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Clinical Trials

Date: 2014-11-20

Type of information: Presentation of results at a congress

phase:

Announcement: presentation of results at the 56th American Society of Hematology (ASH) Annual Meeting taking place from December 6 - 9 2014

Company: Medigene (Germany)

Product: Dendritic Cell (DC) vaccines

Action mechanism:

Disease:

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

* On November 20, 2014, Medigene announced that early clinical data of its Dendritic Cell (DC) vaccines will be presented at the upcoming 56th American Society of Hematology (ASH) Annual Meeting taking place from December 6 - 9 2014 in San Francisco, USA. The clinical data to be presented were collected in a compassionate use program, conducted at the Department of Cellular Therapy at the Oslo University Hospital, Norway, under the responsibility of Prof. Gunnar Kvalheim and Iris Bigalke. The poster presentation titled \"Vaccination with a New Generation of Fast Dendritic Cells Transfected with mRNA from hTERT, Survivin and Autologous Tumor Mount Strong Immune Responses and Prolong Survival.\" shows data from patients with various types of tumour which were included in this program. The first patient treated with the new generation DCs transfected with hTERT and survivin mRNA suffered from stage IV lung cancer with brain metastases. Following diagnosis in June 2011 she was treated with chemotherapy and radiotherapy. Since December 2011 she has been vaccinated and has obtained a status of stable disease. DC vaccination was interrupted in 2/2013 when an attempt was made to re-open an occluded bronchus with radiotherapy. During irradiation the patient developed an inflammation of the pleura, which was treated with high dose cortisone. While on cortisone therapy the patient developed 2 new brain metastases, which were treated with local radiotherapy using the Cyberknife. DC vaccination was continued in 6/2013 and health conditions gradually improved bringing the patient again into a stable disease with no further development of brain metastasis. The second patient receiving DC vaccination had a hormone resistant prostate cancer in a very advanced stage and dropped out immediately after start of treatment. Additionally, four stage IV glioblastoma patients have been treated with hTERT and survivin transfected DCs plus either with autologous tumor mRNA or, where no tumor RNA was available, with hCMVpp65 mRNA DCs. The observation time of these four patients is currently 14, 11, 11 and 10 months and all patients remained in complete remission. All patients treated with the new generation DCs show strong local DTH responses and flu-like symptoms after vaccination at a significantly earlier time point then previously observed by us in patients treated with standard DCs.

Currently Medigene's 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 plans to initiate a further clinical study in AML in 2014.

Is general: Yes