MediGene AG announces the start of a phase 3 trial for PolyphenonE to treat genital warts

The German biopharmaceutical company MediGene AG, Munich, (NMarkt: MDG), announced today that a phase 3 trial for Polyphenon™E to treat genital warts caused by Human Papilloma Viruses was initiated end of December 2000. MediGene currently has three product candidates in clinical trials including two in advanced trials: Etomoxir against Congestive Heart Failure in phase 2 and Polyphenon™E against genital warts in phase 3. Internal development and the planned acquisition of NeuroVir Inc. are to add another three product candidates in clinical trials to the clinical pipeline in the first quarter of 2001.

The multi-center clinical trial will include 260 patients (50% males, 50% females) in 30 centers in Germany and Russia. It will be randomized, double-blinded and placebo-controlled. The major aim of the study will be to test the efficacy of two different formulations of Polyphenon™E for the treatment of external genital warts.

“We are delighted that Polyphenon™E as the first of a number of clinical development projects has entered a phase 3 clinical trial and even ahead of schedule”, stated Peter Heinrich, Ph.D., MediGene’s CEO. “The clinical trials that have been performed for Polyphenon™E in Canada, the US and China have demonstrated safety and a positive trend in efficacy. We are convinced Polyphenon™E is superior to existing treatments.”

The active ingredients of Polyphenon™E are so called polyphenols, which inhibit the infectious properties of the viruses. In addition, they have anti-tumor and anti-inflammatory properties. Polyphenon™E is to be the first product of MediGene’s pipeline to enter the market.

Genital warts are tumors caused by the virus strains HPV 6 and HPV 11. The tumors are non-malignant, but disfigure the genital tract and can be painful. Most treatments of genital warts today involve surgical or chemical procedures often associated with pain, tissue destruction, scarring and local skin reaction such as burning and itching. A further problem is the reappearance of the warts after the end of treatment. Genital warts is one of the fastest growing sexually transmitted diseases worldwide. 14 million people in North America and Europe suffer from the disease, of which only about 3 million are seeking treatment today. Therefore innovative treatments like MediGene’s ointment offer a high market potential.