Lidak Pharmaceuticals announced Monday that it has startedits third Phase II clinical trial of the anti-viral compoundLidakol for treating oral herpes infections.
The double-blind, placebo-controlled U.S.-based trial will testthe safety, tolerance and efficacy of Lidakol as a topicaltreatment for recurrent oral herpes in a minimum of 40patients, according to Michael Lorber, vice president and chieffinancial officer of the La Jolla, Calif., company.
Lidak initiated two other Phase II trials of the topicalformulation of Lidakol in November 1992. One of these -- on72 patients with recurrent oral herpes -- is being conducted inEurope by Lidak's licensing partner, Brocades Pharma b.v. ofthe Netherlands. The other, a U.S.-based trial on 60 patients, isfor treating recurrent genital herpes. Burroughs-Wellcome'sacyclovir is the only FDA-approved drug for treating herpes.
Lidakol is an n-docosanol-based product; Lidak has patentscovering its use by injection or transmucus or transdermalpenetration. Lidak has five issued patents relating to Lidakol.One covers all topical uses, and the others relate to systemicapplications, Lorber told BioWorld.
Lidak had been in negotiations with a potential developmentand marketing partner for Lidakol, but the agreement wasterminated in October 1992.
Lidak is "still discussing the possibilities of licensing thetechnology in the U.S.," Lorber told BioWorld. "We felt it wasimportant to proceed with the clinical trials while that processis ongoing."
The company has 39 million shares outstanding, fully diluted,and more than $9 million in the bank, according to Lorber. Thecompany's burn rate is about $250,000-300,000 a month, hesaid. "We've focused on limiting our burn rate by keeping theinfrastructure relatively small," Lorber told BioWorld.
The company's stock (NASDAQ:LDAKA) lost 6 cents a share onMonday to close at $2.25.
-- Jennifer Van Brunt Senior Editor
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