Nasdaq GlobeNewswire

Novavax Announces Topline RSV F Vaccine Data from Two Clinical Trials in Older Adults

  • Topline data from the Resolve™ Phase 3 trial did not meet pre-specified efficacy objectives
    • The attack rate for the Phase 3 primary objective was approximately 25% of that observed in Phase 2 trial
  • Topline data from our Phase 2 rollover trial suggest improved vaccine efficacy from a second year of dosing

Management will host a conference call at 5:00 pm ET time today

GAITHERSBURG, Md., Sept. 15, 2016 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults.  The Resolve™ trial, a Phase 3 trial of our RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with our previous clinical experience, the vaccine was well tolerated.

Phase 3 Resolve™ Trial

The trial was a randomized, observer-blinded, placebo-controlled trial conducted at 60 sites in the United States. The primary objective of the Resolve trial was to demonstrate efficacy in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV msLRTD), as defined by the presence of multiple lower respiratory tract symptoms. The secondary objective of the trial was to demonstrate efficacy of the RSV F Vaccine in reducing the incidence of all symptomatic respiratory disease due to RSV (RSV ARD). Finally, the trial also evaluated the safety of the unadjuvanted, 135 microgram dose of the RSV F Vaccine compared to placebo.

Topline efficacy results of the trial are shown in the following table:

Summary of Primary and Secondary Objectives – Vaccine Efficacy
  Number of Participants - ITT Population (11,856)
Primary and Secondary 
Efficacy (CI)
Primary:  RSV msLRTD, N(%) 26 (0.44%) 28 (0.47%) -7.9 % (-84, 37) 0.78
Secondary:  RSV ARD, N(%) 117 (1.97%) 102 (1.72%) 12.6 % (-14, 33) 0.32

“We are both surprised and disappointed by the outcome of the Resolve trial, which we recently unblinded. Our initial analyses and review of the key aspects of the trial do not indicate issues with trial execution, data collection, data integrity, or drug product quality. We expect to have preliminary immunogenicity data in the coming weeks to further our understanding of the trial results,” said Gregory Glenn M.D., President, Research and Development. “Historically, annual seasonal RSV ARD attack rates between 3% and 7% have been observed in older adults1. In our Phase 2 trial, we observed an RSV ARD attack rate of 4.9% and an RSV msLRTD attack rate of 1.8%. In contrast, we observed an RSV ARD attack rate of 2.0% and an msLRTD attack rate of 0.4% in our Phase 3 trial. These attack rates indicate a mild RSV season in older adults this year. We are continuing to investigate potential root causes that could have impacted the outcome of this trial. We continue to believe that there is a path forward for our RSV vaccine and that there is an important unmet need for an RSV vaccine in older adults.”

Phase 2 Rollover Trial

Novavax also reported topline results from the Phase 2 rollover clinical trial of its RSV F Vaccine in older adults.

The trial was a randomized, observer-blinded, placebo-controlled rollover trial which enrolled 1,329 older adults from the prior Phase 2 trial, conducted at the same 10 sites in the United States. The primary objectives of the trial evaluated safety and serum anti-F IgG antibody concentrations in response to immunization with the RSV F Vaccine. The exploratory objectives of the trial evaluated the efficacy of a second annual dose of the RSV F Vaccine in the prevention of RSV ARD and RSV msLRTD. Participants previously randomized to receive 135 microgram RSV F Vaccine or placebo were re-enrolled and re-randomized in the current trial to receive either 135 microgram RSV F Vaccine or placebo. This resulted in analysis of four separate trial arms: a) participants receiving a placebo in both the first trial and second trial; b) participants receiving RSV F Vaccine in the first trial and placebo in the second trial (Vaccine-Placebo); c) participants receiving placebo in the first trial and RSV F Vaccine in the second trial (Placebo-Vaccine); and d) participants receiving RSV F Vaccine in both the first trial and second trial (Vaccine-Vaccine).

Topline results of the trial are shown in the following tables:

Summary of Geometric Mean Titer for Anti-F by Visit – ITT Population
  Number of Participants (1,329)
  Placebo (2014/15) 
Placebo  (2015/16) 
(N = 333)
Vaccine (2014/15)
Placebo (2015/16) 
(N = 328)
Placebo (2014/15)
Vaccine (2015/16) 
(N = 337)
Vaccine (2014/15)
Vaccine (2015/16) 
(N = 331)
Day 0 (baseline)  N   333     327     336     329  
GMEU   1012.8     2293.6     962.9     2267.3  
95% CI   (922.0,1112.5 )   (2091.8, 2514.9 )   (869.0,1067.0 )   (2076.4, 2475.8 )
Day 28  N   332     325     333     327  
GMEU   1019.3     2188.7     6071.2     4489.3  
95% CI   (928.6, 1119.0 )   (2005.0, 2389.2 )   (5526.9, 6669.0 )   (4137.7, 4870.7 )
GMEU: geometric mean ELISA units

