Seattle Genetics, Inc. (Nasdaq:SGEN) announced that it has initiated a phase I clinical trial of SGN-70, a humanized monoclonal antibody targeting CD70 that is being developed as an investigational therapy for autoimmune diseases. The trial will assess the safety, tolerability and pharmacokinetics of SGN-70 in healthy volunteers.

“CD70 targeted therapies have shown promise in multiple preclinical models by reducing autoimmune disease activity at well-tolerated doses,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “This clinical trial is designed to evaluate the safety and pharmacokinetics of SGN-70 in humans and to serve as a foundation for future clinical trials in patients with autoimmune disease.”

The phase I study is a dose-escalation trial in which cohorts of healthy volunteers will receive single doses of SGN-70. The clinical trial will be conducted in Switzerland and is expected to accrue approximately 60 volunteers.

The CD70 antigen is highly expressed on activated T- and B-cells but not resting lymphocytes, and has been associated with a variety of autoimmune and inflammatory disorders. SGN-70 has been shown in preclinical models to selectively deplete CD70-positive lymphocytes and block the co-stimulation pathway between CD70 and its receptor, CD27. By specifically targeting the activated cells, SGN-70 may reduce the damaging effects of autoimmune disease without globally suppressing the immune system.

CD70 is also expressed on several types of cancer, including multiple myeloma, lymphoma, renal cell cancer, glioblastoma and several other solid tumors. In addition to SGN-70, Seattle Genetics is advancing SGN-75, an antibody-drug conjugate targeting CD70, for the treatment of cancer and expects to file an investigational new drug (IND) application in 2009.

About Seattle Genetics

Seattle Genetics is a clinical stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The company has a worldwide collaboration with Genentech for SGN-40. Seattle Genetics also has two other product candidates in ongoing clinical trials: SGN-33 and SGN-35. In addition, the company has developed proprietary antibody-drug conjugate (ADC) technology comprising highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics, Daiichi Sankyo and MedImmune, a wholly-owned subsidiary of AstraZeneca, as well as an ADC co-development agreement with Agensys, a wholly-owned subsidiary of Astellas Pharma.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of SGN-70. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to show sufficient safety in this phase I clinical trial and the risk of adverse clinical results as SGN-70 moves into and advances in clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the Company’s filings with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Seattle Genetics

Emergent BioSolutions Inc. (NYSE:EBS) announced that it has submitted a proposal in response to a request for proposal (RFP) issued by the U.S. Department of Health and Human Services (HHS) for a recombinant protective antigen anthrax vaccine (rPA). Emergent’s rPA vaccine candidate is a reformulated and more stable form of the rPA 102 vaccine originally developed at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and is well-positioned to be a leading candidate for an award under this RFP. One Phase II clinical trial of rPA 102 has been completed.

HHS’s RFP is designed to meet the government’s stated goal to procure 25 million doses of an rPA anthrax vaccine for the Strategic National Stockpile (SNS). In the event that Emergent receives an award under the rPA RFP, doses of rPA procured by HHS would be in addition to the 18.75 million doses of the company’s FDA-licensed product, BioThrax® (Anthrax Vaccine Adsorbed), that HHS is procuring under the existing $448M contract with Emergent. HHS has indicated that any awards under the rPA RFP would be granted at the end of 2008, at the earliest.

“We are very pleased with our submission in response to this RFP, and we are confident that our rPA 102 vaccine is a leading candidate to be selected as an advanced rPA anthrax vaccine. Our company is proud of our proven track record of delivering critical biodefense countermeasures to the U.S. government, and we believe our reputation as the premiere domestic biodefense supplier, coupled with our development and manufacturing expertise, uniquely situates Emergent to meet HHS’s stated commitment to procure 25 million doses of a recombinant anthrax vaccine for the Strategic National Stockpile,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

“Considerable resources have been devoted to improving the stability of the rPA 102 vaccine. Analytical testing and non-clinical data indicate the changes made to the formulation of rPA 102 has significantly improved the stability of this vaccine candidate. We are confident that the formulation changes have addressed previous concerns regarding the stability of the product. We believe that the current formulation will meet the U.S. government’s stability requirements for an rPA vaccine,” said Dr. James Jackson, senior vice president and chief scientific officer of Emergent BioSolutions.

