[Asia Economy Reporter Hyungsoo Park] Cellivery is showing strong performance. The news that it has signed a toxicity testing contract with Covance, a Contract Research Organization (CRO) specializing in safety evaluation, and is conducting toxicity tests of the cytokine storm-suppressing severe sepsis treatment drug iCP-NI on large and small animals appears to have influenced its stock price.
At 11:22 AM on the 1st, Cellivery was trading at 84,700 KRW, up 5.22% from the previous day.
iCP-NI is an anti-inflammatory treatment drug for acute pneumonia and severe sepsis caused by cytokine storms resulting from infections such as the novel coronavirus disease (COVID-19).
The toxicity evaluation tests are being conducted on 50 adult monkeys and 300 rats. The purpose is to prove the safety of iCP-NI, which is a final essential requirement for clinical trials by the US FDA and Korea KFDA. These tests are being conducted simultaneously with the efficacy evaluation tests for COVID-19 at Southern Research, which began on the 27th of last month.
Cellivery CEO Daewoong Cho introduced, "The reason for conducting toxicity, pharmacokinetics, and pharmacodynamics safety evaluations of iCP-NI at Covance and simultaneously conducting therapeutic efficacy evaluations for COVID-19 at Southern Research is to pursue simultaneous fast-track clinical trials with the US FDA and Korea KFDA."
He explained, "This is based on the opinion of the FDA clinical consulting CRO that conducting all tests at the highest-level specialized contract research organization in the US is beneficial."
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