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MOLOGEN AG (FRA:MGN) DGAP-News: MOLOGEN AG: Recruitment for the TEACH study with MGN1703 in HIV-patients completed (news with additional features)

Transparency directive : regulatory news

22/09/2015 09:16

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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 --------------------------------------------------------------------- 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. +++++ 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 --------------------------------------------------------------------- 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. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------- Language: English Company: MOLOGEN AG Fabeckstraße 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 --------------------------------------------------------------------- 396511 22.09.2015