DGAP-News: MOLOGEN AG: Treatment with renal cancer therapy MGN1601 generates clear survival benefit for patients
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Treatment with renal cancer therapy MGN1601 generates
clear survival benefit for patients
30.03.2012 / 10:47
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Press Release No. 3/2012 of 03/30/2012
MOLOGEN AG: Treatment with renal cancer therapy MGN1601 generates clear
survival benefit for patients
- First evaluation of survival times provides results that exceed
expectations
- Immunological active principle proven in an exemplary manner
- Data presented at the annual meeting of the American Association for
Cancer Research
In a further evaluation of the phase I/II renal cancer study with MGN1601,
the biotechnology company MOLOGEN AG has analyzed the survival times of
patients enrolled in the study and the first data of the accompanying
immunological tests. The result: patients that were able to completely
finish the twelve-week therapy scheme scheduled in the study protocol with
the study drug MGN1601 (PP group) have an unexpectedly clear survival
benefit in comparison with patients that had to terminate their study
therapy early (non-PP group).
Thus far, the ten patients in the PP group already survived more than ten
months on average. Since only one patient in this group has died by now,
this parameter will continue to improve. In the non-PP group, the median
survival time is a little over two months; all nine patients had died at
the latest after six months. With regard to historical clinical data and
statistical models, a median survival time of five to seven months was
expected. Hence, this was clearly exceeded in this study.
Furthermore it is very remarkable that for two patients who are currently
being treated in the extension phase of the study at fixed intervals, the
disease has not progressed in over ten months.
Immunological principle proven in an exemplary manner
With the evaluation of immunological data it was possible to prove in an
exemplary manner that those patients that completed the entire planned
three-month treatment cycle with MGN1601 in accordance with the study
protocol have generated a clear immune response. The strength of the immune
response increased with continued treatment. With these results, the
mechanism of action demonstrated in preclinical studies could also be
confirmed in patients. In the view of MOLOGEN AG, the observed positive
effects with respect to overall survival can thus be attributed to the
treatment with MGN1601.
Concurrently to the evaluation of the study, MOLOGEN has also applied for
scientific advice at the Paul-Ehrlich-Institut, to discuss, amongst others,
questions relating to the design of future clinical studies. Subsequent
clinical studies with MGN1601 will then be applied for.
Prof. Dr. Burghardt Wittig, Chairman of the Scientific Advisory Board of
MOLOGEN AG, states: 'As a scientist, I am delighted that our molecular
biological and immunological concepts for active therapeutic vaccination
against cancer were able to prove their efficacy so impressively with
MGN1601. I find it particularly noteworthy that we were now able to clearly
show what we had hitherto only been able to assume: active immunotherapies
against cancer, like MGN1601, need time before they can show their effect.
Tragically, all patients for whom the therapy with MGN1601 came too late
have already died, while all other patients - apart from one, who survived
for more than eleven months - are still alive today.'
Dr. Matthias Schroff, Chief Executive Officer at MOLOGEN AG, adds: 'It is a
very positive surprise that our second oncological product candidate
MGN1601 is already showing such excellent efficacy data in phase I/II.
Thereby, our product pipeline has taken a great step forward. For this
reason I am very confident with regard to our further clinical studies,
both for MGN1703, our immunomodulator, which we are applying in the field
of colorectal cancer and lung cancer, and also for MGN1601, our renal
cancer therapy.'
Presentation at the annual congress of the American Association for Cancer
Research
MOLOGEN project manager Ekaterina Weith is to present the data together
with Prof. Dr. Burghardt Wittig (Chairman of the Scientific Advisory Board
of MOLOGEN AG) at the annual meeting of the American Association for Cancer
Research (AACR) as part of a 'Late-Breaking Poster Session' on April 3,
2012 in Chicago, USA (poster no. LB-233). The AACR is the world's oldest
and largest scientific organization that is dedicated to all aspects of
high-quality, innovative cancer research.?About the phase I/II clinical study (ASET study)
Within the framework of the ASET study, patients receive a total of eight
treatments with MGN1601 over a period of twelve weeks. The patients are
examined after completion of the treatment phase. If the patients have at
least responded to the treatment with stabilization of the originally
progressing cancer disease after twelve weeks, they can be treated further
within an extension phase. In this extension phase, the patients receive up
to five further treatments distributed over two years at increasing
intervals. As reported, patient recruitment was finalized ahead of schedule
after acceptance of 19 patients into the study, since it had already been
possible to achieve the primary goal of the study, namely to verify the
safety and tolerability of the compound.
About MGN1601
The tumor therapy with MGN1601 is a therapeutic vaccination to fight
advanced renal cancer and to prevent their recurrence after operation and
medical treatment.
MGN1601 is a cell-based cancer therapy based on genetically modified tumor
cells. A cell bank established by MOLOGEN AG from human renal cancer cells
in accordance with pharmaceutical regulations forms the basis. These cancer
cells from the cell bank, foreign (allogeneic) to the patient, 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 involves induction of a
cross-reaction of the patient's 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. Exactly this approach is
followed with MGN1601.
Orphan Drug Status
The cell-based gene therapy against renal cancer has received the Orphan
Drug Status from the European Medical Agency (EMA). This enables MOLOGEN AG
to market the product exclusively within the European Union within a period
of ten years. The Orphan Drug Program of the European Union is supposed to
promote the development of therapies for rare and serious diseases.
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.
The stocks of MOLOGEN AG are listed in the Prime Standard of the German
stock exchange (ISIN DE0006637200).
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.
www.mologen.com
MOLOGEN AG
PRESS SERVICE:
Prof. Peter W. Huebner
Head of Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Tel: +49 - 30 - 84 17 88 - 50
huebner(at)mologen.com
INVESTOR RELATIONS:
Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Tel: +49 - 30 - 84 17 88 - 50
investor(at)mologen.com
External Investor Relations:
Kirchhoff Consult AG
Sebastian Bucher
T: +49 - 40 - 60 91 86 - 18
F: +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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163240 30.03.2012
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Datum: 30.03.2012 - 10:47 Uhr
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