Prague, March 28 (CTK) – A medicine developed by the firm Sotio, a part of the PPF Group, and designated for the treatment of ovarian cancer, is the first Czech-made medicine to have gained the orphan drug status from the European Medicines Agency (EMA), Sotio said in a press release on Wednesday.
EMA grants the status to firms producing medicines for treating rare diseases, which hit fewer than five people per 10,000 in the EU.
“The granting of the status enables, for example, to launch studies of a smaller volume, compared with other diagnoses, and thereby accelerate the implementation of clinical studies,” Sotio spokesman Richard Kapsa told CTK.
The company has launched four second-phase clinical tests for the time being, the latest of them starting late last year. They have involved about 200 patients so far.
The new status will enable Sotio to launch an international clinical study involving a far higher number of patients earlier than expected.
Sotio expects the European Commission to approve the medicine at its next meeting.
The DCVAC medicine is produced individually for each patients with the use of her own dendritic cells. It has the effect of active cell immunotherapy.
Apart from ovarian cancer, Sotio is developing the drug’s variants for treating prostate and lung cancer.
Sotio is a biotechnological firm developing medicines for tumorous and autoimmunity diseases. Operating in Europe, the USA, Russia and China, Sotio is a part of the PPF financial group belonging to the richest Czech, Petr Kellner.