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
Partnership With FAST Technologies Expands Aptean's European Footprint17.1.2018 21:00 | Pressemelding
ALPHARETTA, Ga., Jan. 17, 2018 (GLOBE NEWSWIRE) -- Aptean, a leading global provider of mission-critical enterprise software solutions, has formed a strategic partnership with FAST Technologies in Northern Ireland. This partnership is an important part of Aptean's growth strategy in the European market, specifically the United Kingdom and the Republic of Ireland. FAST Technologies will sell and support one of Aptean's industry-leading process solutions, Factory Manufacturing Execution System (MES). Process manufacturers use Factory MES to gain real-time visibility into production, operations and quality compliance by adopting a true paperless solution. FAST, a leading provider of industrial automation solutions, is well-established with high-volume manufacturers of retail packaged goods and pharmaceutical products. "We are excited to announce this partnership with Aptean. For many years, we have struggled with an appropriate solution that gives our customers an out-of-the-box experienc
Egyptian Steel recognised in the World Finance 100 guide for 201717.1.2018 15:29 | Pressemelding
LONDON, Jan. 16, 2018 (GLOBE NEWSWIRE) -- Egyptian Steel currently stands as one of the most powerful companies in Egypt. Its prosperity is largely down to the work of founder and CEO, Ahmed Abou Hashima, whose optimistic and bold approach has seen the company go from strength to strength - even in tough conditions. In spite of Egypt's 2011 revolution, which pushed the country through much turmoil, Egyptian Steel was able to take off, having been founded just the year before. Abou Hashima believes that investors shouldn't be put off in times of political uncertainty and economic upheaval. If they are brave, the rewards can be great. And if his organisation's performance is anything to go by, it seems these are wise words; Egyptian Steel's four steel plants now produce 2.3 million tonnes of steel annually. For its outstanding work, Egyptian Steel has been recognised by World Finance in the magazine's World Finance 100 guide, which identifies the world's strongest organisations. Here, co
Investing in Berlin's thriving real estate market17.1.2018 15:05 | Pressemelding
LONDON , Jan. 17, 2018 (GLOBE NEWSWIRE) -- Germany's capital Berlin may be well known as a vibrant tourist destination - the city welcomed 12.7 million visitors last year - but it also offers fantastic investment opportunities. Currently, the real estate market is flourishing, but it is also constantly changing. As such, investors will find that a little market knowledge goes a long way. In 2018, the trend towards renting out furnished apartments looks set to continue, with renovated properties achieving a high sell-on value. Locations will also remain a key factor in determining property prices. In Berlin, real estate buyers will find that high-demand areas like Mitte, Prenzlauer Berg and Friedrichshain offer solid opportunities for return on investment (ROI). Alongside Berlin, other cities in former-East Germany are proving increasingly enticing to real estate developers. Leipzig, for example, has a thriving student population and good job prospects as a result of investment from Por
Innovative Humanized Research Strategies for Immuno-Oncology Drug Development, Crown Bioscience Hosts a Live Webinar17.1.2018 14:12 | Pressemelding
SAN DIEGO, Jan. 17, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, will host a webinar on Thursday, January 18, 2018 at 10 am EST (3pm BST/UK), presented by renowned immunologist, Dr. Jayant Thatte. Dr. Thatte will review currently available humanized models and describe innovative applications for preclinical immuno-oncology research. The evaluation of immunotherapeutics is hindered by a lack of preclinical oncology models that exhibit functional human immunity. To overcome this obstacle, Crown Bioscience uses cutting-edge humanization protocols to develop innovative research solutions with reconstituted, functional human immune components. These humanized models can be combined with human cancer cell lines or patient-derived xenograft (PDX) mo
Colliers Launches Real Estate Technology Accelerator With Techstars17.1.2018 13:30 | Pressemelding
Partnership with Global Technology Investor and Accelerator Leader Highlights Commitment to Real Estate Industry Innovation TORONTO, Jan. 17, 2018 (GLOBE NEWSWIRE) -- Colliers International Group Inc. (NASDAQ:CIGI) and (TSX:CIGI), a global leader in commercial real estate services, today announced the launch of the Colliers Proptech Accelerator powered by Techstars. "Disruptive changes in technology, evolving demographics, fierce global competition and increased connectivity are factors impacting all industries," said Dylan Taylor, Colliers President & COO. "And the commercial real estate industry is no exception. Colliers sees this as an opportunity and is committed to being the most enterprising company in our industry by developing innovative and value enhancing services for our clients and professionals. Partnering with Techstars allows us to harness the best and brightest in operating technology accelerators and selectively evaluate and invest in new technologies. The new Colliers
BnkToTheFuture Raises Initial $30 Million for Tokenized Securities Market and Due Diligence Platform17.1.2018 13:15 | Pressemelding
Largest Online Investment Platform for Fintech, Bitcoin, and Blockchain Ventures to Distribute BnkToTheFuture Token (BFT) for Equity-Backed Token Deals to Accredited Investors GEORGE TOWN, Cayman Islands, Jan. 17, 2018 (GLOBE NEWSWIRE) -- Financial technology investment platform BnkToTheFuture (www.bnktothefuture.com) has raised an initial $30 million for its tokenized equity market and due diligence platform within the first 24 hours of of its token pre-sale open solely to institutional investors and members of its platform. BnkToTheFuture offers the largest online investment platform for investing in the equity of FinTech, Bitcoin, and Blockchain companies as well as Initial Coin Offerings (ICOs) that have passed a stringent due-diligence and compliance process. Already popular as an online investment platform with almost 50,000 professional and accredited investors with over $260 million invested in the funding rounds of FinTech, Bitcoin, and blockchain deals listed on its platform
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom