News (Updated May 17, 2009)

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New approach may outflank AIDS virus

By RANDOLPH E. SCHMID, AP Science Writer Randolph E. Schmid, Ap Science Writer 46 mins ago

WASHINGTON – Like a general whose direct attacks aren't working, scientists are now trying to outflank the HIV/AIDS virus.

Unsuccessful at developing vaccines that the cause the body's natural immune system to battle the virus, researchers are testing inserting a gene into the muscle that can cause it to produce protective antibodies against HIV.

The new method worked in mice and now has proved successful in monkeys, too, they reported Sunday in the online edition of the journal Nature Medicine. The team is led by Dr. Philip R. Johnson of the Children's Hospital of Philadelphia .

That doesn't mean an AIDS vaccine for people is in the wings, Johnson said. Years of work may lie ahead before a product is ready for human use.

Nevertheless, the report was welcomed by Dr. Beatrice Hahn, an AIDS researcher the University of Alabama at Birmingham , who was not part of Johnson's team. "It basically shows there is light at the end of the tunnel," she said in a telephone interview?

"It shows thinking outside the box is a good idea and can yield results, and we need perhaps more of these nonconventional approaches," she added.

According to the International AIDS Vaccine Initiative, AIDS is one of the most devastating pandemics. More than 20 million people have died so far and about 33 million are living with HIV. The Center for Disease Control and Prevention last year estimated there are about 56,000 new HIV infections annually in the United States .

Most efforts at blocking AIDS have sought to stimulate the body's immune system to produce antibodies that fight the disease. This model has worked for diseases such as measles and smallpox. It hasn't done as well with HIV/AIDS; test vaccines have failed to produce a protective reaction.

So Johnson decided to try something different.

"We used a leapfrog strategy, bypassing the natural immune system response that was the target of all previous HIV and SIV vaccine candidates," Johnson said. HIV, or human immunodeficiency virus, causes AIDS in people. The closely related simian virus, or SIV, affects monkeys.

"Some years ago I came to the conclusion that HIV was different from other viruses for which we were trying to develop vaccines and we and might not ever be able to use traditional approaches," Johnson said in a telephone interview.

He said the researchers knew there were proteins that could neutralize the HIV virus, so they began thinking about whether they could use them to fight the disease.

In a decade-long effort, Johnson, K. Reed Clark of Nationwide Children's Hospital in Columbus , Ohio , and their team developed immunoadhesins, antibody-like proteins designed to attach to SIV and block it from infecting cells.

Then they needed a way to get the immunoadhesins into the cells.

The researchers selected the widely used adeno-associated virus as the carrier because it is an effective way to insert DNA into the cells of monkeys or humans. That virus was injected into muscles, where it carried the DNA of the immunoadhesins. The muscles then began producing the protective proteins.

Scientists first tested the idea in mice and then turned to monkeys because SIV is closely related to HIV and would be a good test model.

A month after administering the AAV, the nine treated monkeys were injected with SIV, as were six not treated in advance.

None of the immunized monkeys developed AIDS and only three showed any indication of SIV infection. Even a year later they had high concentrations of the protective antibodies in the blood.

All six unimmunized monkeys became infected; four died during the experiment.

The next step is moving toward human trials, Johnson said. He said he is working with the International AIDS Vaccine Initiative in hopes of getting tests in humans under way in the next few years.

The research was supported by the National Institute of Allergy and Infectious Diseases.

Canada lab researcher faces U.S. smuggling charge

Wed May 13, 4:32 PM

By Rod Nickel

SASKATOON , Saskatchewan (Reuters) - A scientist at a top-ranked infectious disease laboratory in Canada has been arrested on charges of attempting to smuggle vials of biological materials into the United States , Canadian and U.S. officials said on Wednesday.

The researcher, Konan Michel Yao, is alleged to have taken vials of basic biological materials including the Ebola gene for vaccine development from the National Microbiology Laboratory in Winnipeg , Manitoba .

Although the materials contained the Ebola gene, the gene is not infectious and its only possible application would be in developing a vaccine, said Dr. Frank Plummer, the scientific director general of the lab.

"At no time was the health of citizens of Canada or the U.S. at risk, because the seized materials are known to be non-infectious," said Plummer.

The lab is Canada 's top facility for the identification, control and prevention of infectious diseases, and deals with the most deadly organisms.

Yao never had access to Level 3 and 4 pathogens, which include the Ebola virus, HIV and H1N1 flu virus, Plummer said. He did have access to a Level 2 laboratory, similar to those at hospitals and universities.

Had Yao applied to take the materials, he probably would have received permission, Plummer said.

Yao was arrested by U.S. officials as he attempted to enter the United States at the Pembina, North Dakota , border crossing on May 5, said Mike Milne, a spokesman for U.S. Customs and Border Patrol.

Border agents said they conducted a routine search of his vehicle and found 22 vials in a latex glove wrapped in aluminum foil, inside the trunk.

"It was certainly taken seriously," said Lynn Jordheim, the U.S. attorney prosecuting the case. "... But it's been determined that (the materials) are not a hazardous substance."

Yao , who had been working at the Winnipeg lab on a fellowship, told border officials he had been working on vaccines for Ebola and HIV, according to court documents.

He was scheduled to start a new job with the U.S. National Institutes of Health at the Biodefense Research Laboratory in Bethesda , Maryland . According to court documents he told officers he was taking the vials to help him get a head start at his new job.

Yao is charged informally on a complaint of attempted smuggling, which is based on his failure to disclose what he was taking across the border, not the type of materials he had, Jordheim said.

The next step is for a U.S. grand jury to consider the evidence to decide whether to lay formal charges. He will remain in custody pending the grand jury decision.

The Canadian laboratory has also notified Winnipeg police.

Lab officials don't search employees or former employees when they leave, Plummer said.

"I don't think that would be appropriate. At some point you have to rely on trust of the individuals and the integrity of the individuals that work in the building."

The missing materials weren't noticed for several months because the lab doesn't do regular inventories of non-infectious materials. Access to pathogens is more strictly controlled, Plummer said.

(Reporting by Rod Nickel; editing by Rob Wilson)

Gilead sues Teva in Atripla patent dispute

Gilead Sciences sues Teva Pharmaceutical in patent dispute over HIV treatment Atripla

On Thursday May 14, 2009, 5:03 pm EDT

FOSTER CITY, Calif. (AP) -- Gilead Sciences Inc. said Thursday it is suing Teva Pharmaceuticals Industries Ltd. over the drugmaker's plans to make a generic version of the blockbuster HIV treatment Atripla.

Teva is seeking Food and Drug Administration approval to make a generic version of the drug, which is one of Gilead 's best-sellers, with revenue of $509.9 million during the first quarter. It is a combination of three older drugs: Gilead 's Viread and Emtriva, and Sustiva, which is made by Bristol-Myers Squibb.

The specific patents involved in the lawsuit are associated with emtricitabine, or Emtriva. That drug is both a component of Atripla and another combination treatment, Truvada.

The patents are licensed exclusively to Gilead by Emory University , according to Gilead .

Gilead now has two lawsuits pending against Israel-based Teva over HIV treatment patents.

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