Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

Reuters NewMedia - Monday December 16, 2002
Deena Beasley

"This is a significant positive for VaxGen ... once the applications are filed, the FDA can make a decision in fairly short order," said Anna Kazanchyan, an analyst at Investec, which does not have a banking relationship with VaxGen.

On Friday, VaxGen said its shares had come under pressure after an article in the journal Nature raised questions about the effectiveness its AIDSVAX vaccine.

VaxGen spokesman Lance Ignon said the experiment detailed in the Nature article -- which claimed to show that the protein targeted by the AIDSVAX drug is invulnerable to antibodies because it can change shape -- used artificial antibodies against an artificial virus and the results cannot be compared with what happens with a natural HIV infection.

VaxGen is testing the vaccine for preventing HIV infection in a pivotal-stage, or Phase III, trial in 5,400 people in the United States, Canada, the Netherlands and Puerto Rico.

The company said it expects to announce preliminary trial results in the first quarter of 2003. Another pivotal-stage trial of a vaccine version designed to fight HIV subtypes prevalent in Southeast Asia is being conducted in Thailand, and those results are expected in the second half of next year.

"The fast-track designation allows us to file a rolling application with the FDA ... Once we have the data, we can seek a six-month priority review," said VaxGen spokesman Jim Key.

Under the FDA's so-called fast-track program for drugs that treat life-threatening conditions, the agency must notify the company of the acceptance of the marketing application within 45 days of filing, and must take regulatory action within six months, compared with one to two years for other applications.

"Importantly, the FDA may also grant initial marketing approval for a new vaccine based on surrogate endpoints ... thereby improving regulatory risk for AIDSVAX," Kazanchyan said. She said the fast-track review could allow for regulatory approval of the drug -- assuming positive clinical trial results -- within a year, but noted that the company is not expected to have manufacturing facilities on line until 2005.

VaxGen is the largest partner in Celltrion Inc., a joint venture to build and operate a plant in South Korea and another in the San Francisco area for manufacuturing biologics.

Key said the primary end-point of the trials is the prevention of HIV infection, but investigators will also be looking at the vaccine's impact on slowing viral replication in patients who do become infected.

VaxGen's AIDS vaccine is designed to work by inducing the immune system to produce antibodies that attach to the gp120 protein on the surface of the virus. The theory is that by preventing the virus from attaching to cells it will stop infection.

Making a vaccine against HIV is difficult because the virus integrates itself into cells, and because it attacks the very immune cells that are normally stimulated by a vaccine.

The price of VaxGen's shares had more than quadrupled since July after the company said at an AIDS conference in Barcelona that its vaccine could be available by 2005, if results from human safety and efficacy trials were as good as expected.

Shares of the Brisbane, California-based vaccine developer rose $2.72, or 21 percent, to close at $15.73 on the Nasdaq market Monday, gaining back much of the 32 percent drop they suffered last week. They had reached as high as $16.60 during the session.

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