Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
PRNewswire - October 29, 1999
The CDC will contribute $2 million annually, for four years, to the selected clinics. The focus of the additional research supported by the contract is "to answer critical questions about how this and future vaccine trials may impact the attitudes and behaviors of both trial participants and the communities involved," according to the CDC.
"The CDC's support of our trial opens key avenues towards achieving our goals of ending the AIDS epidemic," said Dr. Donald P. Francis, president of VaxGen. "VaxGen will benefit from the vast experience of CDC, the U.S. government's premier HIV prevention organization. In turn, we will be sharing data and data analysis with the CDC."
The five clinical sites that will receive the CDC funds are San Francisco Department of Public Health, Fenway Community Health Center in Boston, Ohio State University, Howard Brown Health Center in Chicago, and the University of Washington in Seattle. The contract calls for CDC to assume clinical expenses for trial volunteers at these sites. Each participating site will continue to implement VaxGen's Phase III protocol, as well as conduct the additional research.
VaxGen is currently conducting two large-scale Phase III trials of its AIDSVAX vaccines. The first, principally in North America, is designed for 5,400 volunteers at 56 clinical sites in the United States, three in Canada and one each in Puerto Rico and The Netherlands. In Thailand, the trial is designed to test another formulation of AIDSVAX at 17 clinical sites in Bangkok, with 2,500 volunteers.
VaxGen received approval from the U.S. Food and Drug Administration on June 3, 1998 to begin the Phase III study, the first large-scale human trials of a vaccine designed to prevent infection by HIV, the virus that causes AIDS. To date, no other vaccine to prevent HIV infection has received FDA approval for testing in Phase III clinical trials.
The CDC funds will support additional epidemiological, social and behavioral research, designed to provide a more powerful analysis of vaccine effectiveness and evaluation of factors contributing to participation and risk behaviors as the trial progresses.
VaxGen, Inc., headquartered in Brisbane, CA, is developing preventive vaccines to eradicate AIDS.
Note: This news release contains "forward-looking statements" with 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 the Company'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 and costs of our 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 the Company's registration statement on Form S-1, filed with the Securities and Exchange Commission for a more detailed description of such factors discussed in the "Risk Factors" 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.
Additional information is available on our web site at: http://www.vaxgen.com
SOURCE VaxGen, Inc.
CONTACT: Donna K.H. Walters of Sitrick And Company, 310-788-2850, for VaxGen/
Web Site: http://www.vaxgen.com /
991029
PR991053
Copyright © 1999 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.
Always watch for outdated information. This article first appeared in 1999. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1999. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .