31.03.2004 – 08:05
euro adhoc: MediGene AG
MediGene Achieves Excellent Clinical
Results With Polyphenon® E Ointment in European Phase 3 Trial (E)
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Martinsried - San Diego, March 31, 2004. The German-American biotech company MediGene AG (Frankfurt, Prime Standard: MDG) has achieved excellent results in a European phase 3 trial of the Polyphenon® E Ointment for the treatment of genital warts. The statistically significant trial with more than 500 patients showed a high and lasting efficacy of the drug with extremely low systemic adverse reactions. The results of this trial, along with the data from the still ongoing American phase 3 trial will be prerequisites for the marketing authorization application for Polyphenon® E Ointment. The pooled results of both trials are expected at the end of 2004.
In these two phase 3 trials, efficacy and safety of Polyphenon® E Ointment for the treatment of external genital warts are being investigated in three groups of patients each (10 % and 15 % ointment compared to placebo). The European trial has achieved all objectives of the trial. Approximately 53 % of the patient treated with the 15 % Polyphenon® E Ointment showed complete clearance of all external genital warts (clear statistical significance p = 0.01 compared to placebo). In about 78 % of all patients treated with Polyphenon® E Ointment, most or all of the genital warts disappeared. Recurrence of genital warts during the twelve weeks of follow-up occurred only in a very small number of patients (less than 5 %). Local skin reactions (e.g. itching, burning) were mostly mild or moderate. The trial is based on discussions with European regulatory authorities, had been agreed with the US FDA and complies with international quality standards.
end of announcement euro adhoc 31.03.2004
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