VaxGen AIDS Vaccine Trials Clear 5th Safety Review

Apr 12, 2001, 01:00 ET from VaxGen, Inc.

    BRISBANE, Calif., April 12 /PRNewswire/ -- The independent organization
 that oversees the only final-stage clinical trials for a preventive HIV/AIDS
 vaccine has once again indicated that the vaccine appears safe and that the
 trials are being conducted appropriately, VaxGen, Inc. (Nasdaq:   VXGN)
 announced today.  Separately, VaxGen said that an average of 95% of volunteers
 continue to participate in the Phase III trials.
     (Photo:  http://www.newscom.com/cgi-bin/prnh/19991112/VAXGENLOGO )
     In its fifth review of VaxGen's trials, the Data and Safety Monitoring
 Board (DSMB) found that the vaccine continues to exhibit a high safety
 profile.  More than 23,000 injections of the vaccine, AIDSVAX, have been
 administered since it entered human clinical trials.
     "Safety is a very important issue for any vaccine, and doubly so for an
 AIDS vaccine, so we are pleased that AIDSVAX continues to appear safe," said
 Phillip W. Berman, Ph.D., VaxGen's senior vice president of research and
 development and the inventor of AIDSVAX.  "If AIDSVAX proves effective, safety
 will be critical to receiving regulatory approval and acceptance among
 potential recipients."
     AIDSVAX is made from a synthetic protein and contains no genetic material,
 so it is incapable of causing HIV or AIDS.
     VaxGen is conducting the world's only Phase III trials for a preventive
 HIV/AIDS vaccine.  Two formulations of the vaccine are being tested in
 separate trials -- one in North America and Europe and a second in Thailand
 -- involving nearly 8,000 volunteers.  The double-blind trials provide a
 series of inoculations to volunteers 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
 know who gets the vaccine or the placebo.  At the end of the trials, the
 vaccine's effectiveness is calculated by comparing the rate of HIV infection
 between the two groups.
     Those who volunteered for the trials continue to participate according to
 the company's expectations.  On an annualized basis, 94.7% of the volunteers
 in the North American/European trial continued to participate in the trial as
 of March 18, 2001.  The annualized retention rate for the Thai trial was
 97.4% as of the same date.
     "I continue to be humbled by the dedication of the trial volunteers," said
 Donald P. Francis, M.D., D.Sc., VaxGen's co-founder and president.  "Their
 high rate of participation gives us further reassurance that the trials will
 deliver an unambiguous answer as to how well AIDSVAX prevents HIV infection."
     All of the DSMB's reviews to date have focused on safety and trial
 conduct.  Looking ahead, the DSMB is scheduled to conduct its first review in
 November to examine how well AIDSVAX prevents HIV infection.  If this interim
 efficacy analysis, which will examine data from VaxGen's trial in
 North America and Europe, shows that the vaccine is effective at a high level
 of statistical confidence, VaxGen expects that the trial would be halted
 early.  The company would then begin the process of applying for regulatory
 approval.  If the interim analysis is inconclusive, the trial will proceed to
 its scheduled conclusion in the fourth quarter of 2002.  The additional
 12 months of testing, if necessary, would generate additional statistical
 power with which to determine the vaccine's efficacy.
     VaxGen is the worldwide leader in developing vaccines for the prevention
 of HIV/AIDS and is the only company with preventive HIV/AIDS vaccines in Phase
 III clinical trials, the final stage before regulatory approval can be sought.
 VaxGen was co-founded by Dr. Francis and Robert Nowinski, Ph.D.
 Dr. Francis leads the development of the vaccine, AIDSVAX, and Dr. Nowinski,
 who retired last year, was the company's entrepreneur, financing the company
 at its origin and key early stages.  AIDSVAX was invented by
 Phillip Berman, Ph.D., head of VaxGen's research and development.  VaxGen is
 located in Brisbane, Calif.  For more information, please visit the company's
 web site at 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 and
 costs 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 availability of manufacturing
 capacity, 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, Inc.
    BRISBANE, Calif., April 12 /PRNewswire/ -- The independent organization
 that oversees the only final-stage clinical trials for a preventive HIV/AIDS
 vaccine has once again indicated that the vaccine appears safe and that the
 trials are being conducted appropriately, VaxGen, Inc. (Nasdaq:   VXGN)
 announced today.  Separately, VaxGen said that an average of 95% of volunteers
 continue to participate in the Phase III trials.
     (Photo:  http://www.newscom.com/cgi-bin/prnh/19991112/VAXGENLOGO )
     In its fifth review of VaxGen's trials, the Data and Safety Monitoring
 Board (DSMB) found that the vaccine continues to exhibit a high safety
 profile.  More than 23,000 injections of the vaccine, AIDSVAX, have been
 administered since it entered human clinical trials.
     "Safety is a very important issue for any vaccine, and doubly so for an
 AIDS vaccine, so we are pleased that AIDSVAX continues to appear safe," said
 Phillip W. Berman, Ph.D., VaxGen's senior vice president of research and
 development and the inventor of AIDSVAX.  "If AIDSVAX proves effective, safety
 will be critical to receiving regulatory approval and acceptance among
 potential recipients."
     AIDSVAX is made from a synthetic protein and contains no genetic material,
 so it is incapable of causing HIV or AIDS.
     VaxGen is conducting the world's only Phase III trials for a preventive
 HIV/AIDS vaccine.  Two formulations of the vaccine are being tested in
 separate trials -- one in North America and Europe and a second in Thailand
 -- involving nearly 8,000 volunteers.  The double-blind trials provide a
 series of inoculations to volunteers 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
 know who gets the vaccine or the placebo.  At the end of the trials, the
 vaccine's effectiveness is calculated by comparing the rate of HIV infection
 between the two groups.
     Those who volunteered for the trials continue to participate according to
 the company's expectations.  On an annualized basis, 94.7% of the volunteers
 in the North American/European trial continued to participate in the trial as
 of March 18, 2001.  The annualized retention rate for the Thai trial was
 97.4% as of the same date.
     "I continue to be humbled by the dedication of the trial volunteers," said
 Donald P. Francis, M.D., D.Sc., VaxGen's co-founder and president.  "Their
 high rate of participation gives us further reassurance that the trials will
 deliver an unambiguous answer as to how well AIDSVAX prevents HIV infection."
     All of the DSMB's reviews to date have focused on safety and trial
 conduct.  Looking ahead, the DSMB is scheduled to conduct its first review in
 November to examine how well AIDSVAX prevents HIV infection.  If this interim
 efficacy analysis, which will examine data from VaxGen's trial in
 North America and Europe, shows that the vaccine is effective at a high level
 of statistical confidence, VaxGen expects that the trial would be halted
 early.  The company would then begin the process of applying for regulatory
 approval.  If the interim analysis is inconclusive, the trial will proceed to
 its scheduled conclusion in the fourth quarter of 2002.  The additional
 12 months of testing, if necessary, would generate additional statistical
 power with which to determine the vaccine's efficacy.
     VaxGen is the worldwide leader in developing vaccines for the prevention
 of HIV/AIDS and is the only company with preventive HIV/AIDS vaccines in Phase
 III clinical trials, the final stage before regulatory approval can be sought.
 VaxGen was co-founded by Dr. Francis and Robert Nowinski, Ph.D.
 Dr. Francis leads the development of the vaccine, AIDSVAX, and Dr. Nowinski,
 who retired last year, was the company's entrepreneur, financing the company
 at its origin and key early stages.  AIDSVAX was invented by
 Phillip Berman, Ph.D., head of VaxGen's research and development.  VaxGen is
 located in Brisbane, Calif.  For more information, please visit the company's
 web site at 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 and
 costs 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 availability of manufacturing
 capacity, 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, Inc.