10:40 | 05.03.2010
DGAP-News: MOLOGEN AG receives approval for clinical study with cancer drug MGN1703
MOLOGEN AG / Miscellaneous
05.03.2010 10:40
Dissemination of a Corporate News, transmitted by
DGAP – a company of EquityStory AG.
The issuer / publisher is solely responsible for the content of this announcement.
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Berlin, March 5, 2010 – The Berlin biotech company MOLOGEN has received
approval from the competent German and Austrian health authorities at the
Paul Ehrlich Institute and the Federal Office for Safety in Health Care
(’Bundesamt für Sicherheit im Gesundheitswesen’), respectively, to conduct
a phase 2 study on the cancer drug MGN1703. MGN1703 is a DNA-based
immunomodulator, which is being developed for DNA immunotherapy in patients
with metastasized tumor diseases. After the cancer drug already
demonstrated excellent tolerability in the phase 1b study, this phase 2
study will now investigate the efficacy of the drug in the treatment of
metastatic colorectal cancer.
The clinical study is supposed to begin soon at several study centers in
Germany and Austria. Professor Hans-Joachim Schmoll, Director of the Halle
University Hospital and Polyclinic for Internal Medicine IV, will act as
the study coordinator. The study will be initiated as soon as the
responsible Ethics Committees have issued their approval, which is
anticipated to occur by March.
Additional study centers shall begin enrollment in Great Britain, Russia,
and other countries as soon as the conduct of the study has been approved
there.
‘We are optimistic that MGN1703 can help patients by delaying the
progression of cancer diseases for longer periods than has been possible up
to now with other cancer drugs,’ according to Professor Burghardt Wittig,
Chairman of the Scientific Advisory Board and Co-founder of MOLOGEN.
‘After a long way through the fundamental research phase, preclinical
developments, and an initial, very successful phase 1b study, our dSLIM(R)
DNA molecule will now be put to its most significant clinical test yet.’
‘In 2009 we were already able to prove the safety and excellent
tolerability of MGN1703. The approval of this phase 2 study for MGN1703 is
another triumph for MOLOGEN’, said Dr. Matthias Schroff, CEO of MOLOGEN AG.
‘We are thrilled that the investigators will soon be able to begin
treatment of the first patients.’
The phase 2, randomized, placebo-controlled, double-blind, multicenter
clinical study (IMPACT study) is designed as a licensing-relevant
confirmatory study and is intended to verify the efficacy of MGN1703 with
statistical significance. The primary objective of the study is to
determine progression-free survival among patients with advanced colorectal
cancer. Secondary study objectives include determining the overall survival
of patients and collecting data on immunological and pharmacodynamic
parameters. Initial evidence on the achievement of the study objectives is
anticipated to become available in the form of an interim report as early
as nine to ten months following the start of the study. The study could
have an overall duration of up to three years.
About the clinical study with MGN1703
The study is a phase 2, randomized, placebo-controlled, double-blind,
multicenter clinical study to determine the efficacy and safety of
subcutaneously administered MGN1703 for the treatment of metastatic
colorectal cancer patients who responded to first-line therapy
(IMPACT-study). The 60-mg dose of MGN1703 is administered twice weekly.
Treatment is continued until a progression of the cancer disease is
identified.
The primary endpoint is the identification of median progression-free
survival among patients based on radiological and clinical results.
Secondary endpoints include the analysis of the responsiveness of the
immune system, pharmacodynamics, and the safety profile of MGN1703.
The patients to be enrolled in the phase 2 study will only have been
treated with a standard chemo-immunotherapy as first-line therapy.
Therefore, in contrast to the patients in the preceding phase 1b study, the
immune systems of the patients in this study will not have already been
damaged by multiple prior lines of therapy and higher tumor burden. It is
anticipated that these patients will respond even better to treatment with
MGN1703.
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
‘danger’ sensing receptors on certain immune cells, primarily TLR.
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.
The results of the completed phase 1b study demonstrate an excellent safety
profile for MGN1703. Treatment with the investigational drug was well
tolerated and no dose-limiting or serious side-effects were identified.
Very promising signs of efficacy were also found. MGN1703 was able to delay
the progression of cancer diseases by at least six weeks in many cases,
including patients with advanced metastatic tumor diseases with no further
standard treatment options like the ones selected for the phase 1b study.
About metastatic colorectal cancer
Over 1 million new cases of colorectal cancer are diagnosed each year
worldwide, making it one of the most commonly occurring types of cancer
there is. In Europe, 412,900 new cases were diagnosed in 2006 (Van Cutsem,
Oliveira, 2009). That is 12.9% of all cancer cases. With over 70,000 new
cases each year, the disease is the second most common cancer disease in
Germany. People over 50 years of age are most commonly affected. In 25% of
patients the disease is already at an advanced stage by the time it is
diagnosed.
First-line therapy for cases of advanced colorectal cancer usually involves
treatment with chemotherapy in combination with bevacizumab or cetuximab
antibodies, depending on the patient’s baseline data. The standard
combination therapy enables a considerable extension of progression-free
survival among patients but is accompanied by serious side effects and
resistance problems, which have a negative impact on the quality of life of
the patient. The median overall survival for patients suffering from
metastatic colorectal cancer is approx. 20-23 months. Median
progression-free survival with first-line therapy is approx. 9-10 months.
About MOLOGEN
MOLOGEN AG, a biopharmaceutical company based in Berlin, specializes in the
research and development of innovative medicines based on DNA structures.
Activities focus on product developments for the treatment of cancer and
vaccines for serious infections.
MOLOGEN was founded in 1998 and is among the few biotechnology companies in
the world with well-tolerated, DNA-based cancer treatment in the clinical
development stage.
MOLOGEN AG shares are listed in the Prime Standard of Deutsche Börse (ISIN
DE 0006637200).
Disclaimer concerning prognoses
Certain statements in this communication contain formulations or terms
referring to the future or future developments, as well as negations of
such formulations or terms, or similar terminology. These are described as
forward-looking statements. In addition, all information in this
communication regarding planned or future results of business segments,
financial classification numbers, developments of the financial situation,
or other financial or statistical data contains such forward-looking
statements. The company cautions prospective investors not to rely on such
forward-looking statements as certain prognoses of actual future events and
developments. The company is neither responsible nor liable for these
forward-looking statements. It is not responsible for updating such
information, which only represents the state of affairs on the day of
publication.
MOLOGEN AG
Contact: Jörg Petraß
Email: investor@mologen.com
Telephone: +49-30-84 17 88-13
Fax: +49-30-84 17 88-50
Kirchhoff Consult AG
Dr. Kay Baden
Email: baden@kirchhoff.de
Telephone: +49 40 60 91 86 39
05.03.2010 10:40 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv at
www.dgap-medientreff.de
and
www.dgap.de
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Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Deutschland
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, München, Düsseldorf, Stuttgart, Hamburg
End of News DGAP News-Service
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