MOLOGEN AG / Key word(s): Study
14.05.2012 07:00
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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MOLOGEN AG - Excellent outcome for phase 2 colorectal cancer study with
MGN1703 - primary endpoint achieved
* Proof of concept confirmed:
- significantly prolonged progression-free survival
- highly significant efficacy
- excellent safety and tolerability
Berlin, May 14, 2012 - The biotechnology company MOLOGEN AG has conducted
an initial assessment of the phase 2 colorectal cancer study with MGN1703.
The assessment of 55 patients showed that the primary endpoint, the
prolongation of the median progression-free survival, was achieved.
Progression-free survival describes the period in which a cancer disease is
not getting worse. Median progression-free survival in the pre-defined
target population (46 patients) was even more than doubled compared to the
placebo control group with high statistical significance (p< 0.02). The
comparison of both groups also shows a statistically significant hazard
ratio: The risk of tumor progression was less than halve for patients
treated with MGN1703 compared to the placebo group. Also the
progression-free survival rate after six months, which is one of the
secondary endpoints, shows a clear and statistically significant difference
between both patient groups.
A randomized, double-blind and placebo-controlled phase 2 clinical study
was conducted to determine the efficacy of the DNA-based immunomodulator
MGN1703. Patients with metastatic colorectal cancer (mCRC) were treated
with MGN1703 as maintenance therapy following the standardized first-line
therapy.
In addition, the study re-confirmed the excellent safety profile for
MGN1703. Treatment was well tolerated also over longer periods. For the
most part minor to moderate side-effects such as minor episodes of fever,
fatigue and reddening of the injection site occurred.
From diligent observation of the study development and following
consultations with their scientific advisors, management decided to
terminate patient recruitment prematurely. A total of 58 patients were
enrolled in the study. Treatment of patients who are still in the study
will be continued according to the protocol. Data on overall survival of
all patients will continue to be collected.
MOLOGEN AG will consult with the FDA and EMA on the basis of these data to
agree on additional steps required for approval. Parallel to this, talks
with potential partners regarding out-licensing of MGN1703 will be
continued.
In addition, a detailed presentation of the results of the study for the
medical community is planned at an international congress for clinical
oncology and cancer research.
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Information and Explaination of the Issuer to this News:
Dr. Matthias Schroff, Chief Executive Officer and Chief Scientific Officer
of MOLOGEN AG explains, 'This is a special day for our research team and
the entire company. These excellent results have even surpassed our own
expectations. Due to the high reliability of the data, especially regarding
the placebo-controlled study design, the results go way beyond a
proof-of-concept, as normally demonstrated in a phase 2 study. They confirm
the enormous potential of immunotherapeutic concepts for the treatment of
cancer. Our special thanks go to the patients and everyone who contributed
to these studies.'
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.
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@mologen.com
INVESTOR RELATIONS:
Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Tel: +49 - 30 - 84 17 88 - 50
investor@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@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 situ
14.05.2012 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
FabeckstraÃe 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: info@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 Announcement DGAP News-Service
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DGAP-Adhoc: MOLOGEN AG: Excellent outcome for phase 2 colorectal cancer study with MGN1703 - primary endpoint achieved
| Source: EQS Group AG