DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Recruitment for the TEACH study with MGN1703 in
HIV-patients completed (news with additional features)
22.09.2015 / 09:16
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PRESS RELEASE N 15 / 2015 of 09/22/2015
MOLOGEN AG: Recruitment for the TEACH study with MGN1703 in HIV-patients
completed
Berlin, September 22, 2015 - The biotechnology company MOLOGEN AG announced
today that its partner, the Danish Aarhus University Hospital, completed
enrollment of 16 HIV patients for the phase I TEACH study with the
immunotherapy MGN1703. Results are expected in the second quarter of 2016.
The aim of the TEACH study is to see if the immunotherapy with MGN1703 can
activate the innate and adaptive immune system in HIV (Human
Immunodeficiency Virus) patients to enhance killing of the HIV infected
cells. Aarhus University Hospital is conducting the trial in two hospital
centers in Denmark and already received respective funding from the
American Foundation for AIDS Research (amfAR). MOLOGEN is providing the
immunomodulator MGN1703. This is the first time that MGN1703 is evaluated
in patients with diseases other than cancer. Thus the potential range of
applications of the product could be expanded.
"We are pleased that the enrollment for TEACH has been completed and that
treatment with MGN1703 is well tolerated. We look forward to seeing all the
results next year", said Dr. Alfredo Zurlo, Chief Medical Officer of
MOLOGEN AG.
Furthermore, MGN1703 is currently being investigated in the registration
trial IMPALA in colorectal cancer and in the randomized trial IMPULSE in
small cell lung cancer. Both studies are currently enrolling patients.
About TEACH
Initiated beginning of June 2015, TEACH (Toll-like receptor 9 enhancement
of antiviral immunity in chronic HIV infection) is a non-randomized
interventional phase I trial of MGN1703 in HIV-infected patients.
Participants receive four weeks of MGN1703 therapy (60 mg s.c. twice
weekly). During these four weeks, each participant is closely monitored for
the safety and therapeutic effects of the drug. 16 patients participate in
two study centers in Denmark.
The primary endpoint of the study is the change in proportions of activated
natural killer cells in the patients. Secondary study endpoints include,
among others, a collection of safety, virological, immunological and
pharmacodynamic data.
HIV infects the immune system and destroys or affects the proper function
of immune cells. Without antiretroviral treatment this eventually leads to
immune deficiency and the immune system can no longer fight off a wide
range of infections and diseases. HIV remains a serious worldwide health
issue. According to estimates by WHO and UNAIDS (United Nations Programme
on AIDS) 35 million people worldwide were living with HIV at the end of
2013. Some 2.1 million people became newly infected in that same year, and
1.5 million died as a result of HIV-related causes globally.
MGN1703
MGN1703 is an innovative DNA-based TLR9 agonist developed by MOLOGEN that
broadly activates the immune system. This activation can be utilized to
enable the immune system to increase the recognition and combat of cancer
cells. Due to this mechanism of action, it is predicted that MGN1703 can be
applied to a number of diseases.
MOLOGEN AG
MOLOGEN AG is a biotechnology company specialized in the research and
clinical development of cancer immunotherapies and DNA vaccines against
infectious diseases.
The cancer immunotherapy MGN1703 is the company's lead product and
best-in-class TLR9 agonist. It is currently developed for first-line
maintenance treatment of colorectal cancer (pivotal randomized trial) and
small cell lung cancer (randomized controlled trial). A second
clinical-stage product is MGN1601, a therapeutic vaccination for the
treatment of renal cancer. A phase I/II clinical study has already been
completed successfully.
For more information on the trials please visit www.clinicaltrials.gov.
With unique, patented technologies and innovative products, MOLOGEN is
pioneering
immunotherapies.
MOLOGEN AG is a publicly listed company, headquartered in Berlin. The
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), EnanDIM(R) and MOLOGEN(R) are registered trademarks of
MOLOGEN AG.
Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
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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Additional features:
Document: http://n.equitystory.com/c/fncls.ssp?u=NHFVARYANC
Document title: MOLOGEN AG: Recruitment for the TEACH study with
MGN1703 in HIV-patients completed
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22.09.2015 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: MOLOGEN AG
FabeckstraÃe 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: presse@mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart
End of News DGAP News Service
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396511 22.09.2015
DGAP-News: MOLOGEN AG: Recruitment for the TEACH study with MGN1703 in HIV-patients completed (news with additional features)
| Source: EQS Group AG