Gregory Glenn, M.D., said, “The rollover trial demonstrated immunogenicity in all active vaccine recipients. As shown in the table above, there was a 6-fold increase in anti-F IgG in the Placebo-Vaccine arm, consistent with the Phase 2 efficacy trial. There was higher anti-F IgG at baseline in the Vaccine-Vaccine arm compared to the Placebo-Vaccine arm. Further, the Vaccine-Vaccine arm showed a greater than 2-fold increase in anti-F IgG from the higher baseline. We observed similar low attack rates and absence of efficacy of a single immunization in this trial as was observed in Phase 3 Resolve trial, although we did observe that a second season immunization could provide efficacy. The event rate comparisons made to either placebo groups suggested that the second season immunization was protective, even in a year with a very low attack rate. Further understanding of these data may come forth with full evaluation of the immune responses.”

Summary of Exploratory Efficacy Objective+
  Number of Participants (1,329)
  Placebo (2014/15) 
Placebo  (2015/16)
(N = 333)
Vaccine (2014/15)
Placebo (2015/16) 
(N = 328)
Placebo (2014/15)
Vaccine (2015/16)  
(N = 337)
Vaccine (2014/15)
Vaccine (2015/16) 
(N = 331)
RSV ARD (%) 8 (2.4%) 7 (2.1%) 11 (3.3%) 2 (0.6%)*
RSV ARD Vaccine Efficacy     11 %   -36 %   75 %
msLRTD (%) 1 (0.3%) 2 (0.6%) 2 (0.6%)   0  
*p-value = 0.079; msLRTD was not calculated due to low N value
+all data in table is not significant (p-value > 0.05); preliminary N

“While the results from the Resolve trial are unexpected, we continue to believe in our technology and product candidates based on the totality of the data from our RSV F Vaccine franchise,” said Stanley C. Erck, President and CEO. “We expect to gain a better understanding of the data from both the Phase 2 rollover and Phase 3 trials as we further analyze and review them internally, as well as with our investigators and potential partners. We intend to provide a more in-depth update at our investor and analyst meeting on October 11, 2016.”

Conference call

Novavax management will host a conference call at 5:00 p.m. ET. The dial-in number for the conference call is 877-212-6076 (U.S. or Canada) or 707-287-9331 (International), passcode 80163880. A webcast of the conference call can also be accessed via a link on the home page of the Novavax website ( or through the "Investor Info"/"Events" tab on the Novavax website.  Presentation slides will be available via the webcast link.

A replay of the conference call will be available starting at 7:30 p.m. on September 15, 2016 until midnight September 20, 2016. To access the replay by telephone, dial 855-859-2056 (Domestic) or 404-537-3406 (International) and use passcode 80163880. The replay will also be available as a webcast and can be found on the "Investor Info"/"Events" on the Novavax website.

About RSV

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.1,2 Each year, RSV is responsible for approximately 207,000 hospitalizations and 16,000 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.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for ground-breaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the company's website,

1. A.R. Falsey et al.  Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med. 2005; 352:1749–59.

2. A.R. Falsey et al.  Respiratory syncytial virus and influenza A infections in the hospitalized elderly.  J. Infect Dis. 1995; 172:389-94.

3. K. Widmer et al. Rates of hospitalizations for respiratory syncytial virus, human metapneumovirus, and influenza virus in older adults. J Infect Dis. 2012; 206: 56-62.

4. K. Widmer et al. Respiratory syncytial virus & human metapneumovirus-associated emergency department and hospital burden in adults. Influenza and Other Respiratory Viruses. 2014; 8(3): 347-352.

Forward-Looking Statements

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, 2015 as 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, 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.

         Novavax, Inc.
         Barclay A. Phillips
         SVP, Chief Financial Officer and Treasurer
         Andrea N. Flynn, Ph.D.
         Associate Director, Investor Relations
         Russo Partners, LLC
         David Schull
         Todd Davenport, Ph.D.

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700

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

Abeona Therapeutics Reports Fourth Quarter 2017 Financial Results and Business Highlights16.3.2018 22:32Pressemelding

Investor Conference Call on Tuesday, March 27th at 10:00 am ET NEW YORK and CLEVELAND, March 16, 2018 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, today announced financial results for the fourth quarter. The Company will host a call to update investors on recent clinical developments and year-end financial results on Tuesday, March 27th at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-407-9210 (toll free domestic) or 201-689-8049 (International). "The past year was marked by several defining events in the company's history, having advanced our two lead clinical programs, EB-101 in Epidermolysis Bullosa and ABO-102 in MPS IIIA, and initiated our third clinical program, ABO-101 in MPS IIIB. The strong safety and biopotency data observed in our three active clinical trials and the s

Mandela Golden Hands Collection Sells for US$10 Million at PDAC 2018 Conference16.3.2018 15:40Pressemelding

