if it was taken orally you do. I don't think that was answered." (Lewis says he did "early consultant work" for Zonagen and has never participated in the company's clinical trials. He has consulted for and been an investigator for several other companies.) Though Zonagen had no serious adverse events in its trials, because the drug is a blood-pressure-lowering agent, several investors wondered if there might be a safety issue. Lewis said, "It gets in the bloodstream and if it's in the blood, one of the side effects of alpha-blockers is hypotension." Phentolamine is in a class of drugs called alpha-blockers. He added, however, that "I haven't heard even anecdotally of severe side effects." <<