Navigation Links
Novavax Reports Positive Results from Preclinical Studies of its VLP-based Trivalent Seasonal Influenza Vaccine Candidate

Results Support Moving Forward with a planned IND Filing for Novavax's

Seasonal Influenza Vaccine Candidate

ROCKVILLE, Md., April 16 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) said today that it has received positive results from an immunogenicity study in ferrets inoculated with the company's trivalent seasonal influenza vaccine candidate. These findings will enable Novavax to complete its planned investigational new drug ("IND") application to support initiation of a Phase II clinical trial targeted to begin in the third quarter of this year.

In the study, ferrets were inoculated with the company's trivalent seasonal influenza vaccine containing a mixture of three virus-like particles (VLPs) representing the H3N1, H1N1, and B virus strains. The vaccine induced protective antibody levels against each of the three strains represented in the vaccine in 100% of ferrets receiving a dose of 15 mcg/strain which is the standard dose for currently licensed split and subunit influenza vaccines. The vaccine candidate also induced protective antibody titers against a drifted strain in approximately 50% of ferrets inoculated. A separate toxicology study conducted in rabbits showed the trivalent vaccine was well tolerated with no unexpected side effects. The ferret and toxicology studies were conducted in collaboration with Dr. Ted Ross at the University of Pittsburgh Center for Vaccine Research and Bridge Laboratories, Gaithersburg, Maryland, respectively.

"Novavax' influenza programs are moving forward rapidly as planned," said Dr. Penny Heaton, Novavax' Chief Medical Officer and VP of Development. "In addition to the positive results from our seasonal influenza vaccine candidate announced today, the dose-ranging study of our H5N1 pandemic flu vaccine is enrolling as projected based on the favorable interim safety and immunogenicity analyses conducted last December. We plan to have the final doses selected for late stage development for both the pandemic and seasonal flu vaccine programs by the second half of this year," Dr. Heaton said.

"These results support on-going development of our trivalent seasonal influenza vaccine and keeps us on track to commence human trials of this vaccine candidate in the third quarter of 2008," said Rahul Singhvi, President and Chief Executive Officer of Novavax, Inc. "We will have two vaccines in Phase II development by the second half of this year."

The company is also preparing its seasonal VLP vaccine candidate for head-to-head human studies against a marketed flu vaccine beginning in the fourth quarter of 2008. Virus-like particles have been created for each of the three new flu vaccine strains recommended by the Centers for Disease Control and Prevention ("CDC") for the upcoming 2008-2009 season. Historically, it is not common for CDC to recommend changing all three strains of the seasonal influenza vaccine, however, even with this recommendation, Novavax has been able to construct the corresponding VLPs within six weeks of the announcement. We believe that the ability of Novavax to respond quickly to emerging flu strains using its proprietary recombinant VLP technology could significantly differentiate Novavax from other flu vaccine companies.

About Novavax

Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide using advanced proprietary virus-like particle (VLP) technology. The Company produces these VLP based highly potent, recombinant vaccines utilizing a new, efficient manufacturing solution.

Forward-Looking Statements

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues, operating expenses, and clinical developments are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax's product candidates under development; uncertainties relating to clinical trials; results of further animal and human testing may result in data inconsistent with previously announced data or with our expectations; risks relating to the commercialization, if any, of Novavax's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

SOURCE Novavax, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Novavax Reports Fourth Quarter and 2007 Year-End Financial Results
2. Novavax Announces Favorable Interim Results from Human Clinical Trial for Its Pandemic Influenza Vaccine Program
3. Novavax Announces Preclinical Results for Seasonal Influenza Vaccine Program
4. GE Healthcare and Novavax Establish Collaboration To Develop and Market Pandemic Influenza Solution
5. Novavax Reports Third Quarter 2007 Financial Results and Progress with Vaccine Development Programs
6. Novavax CEO to Present at ACUMENBioFins 9th Annual Healthcare Conference
7. Pharmacyclics Reports Multiple Presentations at AACR on Its HDAC and Selective HDAC Inhibitors
8. Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting
9. NOLabs AB Reports Success in Fight Against Bacteria Causing Urinary Tract Infection
10. Enanta Reports New Macrolide-Related Drug Class, Bicyclolides, to Combat Hospital and Community Acquired Superbug Infections, Including MRSA
11. MAP Pharmaceuticals Reports Positive Results From Phase 2a Clinical Trial of Combination Therapy in Adult Asthmatics
Post Your Comments:
(Date:11/24/2015)... , 24 de noviembre de 2015 /PRNewswire/ ... Breathing Pacemaker System, se complace anunciar el nombramiento ... consultor clínico.   ... -   --> ... un fisiólogo y consultor en neonatología y cardiología ...
(Date:11/24/2015)... 2015  DILON Diagnostics and GE Healthcare are pleased ... DILON to distribute GE,s Discovery NM750b Molecular Breast Imaging ... this distribution agreement will provide Dilon,s experienced distribution network ... and is considered an initial step in an ongoing ... clinicians and their patients. --> ...
(Date:11/24/2015)... Sectra (STO: SECT B) announces that ... agreement to deploy Breast Imaging PACS in its ... Breast Center a future-proof platform capable of expanding with the ... that Breast Center of Acadiana has entered into ... in its two freestanding imaging centers. This investment will ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... ... Young patients with a wide variety of dental needs can now receive ... who are pediatric dentists in Tucson, AZ . Unlike traditional treatment options that ... minimal discomfort and bleeding to the patient during treatment and the following recovery period. ...
(Date:11/24/2015)... ... ... DMG Productions announced that they will feature Aphria, Inc., in an upcoming episode ... and show times TBA. , Aphria, Inc., is a publicly traded company incorporated under ... medical marijuana pursuant to the Marijuana for Medical Purposes Regulations (the “MMPR”). , Aphria ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... Bolier Reactor System. Brillouin is the developer of renewable energy technologies capable of ... nuclear reactions (“LENR”), announced today that its WET™ and HHT™ Boiler System reactor ...
(Date:11/24/2015)... ... November 24, 2015 , ... American Family Care (AFC), the nation’s ... a holiday pop-up clinic located in Metro Atlanta’s North Point Mall. The clinic is ... different way. The location is scheduled to operate through Dec. 24. , Holiday Pop-Up ...
(Date:11/24/2015)... ... November 24, 2015 , ... Abington Hospital – Jefferson Health ... Quality® Bariatric Surgery Facility for treating individuals living with morbid or extreme obesity. ... available to its members to help them make informed decisions about their healthcare ...
Breaking Medicine News(10 mins):