DGAP-News: MOLOGEN AG: Clinical study with MGN1404 in malignant melanoma initiated
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Clinical study with MGN1404 in malignant melanoma
initiated
18.10.2013 / 08:00
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MOLOGEN AG: Clinical study with MGN1404 in malignant melanoma initiated
- Phase I trial to evaluate safety and tolerability
- Trial is under supervision of Charité- Universitaetsmedizin Berlin
Berlin, October 18, 2013 - The phase I clinical trial with the cancer
immune therapy MGN1404 has been started. The trial evaluates the safety and
tolerability of MGN1404 for the treatment of malignant melanoma.
Furthermore data on the mechanism of action will be collected.
MGN1404 will be applied in different dosages needle-free by jet-injection
into skin metastases. It is planned to overall enroll nine patients in the
trial.
The study is a translational project for non-viral gene therapy and will be
conducted by Charitéin collaboration with CharitéComprehensive Cancer
Center (CCCC), Experimental and Clinical Research Center (ECRC), Max
Delbrueck Center for Molecular Medicine Berlin-Buch (MDC) as well as Skin
Cancer Center Charité(SCCC). Principial investigator is Dr. med. Felix
Kiecker, Specialist of Dermatology and Venerology, Skin Cancer Center
Charitéand scientific coordinator is Prof. Wolfgang Walther, ECRC,
Charité.
Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG, stated, 'With
this study the third drug candidate from our broad pipeline of cancer
immune therapies is entering the clinical development phase. I am
especially glad that the longtime collaboration with the Max Delbrueck
Center for Molecular Medicine, one of the best German institutes in the
field of molecular biology, has now led to this trial. MGN1404 is
addressing a severe disease with high unmet medical need. We are looking
forward to the outcome of the trial.'
www.mologen.com
Additional information:
MGN1404 - MIDGE(R) vector for TNF-alpha expression
Tumor necrosis factor alpha (abbreviated TNF-alpha) is a signaling
substance (cytokine) of the immune system. TNF-alpha can stimulate cell
death and therefore has - in the case of application into the tumor - a
direct antitumoral effect. It also leads to the sensitization of tumors
toward other therapies, such as chemotherapy or radiation therapy.
MGN1404 is a minimalistic, non-viral DNA expression vector encoding for
TNF-alpha, based on MOLOGEN'S proprietary MIDGE(R) platform technology. The
needle-free, intratumoral jet injection of MGN1404 conveys the MIDGE(R)
vectors directly into the tumor cells. The expression of TNF-alpha is
triggered there by the MIDGE(R) vectors aiming to induce cell death in the
tumor.
Malignant melanoma
Malignant melanomas are one of the most malignant forms of skin cancer. The
worldwide occurrence of malignant melanoma in the white population has
increased continually and considerably in recent decades. Approximately
77,000 people in the USA and 100,000 people in Europe develop malignant
melanoma each year. Despite the lack of symptoms and a relatively small
size, melanomas can metastasize early in the lymph nodes and other organs.
If diagnosed when there are already distant metastases the five-year
survival rate is approximately 10-20%. Treatments of late stage malignant
melanoma include chemotherapy, immunotherapy or radiation therapy.
About the Max Delbrück Center for Molecular Medicine (MDC) in Berlin-Buch
The MDC was formed in 1992 to convert the molecular research results into
practice, for the prevention, diagnosis and treatment of diseases. The
location in the Buch district of northeast Berlin, with its clinics,
research institutes and biotechnology companies provides an excellent
environment for interdisciplinary and patient-oriented cutting edge
research. As a result, in recent years the MDC has developed into an
internationally recognized research institute. Thomson Reuters thus ranks
the MDC as the only German institution in its list of the world's 20 best
institutes in the field of molecular biology and genetics, in 14th place.
The MDC currently employs around 1,588 staff and visiting scientists. The
MDC is 90% funded by the federal government and 10% by the State of Berlin.
There is also third-party funding in the millions. 65 research groups work
in three main research areas (cardiovascular and metabolic diseases,
cancer, nervous system disorders and systems biology).
www.mdc-berlin.de
The Experimental and Clinical Research Center (ECRC)
As a joint facility of the MDC and Charité, the ECRC promotes cooperation
between research scientists and clinical researchers. Here, laboratory
findings are made available to patients as quickly as possible, new
approaches for the diagnosis, prevention and treatment of cardiovascular
and metabolic disorders, cancer, and neurological diseases are developed
and promptly used on patients.
The ECRC provides an excellent environment for patient-oriented research,
including clinical trials. This includes a growing number of university
clinics that offer specialized advice for patients, a station specifically
designed for clinical research, a clean room manufacturing facility for
cellular immunotherapy, and access to modern methods of ultra-high field
magnetic resonance imaging.
www.charite.de/forschung/forschungszentren/experimental_and_clinical_resea
rch_center_ecrc
The CharitéComprehensive Cancer Center (CCCC)
The purpose of the CCCC is to bring together clinical and academic oncology
at the Charité, and thus continuously coordinate not only diagnostics,
therapy, medical, psychological, social and after-care of patients but also
the prevention and early detection of cancers.
For successful cancer treatment, the close cooperation of specialists from
different fields is crucial from the onset of the disease. Recognition of
this at the Charitéresulted in the creation of a Comprehensive Cancer
Center in 2008, one of the first comprehensive centers for tumors in
Germany, to improve treatment results further.
The goal is to optimize close cooperation with local doctors and hospitals
to the prospects for curing and caring for cancer patients.
All Charitélocations with their various disciplines involved in tumor
therapy are networked with the CCCC, to ensure interdisciplinary and
comprehensive cancer patient care from the beginning. Under the umbrella of
the CCCC, each patient will receive direct access to the latest national
and international treatment strategies and therapeutic studies.
As a top oncological center the CCCC is supported by the German Cancer Aid
(Deutsche Krebshilfe). It is a member of the Organization of European
Cancer Institutes, and is certified by the German Cancer Society as an
Oncological Center.
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 AGshares (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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18.10.2013 Dissemination of a Corporate News, transmitted by DGAP - a
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The issuer is solely responsible for the content of this announcement.
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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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235173 18.10.2013
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