Innovative therapy method in ovarian cancer treatment – Clinical study launched

The company Prima BioMed Ltd. has launched a clinical study in Europe, supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI. This is a decisive step on the path towards the regulatory approval of the new therapy method. For the development for further cancer indications the partners have launched a joint project that is supported by € 3.8 million.

For several years now the Australian company Prima BioMed Ltd. and its German subsidiary have been developing an autologous immune therapy for treating epithelial ovarian cancer. Supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI the important regulatory hurdles have been cleared to test the procedure in Europe as well. For the first time patients can be treated with the innovative method. The study's preparation and execution are supported by funds provided by the Sächsische Aufbaubank (SAB) and the European Social Fund (ESF), € 4.1 million in total.

The study will involve female patients with epithelial ovarian cancer, who are in remission after successful surgery followed by chemotherapy. The Fraunhofer IZI will support the company in this development stage as well by manufacturing the investigational medicinal products.

At first, the study will start in Eastern Europe followed by other countries in the European Union. In Germany the first patients will be recruited in the second quarter of 2013.

Prima BioMed offers up-to-date information concerning the CANVAS study as well as inclusion of clinical centers in the index for clinical trials by the U.S. National Institutes of Health, NIH on

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Besides the clinical study ("CANVAS") for treating ovarian cancer the method will be developed for further cancer indications so the clinical benefit of the CVac-method will increase. A joint project between Prima BioMed and the Fraunhofer IZI was launched in March 2013 and is supported by € 3.8 million provided by the Sächsische Aufbaubank (SAB).

The autologous immune therapy CVac is based on the modification of the body's own immune cells. Tumor cells sidestep the immune defense in different ways. The CVac-method modifies specialized immune cells in the patient to be able to recognize the tumor cells and activate the immune system's multiple defensive mechanisms. These so-called dendritic cells are coded for a specific protein (biomarker) that only exists on tumor cells. Therefore the immune system is able to specifically attack the tumor cells without harming healthy cells. Therefore this treatment is a very gentle process with limited side effects.