DGAP-News: MOLOGEN AG: Final results from IMPACT study with MGN1703 confirm preliminary findings
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Final results from IMPACT study with MGN1703 confirm
preliminary findings
03.06.2013 / 08:02
---------------------------------------------------------------------
PRESS RELEASE N°5 / 2013 of 06/03/2013
- Full analysis conducted
- Preliminary overall survival data available for the first time
- Presentation at ASCO raised great interest
Berlin, June 3, 2013 - MOLOGEN AG has performed a final analysis of the
phase II clinical trial with MGN1703 in metastatic colorectal cancer
(IMPACT-study). With a median follow up in excess of 17 months, results
confirm the findings on progression-free survival (PFS) of the first
analysis performed in May 2012 and presented at the ESMO conference 2012.
For the first time, preliminary results on overall survival (OS) are also
available, even though data are still immature due to a lack of death
events in the MGN1703 arm. Exploratory analyses on pre-treatment
characteristics and immunological biomarkers were also performed. These
reported interesting results in line with established immunological
signaling pathways of TLR-9 agonists like MGN1703, and will require
confirmation in future clinical trials.
The final analysis reported PFS results for all 59 patients which were
enrolled in the IMPACT study. Notably, some tumor responses on MGN1703
monotherapy were observed. A few patients who never relapsed during the
study are now continuing the treatment with MGN1703 in a compassionate use
extension program.
Overall, the evidence from the IMPACT study will be used in future larger
trials to select those patients, which may benefit most from MGN1703
treatment.
'We are very encouraged by the sign of activity shown in the trial,
including a few clinical responses occurring as late as 9 months after end
of chemotherapy,' said Dr. Alfredo Zurlo, Chief Medical Officer (CMO) of
MOLOGEN. 'Treatment with MGN 1703 appears also well tolerated, even in
patients receiving biweekly treatment for more than one year'.
'The early results of the IMPACT study warrant confirmation in a large
controlled clinical trial,' said Professor Hans-Joachim Schmoll, the study
coordinator and Director of the Oncological and Hematological Department at
Martin-Luther-Universitaet Halle-Wittenberg. He will present the results of
the final analysis at the ESMO 15th World Congress on Gastrointestinal
Cancer (WCGI).
The detailed data from the final analysis have currently been shown in a
poster at this year's Annual Meeting of the American Society of Clinical
Oncology (ASCO) and raised great interest. Further data, including
biomarkers analysis, will be shown in an oral presentation at the WCGI in
Barcelona in July 2013.
MOLOGEN is currently preparing a pivotal phase III study in metastatic
colorectal cancer to confirm the results of the IMPACT-study and to
evaluate the detected predictive biomarkers in a larger number of patients.
Findings from the final analysis will also be taken into account in the
planned lung cancer trial with MGN1703. For this purpose MOLOGEN will
review the current lung cancer study protocol to allow for implementation
of biomarkers.
Results of the IMPACT study in detail:
The poster presented at ASCO reported the results of the final analysis
from the 59 patients randomized into the IMPACT trial. 46 patients received
MGN1703 and 16 patients placebo.
- Progression-free survival / hazard ratio
Concerning the primary progression-free survival (time patients spend
without their disease coming back or worsening) 'on maintenance' endpoint,
a hazard ratio (HR) of 0.56 (p=0.07) was achieved. The secondary 'PFS from
start of induction chemotherapy' endpoint achieved a HR of 0.49 (p=0.03).
- Responses
Three RECIST confirmed responses to MGN1703 therapy were observed as late
as 9 months after randomization. Overall, 4 patients in the MGN1703 arm are
still not progressing and are currently receiving treatment in a
compassionate use program (on treatment since 12, 19, 23 and 27 months).
- Overall survival
Despite a median follow up in excess of 17 months, the overall survival
(OS) data are still immature, due to a lack of events in the MGN1703 arm.
- Safety and tolerability
Toxicity was mild and treatment was well tolerated even in patients
receiving MGN1703 since several months (up to 27 months at the time of this
analysis).
- Further analyses
In exploratory analyses, treatment with MGN1703 had a statistically
significant impact in the subgroups of patients who after induction
chemotherapy achieved shrinkage of their tumor or had normal CEA (a marker
of disease) values.
- Activation of immunity
Immune cell population frequencies were monitored during the course of the
study. Results point to the activation of the innate and adaptive immune
system, in line with the biological mechanism of action.
About the clinical study with MGN1703 (IMPACT study)
The IMPACT study is a phase 2, randomized, placebo-controlled,
double-blind, multicenter clinical study aiming 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 radiologically confirmed.
The primary endpoint of the study is to determine progression-free survival
of the patient. Secondary study endpoints include overall survival,
progression-free survival from start of induction therapy, response rates
and safety, as well as collection of 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.
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
---------------------------------------------------------------------
03.06.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory 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
---------------------------------------------------------------------
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
---------------------------------------------------------------------
214322 03.06.2013
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 03.06.2013 - 08:02 Uhr
Sprache: Deutsch
News-ID 265483
Anzahl Zeichen: 5979
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 249 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: MOLOGEN AG: Final results from IMPACT study with MGN1703 confirm preliminary findings"
steht unter der journalistisch-redaktionellen Verantwortung von
MOLOGEN AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