The company expects to manufacture this rPA anthrax vaccine, as well as BioThrax, in its recently constructed, large-scale manufacturing facility at its Lansing campus. The continued development of this rPA vaccine candidate further solidifies Emergent’s franchise of anthrax countermeasures, which now includes:

BioThrax - the only FDA-approved vaccine to prevent the infection of anthrax. Nearly 2.0 million men and women of the United States military have received the vaccine, and HHS has procured more than 28 million doses of BioThrax for the SNS;

rPA 102 - a recombinant anthrax vaccine candidate, which is composed of a purified protein with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins;

AVA7909 - an anthrax vaccine candidate composed of BioThrax® and the immunostimulatory oligodeoxynucleotide compound CPG 7909 (VaxImmune®) developed by Coley Pharmaceutical Group (purchased by Pfizer Inc. in 2007).;

AVP-21D9 - a human monoclonal antibody product candidate being developed as an intravenous post-exposure treatment for patients who present symptoms of anthrax disease; and

AIG - a polyclonal anthrax immune globulin product candidate being developed as an intravenous post-exposure treatment for patients who present symptoms of anthrax disease, is derived from human plasma from individuals who have been vaccinated with BioThrax.

About rPA 102

The vaccine candidate, rPA 102, is based on a recombinant form of the protective antigen protein. This vaccine contains a purified protein (rPA) formulated with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins. The vaccine candidate does not cause anthrax infection and is based on the pioneering work of USAMRIID. rPA 102 has been the subject of two research and development grants totaling approximately $100 million from the National Institute for Allergy and Infectious Diseases (NIAID).

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a leading, multinational biopharmaceutical company dedicated to one simple mission - to protect life. Emergent develops, manufactures and commercializes immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. The company’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. http://www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our expected revenue growth and net earnings for 2008, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our ability to obtain sales contracts for BioThrax®, rPA 102, AVA7909, AVP-21D9 and AIG with the U.S. government; our plans for future sales of BioThrax, rPA 102, AVA7909, AVP-21D9 and AIG; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Emergent BioSolutions Inc.

With several hundred thousand unvaccinated children across the UK, health protection experts are hoping that new research at the University of Leeds will give parents better information about the MMR vaccine and lead to an increase in immunisation.

The latest figures from the Health Protection Agency (HPA) show that cases of measles in London reached a new peak in May and a teenage boy from West Yorkshire became the first person in the UK to die from measles for two years. Last year there was a record 971 reported cases of measles a rise of 30% on the previous year - making MMR an urgent priority for the medical profession.

A collaboration between health experts at Leeds and Sydney universities is the fourth MMR research project undertaken by the School of Healthcare after parents confidence was knocked following controversy over the safety of the triple vaccine.

Previous research by the Leeds team showed that parents feel isolated when making their decision. The new project will use interactive software developed at Sydney University to help identify parents’ concerns and to provide the information needed to answer their questions on the combined measles, mumps and rubella vaccine.

Dr Martin Schweiger, consultant in communicable disease control at the West Yorkshire Health Protection Unit, said:” Mumps, measles and rubella are all serious diseases and become more so the older you get. If an unvaccinated pregnant woman gets rubella, then a damaged child may be the future price the family will pay for getting this wrong now.

“Health professionals need to have credible and appropriate information to give to those parents about to make a decision about immunising their children.”

Simon Balmer, Head of Health Protection for the Leeds Primary Care Trust, who are also supporting the research project, said: “With the right information we believe that most parents will choose to vaccinate their children against these serious illnesses.”

Dr Cath Jackson, a member of the research team led by Professor Francine Cheater, said: “We will be testing the Australian software alongside more traditional materials to find out the best way of giving parents the right support and information they need to make a decision about MMR.

“Parents criticise the literature and information currently available. They don’t feel confident about saying yes to the vaccine when they don’t know enough.”

