Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - October 23, 2000
(Photo: http://www.newscom.com/cgi-bin/prnh/19991112/VAXGENLOGO)
On Oct. 18, 2000, the independent Data and Safety Monitoring Board (DSMB) that reviews VaxGen's Phase III trials conducted its fourth review. The DSMB said all is well with the vaccine's safety and conduct of the trials. To date, more than 19,000 doses of the vaccine, AIDSVAX(R), have been successfully administered. DSMB reviews for safety and trial conduct occur every six months.
Looking ahead, the DSMB is scheduled to conduct its first review to examine how well AIDSVAX prevents HIV infection in November 2001. If this interim efficacy analysis, which will examine data from VaxGen's trial in North America and Europe, shows that the vaccine reduces HIV infection by at least 30 percent at 95 percent confidence, VaxGen expects to halt the trial.
The company will then begin preparing an application to the U.S. Food and Drug Administration and foreign regulatory agencies for licenses to manufacture and market the vaccine. If the interim analysis is inconclusive, the trial will proceed to its scheduled endpoint in the fourth quarter of 2002, at which point it will have gathered additional statistical power to evaluate the vaccine's efficacy.
"We believe we are at least four years ahead of any other possible vaccine, so the outcome of these trials has important implications for the prevention of HIV/AIDS," said VaxGen President Donald P. Francis, M.D., D.Sc.
VaxGen also announced that, of the nearly 8,000 volunteers who joined the two trials, more than 96 percent in the Thai trial and nearly 95 percent of those in the North American/European trial continue to participate. "We are grateful to our volunteers for staying with the trials in such large numbers," Francis said. "Their participation will ensure that the trials have the necessary statistical power to determine the vaccine's effectiveness."
VaxGen's double-blind, placebo-controlled trials provide a series of inoculations during the course of 36 months. Some of the trial volunteers receive vaccine and the remaining receive placebo. Neither the volunteers, the clinics that administer the injections nor VaxGen knows who gets vaccine or placebo. At the end of the interim and final analyses, the DSMB calculates the vaccine's effectiveness by comparing the rate of HIV infection between the two groups.
VaxGen is the only company with preventive HIV/AIDS vaccines in Phase III clinical trials, the final stage before regulatory approval. The company is located in Brisbane, Calif. For more information, please visit the company's web site at http://www.vaxgen.com. AIDSVAX(R) is a registered trademark of VaxGen.
Note: This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to known and unknown risks, uncertainties or other factors that may cause VaxGen's actual results to be materially different from historical results, expressed or implied by such forward-looking statements. Factors that might cause such a difference include, but are not limited to, uncertainties related to the progress, costs and results of the Company's Phase III clinical trials, the progress of other internal research and development projects, the establishment of collaborative arrangements with governmental agencies, the receipt of research grants and the timing of certain expenses. Reference should be made to VaxGen's Annual Report on Form 10-K, filed with the Securities and Exchange Commission, for a more detailed description of such factors discussed in the "Factors Affecting Future Results" and "Business" sections. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release or to reflect the occurrence of anticipated events.
SOURCE VaxGen Web Site: http://www.vaxgen.com Photo Notes: NewsCom: http://www.newscom.com/cgi-bin/prnh/19991112/VAXGENLOGO AP Archive: http://photoarchive.ap.org PRN Photo Desk, 888-776-6555 or 201-369-3467
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