Navigation Links
NOVAVAX Completes Enrollment in Phase IIa Study of Seasonal Influenza Vaccine in Older Adults
Date:11/30/2009

ROCKVILLE, Md., Nov. 30 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today it has completed enrollment in the Phase II clinical study of its trivalent seasonal influenza (2008/2009 recommended strains) VLP vaccine candidate in healthy adults 60 years of age or older (older adults). This randomized, double-blind, active-controlled study is comparing the safety, tolerability and immunogenicity of two different doses (15 mcg and 60 mcg) of Novavax's trivalent seasonal influenza VLP vaccine to a commercially available trivalent inactivated vaccine, TIV (Fluzone®).

This study enrolled 467 older adults in a three-arm study at six different sites located within the United States. In addition to evaluating hemagglutinin inhibition (HAI) responses, anti-neuraminidase and cell-mediated immune responses are also being examined. Previous studies have shown that VLP-based flu vaccines drive strong neuraminidase inhibition (NAI) antibody titers and T-cell responses, indicating the potential for broader immunologic responses particularly in older adults.

"With the rapid completion of enrollment in this clinical trial as well as the first part of our H1N1 vaccine study in Mexico announced previously, we are on track to report results from our two most advanced clinical programs during the first quarter of next year," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "If results from the seasonal flu vaccine study are positive, we will be able to advance this program into Phase III clinical testing as early as 2010."

Seasonal Influenza

Seasonal influenza infects between 5 percent and 20 percent of the world's population and kills between 250,000 and 500,000 people each year. In the United States, the Centers for Disease Control and Prevention estimates that 15 to 60 million people contract influenza each year leading to over 200,000 hospitalizations and 36,000 deaths. The Advisory Committee on Immunization Practices (ACIP) currently recommends seasonal influenza vaccination for children six months through 18 years of age, pregnant women, and adults over 50 years of age, and individuals of any age with chronic health conditions or who are at high risk of influenza disease. Based on the expanding recommendation of vaccination to new age groups, the growing worldwide population to be vaccinated, and the need of an improved influenza vaccine for the elderly, global market projections of seasonal influenza are estimated to increase from $2.8 billion in 2007 to $6.5 billion by 2013.

About VLPs

Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax's VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.

About Novavax

Novavax, Inc. is a clinical-stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.

Forward-Looking Statements

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical trials and development of the seasonal influenza vaccine and other anticipated milestones 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 forward-looking statements or historical experience include risks and uncertainties, including clinical trial results, which may not be sufficient for regulatory approval or may indicate safety concerns not yet encountered; even if the results of the planned clinical trials are positive, the data may not be accepted by regulatory bodies or the seasonal influenza vaccine may not be approved by the United States government or additional clinical trials may be required; the Company has not yet manufactured, or relied on third parties to manufacture, any vaccines at a commercial scale; competition from already approved vaccines for seasonal influenza; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; the Company's ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the Company's ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration; the cost, timing and success of regulatory filings and approvals; the Company's ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel. 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 www.sec.gov. 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.


'/>"/>
SOURCE Novavax, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Novavax Prices Public Offering of Common Stock
2. NOVAVAX Completes First Stage of Enrollment in Pivotal H1N1 Influenza Vaccine Study in the Country of Mexico
3. Novavax Announces Release Date of 2009 Third Quarter Financial Results and Investor Conference Call
4. NOVAVAX to Present at Oppenheimer 20th Annual Healthcare Conference
5. Novavax Announces Poster Presentation at the 47th Annual Meeting of the IDSA
6. Novavax and CPL Biologicals Break Ground on New Influenza Vaccine Manufacturing Facility in India
7. Novavax Awarded NIH Grant for Respiratory Syncytial Virus (RSV) Vaccine Program
8. Novavax CEO to Present at the World Vaccine Congress 2009, Lyon, France
9. Novavax Announces Board of Director Changes
10. NOVAVAX Announces Positive Results for the Second Phase II Clinical Trial of its Trivalent Seasonal Influenza Virus-like Particle (VLP) Vaccine Candidate
11. NOVAVAX Virus-Like Particle Vaccine Protects Against 2009 Pandemic H1N1 Influenza Virus
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... A person commits a crime, and the detective ... the criminal down. An outbreak of foodborne illness ... (FDA) uses DNA evidence to track down the bacteria that ... It,s not. The FDA has increasingly used a complex, cutting-edge ... illnesses. Put as simply as possible, whole genome sequencing is ...
(Date:6/23/2016)... Calif. , June 23, 2016  The Prostate Cancer Foundation ... increasingly precise treatments and faster cures for prostate cancer. Members of the Class ... across 15 countries. Read More About the Class of ... ... ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry Network for ... Design Lab . Located in Pasadena, Calif., the Design Lab’s mission is to ... are designed, built and brought to market. , The Design Lab is Supplyframe’s ...
(Date:6/23/2016)... , June 23, 2016 Apellis Pharmaceuticals, ... 1 clinical trials of its complement C3 inhibitor, ... and multiple ascending dose studies designed to assess ... of subcutaneous injection in healthy adult volunteers. ... either as a single dose (ranging from 45 ...
Breaking Biology Technology:
(Date:4/28/2016)... and BANGALORE, India , April 28, 2016 ... a product subsidiary of Infosys (NYSE: INFY ), ... a global partnership that will provide end customers ... mobile banking and payment services.      (Logo: ... innovation area for financial services, but it also plays a ...
(Date:4/19/2016)... , UAE, April 20, 2016 ... be implemented as a compact web-based "all-in-one" system solution ... the biometric fingerprint reader or the door interface with ... of modern access control systems. The minimal dimensions of ... ID readers into the building installations offer considerable freedom ...
(Date:4/13/2016)... -- IMPOWER physicians supporting Medicaid patients in Central ... in telehealth thanks to a new partnership with higi. ... patients can routinely track key health measurements, such as ... when they opt in, share them with IMPOWER clinicians ... retail location at no cost. By leveraging this data, ...
Breaking Biology News(10 mins):