DGAP-News: MOLOGEN AG submitted clinical trial application (IND) for MGN1703 to the FDA
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG submitted clinical trial application (IND) for MGN1703 to
the FDA
24.09.2013 / 13:26
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PRESS RELEASE N°8 / 2013 of 09/24/2013
MOLOGEN AG submitted clinical trial application (IND) for MGN1703 to the
FDA
* Investigational New Drug (IND) application for the treatment of solid
tumors
* Phase I clinical study in the U.S. to determine cardiac safety of MGN1703
Berlin, September 24, 2013 - MOLOGEN AG filed an Investigational New Drug
(IND) application for MGN1703 with the U.S. Food and Drug Administration
(FDA) to initiate a phase I clinical trial. The placebo-controlled,
double-blind study is designed to determine the cardiac safety of MGN1703
and to evaluate pharmacokinetic parameters in healthy volunteers. The trial
is expected to start as soon as the FDA has granted its approval.
Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG stated, 'With the
IND application we are preparing the ground to develop our lead drug
candidate MGN1703 for the treatment of solid tumors also in the USA. After
the very promising final results of the IMPACT trial presented earlier this
year we are now very much looking forward to proceeding with our clinical
development program for MGN1703.'
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 IMPACT study with MGN1703
The IMPACT study was a phase II, randomized, placebo-controlled,
double-blind, multicenter clinical study to determine the efficacy of
MGN1703 as maintenance therapy following first-line chemotherapy with or
without bevacizumab in patients with metastatic colorectal cancer.
Patients included in the IMPACT study had stabilization, or partial or
complete remission of their disease after receiving first-line therapy for
4.5 to 6 months. During the study, patients were randomized to receive
either MGN1703 or placebo twice per week. The treatment was continued until
tumor progression was detected. Overall 59 patients were enrolled in the
study. Patients' characteristics were globally balanced between treatment
groups.
At ESMO World Congress on Gastrointestinal Cancer 2013 the data from the
final analysis of the study was presented: The Hazard Ratio (HR) for
Progression-Free Survival on maintenance therapy (primary endpoint of the
study) was 0.55 (p= 0.04) when using the assessment of response and
progression performed by the local investigators and 0.56 (p= 0.07) when
taking into account the independent assessment by two radiologists.
Notably, some prolonged responses to treatment with MGN1703 were observed.
Four patients were still not progressing and received MGN1703 in
compassionate use in excess of 15-30 months. This pattern of very prolonged
disease control is not common with chemotherapy but has been increasingly
reported with other immuno-therapeutic agents in different tumor types.
Overall survival data was immature due to a lack of events.
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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Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50E-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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