DGAP-News: MOLOGEN AG: Detailed study results on colorectal cancer therapy with MGN1703 presented at the ESMO meeting
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Miscellaneous
MOLOGEN AG: Detailed study results on colorectal cancer therapy with
MGN1703 presented at the ESMO meeting
01.10.2012 / 12:29
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Press Release No. 11/2012 of 10/01/2012
MOLOGEN AG: Detailed study results on colorectal cancer therapy with
MGN1703 presented at the ESMO meeting
Berlin, October 1, 2012 - At the meeting of the European Society for
Medical Oncology (ESMO) detailed results for the colorectal cancer study
with the DNA immunomodulator MGN1703 as maintenance therapy were presented
today for the first time to an expert audience of clinical oncologists and
cancer researchers. This immunomodulator MGN1703 is the first candidate of
a whole new class of substances in colorectal cancer which could now be
tested as efficacious in a randomized study.
The efficacy of the DNA immunomodulator MGN1703 was examined in a
randomized, double-blinded and placebo-controlled phase II study. Within
the framework of the study patients with metastatic colorectal cancer were
treated with MGN1703 - as maintenance therapy - following standard
first-line therapy. MOLOGEN conducted a first evaluation of the clinical
study in May 2012 and already reported on the key findings. Overall, 59
patients were included in the study, with the first evaluation involving 55
patients. Already in this first evaluation it could be shown in a
sub-population (n=46) that the median progression-free survival of the
primary endpoint of the study was, at 5.8 months, more than double that of
the placebo group at 2.7 months. The progression-free survival describes
the period in which a cancer makes no further progress. The difference
between the MGN1703 group and the placebo group is statistically
significant with a p-value of 0.01. The hazard ratio is 0.39. This means
that the risk of a renewed tumor progression in patients treated with
MGN1703 when compared to the placebo group was more than halved. The
progression-free survival rate after six months - one of the secondary
endpoints - was 34% in the MGN1703 group and thus considerably higher than
the value of 8% in the placebo group. The difference is also statistically
significant with a p-value of 0.01. In addition, the study confirms the
excellent safety profile of MGN1703. The treatment was also very well
tolerated over long periods. The patients still in the study are currently
receiving further treament in accordance with the protocol.
The clinical phase II study implemented by MOLOGEN AG is led by Prof. Dr.
Hans-Joachim Schmoll. Professor Schmoll is Director of the University
Clinic and Polyclinic for Oncology and Haemotology at the Martin Luther
University at Halle-Wittenberg. The data were presented at the ESMO meeting
by Prof. Dr. Dirk Arnold, the Medical Director of the Hubertus Wald Tumor
Center at the University Clinic of Hamburg-Eppendorf. Both clinical
researchers are responsible for the design of the study.
With regard to the results Professor Arnold made the following comment:
'These surprisingly positive results are equally highly innovative and
clinically relevant in two ways: on the one hand, it is with MGN1703, a DNA
immunomodulator, that the first representative of a whole new class of
substances in colorectal cancer has been tested as efficacious in a
randomized study. And on theother hand, this is the second study ever
which has tested the value of a proprietary maintenance therapy after
another induction therapy.
On the basis of these data MOLOGEN AG shall coordinate further steps on the
way to an authorization with the regulatory authorities for medicines in
the United States and Europe. At the same time discussions shall be pursued
with potential partners regarding the intended licensing of MGN1703.
Further information on the presentation at the meeting of the ESMO
The lecture by Professor Arnold is entitled 'Maintenance treatment with
immunomodulator MGN1703 following induction with standard 1st line therapy
prolongs progression-free survival in patients with metastatic colorectal
(mCRC): results of the phase II/III IMPACT trial'.
Further details about the meeting can be found at
www.esmo.org/events/vienna-2012-congress.
About the clinical study with MGN1703 (IMPACT study)
The study is a phase 2, randomized, placebo-controlled, double-blind,
multicenter clinical study (IMPACT study) to determine the efficacy of
MGN1703 as maintenance therapy following successful first-line therapy in
advanced colorectal cancer. Patients included had stabilization, or
partial, or complete remission of their bowel cancer from receiving
first-line therapy for 4.5 to 6 months, beforehand. The first-line therapy
is a typical combination of chemotherapy and bevacizumab, which is
typically associated with significant adverse effects. During the study,
patients were treated twice per week with MGN1703. In the control arm
patients received a placebo. The treatment was continued until tumor
progression was radiologically confirmed.
The primary endpoint of the study is to determine progression-free survival
of the patient. Secondary study endpoints include determining the overall
survival, progression-free and overall survival rates, as well as
collecting immunological and pharmacodynamic data.
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 universal mechanism of action, MGN1703 can be applied to
different indications of cancer. An application is currently being
submitted for an additional phase 2 clinical study with MGN1703, this time
for the treatment of advanced lung cancer (NSCLC). The study should begin
immediately after approval.
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 (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
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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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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