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Press Release

Genexine, “Hyleukin-7 (GX-I7), US clinical trial approval for COVID-19 treatment for mild patients”
2020.06.11

Genexine announced that NIT, the leader in the development of Hyleukin-7 in the United States, has been approved by the US Ministry of Food and Drug (FDA) for the clinical trials of treat Hyleukin-7 (GX-I7) for a treatment of COVID-19. This phase 1 clinical trial of Hyleukin-7 is a multicenter, double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of Hyleukin-7 in adult patients with mild COVID-19 infection.


Patients infected with COVID-19 are known to have significantly reduced lymphocytes, In particular, it is reported that the more severe the lymphocytic syndrome is, the more it changes from mild cases to a serious illness and eventually leads to death. Interleukin 7 is the only cytokine that can dramatically increase the number of lymphocytes.


Therefore, the innovative immunotherapeutic agent, Hyleukin-7 (GX-I7), which amplifies and enhances the number of T cells that occupy most of the lymphocytes, is expected to show a therapeutic effect in patients with COVID-19 infection. Hyleukin-7 is currently the only clinical developmental stage of long-acting interleukin-7.


Genexine CEO Young Chul Sung said “The severity of COVID-19 is related to the reduction and depletion of lymphocytes, which are essential for immune defense against infection. Hyleukin-7 is expected to more effectively combat viral infections by restoring lymphocytosis and the patient's immune function. The joint development of Hyleukin-7 through close cooperation with Neoimmunetech  is expected to greatly accelerate the commercialization of Hyleukin-7 as an anti-cancer and infectious treatment"


Especially this study will be conducted in collaboration with two world-leading institutions, NIAID/NIH and UNMC, that develop and establish standard antiviral treatments. The goal of this study was to establish the safety and appropriate dosing of Hyleukin-7 for patients with COVID-19, thus developing potential of new treatment options to prevent severe corona progression in people most susceptible to infection, such as the elderly or those with comorbidities.