Arbitrade, a new coin and cryptocurrency exchange, to purchase the unique gold collection with Bitcoin NEW YORK, March 16, 2018 (GLOBE NEWSWIRE) -- The Board of Arbitrade, a new coin and cryptocurrency exchange, has announced it will purchase the Nelson Mandela Golden Hands Collection. Made from 20 lbs, 99.999 of pure gold, it includes 3 life size impressions of Mandela's hands and two others of his palm and fist. It was cast in 2002 by South Africa's Harmony Gold mining group, one of the world's leading gold producers, 12 years after Nelson Mandela was released from prison. The seller, Malcolm Duncan, a South African businessman now living in Calgary, Canada, knew Mandela. He said that Harmony's intention was to make one full set of gold artefacts consisting of a fist, a full hand and a palm impression of his right hand for each of the 27 years Mandela had spent behind bars. Duncan had purchased the sets dedicated to 1964 and 1990, marking the year Mandela was incarcerated and the yea

RSK Chooses Decentral's Jaxx Blockchain Platform, Paving Way For Smart Contracts On Bitcoin16.3.2018 14:44Pressemelding

BUENOS AIRES, Argentina, March 16, 2018 (GLOBE NEWSWIRE) -- RSK, the smart contract platform powered by the Bitcoin network, today announced it has launched on Decentral's Jaxx cryptocurrency wallet and multi-token digital platform. This integration paves the way for RSK's open source platform to implement Ethereum-style smart contracts over the Bitcoin network. RSK combines the flexibility of smart contracts with the Bitcoin infrastructure, bringing endless possibilities to build a more flexible and inclusive financial system that will improve the life of billions of people. RSK successfully released its MainNet network, built as a side-chain to the Bitcoin mainnet, in January 2018. It is now presenting the first wallet that will help dApp developers manage their fuel while creating their solutions powered by RSK and the Bitcoin Network. RSK's CEO, Diego Gutierrez Zaldivar said: "We're very happy to partner with Jaxx, a highly-secure and a very easy-to-use wallet that will be the firs

Up to $200 Billion in Illegal Cybercrime Profits Is Laundered Each Year, Comprehensive Research Study Reveals16.3.2018 13:00Pressemelding

Cybercriminals turning to virtual currencies, video game currency and digital payment systems like PayPal to convert illegal revenue into clean cash CUPERTINO, Calif., March 16, 2018 (GLOBE NEWSWIRE) -- Bromium®, Inc., the pioneer and leader in application isolation using virtualization-based security, today announced the findings of an independent, academic study into the macro economics of cybercrime and how cybercriminals launder and 'cash out' the profits of criminal endeavours. The findings are part of a larger nine-month study titled Into the Web of Profit, sponsored by Bromium. The full findings will be presented at the RSA Conference in April by Dr. Mike McGuire, Senior Lecturer in Criminology at Surrey University, England. According to the report, cybercriminal proceeds make up an estimated 8-10 percent of total illegal profits laundered globally; amounting to an estimated $80-$200 billion each year 1. Other key findings include: Virtual currencies have become the primary tool

Technology empowering an increasingly connected SEA for financially inclusive communities16.3.2018 11:41Pressemelding

Global speakers IFC, MAS shared their views at Ant Financial Technology Exploration Conference in Singapore SINGAPORE, March 16, 2018 (GLOBE NEWSWIRE) -- Ant Financial Services Group ("Ant Financial" or "Ant") today wrapped up its participation at Money20/20 Asia in Singapore with the Ant Technology Exploration Conference (ATEC), with guests Giri Jadeja, Global Head of Financial Innovation at International Finance Corporation (IFC) and Sopnendu Mohanty, Chief Fintech Officer at Monetary Authority of Singapore (MAS) sharing their views on financial inclusion alongside Cheng Li, Chief Technology Officer and Chief Operations Officer for global business group at Ant Financial. Giri Jadeja shared his vision as global head of financial innovation at IFC - to reach out to the 2 billion unbanked and underserved population in the world, the majority of whom reside in Asia. The region has in recent years seen an exponential growth of new fintech companies. Giri is optimistic that technological c

Z-Wave Alliance Dominates Building Automation Space at Light + Building 201816.3.2018 11:00Pressemelding

Exhibitors introduce new products and demonstrate interoperability and collaboration in international Z-Wave smart building and IoT ecosystem FRANKFURT, Germany, March 16, 2018 (GLOBE NEWSWIRE) -- Light + Building 2018 - Hall 9.1, Booth E46 - The Z-Wave Alliance, a global membership organization dedicated to advancing the popular Z-Wave wireless smart home protocol, will host the Z-Wave Pavilion at Light + Building from March 18 - 23, 2018. The Alliance is also demonstrating their award-winning installation toolkit to make installation and testing of a Z-Wave smart home mesh network even easier for the pro installer community. The Z-Wave Pavilion will be on display at the show featuring the latest in European home and building automation and connected lighting products. Z-Wave Alliance members will demonstrate smart home lighting, thermostats, switches, air quality monitors and more. Support for the Z-Wave protocol has never been stronger - the Z-Wave Alliance now boasts over 700-membe

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom