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news.MediGene, a German-American biotech company, has initiated a phase II clinical trial of drug candidate EndoTAG-1, for the treatment of advanced pancreatic cancer.
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EndoTAG-1 is a combination of paclitaxel (sold as Taxol by Bristol-Myers Squibb) and a unique carrier system which targets paclitaxel to newly formed blood vessels. EndoTAG aims at starving cancerous tumors by destroying blood vessels and thereby cutting off nutrient supply.
The trial will evaluate safety, tolerability and efficacy trends of various doses of EndoTAG-1 in combination with gemcitabine, a cytostatic drug approved for the treatment of pancreatic cancer. The study will be conducted in 20 centers in four European countries over the next 18 months and will enroll 200 patients. An interim analysis of the results of the first 100 patients is planned for the end of 2006.
“An efficient, life prolonging therapy for pancreatic cancer does not exist,” said Prof Matthias Lohr, Clinic Mannheim of Heidelberg University, the study’s principal investigator. “Therefore, the need for new therapies is high. We consider EndoTAG a highly promising therapeutic approach for this form of cancer.”