DGAP-News: MOLOGEN AG completed planning for clinical study with MGN1703 in small cell lung cancer
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG completed planning for clinical study with MGN1703 in small
cell lung cancer
10.10.2013 / 08:00
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MOLOGEN AG completed planning for clinical study with MGN1703 in small cell
lung cancer
- Application of MGN1703 expanded by a further indication with high unmet
medical need
- Randomized, controlled trial to evaluate efficacy
- Study will be conducted in collaboration with the German ABC group
Berlin, October 10, 2013 - MOLOGEN AG has completed the planning for a
clinical trial with MGN1703 in small-cell lung cancer. The trial
application shall shortly be submitted to the competent authorities and
ethics committees in Germany, Austria and Belgium. The study is designed as
an open-label, two-arms, randomized and multi-center study. The aim of the
study is to evaluate the efficacy and safety of MGN1703. Primary endpoint
is overall survival. This trial will replace the trial application
submitted in 2012.
The study will include patients who are suffering from an extensive disease
stage of small cell lung cancer (SCLC) 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 disease. It is anticipated that patient
recruitment will be started in the first quarter of 2014, directly after
receipt of the necessary approvals. Principal investigator is Prof. Dr.
med. Michael Thomas, oncologist and Head of the Thoracic Oncology
Department in the Thorax Clinic at the University Clinic Heidelberg. In
Germany, the study will be conducted in collaboration with the 'Aktion
Bronchialkarzinom e.V.' (ABC group) - a renowned German oncologists network
of lung cancer specialists.
Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG comments 'After
the extensive analyses of our successful IMPACT colorectal cancer trial we
have now designed an optimized trial with MGN1703 in small cell lung
cancer. This trial is an important step to expand the potential application
of MGN1703 by a further indication. We are very much looking forward to
starting this trial soon.'
Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG added, 'This
disease is a heavy burden for patients since after first line therapy there
are only very limited treatments available. We hope that MGN1703 may become
an effective option in such unmet medical need. We are particularly pleased
to work with Prof. Dr. Thomas, a renowned expert in the field of small cell
lung cancer, and the ABC group.'
About the ABC group ('Aktion Bronchialkarzinom e.V.')
The ABC group is an association of more than 60 clinics and oncologists in
Germany. The group members perform clinical studies for 12 years now to
optimize therapies for patients with lung cancer and contribute to
improving patients' life. A well-organized dialog among the specialists
ensures that studies are carried out in accordance with most modern
insights.
Commenting on the clinical study of MGN1703 in small cell lung cancer,
Prof. Dr. med. Martin Wolf, Kassel, Chairman of the ABC group said, 'This
trial is very interesting for us because MOLOGEN is exploring an innovative
therapeutic approach to which we attribute great potential.'
About the IMPULSE small cell lung cancer trial
The study with the title 'Randomized Clinical Study of Maintenance Therapy
with immunomodulator MGN1703 in Patients with Extensive Disease Small Cell
Lung Cancer after Platinum-Based First-Line Therapy' (IMPULSE study) will
determine overall survival as primary endpoint. The trial will compare
MGN1703 versus best standard of care. It is planned to enroll approx.110
patients in the study
About small cell lung cancer
Lung cancer is one of the most common cancer diseases. The two main types
are small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).
SCLC is a fast-growing type of lung cancer that usually spreads more
quickly than NSCLC.
In the US the estimated number of new lung cancer cases per year is 228,000
and in Europe it is 410,000. The estimated number of deaths per year is
159,000 in the US and 353,000 in Europe. The proportion of small cell lung
cancer is approximately 15-20% of all lung cancer cases. When first
diagnosed approx. 60-80% of the SCLC-patients have already distant
metastases or extensive local involvement. This advanced stage is called
'extensive disease'. The five-year survival rate for such patients is below
1%.
About MGN1703
MGN1703 is based on dSLIM(R) ('double Stem Loop Immunomodulator'), an
innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM(R) activates
the immune system against tumor-associated antigens by targeting various
receptors on certain immune cells, primarily TLR9. Tumor-associated
antigens (TAA) are released by cancer cells as a result of chemotherapy and
radiation therapy. Once activated by dSLIM(R), the immune system is able to
overcome its fatal tolerance toward cancer cells and TAA and attacks them
selectively.
Due to this mechanism of action, MGN1703 can be applied to different
indications of cancer.
About MOLOGEN AG
MOLOGEN AG is a publicly listed biotechnology company headquartered in
Berlin and specializes in the research and clinical development of
innovative drugs in the fields of oncology and infectious diseases. One of
the company's most important product candidates is the DNA immunomodulator
MGN1703, which is being clinically developed for colorectal cancer and lung
cancer. The cell-based cancer therapy MGN1601 for the treatment of renal
cancer is also currently at the stage of clinical development.
With unique, patented technologies and innovative product developments,
MOLOGEN is one of the leading biotechnology companies in the fields of DNA
medicine and cell-based therapies.
MOLOGEN AG shares (ISIN DE0006637200) are listed in the Prime Standard of
the German Stock Exchange.
www.mologen.com
Memberships in associations:
Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | 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
Fax: +49 - 30 - 84 17 88 - 50
huebner(at)mologen.com
INVESTOR RELATIONS:
Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Fax: +49 - 30 - 84 17 88 - 50
investor(at)mologen.com
External Investor Relations:
Kirchhoff Consult AG
Sebastian Bucher
Tel: +49 - 40 - 60 91 86 - 18
Fax: +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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10.10.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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Media archive at www.dgap-medientreff.de and www.dgap.de
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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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