MediGene successfully completes patient recruitment into EndoTAG(TM)-1 Phase II breast cancer trial

Martinsried/Munich, October 9, 2009. MediGene AG (Frankfurt: MDG, Prime Standard, TecDAX) has successfully completed patient recruitment into its randomized Phase II trial of EndoTAG(TM)-1 for the treatment of triple receptor-negative breast cancer. Results will be available as scheduled in the first six months of 2010. This multinational clinical trial is being conduced across more than 20 centres in Europe and India.




The trial was designed to enrol patients suffering from hormone receptor and HER-2-recepor negative breast cancer who have metastastatic disease. The trial recruited 135 patients divided into three groups: EndoTAG(TM)-1 alone, EndoTAG(TM)-1 in combination with a cytotoxic drug or the cytotoxic drug alone. The study will assess safety, tolerability and efficacy. The primary endpoint of the trial is progression-free survival after 16 weeks,.




Dr. Axel Mescheder, CSO & CDO of MediGene AG, commented: "The completion of patient recruitment in this important trial is another key milestone for MediGene which also shows the high degree of acceptance of this treatment among physicians and patients. It also ensures that we will be able to conclude the trial within the projected time frame. This controlled trial has been powered to allow the assessment of both the efficacy and the safety of EndoTAG(TM)-1 in this very difficult to treat cancer population."




About EndoTAG(TM)-1: The drug candidate EndoTAG(TM)-1 selectively attacks blood vessels needed for the growth of tumors. It is a novel combination of positively charged liposomes and the embedded active substance paclitaxel. EndoTAG(TM)-1 is targeted to the negatively charged cells that are lining newly formed tumor blood vessels. Thus only tumor blood vessels are attacked without harm to healthy tissue. At the same time EndoTAG(TM)-1 inhibits the development of new blood vessels, which is intended to suppress further tumor growth.


MediGene already reported positive results from a Phase II trial of EndoTAG(TM)-1 for the treatment of pancreatic carcinoma.




About triple receptor-negative breast cancer: Breast cancer is the most common cancer in women. Malignant breast tumors that display neither the estrogen or progesterone receptors nor the HER-2 receptor on the cell surface are called "triple receptor-negative". About 15 - 20 % of all breast cancer incidences belong to this subcategory. There are few therapeutic options for patients with triple receptor-negative breast cancer, since the existing anti-hormonal therapies, or those treatments targeted at the HER-2 cannot be used. In the case of recurrence after initial surgery, or development of metastases, the only remaining treatment option is chemotherapy. However, the treatment benefit achieved with the cytotoxiic agents currently available remains low.




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) and EndoTAG(TM) are trademarks of MediGene AG. This trademark may be held or licensed for specific countries.




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MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard, TecDAX) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company to have drugs on the market, which are being distributed by partner companies and has several drug candidates in clinical development, two of which provide significant sales potential. In addition, the company has numerous projects in research and pre-clinical development and possesses innovative platform technologies. MediGene focuses on the research and development of novel drugs for the treatment of cancer and autoimmune diseases




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