DGAP-News: MOLOGEN AG: Approval for phase I study with MGN1703 in the U.S. obtained
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Approval for phase I study with MGN1703 in the U.S.
obtained
23.10.2013 / 08:00
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MOLOGEN AG: Approval for phase I study with MGN1703 in the U.S. obtained
Berlin, October 23, 2013 - The U.S. Food and Drug Administration (FDA) as
well as the responsible Institutional Review Board have approved the phase
I clinical trial with MGN1703.
The placebo-controlled, double-blind study determines the cardiac safety of
MGN1703 in healthy volunteers which is an important safety aspect for the
FDA. Together with further pharmacokinetic parameters the study will
complete the already comprehensive data on tolerability and forms the basis
for the further development of MGN1703 in the U.S. until market approval.
Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG stated, 'We have
taken an important step for our clinical development program for MGN1703.
The approval which was issued very fast enables us to continue with our
plans. Thus the study will start presumably before the end this year.'
MGN1703 has already successfully completed a phase II study in metastatic
colorectal cancer (mCRC) in Europe. MOLOGEN is currently also preparing a
pivotal study in mCRC and a phase II study in lung cancer for MGN1703. In
parallel licensing activities for MGN1703 are ongoing.
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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23.10.2013 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,
Financial/Corporate News and Press Releases.
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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235693 23.10.2013
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