Dr Jackson explained: “Our previous research shows that many parents were unconvinced that the MMR vaccine is safe and 62% did not consider that their MMR decision was informed. However, there was little opportunity to talk about reaching a decision because GPs and nurses simply don’t have the time. We found that some parents feel pressured into making an instant decision about MMR with health professionals assuming they will vaccinate their children.”

This new project, funded with ￡242,252 by the National Institute for Health Research, will see researchers at the University of Leeds recruit hundreds of new parents about to make their first decision on vaccinating their children. They will test out different ways of helping parents make their MMR choices

Leeds Primary Care Trust is helping to recruit more than 500 first time parents. Simon Balmer explained: “We are extremely concerned that the incidence of measles has risen to high levels because MMR vaccination rates have fallen. Therefore we welcome this chance to work with the University of Leeds to enable parents to make informed decisions.”

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Low levels of naturally occurring antibodies may represent an increased risk of developing cardiovascular disease, particularly stroke in men. This discovery, published in the academic journal Atherosclerosis, has now led to attempts to develop an immunization against cardiovascular disease.

Atherosclerosis (hardening of the arteries) is an inflammatory disease in which the walls of the blood vessels are thickened and become less elastic. It can cause blood clots and other cardiovascular diseases. It is not known precisely what causes atherosclerosis, but the immune system probably plays an important role. Research scientists suspect that various oxidised forms of what is known as bad cholesterol, LDL (low-density lipoprotein), contribute to the development of the disease. A research team from Karolinska Institutet, in cooperation with Lund University, has now shown that a particular type of naturally occurring antibodies, anti-PC, which are targeted against the lipid portion of the LDL molecule, play an important role in the development of cardiovascular disease. The findings show that individuals who have low levels of anti-PC are at increased risk of cardiovascular disease. The risk is particularly high in men who develop stroke, with an almost fourfold increase.

This newly discovered risk factor, low levels of anti-PC, is independent of previously known risk factors such as high blood pressure, high blood lipids, diabetes and smoking.

“Our findings suggest that anti-PC can be used as a complement to the traditional risk factors to improve diagnosis and treatment. In addition we are currently developing anti-PC as a vaccine for atherosclerosis and cardiovascular disease,” says Professor Johan Frosteg?rd, who directed the study.

The study is based on data from 349 people who at some time over a 12-year period have suffered a heart attack or stroke and 693 individuals without symptoms of cardiovascular disease. The research has been carried out under the EU consortium CVDIMMUNE, http://www.cvdimmune.com/, which is led by Johan Frosteg?rd at Karolinska Institutet.

Publication:
“Low levels of IgM antibodies against phosphorylcholine - a potential risk marker for ischemic stroke in men.” Beatrice Sj?berg, Jun Su, Ingrid Dahlbom, Hans Gr?nlund, Max Wikstr?m, Bo Hedblad, G?ran Berglund, Ulf de Faire and Johan Frosteg?rd. Atherosclerosis 2008, in press, accepted manuscript, available online.

Karolinska Institutet is one of Europe’s leading medical universities. Karolinska Institutet will contribute to improving human health through education, research and information. It is also Karolinska Institutet that annually awards the Nobel Prize in Physiology or Medicine.

Karolinska Institutet

The use of advanced imaging techniques has allowed researchers to visualize how a key part of the human immunodeficiency virus (HIV) changes shape after binding to immune system cells or to infection-fighting antibodies. Although scientists had been able to visualize individual components of this part of the virus, called the HIV spike, the new research characterizes, for the first time, the structure of the intact spike on virus particles, which is a crucial piece of knowledge that may aid the design of new vaccines or drugs to fight HIV infection. The research was conducted by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health. The results were published online July 30, 2008, in Nature.

“Understanding the structure and design of the HIV spike has been the subject of intensive effort for over a decade because of its potential importance in understanding mechanisms of viral entry into immune system cells and designing treatment and prevention approaches,” said NCI Director John E. Niederhuber, M.D. “The sophisticated imaging techniques used in this HIV/AIDS study have the potential to advance our understanding of not only HIV, but many other diseases, including cancer.”

“Previous research showing how HIV interacts with immune system cells and antibodies has been important in vaccine design,” said Sriram Subramaniam, Ph.D., of NCI’s Center for Cancer Research, and head of the research team that carried out the study. “However, understanding the complete structure of the viral spike may reveal other vulnerable targets. This knowledge will be crucial to solving the puzzles associated with strategies at the heart of virus invasion.”

The HIV virus binds to and infects target cells through the interaction of viral spikes and receptors on the surface of the cells. The spike is composed of two types of proteins, called gp120 and gp41, which interact with one another to form a protein pair. The final structure of the spike is achieved by the interaction of three of these protein pairs on the surface of the virus, forming a structure called a trimer. The head of the spike consists of gp120, and it is responsible for binding to the receptor on the target cell, which is a protein called CD4; gp41 spans the virus’ outer membrane, forming the stalk of the spike. gp41 is responsible for events in which HIV injects its genetic material into the host cells. The trimeric spike is held together by strong contacts among the gp41 proteins at the bottom but by only a few contacts among the gp120 proteins at the top.

The Subramaniam team used imaging techniques, including cryo-electron tomography, to produce three-dimensional renderings of the spike. Basically, the researchers froze the virus and took pictures of it from different angles. Then, they used advanced computer image-processing methods to average thousands of high-resolution images of individual spikes, which enabled them to interpret the three-dimensional images in terms of atomic structures. The researchers found that, upon interaction with CD4 receptors, the gp120 proteins rearrange, causing the spike to spring open, exposing the gp41 stalk and other structures that are required for the virus to infect target cells. This rearrangement also draws the virus and the target cell closer together, which may help gp41 penetrate the target cell, allowing the virus’ genetic material to be injected.

Although most of the antibodies that the body produces to fight HIV are ineffective, some antibodies are produced that can neutralize HIV. To gain a better understanding of how these antibodies work, the researchers visualized the HIV spike bound to an antibody called b12 that can neutralize a broad range of HIV particles. The team showed that, in response to b12, the gp120 proteins rearrange in a similar manner as with CD4, but b12 prevents the spike from opening completely. The antibody locks the spike in a semi-open position, preventing the series of actions that enable HIV to infect the target cell.

“The insights gained by understanding the binding of one of the most effective broadly neutralizing antibodies lays the foundation for designing more effective strategies for blocking HIV infection,” said Subramaniam. “We are working actively to increase the resolution of our structural analyses, and to understand the differences in binding between antibodies that neutralize, which are very rare in HIV-infected individuals, and non-neutralizing antibodies that are found in almost all AIDS patients. Knowing what these differences are will be critical to designing better strategies to neutralize HIV and to providing a new addition to the arsenal of strategies to combat HIV/AIDS.”

The Subramaniam lab has been pioneering advances in electron tomography and related methods for three-dimensional electron microscopy, and is applying these emerging technologies to understanding not only virus-host interactions but also structures inside the cell that distinguish cancer cells from normal cells.

For more information on Dr. Subramaniam’s research, please go to http://ccr.cancer.gov/staff/staff.asp?profileid=5614 and http://electron.nci.nih.gov.

For more information about cancer, please visit the NCI website at http://www.cancer.gov, or call NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

The National Institutes of Health (NIH) - The Nation’s Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

Reference:
Molecular architecture of native HIV-1 gp120 trimers.
Liu J, Bartesaghi A, Borgnia M, Sapiro G, and Subramaniam S.
Nature. Online July 30, 2008.

National Institutes of Health

UNICEF Executive Director, Ann M. Veneman, concluded her visit to Madagascar by launching a tetanus campaign in the rural town of Andilamena with the Minister of Health Dr. Ralainirina Paul Richard and local officials.

Despite impressive progress in decreasing child mortality rates, Madagascar is one of the only countries in the world - and one of nine in the East and Southern African region - that has not eliminated Maternal and Neonatal tetanus.

“Death due to tetanus is painful,” said Veneman. “But one visit to the local health center, for a simple immunization can help save a baby’s life.”

