Cellivery Completes Preparation for COVID-19 Treatment Clinical Trials in Europe..."Approval for Establishment of European Corporation"
[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 24th that it has received approval from the Dutch government for the establishment of a European legal entity to conduct clinical trials of its COVID-19 treatment in Europe, completing the establishment of Cellivery-Europe B.V. Along with this, the Investigational New Drug (IND) filing documents required for the clinical trial application have been finalized, completing preparations for clinical trials of the COVID-19 treatment on the European continent.
The European Medicines Agency (EMA) mandates that sponsors conducting clinical trials within European Union member states appoint a legal representative within Europe. Consequently, Cellivery established a subsidiary in Amsterdam, Netherlands, to conduct clinical trials for the COVID-19 treatment.
A Cellivery spokesperson stated, "Separately from the establishment of the European entity, the clinical trial protocol being developed at the Italy office is nearing completion," adding, "The clinical trial protocol includes the clinical synopsis and protocol based on all research results and non-clinical trial data provided by Cellivery." They further explained, "All necessary details for conducting the clinical trial, interpreting results, and management methods are documented, and the entire clinical trial protocol is now complete."
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After applying for and obtaining approval for clinical trials in Europe, Cellivery will conduct Phase 1 clinical trials in Poland. From Phase 2 onwards, the trials will expand globally, targeting countries severely affected by COVID-19. In the United States, Cellivery plans to independently conduct clinical development. Based on human efficacy data obtained from clinical trials in the US, Europe, and third countries, the company aims to supply this powerful immunotherapy as a standard treatment to all infectious disease patients, including those infected with COVID-19 virus variants. Additionally, development of inhalation formulations and oral capsule formulations for asymptomatic COVID-19 positive patients and mild cases is also underway.
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