MediGene successfully completes patient recruitment into
EndoTAG(TM)-1 Phase II breast cancer trial
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Martinsried/Munich, October 9, 2009. MediGene AG (Frankfurt: MDG,Prime Standard, TecDAX) has successfully completed patientrecruitment into its randomized Phase II trial of EndoTAG(TM)-1 forthe treatment of triple receptor-negative breast cancer. Results willbe available as scheduled in the first six months of 2010. Thismultinational clinical trial is being conduced across more than 20centres in Europe and India.The trial was designed to enrol patients suffering from hormonereceptor and HER-2-recepor negative breast cancer who havemetastastatic disease. The trial recruited 135 patients divided intothree groups: EndoTAG(TM)-1 alone, EndoTAG(TM)-1 in combination witha cytotoxic drug or the cytotoxic drug alone. The study will assesssafety, tolerability and efficacy. The primary endpoint of the trialis progression-free survival after 16 weeks,.Dr. Axel Mescheder, CSO & CDO of MediGene AG, commented: "Thecompletion of patient recruitment in this important trial is anotherkey milestone for MediGene which also shows the high degree ofacceptance of this treatment among physicians and patients. It alsoensures that we will be able to conclude the trial within theprojected time frame. This controlled trial has been powered to allowthe assessment of both the efficacy and the safety of EndoTAG(TM)-1in this very difficult to treat cancer population."About EndoTAG(TM)-1: The drug candidate EndoTAG(TM)-1 selectivelyattacks blood vessels needed for the growth of tumors. It is a novelcombination of positively charged liposomes and the embedded activesubstance paclitaxel. EndoTAG(TM)-1 is targeted to the negativelycharged cells that are lining newly formed tumor blood vessels. Thusonly tumor blood vessels are attacked without harm to healthy tissue.At the same time EndoTAG(TM)-1 inhibits the development of new bloodvessels, which is intended to suppress further tumor growth.MediGene already reported positive results from a Phase II trial ofEndoTAG(TM)-1 for the treatment of pancreatic carcinoma.About triple receptor-negative breast cancer: Breast cancer is themost common cancer in women. Malignant breast tumors that displayneither the estrogen or progesterone receptors nor the HER-2 receptoron 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 triplereceptor-negative breast cancer, since the existing anti-hormonaltherapies, or those treatments targeted at the HER-2 cannot be used.In the case of recurrence after initial surgery, or development ofmetastases, the only remaining treatment option is chemotherapy.However, the treatment benefit achieved with the cytotoxiic agentscurrently available remains low.This press release contains forward-looking statements that involverisks and uncertainties. The forward-looking statements containedherein represent the judgment of MediGene as of the date of thisrelease. These forward-looking statements are no guarantees forfuture performance, and the forward-looking events discussed in thispress release may not occur. MediGene disclaims any intent orobligation to update any of these forward-looking statements.MediGene(TM) and EndoTAG(TM) are trademarks of MediGene AG. Thistrademark may be held or licensed for specific countries. - ends -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 thefirst German biotech company to have drugs on the market, which arebeing distributed by partner companies and has several drugcandidates in clinical development, two of which provide significantsales potential. In addition, the company has numerous projects inresearch and pre-clinical development and possesses innovativeplatform technologies. MediGene focuses on the research anddevelopment of novel drugs for the treatment of cancer and autoimmunediseasesContact MediGene AGE-mail: investor(at)medigene.comFax: +49 - 89 - 85 65 - 2920Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: +49 - 89 - 8565 - 3324Dr. Georg Dönges, Investor Relations, Tel.: +49 - 89 - 85 65 - 2946 --- End of Message ---MediGene AGLochhamer Strasse 11 Martinsried / München GermanyWKN: 502090; ISIN: DE0005020903 ; Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr in Niedersächsische Börse zu Hannover, Regulierter Markt in Frankfurter Wertpapierbörse;
Datum: 09.10.2009 - 08:30 Uhr
Sprache: Deutsch
News-ID 6742
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