BORNHEIM, Germany ¿ MediGene AG said data from a Phase III trial of its drug for genital warts, Polyphenon E, are strongly convincing.
In the trials a cream containing the drug had a clearance rate of 61 percent for men and 57 percent for women, the Martinsried, Germany-based company said. Placebo showed 37 percent clearance.
The randomized, double-blind, placebo-controlled, multicenter trial included 272 patients in 30 centers in Germany and Russia.
Two different formulations of Polyphenon E, cream and ointment, were tested for their efficacy in the topical treatment of external genital warts, MediGene said, adding that both contained an undisclosed adjuvant ingredient, which has a certain efficacy on its own.
All study objectives were attained, such as clearance of warts with few side effects as well as the identification of a superior formulation, MediGene said.
The company added that both formulations were well tolerated, with over 90 percent of patients reporting only mild or moderate side effects.
Recurrence rates of warts to date are promising, MediGene said. ¿Data on recurrence will be assessed finally three months after the end of the trial,¿ MediGene spokeswoman Christine Bohner told BioWorld International. She expects such data to be available by the end of the year or early in 2002.
The results exceeded MediGene¿s expectations, MediGene¿s chief operating officer, Johanna Holdack, said in a prepared statement.
As the FDA requires two independent Phase III trials, preparations for an extended multicenter Phase III clinical trial with the optimal formulation are ongoing, MediGene said. The company expects this trial to start in the first quarter of next year.
MediGene said it expects Polyphenon E to become the second product in its pipeline to enter the market after Leuprogel to treat prostate cancer, a licensed-in product being prepared for registration with the European authorities.