Tetanus, which accounts for an estimated 5 to 7 per cent of all neonatal deaths, is preventable through a vaccination. It is the first immunization that a child will ever receive as it is given by vaccinating the mother before she gives birth.

Veneman also launched an appeal for all families to register their children at birth. An estimated 25 per cent of Madagascar’s children are not registered.

Many of those children will be left behind without access to basic health services and education. A child without a birth certificate is more vulnerable to sexual exploitation, early marriage and child labor.

To better understand the situation of vulnerable children in Madagascar, Veneman met with young victims of abuse and exploitation.

“We want our parents to protect us so that we can go to school and we want the perpetrators to be arrested,” a young girl survivor of sexual exploitation told Veneman.

The UNICEF Executive Director also visited a community in the outskirts of the capital Antananarivo where the Madagascar Rotary Club had installed a pump which provides clean water for a community of 300 families.

“Water is essential to help achieve the Millennium Development Goals,” she said. “Water is critical for life, for health and for food production.”

The President of Madagascar, H.E. Marc Ravalomanana emphasized to Veneman that improving access to safe water and sanitation is a key objective of the Government.

About UNICEF

UNICEF works on the ground in more than 150 developing and transitional countries to help children survive and thrive. The world’s largest provider of vaccines for poor countries, UNICEF works to advance the Millennium Development Goals by supporting child health and nutrition, quality basic education for all boys and girls, access to clean water and sanitation, and the protection of children from violence, exploitation and AIDS.

About the UNICEF Executive Director

Ann M. Veneman assumed the leadership of UNICEF on 1 May 2007, becoming the fifth Executive Director to lead UNICEF in its 60-year history. Prior to joining UNICEF, Veneman served as Secretary of the United States Department of Agriculture.

At UNICEF, Veneman directs a global agency of over 10,000 staff and annual total resources of more than $3 billion, funded entirely by the voluntary contributions of governments, businesses, foundations and individuals. Since assuming the position of Executive Director, she has traveled to more than 40 countries, witnessing firsthand the work of UNICEF, speaking at meetings and conferences, and visiting heads of state or government and other partners.

http://www.unicef.org

A swallowed string may someday replace the invasive, uncomfortable endoscope now used to diagnose a devastating childhood disease of the esophagus.

Steven J. Ackerman of University of Illinois at Chicago College of Medicine and Dr. Glenn T. Furuta, his colleague at the University of Colorado Denver, were recently awarded three grants for an all-fronts attack on eosinophilic esophagitis, an inflammatory disease in which defense cells called eosinophils mistakenly attack the esophagus, causing it to narrow until food can’t pass.

“Most cases are first encountered in the emergency room, where a child is brought in because something he ate is caught in his esophagus,” said Ackerman, professor of biochemistry and molecular genetics at UIC.

To diagnose the disease, doctors insert an instrument called an endoscope down the esophagus and take six to eight samples of tissue, from the top, middle and distal end, near the stomach. Under a microscope, they count the number of eosinophils, “which are not normally present in the esophagus at all,” Ackerman said. The procedure, he said, is not only expensive but uncomfortable and carries some risks. And because repeat testing is needed over the course of treatment, a child may need to undergo as many as 20 endoscopies within three or four years.

Ackerman and his colleagues hope they can replace the endoscope by having children swallow a string encased in a gelatin capsule. As the capsule travels down the esophagus, the string plays out of the dissolving capsule, stretching through the esophagus, the stomach and the small intestine. The string is left in place overnight, then pulled out.

“We can determine which part of the string was in the esophagus, versus in the stomach, mouth or small intestine,” said Ackerman. They then look on the string for certain inflammatory proteins that are expressed only by eosinophils.

The test will be done the day before an endoscopic test is planned. The researchers will compare the thread’s measures of the eosinophil proteins with the cell counts obtained by endoscopy.

“Eventually, of course, our hope is to replace these repeated endoscopies with this simple procedure,” Ackerman said.

The study, funded by the National Institute of Allergy and Infectious Diseases (one of the National Institutes of Health), will be done at two sites, UIC and Denver. Ackerman and Furuta are co-principal investigators on the team, which also includes Dr. Amir Kagalwalla of the UIC Department of Pediatrics.

