Michael Riordan Gilead tenofovir Viread breakthrough

Foster City firm records a first

 November 17, 1995

 

By BARRY KAYE

Times Staff Writer

 

FOSTER CITY – Researchers at a Foster City biotechnology company reported today that, for the first time, a drug that inhibits the ability of the AIDS virus to replicate itself achieved a 100 percent success rate in monkeys.

 

The early, preclinical studies indicate that a revolutionary compound developed by Gilead Sciences provided protection against the development of simian immunodeficiency virus (SIV) in primates up to 24 hours after they were given large doses of the disease.

 

Gilead conducted the study in conjunction with scientists at the National Institutes of Health and researchers at the University of Washington Primate Center in Seattle. The results appear in this month’s issue of the prestigious Science magazine.

 

“No other drug has ever shown this kind of activity. It is really unbelievable,” said Roberta Black, a microbiologist with the National Institute of Allergy and Infectious Diseases, a division of NIH.

 

Finding a cure for AIDS has been especially difficult because the virus that causes it is constantly changing and mutating. Scientists also know very little about how the disease itself actually works.

 

[Photo Caption: MICHAEL RIORDAN: Gilead CEO says, “It turns off the enzyme the virus uses to replicate itself.”]

 

Gilead’s work involves something known in biotechnology circles as a nucleotide analog, a molecule that binds to a substance called reverse transcriptase.

 

“It turns off the enzyme that the virus uses to replicate itself,” said Michael Riordan, chief executive officer at Gilead.

 

Riordan cautioned that the drug, called PMPA, has not yet been tested in humans, although he said the disease in monkeys is very similar to the HIV virus.

 

There is no known cure for AIDS, which attacks the human immune system and is almost always fatal.

 

Researchers at the National Institute of Allergy and Infectious Diseases, which helped fund the study, said early tests show that the Gilead drug blocked all traces of the disease in 25 macaque monkeys more than one year after the experiment began.

 

“It sounds almost too good to be true,” said Dr. Marta Marthas, a virologist at the University of California at Davis’ Regional Primate Research Center. But she added, “You can’t argue with that result.”

 

Dr. Ashley Haase, an expert on lentiviruses, the virus family that includes HIV and SIV (simian), said he was “surprised and pleased” by the finding.

 

He added that the study was carefully done and that it was “if anything, more difficult” to protect against SIV than it was to protect against HIV infections.

 

NIH’s Black, who was on work furlough because of the federal budget impasse, said a tremendous amount of additional research still needs to be completed.

 

Further tests are needed, for example, to determine how well monkeys tolerate high doses of the drug.

 

“Monkeys are not human beings,” she said. “Although it is an excellent model for evaluating drugs, it is still a model.”

 

But among the encouraging benefits of the Gilead compound is that, in achieving a 100 percent success rate, there were no additional complications.

 

“Such complete protection with no toxicity is unprecedented in the monkey model of AIDS,” said Anthony S. Fauci, director of infectious diseases at NIH.

 

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AIDS Drug Works on Monkeys

Article by Barry Kaye of The Times: Researchers at biotechnology company Gilead Sciences reported that for the first time ever, a drug that inhibits the ability of the AIDS virus to replicate itself achieved a 100 percent success rate in a monkey model of AIDS. [Photo caption: “Michael Riordan: Gilead CEO says, “It turns off the enzyme the virus uses to replicate itself.”] 

 

Comments on the research findings from: Dr. Roberta Black, microbiologist with the National Institutes of Health; Dr. Michael L Riordan, the founder and CEO of Gilead Sciences; Dr. Marta Marthas of the University of California at Davis; Dr. Ashley Haase of the University of Minnesota; and Dr. Anthony S Fauci, director of infectious diseases at the National Institutes of Health. The Gilead anti-AIDS medicine tested was PMPA (tenofovir) the active agent of Viread and an essential component of Truvada. “Such complete protection with no toxicity is unprecedented in the monkey model of AIDS,” said Fauci, Director of the National Institute of Allergy and Infectious Diseases, a division of the NIH. November 17, 1995.

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