Medigene Starts Phase I/II Study with DC Vaccine to Treat Acute Myeloid Leukaemia (AML)

Medigene AG / Medigene Starts Phase I/II Study with DC Vaccine to Treat Acute Myeloid Leukaemia (AML) . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

Press Release

 

Martinsried/Munich, 24 March 2015. Biotechnology company Medigene AG (MDG1, Frankfurt, Prime Standard) announces that the company's phase I/II clinical trial with its dendritic cell (DC) vaccine for the treatment of acute myeloid leukaemia (AML) has started. Oslo University Hospital, Norway, the main trial centre, has begun to identify potentially eligible patients for enrollment. The study enables Medigene to evaluate its personalised DC vaccines in its first company-sponsored trial and generate further clinical feasibility and safety data of active immunotherapy, complementing ongoing academic clinical phase I/II and phase II studies.

Study design: Medigene's phase I/II multi-centre, open-label trial will include 20 AML patients after completion of standard chemotherapy to reduce the risk of recurrence of leukaemia by using Medigene's DC vaccines. Patients will be vaccinated for 50 weeks, with a follow-up period of one year or until progression. The primary objective is to prove feasibility and safety of active immunotherapy with Medigene's DCs. Secondary objectives are induction of immune responses, control of minimal residual disease (MRD) and clinical response/time to progression (TTP).

Prof. Dolores J. Schendel, Chief Scientific Officer of Medigene AG, comments: "We are proud that the first company-sponsored clinical trial with Medigene's new immunotherapy programs has started. The initiation of this trial is testament to the hard work by Medigene associates with our clinical partners in Oslo over the past years to develop this individualized DC vaccine approach for patients without further treatment options."

Prof. Gunnar Kvalheim, Head of Department of Cellular Therapy, Oslo University Hospital: "Our success in developing a production process for these precision vaccines combined with initial clinical data from our ongoing investigator-initiated clinical trials with Medigene's DC vaccine approach encourage us to further evaluate these promising new generation dendritic cells to efficiently activate T cell responses for the treatment of cancer."