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Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
Martinsried/Munich, October 9, 2009. MediGene AG (Frankfurt: MDG,
Prime Standard, TecDAX) has successfully completed patient
recruitment into its randomized Phase II trial of EndoTAG(TM)-1 for
the treatment of triple receptor-negative breast cancer. Results will
be available as scheduled in the first six months of 2010. This
multinational clinical trial is being conduced across more than 20
centres in Europe and India.
The trial was designed to enrol patients suffering from hormone
receptor and HER-2-recepor negative breast cancer who have
metastastatic disease. The trial recruited 135 patients divided into
three groups: EndoTAG(TM)-1 alone, EndoTAG(TM)-1 in combination with
a cytotoxic drug or the cytotoxic drug alone. The study will assess
safety, tolerability and efficacy. The primary endpoint of the trial
is progression-free survival after 16 weeks,.
Dr. Axel Mescheder, CSO & CDO of MediGene AG, commented: "The
completion of patient recruitment in this important trial is another
key milestone for MediGene which also shows the high degree of
acceptance of this treatment among physicians and patients. It also
ensures that we will be able to conclude the trial within the
projected time frame. This controlled trial has been powered to allow
the assessment of both the efficacy and the safety of EndoTAG(TM)-1
in this very difficult to treat cancer population."
About EndoTAG(TM)-1: The drug candidate EndoTAG(TM)-1 selectively
attacks blood vessels needed for the growth of tumors. It is a novel
combination of positively charged liposomes and the embedded active
substance paclitaxel. EndoTAG(TM)-1 is targeted to the negatively
charged cells that are lining newly formed tumor blood vessels. Thus
only tumor blood vessels are attacked without harm to healthy tissue.
At the same time EndoTAG(TM)-1 inhibits the development of new blood
vessels, which is intended to suppress further tumor growth.
MediGene already reported positive results from a Phase II trial of
EndoTAG(TM)-1 for the treatment of pancreatic carcinoma.
About triple receptor-negative breast cancer: Breast cancer is the
most common cancer in women. Malignant breast tumors that display
neither the estrogen or progesterone receptors nor the HER-2 receptor
on the cell surface are called "triple receptor-negative". About 15 -
20 % of all breast cancer incidences belong to this subcategory.
There are few therapeutic options for patients with triple
receptor-negative breast cancer, since the existing anti-hormonal
therapies, or those treatments targeted at the HER-2 cannot be used.
In the case of recurrence after initial surgery, or development of
metastases, the only remaining treatment option is chemotherapy.
However, the treatment benefit achieved with the cytotoxiic agents
currently available remains low.
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.
MediGene(TM) and EndoTAG(TM) are trademarks of MediGene AG. This
trademark may be held or licensed for specific countries.
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MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard,
TecDAX) 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 and has several drug
candidates in clinical development, two of which provide significant
sales potential. In addition, the company has numerous 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 Dnges, Investor Relations, Tel.: +49 - 89 - 85 65 - 2946
- End of Message -
MediGene AG
Lochhamer Strasse 11 Martinsried / Mnchen Germany
WKN:
502090; ISIN: DE0005020903 ;
Listed: Prime Standard in Frankfurter Wertpapierbrse, Freiverkehr in
Bayerische Brse Mnchen,
Freiverkehr in Brse Dsseldorf, Freiverkehr in Brse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbrse zu Hamburg, Freiverkehr
in Niederschsische Brse zu Hannover,
Regulierter Markt in Frankfurter Wertpapierbrse;
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