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* Prolonged survival for patients treated with EndoTAG(TM)-1 compared to patients treated with standard therapy in randomized Phase II study in 200 patients
* Further positive efficacy data, including extended progression-free survival and increased tumor stabilization rates
* Favorable safety profile
* Detailed presentation of data to be given at MediGene's analyst day and webcast on October 22
Martinsried / Munich, October 20, 2008. Today MediGene AG (Frankfurt, Prime Standard: MDG) reports final data for its drug candidate EndoTAG(TM)-1 for the treatment of inoperable pancreatic cancer. These final data confirm previously released results regarding median overall survival as well as 6-month and 12-month survival. Moreover, positive results for other study endpoints including increased median progression-free survival and tumor stabilization were shown. Furthermore, the safety profile was favorable.
The study assessed EndoTAG(TM)-1 in pancreatic cancer, a particularly aggressive and difficult to treat tumor in a controlled, randomized Phase II study in 200 patients. EndoTAG(TM)-1 was administered in three different dose levels in combination with gemcitabine. Patients in the control arm were treated with gemcitabine alone.
Study results: Combination treatment with EndoTAG(TM)-1 and gemcitabine resulted in a dose-dependent increase of the median overall survival to up to 9.4 months, compared to 7.2 months in the control arm. The 12-month survival rate of patients treated with EndoTAG(TM)-1 increased to up to 36%, compared to 17% in the control arm. Those patients who had the option to receive repeated treatment cycles with EndoTAGTM-1 showed an even significantly higher median overall survival up to 13.6 months and a 12-month survival rate of up to 52%.
These final data of the Phase II study suggest that the maximum efficacy of EndoTAG(TM)-1 was achieved in the medium and high dose groups. In patients who received EndoTAG(TM)-1 in combination with gemcitabine, the median progression-free survival was 4.1 months (low dose), 4.6 months (medium dose), and 4.4 months (high dose), compared to 2.7 months in patients treated with gemcitabine alone. Tumor stabilization was achieved in 59% (low dose), 69% (medium dose), and 53% (high dose) of patients treated with EndoTAG(TM)-1, whereas 43% of the patients treated with gemcitabine alone showed tumor stabilization. Compared to other combination chemotherapies, the safety profile of EndoTAG(TM)-1 was positive.
"We are very happy that these final data substantiate the convincing study results that EndoTAG(TM)-1 has achieved thus far in the treatment of pancreatic cancer. Therefore, we remain very optimistic about the further development of this innovative drug candidate, which MediGene is currently developing as a potential therapy for both pancreatic and breast cancer," said Dr. Axel Mescheder, MediGene's Executive Board Member for Research & Development.
MediGene intends to continue the development of EndoTAG(TM)-1 in cooperation with a development and marketing partner, and has already established contact with potential partners.
Study design and endpoints: The aim of the study was to assess safety, tolerability, and efficacy of different doses of EndoTAG(TM)-1 in combination with gemcitabine. The patients participating in the study were suffering from inoperable, locally advanced, or metastasizing pancreatic carcinoma. They 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, in combination with weekly gemcitabine. The control group was treated with weekly gemcitabine only. In the second stage of the trial, into which 102 patients were enrolled, patients had the opportunity to continue 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.
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 patient survival is only 6-7 months. On average, around 19% of patients are still alive after 12 months, and the five-year survival rate is only around 4%. Consequently, pancreatic cancer represents a high unmet medical need. At present, gemcitabine is the most common drug used for the treatment of pancreatic cancer.
Mode of action of EndoTAG(TM)-1: EndoTAG(TM)-1 is believed to work by selectively attacking the blood vessels supplying the tumor. EndoTAG(TM)-1 is a novel formulation of positively charged liposomes which systematically transports the dissolved cytostatic drug paclitaxel to the negatively charged endothelial cells lining newly formed tumor blood vessels. The drug attacks the tumor blood vessels and suppresses the development of new vessels at the same time. This prevents further tumor growth.
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 mode of action of EndoTAG(TM)-1 will be broadly applicable, and may be 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
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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;
