Lidak Pharmaceuticals said Wednesday that it started Phase III trialsin the U.S. of Lidakol for treatment of oral herpes.
One part of the double-blind trial will assess Lidakol (n-docosanol10 percent cream) against placebo in patients with early stage oralherpes. The other will look at patients with late-stage episodes oforal herpes. Together the trials will enroll about 750 patients.
The trial differs from an ongoing European Phase III trial of Lidakolin several ways. One, the European trial is being funded bymarketing partner Yamanouchi Europe. And that trial is comparingLidakol to Burroughs-Wellcome plc's approved drug, Zovirax(acyclovir).
Bruce Nuss, vice president/chief financial officer of the La Jolla,Calif., company, told BioWorld that about half of the 400 patientsexpected for the European trial have been enrolled.
The U.S. trial is expected to be conducted at 10 to 12 centers, someof which may be in Canada, Nuss said. "It will be 18 to 24 monthsbefore we have data," Nuss said.
The trials will be clinic-initiated, meaning that the cream will beadministered at a clinic rather than by patients at home. An ongoingU.S. Phase II trial, with 60 patients, is not clinic-initiated, which canresult in misapplication, Nuss said.
"The basic thing we're looking for is healing," Nuss said. "Theefficacy we're hoping to show is that Lidakol does it significantlyquicker than placebo."
Lidak already has completed a Phase II U.S. trial of Lidakol ingenital herpes. But Nuss said the company is going to focus for nowon the oral herpes indication. "We're not in a position [financially] todo two Phase III studies at once," he said.
As of Sept. 30, Lidak had about $17.4 million in cash andequivalents. Nuss said that should last about two years, probablyenough to get through the Phase III trial. Lidak stock(NASDAQ:LDAKA) was up 3 cents per share Wednesday, closingat $2.06. The company has about 28.5 million shares outstanding.
Lidakol is a long-chained fatty alcohol that acts by interfering withviral entry into target cells. Nuss said it also appears to have anti-inflammatory properties.
A month ago Grelan Pharmaceutical Co. Ltd., of Tokyo, gaineddevelopment and marketing rights to Lidakol in Japan. In exchange,Lidakol received an undisclosed up-front licensing fee, milestonepayments and royalties on sales. CTS Chemical Industries of Israelhas rights to the product in that country, and Boryung Pharma Co.Ltd., of Seoul, has rights in Korea.
Nuss said Lidakol "wants the right deal" in its search for a marketingpartner in the U.S. The company's president and CEO, David Katz,earlier had told BioWorld that Lidakol does not plan to market thedrug itself in the U.S.
Nuss said Lidakol is doing preclinical work with Lidakol in otherdiseases, including chicken pox and shingles. The company also is inpreclinical studies with its Large Multivalent Immunogen technologyfor potential therapies against cancer and viral diseases.
"These Phase III trials in the United States are an important part ofLidak's development and growth as a pharmaceutical company,"Katz said in a news release. "If positive results are obtained from thisstudy and the ongoing European Phase III clinical trials, we shouldhave the necessary clinical data for filing a new drug application forLidakol in the United States and an equivalent application inEurope." n
-- Jim Shrine
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