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Medigene Receives Clinical Trial Approval for Phase I/II Study with DC Vaccine to Treat Acute Myeloid Leukaemia (AML)

Press Release

 

 

Martinsried/Munich, 22 December 2014. Biotechnology company, Medigene AG (MDG1, Frankfurt, Prime Standard) announces that the Norwegian Medicines Agency (NoMa) and the relevant Ethic Committee have granted the approval to conduct a phase I/II clinical trial with its dendritic cell (DC) vaccine. Thereby, all regulatory prerequisites for the study start are fulfilled. The trial for the treatment of acute myeloid leukaemia (AML) will enroll patients for which standard therapies failed and will generate further clinical feasibility and safety data for Medigene's personalized DC vaccines. Further information will be published with study start.

About Medigene's DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced platform of the three highly innovative and complementary immunotherapy platforms of Medigene Immunotherapies (formerly Trianta Immunotherapies).

Currently the DC vaccines are being evaluated in two ongoing investigator-initiated trials in clinical phases II (prostate cancer) and I/II (AML, acute myeloid leukaemia). Medigene concentrates on the further development of DC vaccines in hematological malignancies and is preparing a company-sponsored clinical study in AML for which the clinical trial approval has been granted today.

Medigene's dendritic cell product platform allows the design of new generation dendritic cell vaccines. Dendritic cells can take up antigens efficiently, process them and present them on their surface in a form that can induce antigen-specific T cells to proliferate and mature. This way T cells can recognize and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to become active and attack tumour cells. Scientists of Medigene Immunotherapies have developed new, fast and efficient methods for preparing autologous (patient-specific) mature dendritic cells which have relevant characteristics to activate both T cells and NK cells. The dendritic cells can be loaded with various tumour antigens to treat different types of cancer and are suited for treatment of minimal residual disease or use in combination therapies.

Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near Munich, Germany. Medigene concentrates on the development of personalized T cell immunotherapies with a focus on haematological malignancies. Medigene is the first German biotech company to have revenues from a marketed product, which is distributed by commercial partner companies. Medigene has advanced drug candidates which are licensed to partners and additional candidates in clinical development. The company is developing highly innovative treatment platforms concentrating on cancer and autoimmune diseases. For more information, please visit www.medigene.com.

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. Medigene ImmunotherapiesTM is a registered trademark of Medigene Immunotherapies GmbH. Trianta ImmunotherapiesTM is a registered trademark of Medigene Immunotherapies GmbH. These trademarks may be owned or licensed in select locations only.

Contact Medigene
Julia Hofmann, Anja Clausnitzer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com

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