DGAP-News: MOLOGEN AG: Final analysis confirmed preliminary results of renal cancer vaccine MGN1601
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Final analysis confirmed preliminary results of renal
cancer vaccine MGN1601
30.09.2013 / 08:01
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PRESS RELEASE N 9 / 2013 of 09/30/2013
MOLOGEN AG: Final analysis confirmed preliminary results of renal cancer
vaccine MGN1601
- Treatment with MGN1601 was well tolerated and safe
- Patient subgroup showed promising survival benefit
Berlin, September 30, 2013 - The MOLOGEN AG performed the final analysis of
the clinical trial phase I/II with cancer vaccine MGN1601. The study
evaluated safety and tolerability of MGN1601 in 19 advanced renal cancer
patients which had no other treatment options. The data confirm the
preliminary findings presented at last year's 'ESMO 2012 Congress'. The
primary endpoints safety and tolerability were met.
A subgroup of patients showed a promising benefit from the treatment with
MGN1601, and some of them are still alive with follow-up ongoing. Such
response patterns are comparable to the observations from other cancer
immune therapies.
Alfredo Zurlo, M.D., Chief Medical Officer of MOLOGEN AG comments, 'In this
early stage trial the results of our cancer vaccine MGN1601 look promising
and the treatment with MGN1601 was well tolerated. Furthermore, the
survival observed in some of these late stage renal cancer patients is
above our expectations. With these data at hand, we are very much looking
forward to the next stage of clinical testing of MGN1601.'
The full data set from this analysis will be presented at future oncology
conferences.
About the phase I/II clinical trial (ASET study)
In the ASET study patients received a total of eight treatments with
MGN1601 over a period of twelve weeks. The patients were examined after
completion of the treatment phase. If the patients had at least responded
to the treatment with stabilization of the originally progressing cancer
disease after twelve weeks, they could be treated further within an
extension phase. In this extension phase, the patients received up to five
further treatments distributed over two years at increasing intervals.
About MGN1601
MGN1601 is a therapeutic vaccination to fight advanced renal cancer. It is
a cell-based cancer therapy based on genetically modified, allogeneic tumor
cells. A cell bank established by MOLOGEN AG from human renal cancer cells
forms the basis. These cancer cells from the cell bank, foreign
(allogeneic) to the patients, are 'genetically modified' with additional
genetic information with the help of four different MIDGE(R) vectors
developed by MOLOGEN and are combined with the DNA immunomodulator
dSLIM(R), also developed by MOLOGEN, as an adjuvant.
The active principle of the cell-based gene therapy is to induce of a
cross-reaction of the patients' immune system against their own cancer
cells after the immune system has learned what cancer cells typically look
like via its response to the genetically-modified foreign cancer cells.
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 by this
disease 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 medications which are currently
available on the market are accompanied by considerable side effects. Thus
there is still a great medical need for new, effective medications with low
side effects for the treatment of renal cancer.
Orphan designation
MOLOGEN AG obtained the orphan designation from the European Medicines
Agency (EMA) for the renal cancer vaccine MGN1601. The orphan drug program
of the European Union is supposed to promote the development of therapies
for rare life-threatening or very serious diseases. The orphan designation
offers a number of incentives, including protocol assistance and EU market
exclusivity once the medicine is on the market.
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
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30.09.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group 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 AGFabeckstraße 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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232475 30.09.2013
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Datum: 30.09.2013 - 08:01 Uhr
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News-ID 301142
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