Martinsried/ Munich, September 09, 2008. MediGene AG (Frankfurt, Prime Standard: MDG) announces that the European Society for Medical Oncology (ESMO) has selected the late-breaking abstract from MediGene’s drug candidate EndoTAG(TM)-1 for the treatment of pancreatic cancer for presentation at the Gastrointestinal Tumors session of the 33rd ESMO Congress. The abstract LBA7 is entitled: 12-MONTH SURVIVAL DATA OF A PHASE II TRIAL: FIRST LINE TREATMENT OF INOPERABLE PANCREATIC ADENOCARCINOMA WITH CATIONIC LIPID COMPLEXED PACLITAXEL NANOPARTICLES (ENDOTAG-1®) PLUS GEMCITABINE COMPARED WITH GEMCITABINE MONOTHERAPY and will also be highlighted at the ESMO Congress press conference. New 12-month survival data from the 200 patient Phase II study with EndoTAG(TM)-1 will be presented, and the data will be presented by 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.
The ESMO press conference will take place on September 14, 2008, at 12:30 pm while the late-breaking presentation will start on September 16, 2008, at 10:30 am. The presented data is embargoed until the scientific presentation and will be published in a press release on September 16, 2008.
Dr Axel Mescheder, MediGene’s Executive Board Member for Research & Development, commented: “We are delighted to have the opportunity to present further important clinical data from our successful Phase II study with EndoTAG(TM)-1 at Europe’s premier cancer conference. In addition, we regard the selection for both the ESMO press conference and the late-breaking abstract presentation as recognition of our study results.”
In March and April 2008, MediGene presented very encouraging median and six month survival data of the above mentioned, randomized and controlled Phase II study. Final analysis of the study will be available later this year.
With EndoTAG(TM)-1, MediGene’s approach is to fight cancer by “starving it” 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.
At present, MediGene is developing EndoTAG(TM)-1 for the treatment of pancreatic cancer (Phase II study completed) and for the treatment of hormone-resistant breast cancer (Phase II study ongoing). MediGene is planning to conduct further development of EndoTAG(TM)-1 together with a development and marketing partner, discussions with several of which are ongoing.
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. EndoTAG(TM) and MediGene® are registered trademarks of MediGene AG. These trademarks may be owned or licensed in select locations only.
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
