MOLOGEN AG: Skin cancer study with MGN1404 approved

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Evaluation of safety and tolerability
Further product candidate ready for phase I clinical study
Study under the direction of the Charité Universitätsmedizin

The Paul-Ehrlich Institute has granted approval for a phase I clinical study of a gene therapy with MGN1404 for the treatment of melanomas (Press release Mologen, APR 15, 2013, View Source [SID:1234501173]). The study is entitled "Phase I trial of TNF-alpha expressing MIDGE-vector non-viral gene transfer in skin metastases of melanoma." The study will be conducted by collaborative partners Charité Comprehensive Cancer Center (CCCC), the Berlin Experimental and Clinical Research Center of the Charité (ECRC), the Max Delbrück Center for Molecular Medicine (MDC) in Berlin-Buch and the skin cancer center of the Charité (Hauttumorcentrum, HTCC).

The study will examine whether the MIDGE vector is safe and well tolerated when applied by intra-tumor jet injector, and whether the application leads to efficient expression of the hTNF-alpha gene. Further, the magnitude and extent of gene expression and the distribution of the MIDGE vector within and outside the injected tumor will be examined. Three different doses of the MIDGE vector will be used. This study is a first step towards the clinical use of local gene therapy for malignant melanomas.

(Press release, Selvita, APR 15, 2013, View Source [SID:1234505616])

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(Press release, Syros Pharmaceuticals, APR 11, 2013, View Source [SID:1234506060])

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On April 11, 2013 Pharmascience Inc. and Université de Montréal reported the signing of an agreement which formalizes and brings to the next level of activity a collaboration that demonstrates the value of academic research, public institutions, patient disease groups and the pharmaceutical industry working together to bring new hope to patients (Press release, Université de Montréal, APR 11, 2013, View Source [SID1234626501]). The agreement was coordinated by the university’s Institute for Research in Immunology and Cancer – Commercialization of Research (IRICoR).

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The result could be a new use for an old drug, and new hope for people with certain types of acute myeloid leukemia (AML), a blood cancer which today has very few treatment options and only a 10 per cent five-year survival rate. It is a story that demonstrates very clearly the benefits a multi-faceted biopharmaceutical cluster such as the one which exists in Greater Montreal can bring together to make a very complex undertaking possible.

It starts with Dr. Katherine Borden, a Montreal-born research scientist who, after 20 years of education and research in the United States and United Kingdom, was enticed by the Montreal research environment to return in 2004 as the Canada Research Chair in the Molecular Biology of the Cell Nucleus. She is a Professor in the Department of Pathology and Cell Biology in the Faculty of Medicine at Université de Montréal, as well as a Principal Investigator for the university’s Institute for Research in Immunology and Cancer (IRIC).

On April 4, 2013 BioInvent reported that the previously communicated positive results from a phase I trial of BI-505 is presented today at The International Myeloma Workshop in Kyoto, Japan (Press release BioInvent, APR 4, 2013, http://www.bioinvent.com/investors/press-releases/release.aspx?releaseid=760205 [SID:1234500562]). At the same meeting, preclinical data is also presented which demonstrate significantly enhanced efficacy when approved myeloma drugs are combined with BI-505. BI-505 is a human antibody directed against ICAM-1 and is developed for the treatment of multiple myeloma.
The results from the phase I study of BI-505 in patients with advanced multiple myeloma are presented by Associate Professor Markus Hansson at Lund University. The preliminary analysis shows that BI-505 has an advantageous safety profile. In cohorts where extended treatment was available, 24 percent of the patients had stable disease for at least two months, indicating effect of BI-505.
At the same meeting, new preclinical data is also presented showing significantly enhanced anti-myeloma activity when the approved drugs Velcade or Revlimid is combined with BI-505 compared to single agent treatment. Combined treatment was evaluated in two different experimental models and the drugs were given in a similar way as to patients with myeloma. In one of the models enhanced survival was observed following combination therapy with BI-505, compared to single agent treatment with the approved drugs. In the second model, complete remission was observed in the majority of animals when combining BI-505 with Revlimid or Velcade.

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