GeneOne Life Science receives FDA approval for a Phase 2 study of its nasal spray, GLS-1200, for COVID-19 prevention
SEOUL, SOUTH KOREA (PRWEB) MAY 04, 2020
GeneOne Life Science, Inc. announces today an Investigational New Drug (IND) approval by the U.S. Food and Drug Administration of a Phase 2 study of GLS-1200, its nasal spray for the prevention of COVID-19 infection. This study will recruit hospital personnel and other frontline healthcare workers who are at significantly higher risk for infection with COVID-19. In this study, GLS-1200 will be topically self-administered as a spray to the nose, the primary entry point for COVID-19 infection. GLS-1200 acts to stimulate nasal cells to produce nitric oxide (NO). NO has been shown to inhibit SARS coronavirus growth and infectivity. This study of GLS-1200 will enroll a total of 225 participants into a randomized, double-blind, placebo-controlled clinical trial. The study will investigate whether three-times daily nasal administration of GLS-1200 over 4 weeks can prevent infection with COVID-19 while in use.
Dr. Joel N. Maslow, Chief Medical Officer of GeneOne, states that “having a prophylactic treatment like GLS-1200 that is easily scalable and nasally administered to the point of entry of the virus can provide significant benefit.”
Mr. Young K. Park, CEO of GeneOne, states that “we have moved quickly to enable GeneOne to supply millions of doses, as we anticipate the Phase 2 study of GLS-1200 will demonstrate effectiveness in preventing infection.”
ABOUT GENEONE LIFE SCIENCE
GeneOne Life Science, Inc. (“GeneOne” KOSPI: 011000) is an international developer of DNA and RNA vaccines, nucleic acid-based therapeutics, and small molecule therapies. GeneOne sponsored the MERS-001 and MERS-002 clinical trials against MERS-CoV and the ZIKA-001 and ZIKA-002 vaccine studies against the Zika virus. GeneOne’s research group has developed DNA vaccines and products to prevent and treat incurable diseases as well as hematologic diseases, metabolic diseases, and cancers. GeneOne is a recognized leader in the fight against Emerging Infectious Diseases (EIDs) with a pipeline to address a number of pathogenic organisms with a role in numerous international advisory committees regarding vaccine development against EIDs. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne’s wholly-owned manufacturing subsidiary, located in Texas, is the leading cGMP DNA plasmid manufacturing facility in the world for the vaccine, cell therapy, and gene therapy industries. VGXI has manufactured numerous DNA vaccines against EIDs including the GLS-5300 against MERS-CoV and the first COVID-19 DNA vaccine into human clinical trials. For more information, visit http://www.genels.com and http://www.vgxii.com.
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS
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Having a prophylactic treatment like GLS-1200 that is easily scalable and nasally administered to the point of entry of the virus can provide significant benefit.