DGAP-News: MOLOGEN AG applies for lung cancer phase II study with MGN1703
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG applies for lung cancer phase II study with MGN1703
15.03.2012 / 08:30
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MOLOGEN AG applies for lung cancer phase II study with MGN1703
* Clinical examination of MGN1703 in two dosage schemata
* Start of study in 2012 immediately after receiving approval
Berlin, March 15, 2012 - As announced, the biotechnology company MOLOGEN AG
has submitted an application for implementation of a phase II clinical
study in the lung cancer indication to the Paul-Ehrlich-Institut and the
leading ethics commission. In the course of this study, the efficacy of
MGN1703 in the treatment of advanced lung cancer will be examined. The
study is designed as an open-label, two-armed, randomized and multi-center
study. In particular, the efficacy of two dosage schemata of the
investigational medicinal product is to be examined on 78 patients,
altogether.
The study will involve patients who are suffering from an advanced stage of
non-small cell lung cancer (NSCLC) and whose tumors have responded to first
line therapy with chemotherapeutics. Treatment with MGN1703 is to commence
after completion of the first line therapy and will continue until renewed
progression of the cancer. It is anticipated that patient recruitment will
commence in the second half of 2012, directly after receipt of the
necessary approvals. The study will initially be applied for in Germany.
Principal investigator is Prof. Dr. Michael Thomas, Senior Physician and
Head of the Thoracic Oncology Department in the Thorax Clinic at the
University Clinic Heidelberg.
Dr. Matthias Schroff, Chief Executive Officer at MOLOGEN AG: 'It is a
strategically important step that we are now examining MGN1703 in the
treatment of lung cancer as well as colorectal cancer. This expands the
potential application of our medicament candidate MGN1703 by a further
indication with very high global patient numbers. I am particularly pleased
that we have been able to recruit Prof. Dr. Thomas, a renowned expert in
the field of non-small cell lung cancer, as principal investigator.'
Goals of the study
Within the framework of the study, the progression-free survival rate will
be determined after three months of therapy. Secondary endpoints of the
study are to determine the progression-free survival rate and the overall
survival rate at different points in time, progression-free survival and
overall survival. Furthermore, a broad spectrum of immunological parameters
will be examined and data collected on the safety and tolerability of the
investigational medicinal product.
About lung cancer
Lung cancer is one of the world's most prevalent cancer types. According to
estimates by the Robert Koch-Institut and the Gesellschaft der
epidemiologischen Krebsregister in Deutschland e. V. (Association of
Population-based Cancer Registries in Germany), in this year, more than
51,000 people will contract this type of cancer in Germany alone. Here, in
the case of women, the proportion of new illnesses will rise by 15% in
comparison to 2007. The prognosis for lung cancer patients is also
unfavorable: relative 5-year survival is 15% for men and 19% for women.
This means that about 85% of male and about 81% of female lung cancer
patients die within 5 years. Hence the demand for new therapy options is
enormous. Non-small cell lung cancer is the most commonand a very
aggressive form of lung cancer.
Hotline
A study hotline at MOLOGEN AG for MGN1703 provides information individually
and in strict confidence in accordance with medical discretion to
interested doctors and patients on:
+49 (0)800 646 1703
www.mologen.com.
About MOLOGEN AG
MOLOGEN AG, a German biopharmaceutical company with headquarters in Berlin
specializes in the research and development of innovative medications on
the basis of DNA structures. The activities focus on numerous product
developments which are relevant to the immune system; on the one hand
vaccines against infectious diseases and on the other hand cancer
medications. MOLOGEN AG is globally one of the few biotechnology companies
with well tolerated DNA-based cancer treatment in the clinical development
phase.
The stocks of MOLOGEN AG are listed in the Prime Standard of the German
stock exchange (ISIN DE0006637200).
Memberships in associations:
BIO Deutschland e.V. | DECHEMA - Society for chemical technology and
biotechnology e.V. | German industrial association of biotechnology (DIB)
| Association for the Promotion of Science and Humanities in Germany |
Association of German biotechnology companies (VBU) | Association of
researching manufacturers of pharmaceuticals e.V. (VFA) | Association of
the chemical industry e.V. (VCI)
MIDGE(R), dSLIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG.
MOLOGEN AG
PRESS SERVICE:
Prof. Peter W. Huebner
Head of Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Tel: +49 - 30 - 84 17 88 - 50
huebner(at)mologen.com
INVESTOR RELATIONS:
Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Tel: +49 - 30 - 84 17 88 - 50
investor(at)mologen.com
External Investor Relations:
Kirchhoff Consult AG
Sebastian Bucher
T: +49 - 40 - 60 91 86 - 18
F: +49 - 40 - 60 91 86 -16
sebastian.bucher(at)kirchhoff.de
Note about risk for future predictions
Certain information in this report contains forward-looking statements or
the corresponding statements with negation or versions deviating from this
or comparable terminology. These are described as forward-looking
statements. In addition, all of the information given here that refers to
planned or future results of business areas, key financial figures,
developments of the financial situation or other financial figures or
statistical data, is to be understood as such forward-looking statements.
The company points out to investors that they should not rely on these
forward-looking statements as predictions about actual future events. The
company is not obligated and refuses to accept any liability for the
forward-looking statements and has no obligation to update such statements
in order to accurately reflect the current situation.
End of Corporate News
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15.03.2012 Dissemination of a Corporate News, transmitted by DGAP - a
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The issuer is solely responsible for the content of this announcement.
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Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: info(at)mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
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