Further Analysis of VaxGen AIDSVAX Trial Data Shows ‘No Stronger’ Evidence of Protective Effect for MinoritiesVaxGen yesterday at a meeting of HIV researchers in Canada released further scientific analysis of its clinical trial results of its experimental AIDS vaccine AIDSVAX, "show[ing] no stronger proof" of its original conclusion that the vaccine caused a "significant drop" in HIV infection rates among black study subjects, the San Francisco Chronicle reports (Tansey, San Francisco Chronicle, 4/1). VaxGen yesterday also reported that the vaccine failed to boost the immune systems of people already infected with HIV (Sternberg, USA Today, 4/1). VaxGen in late February announced that AIDSVAX reduced the rate of new HIV infections by 3.8% among people who received the vaccine, compared with clinical trial participants who received a placebo injection, but said that the vaccine was effective among African Americans, Asians and other non-white, non-Hispanic volunteers. In a subgroup of 498 non-white, non-Hispanic volunteers the vaccine appeared to provide protection in the range of 30% to 84%. According to the company, the analysis had less than a 1% chance of being random chance, making it statistically significant (Kaiser Daily HIV/AIDS Report, 3/31). The company yesterday announced that efforts to account for racial and ethnic differences by looking for possible problems in the design and implementation of the study have been unsuccessful (Jacobs, San Jose Mercury News, 4/1). In addition, further analysis has yielded no evidence of clear biological differences to account for the varied response in different races. Company executives said that the significance of the findings could be affected by the small number of blacks participating in the study (San Francisco Chronicle, 4/1). Phillip Berman, vice president of VaxGen, said that the company expects a complete analysis of the findings to take an additional six to 12 months. "We want to go through these results with a fine-toothed comb," Berman said (San Jose Mercury News, 4/1).
VaxGen Stock Falls
VaxGen shares yesterday dropped 14% after the announcement. KPMG LLP spokesperson Robert Wade said that the company "has suffered recurring losses from operations during its development stage and expects to have a working capital deficiency for 2003, which raises substantial doubt about its ability to continue as a going concern." Sharon Seiler, an analyst for Punk Zeigel & Co. who has done investment banking for VaxGen, on Feb. 24 said that the company would need to raise money by this summer in order to cover its operating costs. The company, which has spent $81 million on the vaccine since 1995, said that it has plans both to raise money and cut its costs and added that any new AIDSVAX trials would have to be funded by the government or private foundations, the Chronicle reports (San Francisco Chronicle, 4/1). The company also faces a series of lawsuits alleging that the company and its officials engaged in a "fradulent scheme" that hid negative trial results from investors. VaxGen has said that the lawsuits have no merit (Cohen, Science, 3/28).
'Racial Tension' Exposed
USA Today profiles the "racial tension" and concerns over business conflicts of interest that have surfaced since the release of VaxGen's clinical trial results in February. The VaxGen study "raises several key scientific questions: public service vs. corporate survival, ... the insider-trading problem, ... subgroup statistics" and racial tensions, according to USA Today. VaxGen's claims about the possible efficacy of its vaccine in blacks "revealed" a "rift ... of racial tension" that has existed in the AIDS advocacy community for years, Phill Wilson, executive director of the Black AIDS Institute, said (USA Today, 4/1). The complete article is available online.