ROCKVILLE, Md., May 15 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that it has completed enrollment in the Phase I/IIa study of its pandemic influenza vaccine including a total of approximately 230 subjects. Favorable interim results from the first phase of the study, which included dose-escalation in 70 healthy adult volunteers, were reported in December 2007. The interim findings suggested that the vaccine is well tolerated and immunogenic at the 15 microgram and 45 microgram dose levels. Based upon its review of these results, the Data and Safety Monitoring Board (DSMB) recommended that the study continue.
Enrollment has now been completed in the second phase of the trial, which includes approximately 160 healthy adult volunteers. The safety and immunogenicity of three vaccine doses (15 micrograms, 45 micrograms and 90 micrograms) as compared with placebo will be evaluated. Top-line results for this trial are expected in the third quarter.
"This is an important study because the safety data collected in this trial will also be used to support the safety database for our seasonal influenza vaccine program which is expected to begin with a Phase IIa study in the third quarter of this year. Completion of enrollment in the second portion of this Phase I/IIa pandemic influenza vaccine trial keeps us on target to announce top line results from this study in the third quarter," said Rahul Singhvi, President and Chief Executive Officer.
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, potent recombinant vaccines utilizing a new, efficient manufacturing solution. Additional information about Novavax is available at http://www.novavax.com and in the Company's various filings with the Securities and Exchange Commission.
FORWARD LOOKING STATEMENTS
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding revenues, operating expenses, cash burn, and clinical developments and 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 the Company's ability to progress any product candidates in preclinical or clinical trials; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; clinical trial results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; Novavax's pilot plant facility is subject to extensive validation and FDA inspections, which may result in delays and increases costs; the effect or outcome of the Company's decision to sell Estrasorb(R); the human capital and other costs Novavax will incur to exit the manufacturing facility; our ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our 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; our 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 http://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.|
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