MARTINSRIED, Germany and SAN DIEGO, Aug. 24 /PRNewswire-FirstCall/ -- Today the German-American biotech company MediGene AG (Frankfurt, Prime Standard: MDG) announced the initiation of a phase II clinical trial of drug candidate EndoTAG(TM)-1* for the treatment of advanced pancreatic cancer. EndoTAG(TM)-1 is a combination of paclitaxel and a unique carrier system which targets paclitaxel to newly formed blood vessels. EndoTAG(TM) 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(TM)-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. Dr. Matthias Lohr, Clinic Mannheim of Heidelberg University, the study's principal investigator. "Therefore, the need for new therapies is high. We consider EndoTAG(TM) a highly promising therapeutic approach for this form of cancer." "Following several phase I/II trials in different indications with 151 patients showing safety and promising efficacy trends of EndoTAG(TM)-1, we are continuing the clinical development of this innovative drug candidate," said Dr. Peter Heinrich, MediGene's Chief Executive Officer. "The platform technology EndoTAG(TM) has a great potential for the treatment of various solid, highly vascularized tumors. Therefore we plan to start further trials in other cancer indications in 2006." EndoTAG(TM)-1*: EndoTAG(TM)-1 is a combination of the established cytostatic drug paclitaxel and a targeted delivery system made up of cationic lipids. This system affects the specific delivery of the drug and destruction of newly formed tumor blood vessels thereby cutting off nutrient supply. At the same time the tumor's permeability for the simultaneously administered gemcitabine is expected to increase. A synergistic effect of paclitaxel and gemcitabine has been shown in preclinical experiments. Study's design and aims: The patients enrolled in the study suffer from inoperable, advanced and metastasized pancreatic carcinoma. They will be randomly assigned to one of four groups. The patients in these groups will be administered various doses of EndoTAG(TM)-1 twice a week for seven weeks. Once a week, EndoTAG(TM)-1 will be given in combination with gemcitabine. The control group patients will receive only the standard medication (gemcitabine) once a week. The primary objective of the trial is to evaluate safety, tolerability and trends of various doses of EndoTAG(TM)-1 in combination with gemcitabine. A further goal is to determine a dose suited for further clinical development. The effect on the six-month survival rate, the response of the tumor to treatment, and the influence of the therapy on the patients' quality of life will be assessed. Pancreatic carcinoma: With approximately 32.000 new cases annually in the US and a similar number of deaths, pancreatic carcinoma ranks fourth among the tumor related causes of death. Only 5 to 25 % of patients are operable at the time of diagnosis. Due to the extremely aggressive course of the disease and the dissatisfying therapeutic options, the average survival is as low as six months. One year survival is approximately 19 % and five year survival drops to 4 %. Pancreatic carcinoma is one of the most aggressive forms of cancer and an enormous challenge in Oncology. Therefore, the need for new therapeutic options is very high. * temporary name while under development This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGene(TM) is a trademark of MediGene AG. MediGene AG is a publicly quoted (Frankfurt: Prime Standard), German- American biotechnology company located in Martinsried, Germany and San Diego, USA. MediGene is the first German biotech company with a drug on the market. The company has the most mature drug development pipeline in the German biotech industry and possesses innovative platform technologies. MediGene's core competence lies in research and development of novel approaches for the treatment of various tumor diseases. Thus MediGene focuses on indications of high medical need and economic opportunities. DATASOURCE: MediGene AG CONTACT: , Fax: +49-89-85-65-2920; Dr. Georg Donges, Public Relations, +49-89-85-65-3317, or Dr. Michael Nettersheim, Investor Relations, +49-89-85-65-2946, all for MediGene AG

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