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* Longer survival times for EndoTAG(TM)-1 treated patients compared to standard therapy in controlled Phase II study with 200 patients * Data will be presented today at the Late-Breaking abstract session of the 33rd ESMO Congress in Stockholm * Analysts conference call and webcast today, 2pm CEST, 1pm BST, 8am EDT
Martinsried / Munich, September 16, 2008. MediGene AG (Frankfurt, Prime Standard: MDG) today reports new clinical data for its drug candidate EndoTAG(TM)-1. After 12-months of treatment in a controlled Phase II study conducted with 200 pancreatic cancer patients, those patients treated with EndoTAG(TM)-1 in combination with standard therapeutic Gemcitabine showed noticeably higher survival rates than patients treated with Gemcitabine alone. The data will be presented today at the late-breaking session of the European Society of Medical Oncology (ESMO) Congress in Stockholm, Sweden.
Study results: This study assessed EndoTAG(TM)-1 in pancreatic cancer, an especially aggressive and difficult to treat indication. In the controlled, randomized, Phase II study, 200 patients were treated with Gemcitabine alone (the control arm) or Gemcitabine in combination with EndoTAGT(TM)-1 at three different dose-levels. The 12-month survival rate of patients treated with Gemcitabine alone was 17%, while it was 22% (low dose), 36% (medium dose), and 33% (high dose) for patients receiving EndoTAG(TM)-1 in combination with Gemcitabine. In the EndoTAG(TM)-1 groups, the second half of patients enrolled had the opportunity to receive treatment with EndoTAG(TM)-1 repeatedly and for a longer period of time. The 12-month survival rates of these patient groups were higher still, with 25% (low dose), 52% (medium dose), and 40% (high dose). Based on the data available so far, this study confirmed the favorable safety profile of EndoTAG(TM)-1 observed in previous studies. Final data from this Phase II study will be available in the fourth quarter of 2008.
"These study data demonstrate a noticeably higher efficacy from EndoTAG(TM)-1 treatment compared to currently available treatments for pancreatic cancer. Accordingly, the results suggest that, if further development is successful, EndoTAG(TM)-1 has the potential to offer a significant improvement in the therapy of this very aggressive cancer type", commented the trial's principal investigator, Prof Dr Mathias Löhr, Professor of Gastroenterology and Hepatology at Karolinska Institutet, Stockholm, and Head of Molecular Gastroenterology at the German Cancer Research Center (DKFZ), Heidelberg.
"These 12-month survival data confirm the convincing results we have already observed with EndoTAG(TM)-1 in the treatment of pancreatic cancer, and they leave us very excited and optimistic about the further development of this innovative drug candidate. MediGene is currently developing EndoTAG(TM)-1 as a potential therapy for pancreatic and breast cancer", said Dr. Axel Mescheder, MediGene's Executive Board Member for Research & Development.
MediGene expects to continue the development of EndoTAG(TM)-1 with a development and marketing partner, and is already in contact with potential partners.
Study design and endpoints: Patients participating in the study were suffering from inoperable, locally advanced or metastasizing pancreatic carcinoma. The aim of the study was to assess the safety, tolerability and efficacy of different doses of EndoTAG(TM)-1 in combination with Gemcitabine, and patients were randomized to one of four study groups. Three groups received EndoTAG(TM)-1 at different doses (11, 22, and 44 mg/m2, respectively) twice weekly for seven weeks. On top of that, Gemcitabine was administered once a week. The control group was treated once a week with Gemcitabine only. In the second stage of the trial with 102 patients included, there was an opportunity to continue the treatment with EndoTAG(TM)-1 if the tumor showed a response. The patients in the control group had the opportunity to receive further treatment with any other drug available. In addition to median survival and 12-month survival data, both of which have now been reported, the final analyses of the study will include data on tumor response and on the influence on the patients' quality of life.
Pancreatic cancer: With an incidence of more than 90,000 in the US, Japan, and the five biggest European countries and about the same number of deaths, pancreatic cancer constitutes the fourth most common tumor-related cause of death. Less than 20% of the newly diagnosed patients are eligible for surgical removal of the tumor, and median survival of patients is only 6-7 months. On average, around 19% of patients are alive after 12 months, and five-year survival is only around 4%. As a result, pancreatic cancer represents a high unmet medical need. At present, Gemcitabine is the most common drug used for the treatment of pancreatic cancer.
Mechanism of action of EndoTAG(TM)-1: The concept of EndoTAG(TM)-1 is to "starve" the cancer through the targeted destruction of endothelial cells of the blood vessels supplying the tumor. EndoTAG(TM)-1 is a positively charged lipid complex which attaches itself selectively to the negatively charged cells lining newly formed tumor blood vessels. Thereafter, the lipid complex releases the cytostatic drug paclitaxel, in order to destroy the blood vessels and to cut off supply of the tumor tissue.
MediGene believes that this targeted destruction of endothelial cells will not give rise to treatment drug resistance, a common problem of many current tumor therapies. In addition, it is expected that the mechanism of action of EndoTAG(TM)-1 will be broadly applicable and suited for the treatment of multiple types of cancer.
In pancreatic cancer, tumor cells are known to be insensitive to treatment by taxanes such as paclitaxel. Therefore, this tumor type is well suited to test hypotheses of the specific mode of action of EndoTAG(TM)-1: if the tumor responds to treatment, the effect is caused by the vessel-destroying properties of EndoTAG(TM)-1 and not by the mere transport of the cytostatic drug to the tumor. However, in taxane-sensitive tumors such as breast cancer, the accumulation of paclitaxel in the tumor tissue is expected to show additional, direct effects on the tumor.
EndoTAG(TM)-1 clinical development projects: In addition to the Phase II study with EndoTAG(TM)-1 in pancreatic cancer, MediGene is currently conducting a Phase II study in patients with hormone-resistant breast cancer. Results of this study are expected in 2009.
EndoTAG(TM) technology platform: MediGene's EndoTAG(TM) platform provides the opportunity to develop the technology in further therapeutic applications, both in oncology indications and beyond.
Conference call with webcast: MediGene will present the clinical data of the above Phase II study in a conference call to analysts and investors alongside with a live webcast. The call is held in English and starts today at 2pm CEST, 1pm BST and 8am EDT.
The conference will be accessible by live webcast. Access, including synchronized slides, will be available on the MediGene website at www.medigene.com. Following the live presentation, a replay will also be available.
This press release contains forward-looking statements representing the opinion of MediGene as of the date of this release. The actual results achieved by MediGene may differ significantly from the statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene® and EndoTAG(TM) are trademarks of MediGene AG. These trademarks may be owned licensed in select locations only.
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MediGene AG is a publicly listed (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 to have drugs on the market, which are being distributed by partner companies. MediGene has several drug candidates in clinical development, some of which with an individual annual peak sales potential exceeding 1 billion €. Moreover, the company has 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.
Contact MediGene AG E-mail: investor@medigene.com Fax:++49 - 89 - 85 65 - 2920 Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: ++49 - 89 - 85 65 - 3324 Dr. Georg Dönges, Investor Relations, Tel.: ++49 - 89 - 85 65 - 2946
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MediGene AG Lochhamer Strasse 11 Martinsried / München Germany
WKN: 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, Geregelter Markt in Frankfurter Wertpapierbörse;
