MediGene Completes Patient Recruitment for Clinical Phase II Trial of
EndoTAG®-1
Martinsried/Munich, April 25, 2007. Today MediGene AG (Frankfurt,
Prime Standard: MDG) has completed patient recruitment for the
clinical phase II trial of EndoTAG®-1 for the treatment of pancreatic
cancer as scheduled. The last of the 200 patients enrolled received
treatment for the first time and will be monitored for a period of
six months. MediGene expects the final results in the first six
months of 2008.
The trial plan is designed for the treatment in four groups of 50
patients each, three groups receiving a different dosage of
EndoTAG®-1, and one control group. In April 2007, MediGene initiated
another phase II trial of EndoTAG®-1 in the indication
receptor-negative breast cancer, which is planned to enroll 135
patients.
EndoTAG®-1: EndoTAG®-1 destroys tumor blood vessels, thus "starving
out" tumor cells. It is a combination of the cytostatic drug
paclitaxel and a targeted delivery system made up of cationic lipids.
This delivery system provides for a specific transport to newly
formed tumor blood vessels where the cytostatic drug is released,
thus destroying the blood vessels and cutting off nutrient supply.
The ongoing phase II trial is also designed to make the tumor more
accessible for the gemcitabine which is administered simultaneously.
Preclinical experiments showed a synergistic effect of these two
substances.
Trial design and objective (phase II, pancreatic cancer): The
patients enrolled in the trial suffer from inoperable, advanced, or
metastasized pancreatic carcinoma. They are randomly assigned to one
of four groups. The patients in these groups are administered various
doses of EndoTAG®-1 twice a week for a period of seven weeks. Once a
week, EndoTAG®-1 will be administered in combination with
gemcitabine. The control group patients will receive only the
standard medication (gemcitabine) once a week. The primary objective
of the trial is to investigate safety, tolerability, and efficacy
trends of various doses of EndoTAG®-1 in combination with
gemcitabine. The effect on the six-month survival rate, the tumor
response to treatment, and the influence of the therapy on the
patients' quality of life will be assessed.
Pancreatic carcinoma: With approximately 32,000 incidences annually
in the US, and a similar number of deaths, pancreatic carcinoma ranks
fourth among the tumor-related causes of death. Only 5 to 25 % of
patients are operable at the time of diagnosis. Due to the extremely
aggressive course of the disease, and the dissatisfying systemic
therapy options, the average survival is as low as six months.
Approximately 19 % of the patients survive one year, and the
five-year survival rate is only 4 %. Pancreatic carcinoma is one of
the most aggressive types of cancer, and represents an enormous
challenge in oncology. Therefore the need for new therapeutic options
is very high.
This press release contains forward-looking statements that involve
risks and uncertainties. The forward-looking statements contained
herein represent the judgment of MediGene as of the date of this
release. These forward-looking statements are no guarantees for
future performance, and the forward-looking events discussed in this
press release may not occur. MediGene disclaims any intent or
obligation to update any of these forward-looking statements.
MediGeneTM and EndoTAG®-1 are trademarks of MediGene AG,
- Ends -
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 with a drug on the market. A second drug has
been approved by the FDA. A third drug was recently inlicensed to
market this drug in Europe. In addition, several drug candidates are
currently in clinical development. MediGene also possesses innovative
platform technologies. The company's core competence lies in research
and development of novel approaches in anti cancer therapies. Thus
MediGene focuses on indications of high medical need and great
economic opportunities.
Contact MediGene AG:
Email:
investor@medigene.com
Fax: ++49 - 89 - 85 65 - 2920
Julia Hofmann/Dr. Georg Dönges, Public
Relations Tel.: ++49 - 89 - 85
65 - 3317
Dr. Michael Nettersheim, Investor Relations
Tel.: ++49 - 89 - 85 65 - 2946
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MediGene AG
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