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

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.

For more information, please visit http://www.genexine.com/.