Clinical development program with MGN1601

 

In June 2010, MOLOGEN received the permission from the responsible authority in Germany, the Paul-Ehrlich-Institute, to carry out a phase I/II clinical study with the cancer medicine MGN1601 against renal cancer. The purpose of the study is to investigate the safety and efficacy of MGN1601 and will soon start at three oncological clinics in Germany. The study is designed as an open, non-randomized, multi-center proof-of-principle phase I/II study. Within the scope of the study, 24 patients suffering from advanced renal cancer and with whom the standard treatment has proved to be unsuccessful will be treated with MGN1601. The primary aim of the study is to collect safety and tolerability data. In addition, efficacy data, including clinical, immunological and radiological parameters of the patients, will also be collected.

Orphan drug status for MGN1601

 

The cell-based gene therapy against renal cancer developed by MOLOGEN was granted Orphan Drug Status by the European Medicines Agency (EMEA). Orphan Drug Status permits the product's marketing exclusivity within the European Union for 10 years. The company is also granted the encompassig consulting support from the EMEA during the approval process. The Orphan Drug Program of the European Union was created to promote the development of therapies for rare and severe illnesses.

 

Information on renal cancer

 

Renal cancer is the most frequent of malignant kidney cancers. Approximately 209,000 newly diagnosed cases are annually registered on a worldwide scale (source: European society for Medical Oncology, ESMO, 2009). 15,000 patients are affected by the disease in Germany alone (source: Robert-Koch-Institute and the Epidemiological Cancer Register Association, 2008), whereby approximately 30% of all patients already have distal metastases during initial diagnosis, which diminishes a therapy's chances of success considerably. The tumor is known not to respond to radiation or chemotherapy. Although newly developed and specialized (targeted) drugs recently approved for this indication can improve therapy results, they cannot cure the disease. The use of these drugs is further accompanied by not inconsiderable side-effects. This clearly shows that there is still great medical demand for effective and simultaneously well tolerated drugs for the treatment of renal cancer.

 

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