GeneOne Life Science Announces US FDA Approval of a Phase 2 Study of GLS-1200 Nasal Spray for COVID-19 Prevention

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GeneOne Life Science receives FDA approval for a Phase 2 study of its nasal spray, GLS-1200, for COVID-19 prevention

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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.

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
Materials in this press release contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements relate to expectations or forecasts of future events. These statements can be identified by the fact that they do not relate strictly to historical or current facts. They include words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of potential future events, circumstances or future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be incorrect. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed, and forward-looking statements may be adversely affected by factors, including general market conditions, competitive product development, product availability, current and future branded and generic competition, federal and state regulations and legislation, manufacturing issues, timing of the elimination of trade buying, patent positions, litigations and investigations. Our actual results may vary materially, and there are no guarantees about the performance or valuation of GeneOne stock. It is also important to read the disclosure notice contained in many of the individual GeneOne documents available on the website, as many contain important information on such cautionary factors as of the date of the individual document. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our reports.

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