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 GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Brookfield and GLP Establish Partnership to Pursue Rooftop Solar Opportunities in China21.3.2018 09:00 | Pressemelding
All amounts in U.S. dollars unless otherwise stated GLP and Brookfield establish 50:50 joint venture to develop and operate rooftop solar projects on logistics and commercial rooftops in China Partnership intends to become the largest rooftop solar power provider in China Expected to develop and operate capacity of 300 megawatts over the next three years, with a broader 1 gigawatt development pipeline - equivalent to the annual consumption of approximately 750,000 households SHANGHAI, China and NEW YORK, March 21, 2018 (GLOBE NEWSWIRE) -- GLP, the leading global provider of modern logistics and industrial facilities and technology-led solutions, and Brookfield Asset Management (TSX:BAM.A) (NYSE:BAM) (Euronext:BAMA), a leading global alternative asset manager, today announced the formation of a 50:50 joint venture dedicated to building a leading platform for distributed solar energy on logistics and commercial rooftops in China. The joint venture, by affiliates of GLP and Brookfield, in
LCM Partners and Brookfield Asset Management enter into strategic partnership21.3.2018 08:30 | Pressemelding
LONDON and TORONTO, March 21, 2018 (GLOBE NEWSWIRE) -- LCM Partners ("LCM"), a European alternative credit investment manager, announces that it has entered into a strategic partnership with Brookfield Asset Management Inc. (TSX:BAM.A) (NYSE:BAM) (Euronext:BAMA) ("Brookfield"), a leading global alternative asset manager, aimed at jointly growing LCM's leading asset management and credit servicing business globally. Under the terms of the agreement, Brookfield will acquire a 25% strategic interest in Link Financial Group, which comprises both LCM and its sister companies which operate a pan-European loan servicing platform under the Link Financial brand, with an option to acquire another 24.9% interest over time. Link Financial Group was established in the UK in 1998 and has since grown across 10 European offices to become a leading alternative investment manager focussed on credit, and specialised in investing in and servicing consumer, SME, auto, leasing and commercial loans. The firm
VPN.com Puts Netflix CEO Reed Hastings on Notice About Security Risks & VPN Ban21.3.2018 08:00 | Pressemelding
ATLANTA and SAN FRANCISCO, March 21, 2018 (GLOBE NEWSWIRE) -- VPN.com CEO, Michael Gargiulo, is taking the fight to Netflix, Inc. CEO, Reed Hastings, on behalf of 120 million Netflix subscribers worldwide who cannot securely access the service with a Virtual Private Network (VPN). "I wrote this letter because Netflix subscribers are unable to securely connect to the platform they're paying to access," explains Gargiulo. "This comes after Netflix decided to ban VPN connectivity to its platform altogether in 2016, citing copyright concerns from content providers like Sony Corporation, 21st Century Fox, Inc. and NBCUniversal, Inc." Currently, the VPN ban at Netflix forces users to choose between their online security and entertainment. With a large portion of customers connecting via public WiFi-including any of the estimated 500 million hotpots found in coffee shops, airports and hotels worldwide-the liability is omnipresent. "This is a huge problem for Netflix that is coming to a head,"
Boyden Focuses on Expansion in Nordic Region21.3.2018 06:01 | Pressemelding
Premier leadership solutions and talent advisory firm's growth in the Nordics and Northern Europe attracts next generation partners and investment to the region COPENHAGEN, Denmark, March 21, 2018 (GLOBE NEWSWIRE) -- Boyden, a premier global leadership and talent advisory firm with more than 65 offices in over 40 countries, today is announcing transitional changes to its team in Denmark effective 1 July, 2018. Boyden's offices in Sweden, Finland and Norway have experienced significant growth recently, and in support of this growth, Boyden anticipates sharing news on an expansion to the capabilities and expertise in the firm's Denmark office in the near future. "Our clients in the region have come to expect our world-class talent advisory and leadership expertise to help them achieve their growth objectives," said Katarina Brixéus, a Managing Partner of Boyden Sweden. She added, "We will continue to expand our on-the-ground capabilities to meet the aggressive goals of our clients in the
Intesa Sanpaolo, Iberdrola, and Ryanair Among Big Winners on Institutional Investor's 2018 All-Europe Executive Team Rankings21.3.2018 06:00 | Pressemelding
NEW YORK, March 21, 2018 (GLOBE NEWSWIRE) -- Airbus (France), Lonza Group (Switzerland), Nestlé (Switzerland), Allianz (Germany), Subsea 7 (United Kingdom), ASML Holding (Netherlands), Ryanair Holdings (Ireland) - swept their respective sectors, ranking first across the CEO, CFO, and investor relations categories. More than 2,400 buy-side analysts, asset managers, and sell-side researchers at over 800 firms named the best chief executives, top CFOs, investor relations professionals, and investor relations companies across 31 business sectors. Buy-side analysts, money managers and sell-side researchers at securities firms and financial institutions that cover the region identified up to four companies that excel in up to seven investor relations attributes including: Senior executives are accessible IR team is well informed and empowered to speak authoritatively on the company's behalf Timely and appropriate level of financial disclosure Responds quickly and thoroughly to requests Most
Orion Biotechnology Canada Announces Closing of $5 Million Financing20.3.2018 22:03 | Pressemelding
OTTAWA, March 20, 2018 (GLOBE NEWSWIRE) -- Orion Biotechnology Canada Ltd today announced it has completed a US$5 million private placement financing late last year. "We are delighted to have secured the financial resources during this period of rapid expansion," said Mark Groper, President and Chief Executive Officer. "This financing allows Orion, as a private company, to continue development of its expanding pipeline of innovative products, including expansion of our infrastructure and human resources. It also provides external validation of the unique value proposition of the company's pipeline products which include candidates in the areas of Sexual Health, Oncology and Multiple Sclerosis. Orion is a research and development organization committed to developing novel approaches to address serious health issues. A prime example of this is the company's microbicide candidate, OB-001, which is being evaluated as a contraceptive gel which also prevents the transmission of HIV. "This is
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom