Cellivery's COVID-19 Treatment iCP-NI... "Simultaneous Clinical Trials in Korea and the US"

[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 24th that it will simultaneously conduct clinical trials in both the U.S. Food and Drug Administration (FDA) and the Korea Food and Drug Administration (KFDA) to expedite the clinical entry and commercialization of iCP-NI, a 'cytokine storm suppressing severe sepsis treatment' being developed as a therapeutic agent for the novel coronavirus infection (COVID-19).

A company official stated, “To administer the treatment to patients with severe pneumonia and sepsis caused by coronavirus infection as quickly as possible, we decided to pursue clinical trials simultaneously in Korea and the U.S. We have submitted a clinical trial application to the Korean FDA, and in the U.S., we have agreed to a contract with Covance, which provides new drug development services.” He added, “Covance will be responsible for overall clinical management, from preparing clinical trial documents to designing and conducting the trials.”

He emphasized, “To directly verify the efficacy of iCP-NI against COVID-19, we have completed consultations with Southern Research, a specialized contract research organization in the U.S., and will conduct efficacy tests using a non-human primate COVID-19 disease model that mimics the lesions of human novel coronavirus infection.”

Countless people worldwide catch colds every year. Among various cold viruses, one is the coronavirus. When this virus invades, the body remembers and can sufficiently defend itself; however, COVID-19 is a novel virus. According to the company, it is a new virus that has crossed the species barrier from animals to humans, which we have never experienced before.

He explained, “Its infectivity is significantly stronger compared to existing cold viruses, and since our immune system has never encountered it before, naturally, there are no immune antibodies, so our body reacts much more severely, causing symptoms that can be life-threatening. SARS, which occurred 17 years ago, and MERS, which emerged 5 years ago, are also coronaviruses. Antibody treatments or vaccines for these have not yet been developed, and even if vaccines are made, the virus continuously mutates to evade our immune system. Therefore, developing preventive vaccines for such novel viruses is even more difficult.”

The company explained that iCP-NI suppresses the cytokine storm by controlling more than 20 types of inflammatory cytokines, making it possible to treat not only COVID-19 but also severe sepsis caused by various pathogenic bacterial and viral infections. Unlike conventional vaccine therapies that must be newly developed each time a novel virus pandemic occurs, iCP-NI can be used for sepsis, a severe inflammation caused by all pathogenic viral infections, regardless of viral mutations or variations.

Cellivery CEO Daewoong Cho stated, “Our hope is to enter clinical trials in Korea and the U.S. within the shortest possible time and develop iCP-NI as a new drug that not only addresses the current COVID-19 pandemic but also serves as the ultimate therapeutic agent effective against infectious contagious diseases that will continue to occur periodically in the future.”

This content was produced with the assistance of AI translation services.