Novavax Initiates Pivotal Phase 3 Trial of the RSV F Vaccine in Older Adults
GAITHERSBURG, Md., Nov. 09, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the initiation of a Phase 3 clinical trial, known as Resolve™, of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older).
The Resolve trial is a randomized, observer-blinded, placebo-controlled trial designed to enroll up to 11,850 older adults at 60 sites in the United States. Participants are being enrolled and vaccinated in advance of the 2015-16 RSV season, with top-line results expected in the second half of 2016.
The primary efficacy objective of the Resolve trial is the prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. The trial’s objectives, endpoints and statistical approach were finalized based on the FDA’s recommendations during the recent End of Phase 2 meeting. The results of a Phase 2 trial in older adults, reported by Novavax in August 2015, provided the basis for the Phase 3 trial design, including the determination of the attack rate, vaccine efficacy and case definitions.
“We have taken advice and recommendations from the FDA, along with numerous key opinion leaders and clinical experts, to design the Resolve trial to align with and build on the strength of our previous clinical results,” said Stanley C. Erck, President and CEO. “The primary objective of this clinical trial captures moderate-severe RSV disease that drives an estimated annual economic burden of more than $24 billion in the United States alone. The Resolve trial takes Novavax one step closer to bringing this important vaccine to licensure, years ahead of other RSV vaccine development efforts.”
Respiratory syncytial virus, commonly referred to as RSV, is a respiratory infectious disease that causes serious infection of the respiratory tract, similar to influenza. For some, RSV may progress in severity, and lead to hospitalization or even death. The spread of RSV occurs annually, with an incidence rate of 2.5 million infections per year in the United States, RSV is increasingly being recognized as a significant cause of morbidity and mortality in the population of 64 million older adults.1,2The U.S. Centers for Disease Control and Prevention (CDC) reports that each year the disease causes 177,000 hospitalizations and 14,000 deaths among adults older than 65.3 Annually, there are approximately 900,000 medical interventions directly caused by RSV disease.4,5 Currently, there is no approved RSV vaccine available.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company’s website, novavax.com.
- Falsey, A.R. et al. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med, 2005; 352:1749–59; extrapolated to 2015 census population.
- Falsey, A.R. et al. Respiratory Syncytial Virus and Influenza A Infections In The Hospital Elderly. J. Infect Dis,1995;172:389-94
- CDC: http://www.cdc.gov/rsv/research/us-surveillance.html
- Widmer, K. et al. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus and Influenza Virus in Older Adults. J Infect Dis, 2012; 206: 56-62.
- Widmer, K. et al. Respiratory Syncytial Virus & Human Metapneumovirus-Associated Emergency Department and Hospital Burden in Adults. Influenza Other Respir Viruses, 2014; 8(3): 347-352.
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2014, and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2015 and June 30, 2015, filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
Russo Partners, LLC
Todd Davenport, Ph.D.
Om NASDAQ OMX
NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra NASDAQ OMX
Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra NASDAQ OMX
BroadSoft Hospitality Enhanced with Mobile UC-One Workstream Collaboration Capabilities to Amplify Productivity and Guest Experiences23.10.2017 07:30 | Pressemelding
New BroadSoft Hospitality features integrated into UC-One Connect allow hotels to access, respond to and act on guest requests in real-time, no matter where they are on the property PHOENIX, Oct. 23, 2017 (GLOBE NEWSWIRE) -- BroadSoft, Inc. (NASDAQ:BSFT), a global market share leader in cloud business software for unified communication as a service (UCaaS), and provider of collaboration and contact center as a service (CCaaS), today announced new UC-One mobile features for the BroadSoft Hospitality solution. The new features provide hotels with the ability to control the guest experience at any time from the UC-One mobile client. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/1fcfab75-3ddf-4c39-93f1-7c3e74458115 This new offering is a continuation of ongoing efforts by BroadSoft to help hotels deliver a greater level of experience to their guests. The mobile integration allows front desk hotel
BroadSoft Announces New Integrated and Intelligent Cloud Communication and Collaboration Experiences23.10.2017 07:30 | Pressemelding
Upgrades deliver on the BroadSoft Business cloud unified communication vision to deliver intuitive, consistent client experiences across the entire suite and reinvent workflow efficiencies PHOENIX, Oct. 23, 2017 (GLOBE NEWSWIRE) -- BroadSoft, Inc. (NASDAQ:BSFT) a global market share leader in cloud business software for unified communication as a service (UCaaS), and provider of collaboration and contact center as a service (CCaaS), today unveiled several enhancements to its BroadSoft Business portfolio at its annual user conference, BroadSoft Connections. Now leveraging a microservices architecture, BroadSoft Business offers updated app experiences and next-generation capabilities across the BroadSoft Business applications, UC-One, Team-One and CC-One. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0df82bc5-5481-4429-9586-bba075849626 Business users today are overwhelmed with managing their workfl
Powered by BroadSoft Channel Program Introduces New Digital Customer Lifecycle Platform and Services to Enhance Revenue Growth23.10.2017 07:30 | Pressemelding
Powered by BroadSoft now includes more than 100 global channel partners to realize the full potential of the cloud unified communication and collaboration market opportunity PHOENIX, Oct. 23, 2017 (GLOBE NEWSWIRE) -- BroadSoft, Inc. (NASDAQ:BSFT) a global market share leader in cloud business software for unified communication as a service (UCaaS), and provider of collaboration and contact center as a service (CCaaS) today announced the addition of new digital customer lifecycle management tools including the BroadCloud® Channel Support System (CSS) and three new services: BroadSoft go-to-market services, BroadSoft onboarding services and BroadSoft adoption services. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/b86c0264-fb6d-44fd-a7ae-38bba426e281 Powered by BroadSoft, which launched at BroadSoft Connections last year, currently supports 116 channel partners across the globe, v
BroadSoft Business Cloud PBX, Team Collaboration and Contact Center Apps Now Available for Multinational Enterprises23.10.2017 07:30 | Pressemelding
New, localized data centers offer multinational enterprise customers secure, multi-language calling and collaboration between global offices via a single, borderless BroadCloud platform PHOENIX, Oct. 23, 2017 (GLOBE NEWSWIRE) -- BroadSoft, Inc. (NASDAQ:BSFT) a global market share leader in cloud business software for unified communication as a service (UCaaS), and provider of collaboration and contact center as a service (CCaaS), today announced its BroadSoft Business cloud communication suite is available worldwide via several new BroadCloud ® data centers throughout EMEA and APAC. This expansion allows multinational enterprises to rely on a single provider across their international locations to collaborate with peers and customers around the globe, while meeting full regulatory and security compliance across different countries. A recent McKinsey Global Institute 2016 report noted that cross-border bandwidth is projected to increase nine times over the next
Cappasity Starts ARToken crowdsale and Adds Cryptocurrency Expert David Drake to its Advisory Board23.10.2017 06:45 | Pressemelding
SANTA CLARA, Calif., Oct. 23, 2017 (GLOBE NEWSWIRE) -- Cappasity, a company that develops a platform and an AR/VR blockchain ecosystem for 3D content production and mass distribution, is announcing the start of a crowdsale of ARToken (AR) on October 25, at 1 PM UTC. David Drake, Chairman at LDJ Capital, joins Cappasity's advisory board to provide counsel on critical issues relating to the specifics of the ICO process, blockchain and investor relations. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/aaaee806-98e3-476f-90ce-eb06e91d7e43 Today, Cappasity is announcing the start of the crowdsale of ARToken - a new digital currency that will be used as the primary payment unit within the global decentralized AR/VR Ecosystem for 3D content exchange. As a token sale is a very important step for the development of the company's project, Cappasity has decided to consult the deep expertise of one o
H.B. Fuller Poised for Global Growth with Acquisition of Royal Adhesives & Sealants23.10.2017 02:00 | Pressemelding
ST. PAUL, Minn., Oct. 22, 2017 (GLOBE NEWSWIRE) -- Boosting H.B. Fuller's (NYSE:FUL) problem-solving potential, the company today announces it has finalized its acquisition of Royal Adhesives & Sealants for $1.575 billion. Few people realize the impact of adhesives. They are everywhere, making virtually any durable or consumer product better. Adhesives have the potential to make the world a better place, and H.B. Fuller is tapping adhesives in unique ways to improve a range of global issues. H.B. Fuller, combined with Royal, deepens its expertise in specialty and high-value applications used in a range of sectors, including electronics, hygiene, medical, transportation, clean energy, construction, and more. Together, the companies will enable an interconnected world, support better use of the world's finite resources, improve food security and access to clean drinking water, and address the challenges of a globally disperse and aging population. "This is an exciting step
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom