http://www.denverpost.com/Stories/0,1002,6439%257E207087,00.html

Better anthrax vaccine claimed

By Marsha Austin
Denver Post Business Writer

Friday, November 02, 2001 - Scientists at GlobeImmune Inc., a Denver-based company best known for its work on an HIV vaccine, say they have the technology to quickly produce a safer, more effective anthrax vaccine than is being produced now.

"What takes them six shots over 18 months we could do in three shots over two months," said Richard Duke, president and CEO of GlobeImmune. "We have something we think can help. We're just saying give us a chance."

GlobeImmune's vaccine technology uses yeast, which makes a fast inoculant that's easy to grow and is capable of delivering multiple antibodies - imagine a bioterrorism cocktail vaccine that protects against smallpox, plague, anthrax and salmonella. In addition, it has no known side effects because it boosts the immune system at a cellular level, Duke said.

The company's scientists have talked with officials at the Army Medical Research Institute of Infectious Diseases in Fort Detrick, Md., about making their vaccine technology available to the military. But so far, the government's efforts to accumulate vaccine have focused on its current contracted manufacturer, Lansing, Mich.-based BioPort.

The anthrax vaccine produced by BioPort is made from toxins, grown in the lab and then purified to make the vaccine safe for human injection. The vaccine is administered six times over the course of a year and a half before a recipient is considered fully immune to deadly anthrax exposure.

The Food and Drug Administration has refused to use vaccine produced by BioPort, the nation's sole licensed producer of anthrax vaccine, since 1998, when it found impurities in the company's plant. BioPort reapplied this week to resume making anthrax vaccine and could begin production this month if it gets FDA approval. But even with that approval, it could take months for BioPort to get a vaccine that is ready for human use.

The Department of Defense is already vaccinating special forces units with the limited amounts of stockpiled vaccine and wants to eventually immunize 2.4 million active-duty military personnel, reservists and civilians in high-risk positions.

The Defense Department has no idea when additional anthrax vaccine will be available, spokesman James Turner said.

"They (BioPort) have to produce the vaccine first to demonstrate they can do it," he said.

A BioPort spokeswoman said Thursday the company expects to get FDA approval to resume production of the vaccine this month. She could not answer questions about the company's production process or the speed at which the vaccine could be produced.

GlobeImmune's anthrax vaccine would be made using the company's formula for boosting the immune systems of AIDS patients and those exposed to HIV. That HIV vaccine research, which is being funded by the National Institutes of Health, is still in the testing phase.

Clinical trials will begin this June.

GlobeImmune's vaccine hasn't been approved by the FDA, but if granted emergency fast-track status, Duke said, the company - with $3 million in funding assistance - could have an anthrax vaccine ready in three months. He said the company could produce as many as 3,000 doses a day if it had access to a manufacturing plant, possibly through a partnership with the government or a big pharmaceutical company.

Duke said the vaccine could be combined with existing vaccine to ensure safety and efficacy until full clinical trials are completed.

"We can take the existing technology and make it better. If the government thinks we need a fast track, that's what we want to do," he said.

Before the Sept. 11 terrorist attacks and recent anthrax outbreaks, federal funding for protecting military personnel and civilians against bioterrorist threats was sparse, said Jack Wheeler, former CEO of Extrana, maker of a rapid detection system for plague.

Now, companies with emerging technologies such as GlobeImmune may get some serious federal funding, he said. "The Defense Department has been caught off guard."

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