DGAP-News: MOLOGEN AG: Skin cancer study with MGN1404 approved
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Skin cancer study with MGN1404 approved
15.04.2013 / 08:00
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MOLOGEN AG: Skin cancer study with MGN1404 approved
- Evaluation of safety and tolerability
- Further product candidate ready for phase I clinical study
- Study under the direction of the CharitéUniversitätsmedizin
Berlin, April 15, 2013 - The Paul-Ehrlich Institute has granted approval
for a phase I clinical study of a gene therapy with MGN1404 for the
treatment of melanomas. The study is entitled 'Phase I trial of TNF-alpha
expressing MIDGE-vector non-viral gene transfer in skin metastases of
melanoma.' The study will be conducted by collaborative partners CharitéComprehensive Cancer Center (CCCC), the Berlin Experimental and Clinical
Research Center of the Charité(ECRC), the Max Delbrück Center for
Molecular Medicine (MDC) in Berlin-Buch and the skin cancer center of the
Charité(Hauttumorcentrum, HTCC).
The study will examine whether the MIDGE(R) vector is safe and well
tolerated when applied by intra-tumor jet injector, and whether the
application leads to efficient expression of the hTNF-alpha gene. Further,
the magnitude and extent of gene expression and the distribution of the
MIDGE(R) vector within and outside the injected tumor will be examined.
Three different doses of the MIDGE(R) vector will be used. This study is a
first step towards the clinical use of local gene therapy for malignant
melanomas.
www.mologen.com
Additional information:
MGN1404 - MIDGE(R) vector for the expression of TNF-alpha
Tumor necrosis factor-alpha (TNF-alpha) is a signaling molecule (cytokine)
produced by the immune system. Among its effects, TNF-alpha can induce cell
death, and thus has direct antitumor effects when applied to tumors.
Furthermore, it leads to the sensitization of tumors to other therapies,
such as chemotherapy or radiotherapy. MGN1404 is a MIDGE(R)-based
(non-viral) expression vector. The needle-free intra-tumor jet injection of
MGN1404 transports MIDGE(R) vectors directly into the tumor cells. There,
the expression of TNF-alpha is triggered by the MIDGE(R) vector and cell
death is induced in the tumor cells.
Malignant melanoma
Malignant melanoma of the skin is one of the most virulent forms of skin
cancer. The incidence of malignant melanoma has shown a steady and
significant increase worldwide in the Caucasian populations in recent
decades. Every year in Germany, almost 14,000 people are diagnosed with
malignant melanoma, including about 8,000 women and 6,000 men. The risk of
developing melanoma later in life is about 1 in 50 in Germany, and 1 in 20
in Australia. Middle-aged individuals between ages 45 and 60 are frequently
affected. Despite a lack of symptoms and relatively small size, melanomas
can form metastases in the lymph nodes and other organs at an early stage.
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
non-small cell lung cancer. The cell-based cancer therapy MGN1601 for the
treatment of advanced renal cancer (renal cell carcinoma) 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.
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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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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