Genexine said NeoImmuneTech, its U.S. affiliate, has received approval from the U.S. Food and Drug Administration to conduct the phase 1 clinical trials of its HyLeukin-7 (GX-I7), a treatment for the Covid-19 patients.
The study will be a multi-institutional, randomized, double-blind, placebo-controlled trial that will evaluate the tolerability, safety, and efficacy of GX-I7 in adult patients with mild Covid-19 infections, the company said.
"It has been reported that patients infected with Covid-19 have a marked decrease in lymphocytes," Genexine said. "Notably, severe lymphocytosis decrease can be fatal if the patient's Covid-19 infection turns from mild to severe."
The company added that interleukin-7 is the only cytokine that can dramatically increase this lymphocyte count. It expects that GX-I7, a T-cell amplifier that applied Interleukin-7 to Genexine's platform technology, will show a therapeutic effect in Covid-19 patients.
"The severity of Covid-19 is related to the reduction and depletion of lymphocytes, which are essential for immune defense against infection," Genexine CEO Sung Young-chul said. "GX-I7 is expected to help patients combat viral infections more effectively by restoring lymphocytosis and restoring their immune function."
The company expects that the joint development of GX-I7, in collaboration with NeoImmuneTech will speed up the commercialization of GX-I7 as an anticancer and infectious agent, Sung added.
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