MediGene Presents Details of the Excellent Clinical Efficacy Data Obtained with EndoTAG(TM)-1 in the Indication Pancreatic Carcinoma
In a controlled phase II trial, EndoTAG(TM)-1 shows a clear survival benefit compared with the approved standard therapy, and proves the mode of action of EndoTAG(TM)-1 / Conference call and internet webcast to start at 4 PM CEST today
MediGene tested EndoTAG(TM)-1 in the indication pancreatic cancer which is extremely difficult to treat. Inoperable pancreatic carcinoma is one of the most aggressive types of tumor, and if it has reached an advanced stage, there is no effective therapy for this disease. In comparative clinical trials with existing therapies, the median survival time of patients was only 6 - 7 months. The drug last approved, Erlotinib, received marketing authorization due to a median survival advantage of about 2 weeks compared with the standard therapy with gemcitabine. Since then no significant improvement has been published in pivotal clinical trials.
Trial results: During the controlled phase II trial, 200 patients suffering from pancreatic carcinoma received gemcitabine (control group), or gemcitabine in combination with EndoTAG(TM)-1 in three different dosages. The median survival time of the patients treated with gemcitabine was 7.2 months. The combination therapy with gemcitabine and EndoTAG(TM)-1, however, resulted in a dose-dependent increase in the median survival time to 8.1 months, 8.8 months, and 9.4 months, respectively in the three EndoTAG(TM) groups. The six-month survival rate also increased dose-dependently, i.e. from 63.3 % in the group treated with gemcitabine, to 66.1 %, 72.4 %, and 80.7 %, respectively in the three EndoTAG(TM) groups. The second half of the patients enrolled had the opportunity to receive treatment with EndoTAG(TM)-1 repeatedly and over a longer period of time. Dependent on the dosage administered, these patients even showed a median survival time of up to 11.5 months. The positive safety profile of EndoTAG(TM)-1 known from earlier trials was also confirmed in this phase II trial, according to the present state of knowledge. MediGene will conclude the detailed data evaluation in the fourth quarter of 2008.
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: "These convincing data represent a breakthrough in the development of EndoTAG(TM), and they are the most outstanding trial results ever achieved in our company's history. The impressive proof of the mode of action provides enormous opportunities for both our drug candidate EndoTAG(TM)-1 and the EndoTAG(TM) platform technology from which additional drug candidates may emerge in the future. Reacting to our ad-hoc release in March, several leading pharmaceutical companies already showed interest in the technology and initiated discussions for licensing EndoTAG(TM)-1. For this, the trial results form a perfect basis."
Design and objectives of the phase II trial in the indication pancreatic carcinoma: The patients enrolled in the trial suffered from inoperable, advanced, or metastasized pancreatic carcinoma. They were randomly assigned to one of four groups. In three of these groups, the patients received various doses (11, 22, and 44 mg/m²) of EndoTAG(TM)-1 twice a week for a period of seven weeks. Once a week, gemcitabine was administered in addition. In the control group, the patients received monotherapy once a week, with gemcitabine only. In the second stage of the trial, 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 drug available. The objective of the trial was to obtain information regarding safety, tolerability, and efficacy of the various doses of EndoTAG(TM)-1 in combination with gemcitabine. In addition to the data reported today regarding the median survival time and the six-month survival rate, there will be a final evaluation of the twelve-month survival rate, the tumor response to treatment, and the influence of the therapy on the patients' quality of life.
Pancreatic carcinoma: With more than 90,000 incidences annually in the US, Japan, and the five largest European countries, and a similar number of deaths, pancreatic carcinoma ranks fourth among the tumor-related causes of death. Less than 20 % of the newly diagnosed patients are still operable at the time of diagnosis. The average survival time of the patients is as low as 6 - 7 months. Approximately 19 % of the patients survive one year, and the five-year survival rate is only 4 %. Therefore there is a tremendous unmet need for novel therapeutic options for this aggressive types of cancer. At present, gemcitabine is the most common drug for the treatment of pancreatic carcinoma.
Mode of action of EndoTAG(TM)-1: EndoTAG(TM)-1 fights cancer by "starving it out", through selective destruction of tumor blood vessels. EndoTAGTM-1 is a positively charged lipid complex which attaches itself specifically to negatively charged endothelial cells of tumor blood vessels. There the cytostatic drug paclitaxel contained in EndoTAG(TM)-1 is discharged, in order to destroy the blood vessels, thus preventing nutrient supply of the tumor tissue.
The pancreatic carcinoma cells are regarded as non-sensitive to taxanes such as paclitaxel. For this reason this tumor is especially suited for the examination of the mode of action of EndoTAG(TM)-1: if the tumor shows a response, it is due to the vascular disruptive effect of EndoTAG(TM)-1, and not due to the mere transport of the cytostatic drug to the tumor. In tumors sensitive to taxanes such as breast cancer, the accumulation of paclitaxel should therefore have an additional direct effect on the tumor.
Clinical development projects with EndoTAG(TM)-1: besides the phase II trial in the indication pancreatic carcinoma, Medigene is currently conducting a phase II trial of EndoTAG(TM)-1 for the treatment of advanced breast cancer, the results of which are expected in 2009. For these two types of cancer alone, the annual sales potential of EndoTAG(TM)-1 is estimated to be 1.2 billion Euros. Further fields of application against other solid tumors, e.g. lung cancer, hepatic cancer, or intestinal cancer, increase the potential of EndoTAG(TM)-1 significantly.
EndoTAG(TM) platform technology: Based on the EndoTAG(TM) platform technology, MediGene explores therapeutic approaches with EndoTAG(TM) in other indications besides oncology. The mode of action is targeted at all diseases associated with pathological vascularization, including a number of autoimmune diseases, i.e. the common disease rheumatoid arthritis. MediGene's research activities with EndoTAG(TM) in the field of immunology are supported by federal research grants awarded to innovative projects of high benefit for the public.
Conference call with webcast: MediGene will present the clinical results from the phase II reported above on the occasion of an analyst and investor conference which will be webcast live. The conference call will take place in English at 4 PM CEST today.
The conference will be accessible by telephone or live webcast. Access including synchronized slides is available on the MediGene website at www.medigene.com. Following the live presentation, a recording will also be available.
The dial-in numbers for the conference are:
Participants from Germany:+49(69)22222246
Participants from the UK:+44(20)71380837
Participants from the USA:+1(718)3541172
Please dial in 10 minutes before the conference starts.
MediGene AG is a publicly quoted (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. In 2008, the company plans to start its own sales activities in select European countries. MediGene's drug pipeline includes several products in clinical development, among them two drug candidates with an estimated revenue potential of more than one billion Euro. In addition, MediGene is active in various research projects and possesses platform technologies for developing active compounds.
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