Martinsried/Munich, April 25, 2007. Today MediGene AG (Frankfurt, Prime Standard: MDG) has completed patient recruitment for the clinical phase II trial of EndoTAG®-1 for the treatment of pancreatic cancer as scheduled. The last of the 200 patients enrolled received treatment for the first time and will be monitored for a period of six months. MediGene expects the final results in the first six months of 2008.
The trial plan is designed for the treatment in four groups of 50 patients each, three groups receiving a different dosage of EndoTAG®-1, and one control group. In April 2007, MediGene initiated another phase II trial of EndoTAG®-1 in the indication receptor-negative breast cancer, which is planned to enroll 135 patients.
EndoTAG®-1: EndoTAG®-1 destroys tumor blood vessels, thus “starving out” tumor cells. It is a combination of the cytostatic drug paclitaxel and a targeted delivery system made up of cationic lipids. This delivery system provides for a specific transport to newly formed tumor blood vessels where the cytostatic drug is released, thus destroying the blood vessels and cutting off nutrient supply. The ongoing phase II trial is also designed to make the tumor more accessible for the gemcitabine which is administered simultaneously. Preclinical experiments showed a synergistic effect of these two substances.
Trial design and objective (phase II, pancreatic cancer): The patients enrolled in the trial suffer from inoperable, advanced, or metastasized pancreatic carcinoma. They are randomly assigned to one of four groups. The patients in these groups are administered various doses of EndoTAG®-1 twice a week for a period of seven weeks. Once a week, EndoTAG®-1 will be administered 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 investigate safety, tolerability, and efficacy trends of various doses of EndoTAG®-1 in combination with gemcitabine. The effect on the six-month survival rate, the tumor response to treatment, and the influence of the therapy on the patients’ quality of life will be assessed.
Pancreatic carcinoma: With approximately 32,000 incidences 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 systemic therapy options, the average survival is as low as six months. Approximately 19 % of the patients survive one year, and the five-year survival rate is only 4 %. Pancreatic carcinoma is one of the most aggressive types of cancer, and represents an enormous challenge in oncology. Therefore the need for new therapeutic options is very high.
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. MediGeneTM and EndoTAG®-1 are trademarks of MediGene AG.
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MediGene AG is a publicly quoted (Frankfurt: Prime Standard: MDG) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company with a drug on the market. A second drug has been approved by the FDA. A third drug was recently inlicensed to market this drug in Europe. In addition, several drug candidates are currently in clinical development. MediGene also possesses innovative platform technologies. The company’s core competence lies in research and development of novel approaches in anti cancer therapies. Thus MediGene focuses on indications of high medical need and great economic opportunities.
Contact MediGene AG: Email: investor@medigene.com Fax: ++49 - 89 - 85 65 - 2920 Julia Hofmann/Dr. Georg Dönges, Public Relations, Tel.: ++49 - 89 - 85 65 - 3317 Dr. Michael Nettersheim, Investor Relations, Tel.: ++49 - 89 - 85 65 - 2946
