diaDexus, Inc. – ‘8-K’ for 11/12/03 – EX-99.1

On:  Wednesday, 11/12/03, at 5:15pm ET   ·   For:  11/12/03   ·   Accession #:  1169232-3-6538   ·   File #:  0-26483

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Current Report   —   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Current Report                                         3      8K 
 2: EX-99.1     Miscellaneous Exhibit                                  3     12K 

EX-99.1   —   Miscellaneous Exhibit

EX-99.1
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                                                                    Exhibit 99.1

 VaxGen Announces Results of its
Phase III HIV Vaccine Trial in Thailand: Vaccine Fails
 to Meet Endpoints

    BRISBANE, Calif. - November 12, 2003 - VaxGen, Inc. (Nasdaq: VXGN) today
announced preliminary results from its randomized, double-blind,                
placebo-controlled Phase III clinical trial in Thailand to evaluate AIDSVAX B/E,
an investigational vaccine (rgp 120) for the prevention of HIV infection.       

 The vaccine candidate did not show efficacy for either the primary or
secondary endpoints. The primary endpoint for the trial was the prevention of   
infection by HIV, the virus that causes AIDS. The secondary endpoints concerned 
whether vaccination slowed the progression of disease among those who received  
the vaccine but later became infected with HIV. The vaccine candidate appeared  
to be well tolerated with no serious adverse events related to the vaccine. The 
vaccine cannot cause HIV infection.                                             

The trial was well conducted in accordance with international good  
clinical practices. Extensive education and risk-reduction counseling were      
provided during the trial. Data indicate that study volunteers reported marked  
reductions in behaviors, including sharing of needles, associated with HIV      
infection.                                                                      

     "This trial was conducted according to the highest international clinical
standards, and is one of many examples of Thailand's long-standing commitment to
HIV vaccine development," said Kachit Choopanya, M.D., the trial's principal    
investigator. "With the help of the trial volunteers and national and           
international collaborators, Thailand has strengthened its research capacity and
acquired valuable expertise with which to carry on clinical research."          

  The trial results were analyzed by scientists from the Bangkok Vaccine
Evaluation Group (BVEG), the U.S. Centers for Disease Control and Prevention    
(CDC), the Statistical Center for HIV/AIDS Research and Prevention (SCHARP) of  
the Fred Hutchinson Cancer Research Center, and VaxGen.                         

     "The outcome of this trial is one more reminder of how difficult it is to
combat HIV and how important it is for the international public health community
to redouble the effort to develop an effective vaccine," said Donald P. Francis,
M.D., D.Sc., VaxGen's president. "Although we are disappointed with the outcome,
VaxGen and our Thai collaborators have created a model that can be used around  
the world for advanced clinical research of an HIV vaccine."                    

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About the Phase III Clinical Trial of AIDSVAX B/E                   

      The trial was designed to evaluate the safety and efficacy of AIDSVAX B/E,
primarily against the blood-borne transmission of HIV subtype E and one strain  
of HIV subtype B. The study volunteers were 2,546 injecting drug users in       
Bangkok, Thailand. During the 36-month trial, a total of seven injections were  
administered at months 0, 1, 6, 12, 18, 24 and 30. The ratio of vaccine to      
placebo recipients was 1:1.                                                     

      During the trial, 105 volunteers who received placebo became infected with
HIV; 106 volunteers who received at least one injection of AIDSVAX B/E became   
infected. The annualized infection rate in placebo and vaccine recipients was   
3.1%.                                                                           

The trial was conducted at 17 clinical sites in the greater Bangkok 
Metropolitan Area. Trial volunteers received education and counseling every six 
months to avoid behavior that could lead to HIV infection and were advised to   
assume that they may have received a placebo or that the vaccine might be       
ineffective.                                                                    

  "This was an international effort that brought together the public and
private sectors to focus on a common cause," Kachit said. "We owe a special debt
to the people who stepped forward to volunteer for this trial. More than 90% of 
the volunteers completed their full three-year commitment to the study, and     
their dedication should serve as an inspiration for others to volunteer for HIV 
vaccine studies."                                                               

The trial design was reviewed by the Thailand Food and Drug         
Administration, the Thailand Ministry of Public Health (MOPH), the Thailand     
National AIDS Subcommittee on AIDS Vaccines, the Bangkok Metropolitan           
Administration Ethical Review Committee, the Committee on Human Rights Related  
to Human Experimentation, Mahidol University, the UNAIDS Vaccine Advisory       
Committee, the U.S. FDA and its Vaccine Advisory Committee, and the             
Institutional Review Board of the CDC. The study was primarily funded and       
overseen by VaxGen and administered by BVEG, a partnership among the Bangkok    
Metropolitan Administration, Mahidol University, the Thailand MOPH-U.S. CDC     
Collaboration and VaxGen.                                                       

About VaxGen                                                        

    Based in Brisbane, Calif., VaxGen is a biopharmaceutical company engaged
in the development, manufacture and commercialization of biologic products for  
the prevention and treatment of serious human infectious disease, including     
anthrax and smallpox. For more information, please visit the company's website  
at www.vaxgen.com.                                                              

     Note: This press release contains "forward-looking statements" within the
meaning of the federal securities laws. These forward-looking statements include
without limitation, statements regarding VaxGen's plans regarding the future    
development of any HIV vaccines. These statements are subject to risks and      
uncertainties that could cause actual results and events to differ materially   
from those anticipated. Reference should be made to VaxGen's Quarterly Report on
Form 10-Q, filed with the Securities and Exchange Commission on August 18, 2003,
under the heading "Risk Factors", and the company's Annual Report on Form 10-K, 
filed with                                                                      

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the Securities and Exchange Commission on March 31, 2003, under the heading     
"Business", for a more detailed description of such factors. 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 except as required by   
law.                                                                            

Contact:                                                            
Lance Ignon                                                         
Vice President                                                      
Corporate Communications                                            
(650) 624-1041                                                      

Dates Referenced Herein   and   Documents Incorporated by Reference

				Referenced-On Page
This ‘8-K’ Filing		Date		First		Last			Other Filings
Filed on / For Period End:		11/12/03		1
		8/18/03		2					10-Q
		3/31/03		3					10-K,  10-Q,  10-Q/A
									List all Filings