EU/3/20/2266: Orphan designation for the treatment of ovarian cancer

DNA plasmid encoding IL-12 p35 and p40 genes


On 22 April 2020, orphan designation EU/3/20/2266 was granted by the European Commission to FGK Representative Service GmbH, Germany, for DNA plasmid encoding IL-12 p35 and p40 genes (also known as GEN-1) for the treatment of ovarian cancer.

Key facts

Active substance
DNA plasmid encoding IL-12 p35 and p40 genes
Intended use
Treatment of ovarian cancer
Orphan designation status
EU designation number
Date of designation

Heimeranstrasse 35
80339 Munich
Tel: +16094822457

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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