DGAP-News: MOLOGEN AG: First evaluation data on clinical trial with MGN1601 - results for renal cancer therapy considerably better than anticipated

DGAP-News: MOLOGEN AG / Key word(s): Miscellaneous
MOLOGEN AG: First evaluation data on clinical trial with MGN1601 -
results for renal cancer therapy considerably better than anticipated

29.08.2011 / 08:00

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- Compound shows very good tolerability and safety
- Efficacy data much better than expected

Berlin, 29th August 2011 - Today, MOLOGEN AG published the first results
from the phase I/II clinical trial with the cell-based renal cancer therapy
MGN1601. The primary goal of this study is the investigation of safety and
tolerability of the medicament.

According to the investigators safety and tolerability has to be assessed
as very positive up to now. The tolerability of MGN1601 proved to be very
good without exception. No adverse events that could be classified as
serious were observed. Only in singular cases did patients report fatigue
or mild fever; signs that might rather indicate activation of the immune
system.

In addition, the first efficacy data have been collected using clinical,
immunological and radiological patient parameters.
These are very promising: for example, two patients have responded in part
very well to the cell-based cancer therapy MGN1601. In one case, progress
of the renal cancer was halted and in the case of the other patient, the
size of the metastases was reduced by more than 50 %.

At the same time the state of health of the patients is a challenge: the
trial only accepts patients whose tumor growth could not be halted with
medicaments that are currently available. The patients are initially
treated with MGN1601 over a time period of three months. Those patients who
respond to the treatment with MGN1601 are treated further during an
extension phase. The clinical trial will be conducted at three study
centers in Berlin, Hanover and Bonn.

'I am very pleased that two patients have responded so positively to our
innovative cell-based cancer therapy. Of course, these are isolated cases
in the first instance. But they are incredible, because in this study we
are solely dealing with seriously ill people for whom, often after very
long courses of therapy, the currently available meds are no longer showing
any effect', comments Dr. Matthias Schroff, CEO of MOLOGEN AG, on the
intermediate results. 'We are therefore optimistic about the further
progress of the trial. At the same time, we will continue to plan a more in
depth clinical trial to confirm the efficacy of MGN1601.'
 
Following the presentation last year of very promising efficacy data for
the DNA cancer therapy MGN1703, collected during a phase Ib clinical trial,
the cell-based cancer therapy MGN1601 is now also showing the first very
good efficacy data. As the leading research company in DNA medicine and
cell-based medicine, MOLOGEN AG is thus consistently pursuing its goal of
developing highly-effective and safe medicaments for the treatment of
cancer.

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.

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.

The stocks of MOLOGEN AG are listed in the Prime Standard of the German
stock exchange (ISIN DE0006637200).

Memberships in 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. Huebner
Head of Corporate Communications

Tel:  +49 - 30 - 84 17 88 - 38
Tel:  +49 - 30 - 84 17 88 - 50
huebner@mologen.com

INVESTOR RELATIONS:

MOLOGEN AG
Joerg Petrass
Tel:  +49 - 30 - 84 17 88 - 13
Tel:  +49 - 30 - 84 17 88 - 50
investor@mologen.com

External Investor Relations
Kirchhoff Consult AG
Janina Schumann M.A.
T:  +49 - 40 - 60 91 86 - 50
F:  +49 - 40 - 60 91 86 -16
janina.schumann@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.


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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@mologen.com                                      
Internet:    www.mologen.com                                       
ISIN:        DE0006637200                                          
WKN:         663720                                                
Listed:      Regulierter Markt in Frankfurt (Prime Standard);      
             Freiverkehr in Berlin, Düsseldorf, Hamburg, München,  
             Stuttgart                                             
 
 
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