BioWorld International Correspondent

BORNHEIM, Germany - MediGene AG has taken Polyphenon E for the treatment of genital warts into Phase III clinical trials.

"We'll run this study at 30 centers in Germany and Russia," MediGene CEO Peter Heinrich said, adding that 260 patients will be included. The placebo-controlled, randomized, double-blind trials will include an equal number of men and women.

The warts to be treated are tumors caused by human papilloma virus strains HPV 6 and HPV 11. Such warts are benign, MediGene said, but distorting and sometimes painful. Therapy now includes surgery, cautery or drugs. "Current treatments are combined with a high recurrence rate," said Heinrich.

Polyphenon E appears to have a wide variety of activities, such as being antioxidative, anti-inflammatory andblocking virus binding to the cell, as well as having strong antitumor activity, he said. In the trials it will be applied as cream or as ointment.

Epitome Inc., of San Diego, invented the drug.

"We in-licensed the substance with Phase II studies going on already," Heinrich said. "These had been run in the U.S., Canada and China and have demonstrated safety and a positive trend in efficacy. We are convinced Polyphenon E is superior to existing treatments."

MediGene has no partner for the candidate.

"We want to maximize the value of our products," he said. "Therefore we intend to drive products into clinical trials as far as we can on our own. And we want to keep options to commercialize most products on our own label. Over the long run raising only 5 percent to 10 percent royalties from early strategic partnerships would not be enough for long-term survival and sustainability," Heinrich told BioWorld International. He expects potential peak sales of EUR50 million.

Heinrich said the study should be completed this year, a short development time compared to the industry norm.

"In treating a wart, we do not need any long-time surveillance to find out whether our drug works," he said. "The wart either vanishes or it stays. That means we'll see success close to treatment."

MediGene expects the drug to be its first launched. The company has five products in its clinical pipeline, assuming its acquisition of San-Diego based NeuroVir Inc. will be completed.