The two other grants are from the American Gastroenterological Association (AGA) and the CURED Foundation (Campaign Urging Research for Eosinophilic Diseases).

The AGA awarded Ackerman and Furuta its 2008 translational research award to determine the mechanisms that regulate changes in the esophagus caused by the disease, including the growth of scar tissue. The researchers will use the string test to look for biomarkers of the changes that characterize the disease.

CURED awarded the team an unrestricted gift for research to investigate pathogenic mechanisms in eosinophilic esophagitis and related gastrointestinal diseases. CURED has raised more than $1.4 million over the past five years, most recently as the beneficiary charity of the annual Highland Park (Ill.) High School fund-raising event, which raised $500,000 this year.

The investigators are also planning a proteomics study that will measure all the proteins on the string to develop a more complete diagnostic profile of the disease, Ackerman said.

“These grants present us with an exciting opportunity to increase our understanding of this difficult, newly emerging disease, which has increased in detection, and also possibly in incidence.”

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For more information about UIC, visit http://www.uic.edu/.

Source: Jeanne Galatzer-Levy
University of Illinois at Chicago

Two newspapers recently published an editorial and a letter to the editor in response to the cancellation of an NIH vaccine trial. Summaries appear below.

Editorial
“For nearly two decades, scientists have worked to develop a shot that would ward off the HIV infection that leads to AIDS,” but “trial after trial has failed, with the latest and most disappointing setback” announced earlier this month with the cancellation of the NIH trial, a San Francisco Chronicle editorial says. With about 40 million people worldwide living with HIV, there is “no question that work” to develop a vaccine “will continue,” the editorial says, adding that more “money than ever is spent on prevention and treatment” and that each year, “more people are receiving treatment, though this help comes after infection.” Although educational “programs are also credited with holding down the numbers of people who could” contract the virus, what “everyone is waiting for is a fail-safe vaccine, a medical brick wall that can stop an infection from taking hold,” according to the editorial. An HIV/AIDS vaccine “remains frustratingly distant,” the editorial says, adding, “For starters, the federal initiative must continue. That means a larger budget for” NIH. Private biotechnology companies “remain leery of heavy investments in a vaccine that could be quickly copied by rivals or face heavy public pressure to limit prices,” according to the editorial. It adds that although HIV/AIDS vaccine research is a “towering challenge,” it is “one that can’t be avoided. An AIDS vaccine must be found” (San Francisco Chronicle, 7/28).

Letter
Joseph O’Neill, New York Times: “Congress, policymakers and AIDS activists, along with researchers, must also rethink their approach to HIV vaccine discovery,” O’Neill, former director of the White House Office of AIDS Policy, writes in a Times letter to the editor. According to O’Neill, the “lion’s share of financing comes from American taxpayers and is distributed almost exclusively to academic centers.” He adds, “The sector most adept at developing vaccines, our biotechnology and research-based pharmaceutical companies, have remained largely on the sidelines.” In addition, “[h]ope of return on investment that would have motivated an all-out effort has been eroded by years of popular activism and sanctions … and overreliance on the academy’s ability to develop practical solutions to health problems,” O’Neill writes, adding that a multisectoral “approach and redirection of some public resources to stimulate market forces is warranted: the promise of a substantial financial prize to the inventor of an effective vaccine, advance-purchasing commitments and other means of motivating private capital would be a good place to start” (O’Neill, New York Times, 7/25).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

When it comes to risk for a heart attack, having excess fat around the heart may be worse than having a high body mass index or a thick waist, according to researchers from Wake Forest University Baptist Medical Center and colleagues reporting in the August issue of the journal Obesity.

The study was among the first to explore whether there is a link between fat deposits around the heart, known as pericardial fat, and the development of hard, calcified plaque in the arteries. Calcified plaque itself is not considered risky, but it is associated with the presence of less stable fatty deposits that can lead to heart attack and stroke.

“The distribution of body fat may be as important as the amount of body fat in determining risk of heart attacks,” said Jingzhong Ding, M.D., lead author and an assistant professor of gerontology. “Even a thin person can have fat around the heart.”

