StemCell Therapy

SOUTH SAN FRANCISCO, Calif., Jan. 27, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, including a Phase 2 ready norovirus program, announcedtoday health care economic findings published in the American Journal of Preventative Medicine. Computational modeling simulating norovirus infection and transmission in a community setting showed that a potential norovirus vaccine can avert symptomatic cases and result in cost savings. The study found, among other things, that vaccination against the norovirus can reduce the economic burden of the virus and is cost effective even if priced at $500 per course when vaccinating children under 5 and older adults, a much higher value than previously estimated. The manuscript titled, Potential Clinical and Economic Value of Norovirus Vaccination in the Community Setting can be accessed here.

This study highlights the fact that norovirus is highly contagious and can lead to missed school and work, with productivity losses that can add up, said Bruce Y. Lee, MD, MBA, senior author of the study, Professor of Health Policy and Management at the City University of New York (CUNY), and executive director of the Public Health Informatics, Computational, and Operations Research (PHICOR). The preschool-age population can be particularly vulnerable due to heavy social mixing leading to greater spread of the virus, and the older adult population can be susceptible to more severe disease and subsequently experience high rates of outpatient visits and hospitalizations.

The PHICOR team developed a computational simulation model of different segments of the US population and the spread of norovirus to better understand the value of vaccinating children <5 and adults 65 years old against norovirus. The model simulated the spread of norovirus, subsequent clinical outcomes (e.g., symptoms, hospitalization, death) and associated costs (e.g., direct medical, productivity loss), as well as vaccination.

Key Findings:

These important findings confirm our view of the significant potential clinical and economic benefit of a norovirus vaccine, saidAndrei Floroiu, chief executive officer ofVaxart. The significantly higher cost levels from this analysis increase meaningfully our view of the value creation potential of our oral tablet norovirus vaccine. We are very excited to advance our norovirus program with the three clinical trials we expect to start in 2021 and look forward to confirming the efficacy and tolerability profile suggested by the very encouraging data from our previous Phase 1 studies.

Norovirus is the leading cause of acute viral gastroenteritis in all age groups in the United States. However, there are no approved vaccines for noroviruses. Each year, on average, norovirus causes 19 to 21 million cases of acute gastroenteritis and leads to 56,000 to 71,000 hospitalizations and 570 to 800 deaths, mostly among young children and older adults.

Vaxart, Inc. supported the PHICORs research team.

About PHICOR

Since 2007, PHICORs team of scientists and medical, public health, and communication experts have been researching and developing systems and computational approaches, methods (e.g., artificial intelligence (AI), machine learning, data science), models, and tools to help a wide range of decision makers address various health and public health issues. PHICOR helps local, state, and federal governments respond toinfectiousdiseasethreats, ranging from the flu to Ebola to Zika to the current COVID-19 pandemic. For example, during the 2009 H1N1 flu pandemic, the PHICOR team was embedded in the U.S. Department of Health and Human Services (HHS) to help with the national response. This included working with the Department of Homeland Security (DHS) and the Centers forDiseaseControl and Prevention (CDC).

AboutVaxart

Vaxartis a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform.Vaxartinvestigational vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury.Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxarts first immuno-oncology indication.Vaxarthas filed broad domestic and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxarts strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as should, believe, could, potential, will, expected, plan and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to the potential clinical and economic value of a norovirus vaccine in a community setting; Vaxarts ability to develop and commercialize its vaccine candidates and preclinical or clinical results and trial data; Vaxarts expectations with respect to the advantages it believes its oral vaccine platform can offer over injectable alternatives; and Vaxarts expectations with respect to the effectiveness of its products or product candidates.Vaxartmay not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements thatVaxartmakes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials or preclinical studies, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial and preclinical study data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxarts product candidates may not be approved by the FDA or non-U.S.regulatory authorities; that, even if approved by the FDA or non-U.S.regulatory authorities, Vaxarts product candidates may not achieve broad market acceptance; that aVaxartcollaborator may not attain development and commercial milestones; thatVaxartor its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxarts or its partners control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; thatVaxartmay not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxarts capital resources may be inadequate; Vaxarts ability to obtain sufficient capital to fund its operations on terms acceptable toVaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the Risk Factors sections of Vaxarts Quarterly and Annual Reports filed with theSEC.Vaxartdoes not assume any obligation to update any forward-looking statements, except as required by law.

References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vaxart is not responsible for the contents of third-party websites.

Continued here:
Vaxart Announces Publication of a Peer-reviewed Journal Article Showing the Potential Clinical and Economic Value of a Norovirus Vaccine -...

This entry was posted on January 27, 2021 at 9:53 am and is filed under Preventative Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |