News (Updated May 1, 2011)

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Finding Molecular Targets of an HIV Drug used in Cancer Therapy

Use of chemical systems biology may represent the future of drug discovery

Researchers at the University of California , San Diego and Hunter College of the City University of New York (CUNY) have identified potential human molecular targets of the anti-HIV drug Nelfinavir, which may explain why the drug is also effective as a cancer therapy. Their study will be published in the online edition of PLoS Computational Biology on April 28.

Nelfinivir is a protease inhibitor that prevents replication of the HIV virus, but it has also been found to have a positive effect on a number of solid tumor types, and is currently in clinical trial as a cancer therapy. However, the mechanism of how the drug worked in humans was not clear.  

The researchers discovered that Nelfinavir may interact with multiple human protein kinases – enzymes that modify other proteins and regulate the majority of cellular pathways.  Protein kinases comprise approximately 2 percent of the human genome, and are important anti-cancer drug targets.

Surprisingly, the interactions between Nelfinavir and kinases are much weaker than those from more specific, rationally designed drugs, said Philip Bourne, PhD, professor of pharmacology at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences.  Bourne and colleagues suggest that it is the collective effect of these weak interactions that leads to the clinical efficacy of Nelfinavir. 

The research team – Li Xie, PhD, from UC San Diego, Thomas Evangelidis, a former graduate student in Bourne’s lab, now at the University of Manchester , and research scientist Lei Xie, PhD, now an associate professor at Hunter College , CUNY – combined a wide array of computational techniques to investigate the molecular mechanisms underlying Nelfinavir’s observed anti-cancer effect. 

While drug molecules are designed to bind to targeted proteins in order to achieve a therapeutic effect, small drug molecules can attach to off-target proteins with similar binding sites.  The result may be unwanted side effects or, as in the case of Nelfinavir, a secondary and positive effect.

In the traditional strategy for drug discovery, scientists use high-throughput screening to find a suitable drug target.  However, utilizing the RCSB Protein Data Bank – a worldwide repository of tens of thousands of three-dimensional protein structures – the UCSD researchers computationally compared binding sites in order to identify which proteins might be unintended targets. 

Taking a single drug molecule, they looked at all proteins encoded by the human proteome to which that molecule could possibly bind. 

“Computer analysis allows us to search for other binding sites that match a particular drug-binding site – like looking for other locks that can be opened by the same key,” said Lei Xie.

While this novel computational pipeline is promising in fishing for drug targets from a significant portion of the human genome, Lei Xie cautioned that “it is especially challenging to validate weak drug-target interactions both computationally and experimentally.”  He added that modeling such drug actions requires that scientists find relevant proteins and then examine them in the context of a biological network, while at the same time simulating their cumulative effects.

“This is indeed challenging, but uncovering which protein receptors Nelfinavir binds to may help us design better anti-cancer drugs,” said Bourne.  “It is hard not to believe that this broad-based systems approach represents the future of drug discovery, at least as far as small-molecule drugs are concerned.”

 

BYU researchers hope twins unlock AIDS mysteries

(AP) – 30 April, 2011

SALT LAKE CITY (AP) — Researchers at Brigham Young University are trying to unlock some of the mysteries surrounding the virus that causes AIDS with a trio of studies addressing unusual cases involving a set of twins, a failed vaccine and a protein "stop sign."

The twin identical baby boys received a tainted transfusion and both became HIV-positive a few years ago.

Now, one of the twins has a near-normal immune system and pretty good health, while the other boy is five years behind him on the growth chart and has experienced a number of complications.

That provocative difference became the foundation of one of the studies, as researchers led by BYU biology department chairman Keith Crandall try to figure out how the virus changed in each twin. They've been joined in the study by scientists at the National Cancer Institute.

Crandall said there are competing theories about the differences in their clinical outcomes. One theory is that natural selection drives it, so the results should be similar. The other holds that random genetics plays a role and it therefore cannot be predicted.

A second study focuses on an HIV vaccine scientists in Thailand were trying to develop that proved ineffective. Crandall said they hope samples from that case will help them learn more about how the virus evolved and whether vaccinations to guard against HIV show promise.

"I think the HIV community is still split in terms of how to pursue treatment against HIV infection," Crandall told the Deseret News.

"There is a strong camp that thinks vaccine is still the way to go. We need to do more intelligent vaccine design," carefully considering everything they've learned in other attempts to create a vaccine that works.

"Others say no way," he said. "The focus needs to be on drug therapy. But the virus tends to hide out in places where drugs can't get to them."

The final study is led by Greg Burton, chairman of BYU's Department of Chemistry and Biochemistry, and Xueyuan Zho, a student at the University of Colorado 's Health Sciences department. They confirmed an earlier report that a naturally occurring protein prevents HIV from multiplying. But they've gone further to explain how the protein works, not just what happens.

"The importance of this study is that we moved ahead from earlier research. The effect was known, but we showed the mechanism," Burton said.

Information from: Deseret News, http://www.deseretnews.com

Copyright © 2011 The Associated Press. All rights reserved.

 

Canadian-led program fights AIDS around the world

April 26, 2011

Thanks to a program pioneered in Canada , future cases of AIDS around the world are being prevented.

HAART, which stands for highly active antiretroviral therapy, uses triple-drug therapy to stop HIV in its tracks. B.C. has been using HAART treatment as prevention since 1996, with dramatic results. “While an outright cure for HIV remains elusive, HAART has transformed HIV infection from a short-term death sentence into a chronic, manageable condition and helped restore the health of thousands in Canada and millions worldwide,” says Dr. Julio Montaner, director of the British Columbia Centre for Excellence in HIV/AIDS at St. Paul ’s Hospital.

The B.C. Centre for Excellence in HIV/AIDS pioneered the concept of Treatment as Prevention and proved that it not only transforms HIV infection into a long-term chronic manageable disease, it also dramatically decreases HIV transmission rates. HAART therapy is available across Canada .

China recently adopted a similar program as its national HIV policy. The made-in-Canada strategy is also being echoed in San Francisco , New York (the Bronx) and Washington .

Here’s the impact the program has had in BC: In the early 1990s, at least one British Columbian per day was dying of AIDS. Since HAART’s introduction in 1996, AIDS-related mortality has fallen by more than 90 per cent among those receiving treatment, says Dr. Montaner, who is also chair in AIDS research and head of division of AIDS at the University of British Columbia .

“In appropriately treated individuals, HAART reduces the concentration of HIV present in plasma and in sexual fluids to levels so low as to be undetectable by the best commercially available tests,” says Montaner.
Reducing the infection allows people’s immune systems to recover and stops the progression of HIV disease and even AIDS. 

 

Oral pill trial to halt HIV in women is stopped

(AFP) – Apr 19, 2011

WASHINGTON — A trial of an oral pill aimed at preventing HIV infection in African women has been halted due to poor results, the US Centers for Disease Control announced this week.

The CDC described the results as "disappointing," and in a Monday statement said the trial's monitoring committee had decided it "could not demonstrate efficacy even if it continued to its originally planned conclusion."

A similar oral treatment, known as pre-exposure prophylaxis (PrEP) for HIV prevention, has shown promise in men who have sex with men.

The trial included 2,000 African women in Kenya , South Africa and Tanzania . Trial subjects were taking oral tenofovir and emtricitabine, marketed as Truvada by the California-based Gilead Sciences Inc., or a placebo.

Researchers said that the rate of new HIV infections in both the drug and placebo groups was the same, with 56 new HIV cases equally distributed across both sections of the study.

They also noted that the overall pregnancy rate among women in the study was nine percent, with the highest rates seen in women taking birth control pills. More study is needed to determine if the anti-HIV treatment had a disabling effect on the oral contraceptives.

"Given today's results, CDC cautions against women using PrEP for HIV prevention at this time," the US government agency's statement said.

"We will not know if PrEP is effective for women, couples, or injection drug users until the conclusive results of this and other trials are reported."

Copyright © 2011 AFP.

 

HIV infection raises heart failure risk: study

Activists from a non-governmental organisation (NGO) light candles during an AIDS awareness campaign ahead of World AIDS Day in Agartala, capital of India 's northeastern state of Tripura November 30, 2010.

Credit: Reuters/Jayanta Dey

Apr 25, 2011

NEW YORK (Reuters Life) - Infection with HIV, the virus that causes AIDS, can increase the risk of heart failure even in patients who don't have a prior history of heart disease, a U.S. study said.

And as the HIV virus replicates, the risk increases, added the study, published in Archives of Internal Medicine.

"Health care providers traditionally think of HIV and its therapies increasing the risk of atherosclerotic heart disease," said lead author Adreel Butt, at the University of Pittsburgh School of Medicine in Pennsylvania .

"The surprising finding from our study was the association of HIV with heart failure in the absence of prior coronary heart disease."

The study involved nearly 8,500 adults, with a median age of 48 years in both HIV infected subjects and controls.

The HIV group was more likely to also be infected with Hepatitis C, 31 percent to 11 percent, and to abuse cocaine -- 22 percent to 16 percent.

They were also more likely to be smokers but less likely to have hypertension or diabetes.

During a median follow-up of 7.3 years, 286 people developed heart failure. Rates of heart failure per 1,000 person-years, adjusted for age as well as race and ethnicity, were 7.12 for HIV patients and 4.82 for the controls.

After accounting for traditional risk factors, the hazard ratio for heart failure with HIV was 1.81.

In addition, ongoing replication of the virus led to a significantly higher risk of heart failure.

"On the other hand, if HIV replication is well controlled, then the risk of heart failure is closer to that seen among HIV-uninfected persons," Butt said.

The exact mechanism by which HIV infection is linked to heart failure remains unclear, but possible explanations include the direct effects of the HIV infection, antiretroviral treatment that leads to an increased risk of coronary heart disease, and nutritional deficiencies.

"Our results suggest that HIV itself is playing an important and independent role," Butt and her colleagues wrote.

The message for HIV care providers is clear, though.

"Be on the lookout for early signs of heart failure in HIV-infected persons, even if there is no history of preceding coronary heart disease," Butt told Reuters Health.

"Controlling HIV well may reduce the risk of heart failure."

(Reporting by Megan Brooks at Reuters Health; editing by Elaine Lies)

 

FDA says Vertex hepatitis drug is highly effective

(AP) – 26 April, 2011

WASHINGTON (AP) — Federal health officials said Tuesday a highly anticipated hepatitis C drug from Vertex Pharmaceuticals successfully treats the majority of patients with the virus in less time than older medicines that have been used for 20 years.

The Food and Drug Administration posted its review of Vertex's telaprevir ahead of a meeting Thursday where outside experts will vote on the benefits of the experimental drug. On Wednesday the experts will review a similar drug from Merck & Co. Inc.

Both new drugs work by blocking the enzyme protease, which allows the hepatitis virus to reproduce. The new approach represents a breakthrough from older medicines, which are designed to help boost the immune system to fight hepatitis.

Like HIV drugs, the new drugs will be prescribed as part of a cocktail with the two older drugs to help lower viral levels.

"A drug like telaprevir does an amazing job clearing the virus, but there's a small portion that is just intrinsically less responsive and it's the job of the older drugs to clear up that mess that's left behind," said Dr. Camilla Graham, Vertex's vice president for global medical affairs.

The current two-drug treatment for the virus cures only about 40 percent of people and causes side effects like nausea, fatigue and vomiting.

FDA scientists said 79 percent of first-time hepatitis C patients taking telaprevir and the older medicines were cured, compared to 46 percent of those taking the older medications alone, according to Vertex's studies. Among patients who had already been treated for hepatitis C once, 65 percent achieved a cure after taking telaprevir, compared with 17 percent of those taking the older medications.

In general, telaprevir's cure rates are higher than those seen with Merck's boceprevir. The two drugs are expected to compete in a multibillion dollar global market.

Shares of Vertex Pharmaceuticals Inc. rose $5.96, or 12.4 percent, to $54 in midday trading.

Vertex's studies were designed to show that adding telaprevir to the older drug combination could cure most patients in six months — cutting the standard treatment time in half and reducing exposure to negative side effects.

According to the FDA, 58 percent of new patients were eligible for this shorter treatment regimen based on reduced viral levels after four or 12 weeks. The FDA's review states that patients who have previously been treated for the disease should respond similarly.

FDA notes that the drug was significantly less effective for African Americans. The most common side effect with the drug was a skin rash and fatigue.

The agency will ask its panel to comment on those issues on Thursday. The FDA is not required to follow the advice of its panelists, though it usually does

Hepatitis C is a major cause of liver transplants, and it kills about 12,000 U.S. patients a year, a number expected to triple by 2030 as baby boomers succumb to the disease.

The disease is often associated with users of illegal injectable drugs like heroin, though it could also be picked up from blood transfusions before 1992, when testing of the blood supply began.

Most people with hepatitis C don't even know they have the virus until years later when liver damage has occurred, which can cause abdominal pain, fatigue, itching and dark urine.

Vertex Pharmaceuticals is based in Cambridge , Mass. , and was founded in 1989 by a former Merck scientist. If approved, telaprevir would be the company's first commercialized product in the U.S. Vertex holds marketing rights for North America , while Johnson & Johnson will market the drug in other parts of the world.

Copyright © 2011 The Associated Press. All rights reserved.

 

CEO: J&J learned recall lessons, will bounce back

(AP) – 28 April, 2011

NEW BRUNSWICK , N.J. (AP) — Johnson & Johnson's chief executive told shareholders at their annual meeting Thursday that the company will come back "stronger than ever" after addressing quality problems that led to an astounding string of product recalls.

William Weldon, who became CEO in 2002, said the series of "disappointing recalls" troubled him and employees and meant thousands of parents could not get medicines they needed for their children.

Since September 2009, the company has had about two dozen recalls of prescription and nonprescription medicines, replacement hips, contact lenses and diabetes test strips, including tens of millions of bottles of children's and adult Tylenol and Motrin.

Many of those nonprescription drugs were made at a nonprescription medicine factory in Fort Washington , Pa. , that J&J closed a year ago, gutted and is rebuilding as a state-of-the-art liquid medicines factory. Shareholders saw photos of the plans and steel framework as work there continues, while Weldon tried to reassure them.

"You would be right to ask if we made mistakes, and yes, we did," Weldon said. "Our goal is to restore McNeil Consumer Health Care to the highest level of quality ... thus restoring confidence in McNeil."

Weldon, 62, said J&J has inspected 120 plants around the world and invested millions to improve the quality of its manufacturing and satisfy federal regulators, who have three of its factories under scrutiny. J&J has shifted manufacturing of some products to other factories.

Roughly 1,300 shareholders packed into four different rooms at a hotel opposite J&J's headquarters seemed satisfied with Weldon's explanation of the recalls and what J&J has been doing to rectify the problems. The audience clapped repeatedly during his comments and lengthy presentations about the company's financial results and innovative medicines and medical devices in development.

Analyst Steve Brozak of WBB Securities said Weldon handled the mostly elderly shareholders at the meeting well. Weldon opened with news of a deal reached Wednesday for a huge acquisition, a big hike in J&J's generous quarterly dividend and the recent settlement of a long arbitration battle with Merck & Co.

Shareholders also were treated to goody bags full of Johnson & Johnson products and a fancy food spread.

"It's bread and circuses," Brozak said. "If it was any other company that had gone through this, they would not have been able to leave an annual shareholders meeting unscathed."

But after 2 1/4 hours of speeches, slideshows and testimonials about J&J products and health care programs, only six people in the audience asked questions or made comments.

"When I look at what's been happening at J&J over the last couple of years, I see a fundamental attack on the credo," Tom Williamson told Weldon.

He referred to J&J's corporate pledge, displayed prominently at headquarters, that stresses responsibility to patients, doctors and nurses.

"Your company tried to do a stealth recall of Motrin," he added.

Congress has been investigating that 2008 incident, in which J&J paid a third company to quietly buy up faulty Motrin packets, rather than issuing a recall.

But another shareholder, Kathleen Bennett, told Weldon she appreciates his efforts to fix the recall-related problems.

"I say, Mr. Bill Weldon, well done," she said, drawing loud applause.

About 90 percent of shareholders voted for a J&J proposal to give them an advisory vote every year on compensation for top officers.

Yet only 61 percent supported the company proposal for advisory approval of its executive compensation policies and the compensation top officers received last year. Weldon's 2010 pay package was worth more than $23 million, down about $2.5 million after two unprecedented years of revenue declines.

Stockholders voted down all three shareholder proposals on the agenda, each by 95 percent or more.

One, by the Sisters of Charity of Saint Elizabeth and other religious groups, would have restricted future prescription drug price increases sharply. Another would have expanded J&J's employment nondiscrimination policy to include people with health problems, but J&J said its broad policy is sufficient.

The third would have required ending use of animals in training surgeons to use J&J's high-tech surgical tools; Weldon said J&J already tries to use alternatives when possible. That proposal was presented by Alka Chandna, a spokeswoman for People for the Ethical Treatment of Animals. The group had four picketers outside the hotel protesting on the issue, two in big pink piggy suits because pigs are sometimes used in surgical training.

A second group of three medical students picketed beside them, because J&J has not agreed to join an international "medicine patent pool" that would make it easier and cheaper for generic drugmakers to produce inexpensive HIV medicines for developing countries.

Weldon told the audience an acquisition reached the day before is J&J's biggest ever. J&J agreed to buy U.S.-Swiss medical device maker Synthes Inc. for $21.3 billion. The deal would give J&J a much bigger share of the market for surgical trauma equipment and orthopedic implants.

"It is consistent with our long-term strategy to strengthen our leadership position around the world," Weldon said.

"Our pipeline today is considered one of the best in the industry," Weldon added.

Meanwhile, J&J's board decided to raise the quarterly dividend on company stock by 5.6 percent, from 54 cents to 57 cents per share.

In trading Thursday, shares of the company fell 19 cents to $65.38.

Copyright © 2011 The Associated Press. All rights reserved.


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