Efficacy, Safety, and Tolerability of Adjuvant GLS-1200 Topical Nasal Spray in the Prevention of Acute Rhinosinusitis Following Functional Endoscopic Sinus Surgery (FESS)

This clinical trial will evaluate the safety, tolerability and effectiveness of GLS-1200 nasal spray in addition to the standard of care after endoscopic sinus surgery in people with chronic sinusitis.

开始日期2023-12-01

申办/合作机构

GeneOne Life Science, Inc.

NCT04408183

/ Terminated临床2期

Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection

This clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.

开始日期2020-06-10

申办/合作机构

GeneOne Life Science, Inc.

100 项与 GLS-1200 相关的临床结果

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100 项与 GLS-1200 相关的转化医学

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100 项与 GLS-1200 相关的专利（医药）

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项与 GLS-1200 相关的文献（医药）

Cochrane Database of Systematic Reviews

Use of antimicrobial mouthwashes (gargling) and nasal sprays by healthcare workers to protect them when treating patients with suspected or confirmed COVID-19 infection

Review

作者: Webster, Katie E ; Burton, Martin J ; Goulao, Beatriz ; Worthington, Helen V ; Schilder, Anne GM ; McBain, Andrew J ; Glenny, Anne-Marie ; Clarkson, Janet E

BACKGROUND:

COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of HCWs are irrigated with antimicrobial solutions, this may help reduce the risk of active infection being passed from infected patients to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves, or alterations in the natural microbial flora of the mouth or nose. Understanding these possible side effects is particularly important when the HCWs are otherwise fit and well.

OBJECTIVES:

To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays used by healthcare workers (HCWs) to protect themselves when treating patients with suspected or confirmed COVID-19 infection.

SEARCH METHODS:

Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020. SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed randomised controlled trials (RCTs). We therefore planned to include the following types of studies: RCTs; quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies. We sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to HCWs, with or without the same intervention being given to the patients with COVID-19.

DATA COLLECTION AND ANALYSIS:

We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) viral content of aerosol, when present (if intervention administered to patients); 4) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 5) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.

MAIN RESULTS:

We found no completed studies to include in this review. We identified three ongoing studies (including two RCTs), which aim to enrol nearly 700 participants. The interventions included in these trials are povidone iodine, nitric oxide and GLS-1200 oral spray (the constituent of this spray is unclear and may not be antimicrobial in nature). AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by two RCTs and a non-randomised study. We are concerned that only one of the ongoing studies specifically states that it will evaluate adverse events and it is not clear if this will include changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular, where those receiving the intervention are otherwise fit and well, it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.

项与 GLS-1200 相关的新闻（医药）

2024-08-20

·PRNewswire

VGXI accepted as a Member of the Biopharmaceutical Manufacturing Preparedness (BioMap) Consortium

CONROE, Texas, Aug. 20, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is honored to announce its acceptance into the Biopharmaceutical Manufacturing Preparedness (BioMap) Consortium. The BioMap Consortium is focused on expanding the United States' biopharmaceutical industrial capabilities and bio-manufacturing output, including funding requisite capabilities, enhancing supply chain flexibilities, and facilitating strategies to secure medical supplies to meet public health preparedness and response requirements. The BioMap Consortium is supported by the Pharmaceutical Countermeasure Infrastructure (PCI) Division and BioMap Branch of the Biomedical Advanced Research and Development Authority (BARDA). With this acceptance, VGXI joins the ranks of more than 200+ member firms with the expressed mission of ensuring adequate manufacturing capabilities and developing biopharmaceutical products and related materials so that countermeasures and therapies can be rapidly delivered to civilian populations. With more than two decades of experience in plasmid DNA manufacturing, VGXI has the largest plasmid manufacturing capacity (4000L) in the world and provides the agility and scalability to support the development of next-generation therapeutics across all scales and stages – from preclinical research to full-scale commercial production. Young Park, CEO at VGXI, celebrated the milestone by stating, "We are proud to be a part of the BioMap Consortium. Our demonstrated history of manufacturing solutions for public health allows VGXI to be a valuable contributor to this consortium and to support our fellow members and US-based biomanufacturing to address health-related threats to the nation's public health." ABOUT VGXI, INC. VGXI is a leader in plasmid DNA contract manufacturing, with 20+ years of experience providing high quality products to biomedical researchers worldwide. We support clients that develop DNA vaccines, immunotherapies, cell therapies, and gene therapies. VGXI's manufacturing process and quality controls are coupled to a continuous, low-shear AIRMIX® patented lysis technology, and proprietary purification processes that provide highly supercoiled plasmid production and exceptional purity. VGXI's portfolio includes high quality plasmid for preclinical research, Highly Documented (HD) plasmid as a critical raw material for GMP viral vector production or pharm/tox studies, cGMP plasmid DNA for clinical utilization through commercial supply, and custom services. To learn more, visit . ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II). For more information, visit . CONTACT: Justin Smith, Director of Marketing, [email protected]. SOURCE VGXI, Inc.

