Lidak Pharmaceuticals, which currently is narrowing its focus forLidakol, started another U.S. Phase III trial of the anti-viral agent inoral herpes, the La Jolla, Calif., company said Wednesday.
Lidak already had two U.S. Phase III trials under way, one in earlystage oral herpes and one in late-stage episodes. The new trial willassess Lidakol in early stages to see whether the cream can stop theoutbreak of cold sores or fever blisters.
The additional trial is designed to supplement existing studies so thecompany will be better prepared to file for marketing approval, saidBruce Nuss, Lidak's vice president and chief financial officer.
The new double-blind study will include up to 320 patients. Theother two studies are expected to enroll about 750 patients. All arecomparing Lidakol (n-docosanol 10 percent cream) to placebo. AEuropean study, being funded by marketing partner YamanouchiEurope, is comparing Lidakol to the approved drug Zovirax(acyclovir).
Phase II trials of Lidakol already have been conducted in genitalherpes. But further development in that indication is on hold becauseof financial concerns, Nuss said. We want to focus on the areas wherewe expect the most promise," he said. "The results from our oralstudies in Phase II were better than the genital studies in Phase II."
Nuss said the company is seeking a marketing partner in the U.S.
Lidak's stock (NASDAQ:LDAKA) closed unchanged Wednesday at$4 per share. _ Jim Shrine
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