SOTIO Receives Positive Opinion for Orphan Drug Designation for DCVAC/OvCa from European Medicines Agency (EMA)

March 28, 2018
Source: Press Release

SOTIO, a biotechnology company owned by the PPF Group, today announces that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending orphan medicinal product (orphan drug) designation for DCVAC/OvCa for the treatment of patients with ovarian cancer. The EMA’s positive opinion follows a similar decision issued previously by the U.S. Food and Drug Administration (FDA).

The orphan drug designation issued by the European Committee is available to companies developing products intended to treat life-threatening diseases that affect fewer than five in 10,000 persons in the EU. The positive opinion issued by COMP is expected to be adopted by the European Commission at its upcoming meeting. The EMA’s opinion supports positive signals from ongoing SOTIO clinical trials evaluating DCVAC/OvCa.

"We are delighted to have received the positive opinion for orphan drug designation for DCVAC/OvCa. In its opinion, the EMA stated that SOTIO has provided sufficient clinical data to justify the assumption that DCVAC/OvCa will be of significant benefit to patients affected by ovarian cancer. Granting DCVAC/OvCa the positive opinion recommending the Orphan Drug Designation for ovarian cancer treatment will help us to speed up our clinical development in this designation so that we can help patients affected by this devastating disease. We will initiate further clinical trials including Phase III," commented Radek Spisek, CEO of SOTIO.

EMA Orphan Drug Designation (ODD)

To qualify for European Medicines Agency's orphan drug designation, a medicine must be intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition that is rare (affecting not more than five in 10,000 people in the European Union) or where the medicine is unlikely to generate sufficient profit to justify research and development costs.

About DCVAC:

The SOTIO DCVAC product candidates are active cellular immunotherapy treatments which are produced individually for each patient using the patient’s own dendritic cells (which form part of the immune system), to induce an immune reaction against tumor antigens. SOTIO is developing three product candidates using the DCVAC platform to affect multiple different cancers in various stages of the disease - DCVAC/OvCa for patients with ovarian cancer, DCVAC/PCa for patients with prostate cancer and DCVAC/LuCa for patients with lung cancer.

The company is currently testing the safety and efficacy of investigational medicinal treatment DCVAC through multiple Phase I to Phase III clinical trials. SOTIO has been sponsoring four Phase II clinical trials for patients with ovarian cancer (DCVAC/OvCa treatment).

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