The researchers examined data from the Multi-ethnic Study of Atherosclerosis (MESA), a $68 million study involving 6,800 participants nationwide, to explore their hypothesis that fat around the arteries in the heart contributes to inflammation and to increased risk of fatty deposits in the vessels.

In addition to its role as energy storage, fat is considered to be an “organ” that produces proteins and hormones that affect metabolism and health. Ding’s study is based on a new idea in medicine - that excess fat around the heart and other organs may impair their function. Pericardial fat, or stores of fat around the heart, is known to have a higher secretion of inflammatory cytokines, proteins that regulate inflammation, than fat stored just under the skin. The scientists suspect that constant exposure of inflammatory proteins produced by fat around the heart may accelerate the development of atherosclerosis.

For the analysis, the researchers measured the volume of pericardial fat in 159 study participants who were 55 to 74 years old. Calcified coronary plaque was observed in 58 percent of participants. Participants were divided into four groups based on the volume of pericardial fat. Those in the group with the highest levels of fat were almost five times (4.65) more likely to have calcified coronary plaque.

The scientists found that while the volume of pericardial fat was related to levels of calcified coronary plaque, body mass index and waist circumference were not related.

“Our findings suggest that local fat deposits, rather than total body fat, are most related to calcified coronary plaque,” said Ding. “Inflammatory mediators released from pericardial fat may promote inflammation in local coronary arteries and lead to coronary atherosclerosis.”

Ding hopes to continue the research to learn more about whether the buildup of fat around the heart can be prevented.

“Because coronary heart disease kills so many people, it is imperative to find new treatments and prevention strategies,” he said.

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The study was sponsored by the National Heart, Lung, and Blood Institute and the Wake Forest University Claude D. Pepper Older Americans Independence Center.

Co-researchers were Stephen Kritchevsky, Ph.D., Gregory Burke, M.D., and Jeffrey Carr, M.D., all with Wake Forest, Tamara Harris, M.D., National Institute on Aging, Robert C. Detrano, M.D., Los Angeles Biomedical Research Institute, and Moyses Szklo, M.D., the Johns Hospkins Bloomberg School of Public Health.

Wake Forest University Baptist Medical Center (http://www.wfubmc.edu/) is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children’s Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university’s School of Medicine and Piedmont Triad Research Park. The system comprises 1,154 acute care, rehabilitation and long-term care beds and has been ranked as one of “America’s Best Hospitals” by U.S. News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America’s Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.

Source: Jessica Guenzel
Wake Forest University Baptist Medical Center

New researchers and innovative ideas are needed to further research on developing an HIV/AIDS vaccine, U.S. scientists wrote in Friday’s edition of Science magazine, the AP/Google.com reports. The researchers, including an NIH official, wrote that research should focus on developing a vaccine rather than on clinical trials for medicines that may not be effective. “Design of a vaccine that blocks HIV infection will require enormous intellectual leaps beyond present day knowledge,” the researchers wrote.

NIH is looking for “fresh ideas” about developing an HIV/AIDS vaccine and is emphasizing laboratory research to fill knowledge gaps, according to the AP/Google.com. Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, in a Science podcast said that the failure of a Merck vaccine candidate illustrated that researchers “were maybe on the wrong track a bit.” He added, “We will be turning the knob, as I like to say, more preferentially toward answering some of the fundamental questions that have gone unanswered.” Increased research in chimpanzees will be a priority, although NIAID will continue to support studies in people under raised standards for federal funding, the AP/Google.com reports.

The need for increased resources aimed at vaccine research comes at a time when NIH’s budget remains flat, the researchers wrote. They added that if the agency’s budget increases in future years, “one of the highest priorities will be to target those additional resources to HIV vaccine programs, particularly vaccine discovery research” (Freking, AP/Google.com, 7/24).

The researchers’ comments in Science follow a summit held by NIAID in March, which was held to re-evaluate vaccine research after the failure of the Merck HIV vaccine candidate in September 2007 (Kaiser Daily HIV/AIDS Report, 3/26).

The issue of Science is available online.

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