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Novavax completes enrollment in phase 1/IIa pandemic influenza vaccine clinical trial |
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15 May 2008 |
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Novavax Inc. 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
ROCKVILLE, MD, USA | May 15, 2008 | 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.
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, potent recombinant vaccines utilizing a new, efficient manufacturing solution. Additional information about Novavax is available at www.novavax.com and in the Company’s various filings with the Securities and Exchange Commission.
SOURCE: Novavax Inc. |
