DGAP-News: MOLOGEN AG: A further clinical study has currently been started - a new therapy approach for the treatment of renal cancer.
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Miscellaneous
MOLOGEN AG: A further clinical study has currently been started - a
new therapy approach for the treatment of renal cancer.
14.12.2010 / 15:00
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Berlin, 14/12/2010 - The Charité- Medical University of Berlin has today
begun the implementation of the clinical study phase I/II with the renal
cancer medication MGN1601 (ASET Study). With this MOLOGEN AG product, an
innovative cell-based gene therapy for the treatment of advanced renal
cancer is entering the first important test phase.
MOLOGEN AG, which has since the outset been building its research
activities on a diversified product pipeline, has also achieved a decisive
milestone in an additional product segment with the start of the clinical
study for the renal cancer medication MGN1601.
The primary goal of this study is the investigation of the safety and
tolerability of the medication. In addition effectiveness data is recorded,
which contain the clinical, immunological and radiological parameters of
the patients.
As a leading research company in DNA medicine and cell-based medicine,
MOLOGEN AG is consistently pursuing its goal of developing highly effective
and safe medications for the treatment of cancer illnesses.
Therapeutic vaccination
The procedures developed by MOLOGEN AG for cell-based gene therapy against
renal cancer involve a therapeutic vaccination to combat advanced tumors of
the kidneys and the prevention of their reappearance after operations and
medical treatment.
The basis of the therapy is human renal cancer cells. MOLOGEN itself has
established a unique renal cancer cell line for this purpose. These cancer
cells which are foreign (allogenic) for the patient are 'gene-modified'
with the help of MIDGE(R) DNA vectors with additional genetic information
and combined with MOLOGEN's own DNA immune modulator dSLIM(R) as
effectiveness enhancer (adjuvant).
The active principle of the cell-based gene therapy consists of provoking a
cross-reaction of the immune system of the patients against their own
cancer cells after the immune system has learned by the reaction against
the gene-modified, foreign cancer cells how cancer cells typically appear.
In preclinical investigations, the preparation has already exhibited
outstanding tolerability and effectiveness.
Dr. Marina Tschaika, director of the clinical development department at
MOLOGEN AG, explains: 'With MGN1601 we hope to have developed a cancer
therapy with few side effects, which will lead to long-term relief of
cancer suffering and, at the same time, to a clear improvement in the
quality of life for patients with advanced renal cancer. I am convinced
that we are on the right track with this'.
Study director PD Dr. Steffen Weikert, CharitéBerlin
The clinical study is being directed by Dr. Steffen Weikert, assistant
director of the clinic for Urology at the Charitéof Berlin.
PD Dr. Steffen Weikert, an expert in the area of renal cancers, comments
about the start of the study: 'The ASET study with the preparation MGN1601
is an extremely interesting and promising study for us, because it builds
on an advanced concept of therapeutic vaccination against renal cancer
cells. We hope to continue to improve the prognosis for patients with
advanced renal cancer with this therapeutic approach. This study will also
open up to our patient perspectives for a better quality of life since the
vaccination can be considered as low in side effects according to the
current state of the art. We are pleased that the first patients can now be
accepted for the study at Charite'.
CharitéMedical University of Berlin
With the Charitéas a test centre, this clinical study can fall back on a
wealth of expertise. This is because the CharitéComprehensive Cancer
Center comprehensively organizes and coordinates holistic collaboration in
the area of tumor medicine among the various Charitécenters. Thanks to the
close cooperation and involvement of the entire medical, psycho-oncological
and social care chain as well as innovative research projects and clinical
studies, a comprehensive and modern therapy for tumor patients is
sustainably supported. The CharitéComprehensive Cancer Center is certified
by the German Cancer Association DKG (Deutsche Krebsgesellschaft) and
pursues medical-oncological care on a high clinical and scientific level.
As additional test centers MHH - Hanover Medical School (Dr. Viktor
Grünwald) and the University Clinic of Bonn (Univ.- Prof. Dr. med. Ingo
Schmidt-Wolf) are also involved in the study.
Study hotline / study portals
The study is listed on all relevant Internet portals.
A study hotline of MOLOGEN AG on MGN1601 informs interested medical
specialists and patients individually at: +49 (0)800 1601 646.
www.mologen.com
www.charite.de
http://cccc.charite.de
About renal cancer
Renal cancer is the most frequently occurring malignant tumor of the
kidneys with 200,000 incidences annually throughout the world. According to
the Robert Koch Institute, there are 15,000 patients affected with this
illness in Germany alone. Among these patients around 30% already have
distant metastases at the time of initial diagnosis, which significantly
reduces the success of a therapy. The tumor is known for not responding to
radiation or chemotherapy. The use of preparations which are currently
available on the market are accompanied by considerable side effects.
Therefore a great medical need still exists for new, effective medications
with low side effects for the treatment of renal cancer. With MGN1601, this
approach is precisely followed.
Orphan Drug Status
The cell-based gene therapy against renal cancer has received the Orphan
Drug Status from the European Medical Agency (EMA). This allows MOLOGEN AG
to have a 10-year marketing exclusivity of the product within the European
Union. The Orphan Drug Program of the European Union should promote the
development of therapies for rare and serious illnesses.
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.
MOLOGEN AG shares are listed on the Prime Standard of the German Stock
Exchange (ISIN DE 0006637200).
Memberships and 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. Hübner
Head of Corporate Communications
Fabeckstraße 30
D - 14195 Berlin
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
huebner(at)mologen.com
INVESTOR RELATIONS:
MOLOGEN AG
Jörg PetraßTel: +49 - 30 - 84 17 88 - 13
Fax: +49 - 30 - 84 17 88 - 50
investor(at)mologen.com
External Investor Relations
Kirchhoff Consult AG
Janina Wismar M.A.
Tel: +49 - 40 - 60 91 86 - 50
Fax: +49 - 40 - 60 91 86 - 16
janina.wismar(at)kirchhoff.de
Disclaimer with regard to statements regarding future events
Certain information in this release contains forward-looking statements or
relevant statements that are negated or versions that deviate from this or
comparable terminology - these are called 'forward-looking statements.' In
addition, all information presented here that refers to planned or future
developments in business areas, key figures, financial results or other
financial numbers or statistical statements contains such forward-looking
statements. The company advises discerning investors not to rely on these
forward-looking statements as predictions regarding the future occurrence
or development of real future events. The company does not commit to
updating the forward-looking statements and refuses any liability in this
regard. The forward-looking statements only reflect the status on the day
the statement is released.
End of Corporate News
14.12.2010 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,
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Media archive 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(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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106439 14.12.2010
Datum: 14.12.2010 - 15:00 Uhr
Sprache: Deutsch
News-ID 32856
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