DGAP-News: MOLOGEN AG: Updated data on renal cancer therapy MGN1601 with further improved results
(firmenpresse) - DGAP-News: MOLOGEN AG / Key word(s): Miscellaneous/Study
MOLOGEN AG: Updated data on renal cancer therapy MGN1601 with further
improved results
01.10.2012 / 12:20
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Press Release No. 10/2012 of 10/01/2012
MOLOGEN AG: Updated data on renal cancer therapy MGN1601 with further
improved results
* Median overall survival now over 16 months
* Presentation at the ESMO Meeting in Vienna
Berlin, October 1, 2012 - Updated data on the overall survival of patients
participating in the ASET study was presented within the framework of a
scientific poster at this year's meeting of the European Society for
Medical Oncology (ESMO). The clinical study with the renal cancer therapy
MGN1601 has progressed further and now shows a median overall survival in
the PP group of over 16 months.
In patients who were able to fully complete the three-month therapy program
provided for in the study protocol (PP group) the survival benefit observed
showed an impressive increase. The ten patients in the PP group so far
survived on average more than 16 months. In this group also only three
patients have died, so the median overall survival in this group can
improve still further. In the patients who had to cancel their study
therapy prematurely (non-PP group) the median period of survival was only a
little more than two months; all nine patients in this group died within
six months.
Two patients from the PP group, in which the disease was under control
after conclusion of the three-month therapy program, were treated further
withinan extension phase of the study at set intervals. In one of the two
patients a progression of the cancer could be stopped for 14 months. The
second patient exhibited a regression of metastases for around 17 months.
Ekaterina Weith, Project Manager in the Department of Clinical Development
at MOLOGEN AG, added: 'The course of our clinical study with MGN1601
confirms not only our forecast, but has now gone further. What we are
presenting at the ESMO meeting is the data from the remainder of the study.
That is, of course, neither a complete nor final picture, but one that can
really be looked at.'
The phase I/II ASET study primarily examines the safety and tolerability of
MGN1601 in the treatment of patients with advanced renal cancer. As
previously reported, treating the patients with MGN1601 was well tolerated.
In addition, the active principle of the therapy could be proven in an
exemplary manner.
ESMO is the leading European non-profit organisation for internal oncology.
It is committed to a multidisciplinary approach to the treatment of cancer
and joins under its roof the leading oncologists in Europe.
Further information on the ESMO poster
Poster No. 813P is entitled 'The novel cancer vaccine MGN1601, consisting
of genetically modified allogeneic tumor cells and immunomodulator dSLIM:
updated results of a phase 1-2 study in patients with advanced renal cell
carcinoma'. It was presented on September 29th, 2012.
Further details on the ESMO Meeting can be found at
www.esmo.org/events/vienna-2012-Meeting.
About the ESMO Annual Meeting in Vienna
The 37th Annual Meeting of the European Society for Medical Oncology (ESMO)
is being held at the ACV (Austria Center Vienna) in Vienna, Austria from
September 28th until October 2nd, 2012. More than 17,000 participants from
around the world are expected to discuss the newest scientific results in
the field of cancer research. The meeting is the most important platform
for the exchange of professional experience in addition to the Annual
Meeting of the American Society for Clinical Oncology (ASCO). Here, among
other things, the world's current research results are presented and
discussed with experts but also with the attending pharmaceutical industry.
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 (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
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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