Sticking Point

An AIDS vaccine designed by renowned researcher Don Francis is in final testing. The Plague could be over - but the gay and scientific establishments are utterly unenthused.

But these encounters were mere skirmishes compared to Francis' 11-year, all-out battle for his own approach to creating an AIDS vaccine.

As any good epidemiologist knows, a vaccine is the only way to really wipe out a disease. You can teach sanitation -- or safe sex -- until your lips turn blue. You can distribute remedies to everybody and their uncles and wives, but without a global NORAD of reinforced immune systems, diseases will generally survive.

In this light, Francis wrote a paper in 1985 describing a technique he thought might allow a vaccine to combat HIV without infecting people with the disease. Using the emerging alchemy of biotechnology, Francis imagined a way technicians might devise synthetic proteins identical to ones present on the outer covering of the HIV virus. Appearing, as they would, to contain a complete, deadly virus, these blank shells might startle the immune system into developing defenses against the virus just as a weakened real virus might, Francis postulated. A similar technique had been used in developing a vaccine for hepatitis B.

Researchers at Genentech, the South San Francisco biotechnology company, set out to synthesize such a protein -- in scientific terms a glycoprotein with a molecular weight of 120, gp120 for short -- and figured out how to replicate it in cells taken from a hamster.

The first version of the protein, created in 1986, failed to provoke the sort of response Francis had predicted. But after further tinkering by Genentech scientists, a modified version of the protein produced in 1989 appeared to protect chimpanzees -- the animal whose body reacts most similarly to humans in response to HIV -- from becoming infected.

This, Francis says, was the first evidence that an AIDS vaccine might work.
"Chimps are expensive, around $60,000 each. They're endangered, and you can't get that many, but chimps are the only susceptible animal. If we could use monkeys, pigs, rabbits, it would be great, but we have to use protected chimps, and they had a 100 percent immune response," Francis says.

In 1992, Francis retired from the Centers for Disease Control to run trials of Genentech's new vaccine. That year, a vaccine made with the new protein was injected into volunteers to prove that it was safe. This Phase I trial went off without a hitch, and the company began Phase II trials, designed to determine whether the vaccine caused recipients' immune systems to produce HIV-specific antibodies, and to further test for safety.

By December of that year, it appeared as if Phase II volunteers were producing healthy batches of HIV antibodies. But there was a catch. The antibodies produced in Francis' volunteers reacted specifically to a virus cultured in a Genentech lab. Given HIV's chameleonlike talent for genetically refashioning itself, the results indicating the vaccine provided protection against an artificially crafted strain had little real-world meaning, critics said. Worse, when these artificially provoked HIV antibodies were mixed in a test tube with real-world HIV, the antibodies had no effect at all.

The results of these Phase II tests were enough to convince Anthony Fauci, director of the National Institute for Allergy and Infectious Disease (NIAID), that government money shouldn't be used to fund Phase III trials that would prove whether the vaccine did or did not provide some level of immunity to HIV infection.

Without government money to fund the trials, Genentech decided not to continue developing the vaccine, and it was shelved. Fauci's decision was savaged in a March 1995 New York Times Magazine cover story, which suggested that his agency had succumbed to pressure from gay activists who felt the money would be better spent on education and other AIDS prevention programs.

After 10 years and $50 million in research, gp120 was dead. Or so it seemed.
Francis found a way to rise again. Somewhat in the manner of his chameleonlike viral foe, Francis has mutated from research scientist to political crusader to his current manifestation, that of a Silicon Valley entrepreneur.

In 1995, he convinced Genentech to spin off its gp120 division into a separate company that Francis would run, with Genentech keeping a 25 percent interest. With the help of a Seattle financier, Francis raised $20 million in venture capital, and rented a suite of offices near the San Francisco airport. Just last month the company, VaxGen, opened a production facility for vaccines to be used in the trials. Funding in hand, Francis convinced the government of Thailand -- a popular destination for "sex tourists," and a country ravaged by AIDS -- to cooperate in the first gp120 trials. And earlier this year, following an additional round of safety trials, the FDA gave its approval for large-scale Phase III testing in the United States.

For the past few months, Francis has been flying around the country doing road shows for an initial public offering of VaxGen stock. He has found it much easier to convince Wall Street financiers of his vaccine's promise than to convince rival scientists. The offering has proven wildly successful, raising $40 million. Last week, shares had increased in value from their $13 offering price to $17.06.

The market's bet would seem an odd one, given the slim chance scientists give VaxGen's vaccine of working. But when you consider the potential reward, VaxGen shares begin to resemble gold-mining stocks traded in Toronto, rather than your ordinary shares from the NYSE. If the gp120 vaccine is successful, or even if it is only partially successful and becomes a mere component of a future vaccine, VaxGen patent medicine will eventually be injected into virtually every arm in the world.

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