疫苗临床2期免疫疗法信使RNA基因疗法

2024-07-30

·PRNewswire

VGXI, accepted as a Member of the US Government's Rapid Response Partnership Vehicle (RRPV)

CONROE, Texas, July 30, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is proud to announce its selection as a member of Rapid Response Partnership Vehicle (RRPV) which supports the Biomedical Advanced Research and Development Authority (BARDA) in its objective to accelerate Medical Countermeasure (MCM) product and technology development to address evolving needs including pandemic influenza, emerging infectious diseases, and other biological threats. With more than two decades of experience in plasmid DNA manufacturing, VGXI has the largest plasmid manufacturing capacity (4000L) in the world from its two state-of-the-art facilities covering 160,000 sq. Ft. Young Park, the CEO of VGXI, stated, "We are honored to be accepted as a member of RRPV. We have a track record to be in the forefront of global response for manufacturing vaccines needed for infectious disease like Influenza, Ebola, MERS and COVID19. This gives us an opportunity to happily support the RRPV members and any partners in the US Government to protect our country from any future pandemics. VGXI is open for partnerships to support nucleic acid-based manufacturing and provide end-to-end solutions under one roof." ABOUT VGXI With over 20 years of experience VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI's ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and highly experienced development team. VGXI, Inc. is a GeneOne company. To learn more, visit . ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II). For more information, visit . CONTACT: Justin Smith, Director of Marketing, [email protected] SOURCE VGXI, Inc.

疫苗临床2期免疫疗法信使RNA

2024-03-27

·PRNewswire

Stephanie Burke Named as VGXI's New Chief Accounting Officer

CONROE, Texas, March 27, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is pleased to announce the appointment of Stephanie Burke as the Chief Accounting Officer (CAO) for VGXI. Ms. Burke joined the company in 2015 bringing with her over a decade of accounting and leadership expertise and has since played an instrumental role in the company's financial operations. Ms. Burke has previously held leadership roles overseeing both the VGXI Accounting/Finance and Materials teams. Her expertise was essential to guide VGXI through the successful implementation of MISys, the company's electronic MRP system, to streamline manufacturing operations and enhance efficiency. "I am honored to take on the position of Chief Accounting Officer," said Ms. Burke. "I look forward to working with our talented team in my new role to drive financial excellence to support VGXI's future growth initiatives in the years to come." Prior to VGXI, Ms. Burke served as the Financial Controller at Manuli RYCO / Fliuconnecto, a global manufacturer and distributor of hydraulic products and was the General Manager of International Expo Service, an exhibit builder and service company for trade shows, overseeing operations. Ms. Burke received her Bachelor of Business Administration in Accounting from Washington State University. "Stephanie has been an invaluable member of the VGXI team since 2015. Her exceptional financial acumen coupled with her leadership skills make her the ideal candidate for the Chief Accounting Officer position. This well-deserved promotion recognizes the significant contributions Stephanie has made to VGXI during her tenure and she will undoubtedly play a critical role in shaping our financial strategies as we enter our next phase," said VGXI's CEO, Young Park. ABOUT VGXI, INC. With over 20 years of experience VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI's ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and highly experienced development team. VGXI, Inc. is a GeneOne company. To learn more, visit . ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II). For more information, visit . Contact: Justin Smith, Director of Marketing [email protected] SOURCE VGXI, Inc.

疫苗高管变更临床2期

100 项与 GLS-1200 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性鼻窦炎	临床2期	美国	GeneOne Life Science, Inc.	2023-12-01
慢性鼻窦炎	临床2期	美国	GeneOne Life Science, Inc.	2023-12-01
鼻窦炎	临床2期	美国	University of Pennsylvania	2023-12-01
新型冠状病毒感染	临床2期	美国	GeneOne Life Science, Inc.	2020-06-10

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04408183 (CTgov)	临床2期	新型冠状病毒感染	184	GLS-1200 (GLS-1200)	膚觸壓窪繭遞齋窪願築 = 繭蓋蓋窪廠觸獵簾獵遞膚齋築積憲膚憲製襯繭 (壓齋餘夢網膚衊窪憲餘, 餘顧構醖夢衊夢憲積壓 ~ 築糧糧膚簾艱齋餘願艱) 更多	-	2025-07-31
				Placebo (0.9 %Saline)	膚觸壓窪繭遞齋窪願築 = 糧觸獵齋願壓廠餘網憲膚齋築積憲膚憲製襯繭 (壓齋餘夢網膚衊窪憲餘, 獵繭夢窪蓋鏇衊鏇鏇艱 ~ 鬱構廠廠淵遞窪顧獵鏇) 更多