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MediGene Achieves Excellent Efficacy Data of EndoTAG(TM)-1 in Clinical Phase II Trial in Pancreatic Carcinoma
Novel mode of action of selectively destroying tumor vascularization has been demonstrated

19 Mar 2008 - MediGene AG achieved excellent efficacy data in a clinical phase II trial of EndoTAG(TM)-1 in the indication pancreatic carcinoma. The trial in 200 patients showed substantially extended survival time of those patients treated with EndoTAG(TM)-1 in combination with the standard drug gemcitabine, compared to those receiving only gemcitabine. The survival time of the patients treated improved coinciding with increased dosage of EndoTAG(TM)-1, and particularly with increased duration of treatment.
 
The trial was conducted in three groups receiving different dosages, and one control group (only gemcitabine). The median survival time of the group treated with the highest dosage of EndoTAG(TM)-1 increased by 30 % compared to the control group. After six months of treatment, the survival rate in this dosage group was also still about 30 % higher than in the control group. Patients who received treatment with EndoTAG(TM)-1 repeatedly over a longer period of time showed even a substantially better survival time and survival rates. The positive safety profile of EndoTAG(TM)-1 shown in the interim analysis was maintained as well as its positive effect on the patients' quality of life. MediGene intends to present data at an upcoming clinical conference. The detailed data evaluation will be published in the fourth quarter of 2008. The European Commission granted the orphan drug designation for EndoTAG(TM)-1 in the indication pancreatic cancer, ensuring EU market exclusivity for the drug for a period of ten years following marketing authorization.