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12 Volunteers to Start Getting HIV Vaccine

Human volunteers this week began signing up for an experimental HIV vaccine developed at Atlanta's Emory University.

Twelve people are expected to take part in the trial at four participating research centers _ St. Louis University, Vanderbilt University, the University of Maryland and the University of Alabama at Birmingham.

Volunteers should begin getting shots any day now, said Don Hildebrand, the chief executive of GeoVax Inc., the Atlanta biotechnology firm that licensed the vaccine.

It's a phase one trial, in which healthy, uninfected volunteers are given low doses in a check for safety and immune response, Hildebrand said Friday.

A second, higher-dose trial _ with 36 people _ is expected to begin in a few months.

If these trials are successful, future trials will be done to see if the vaccine actually prevents the virus from causing AIDS, he said.

The GeoVax product is one of more than 30 preventive AIDS vaccines in early stages of human clinical trials in approximately two dozen countries, according to the International AIDS Vaccine Initiative, a not-for-profit organization devoted to AIDS prevention.

One of the furthest along is a Merck & Co. vaccine, which tries to build immunity using a modified cold virus. About 3,000 people are being enrolled in Merck's phase two trial of the vaccine... HIV vaccine

Biotech event puts Arizona delegation on global stage

Arizona got a chance to take its biotech efforts on an international road show last week. And state biotech leaders didn't have to leave the country to do it.

A 26-member delegation from the state traveled to Chicago for BIO 2006, one of largest annual gatherings of its kind in the world.

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and other nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.

BIO 2006 organizers say the event is growing more international, with more than 60 countries represented. About one-third of the participants came from other countries.

That meshes with the latest findings from Ernst and Young's annual global biotechnology report titled, "Beyond Borders."

According to the report, biotechnology is growing worldwide. In Europe, biotech growth has increased by 28 percent over the past year; in Asia, it increased by 46 percent.

It's key to Arizona's biotech effort that the state thinks globally, said Micah Miranda, biosciences manager for the state Commerce Department.

International companies are looking to expand or relocate their bioscience operations... continue

Look out San Diego: Peoria and Phoenix are on your tail

While San Diego, the Bay Area and the Boston area remain the country's dominant centers of biotechnology, other regions have popped onto the industry's map in the last four years, according to a study released yesterday at the Biotechnology Industry Organization's annual convention.

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In Phoenix, $50 million over five years from the Virginia G. Piper Charitable Trust has helped the city in its goal to attract 10 of the world's most distinguished leaders in the development of personalized medicine.

Pennsylvania is proposing to use $35 million annually in tobacco settlement dollars to create the $500 million Jonas Salk Legacy Fund to support bioscience faculty recruitment and facilities construction.

Northwestern University, the University of Chicago and the University of Illinois at Chicago have formed a consortium called the Chicago Community Trust. With up to $50 million in grants from the Searle Funds, they will try to build collaborations in biosciences.

More than 1.2 million people are employed in more than 37,000 bioscience facilities across the nation and Puerto Rico, according to the report prepared for BIO by the Battelle Technology Partnership. Biomedical research and testing labs were included in the figures, as were medical device companies, drug and pharmaceutical companies and agricultural and industrial biotech firms.

From 2000 to 2004, the years analyzed for the study, bioscience employment increased while overall employment nationwide declined by 0.7 percent, the study found.... continue

Gene Hunting in Canada

Genizon is using the genetic homogeneity of French Canadians to find new drug targets -- and redefine human disease.

In the 17th century, 15,000 French immigrants bravely made their way to eastern Canada. Some headed further west, many returned to France, but a hardy few stayed in Quebec. Starting with a total of just 2,600 people between 1608 and 1760, this group would grow 800-fold over the next 10 or so generations, with little marriage outside the group. The result is the Quebec "founder" population -- a genetically homogenous group of individuals that is ideally suited to the genetic study of disease.

Geneticists have long taken advantage of founder populations -- so named because only a few ancestors founded the entire population -- such as the Ashkenazi Jews and Icelandic people. Members of these groups share long stretches of DNA, which simplifies genetic studies of disease by reducing the background noise of other genetic variations.

Today's best-known gene-hunting company, deCODE genetics, an Icelandic gene and drug discovery company, has identified genes for diabetes, heart disease, and asthma within the small Icelandic population. Now a biotech company, Genizon BioSciences, is finding similar success with the French Canadians of Quebec. Based in Quebec, the company is taking advantage of new advances in genomics to find disease genes that have been hard to detect with other methods.

Gene-hunting studies have traditionally focused on families in which some members are afflicted with a disease, a technique known as linkage analysis. Because families share so much DNA, scientists can survey the genome in relatively few spots to find a region that looks different in those with the disease. This technique is efficient at identifying genes that play a large role in rare diseases because it is easy to identify those individuals with the disease... gene hunting in Canada

Fossils fill gap in human lineage

Fossil hunters have found remains of a probable direct ancestor of humans that lived more than four million years ago.

The specimens of this ancient creature are helping bridge a long gap during a crucial phase of human evolution.

Professor Tim White of the University of California, Berkeley, and colleagues unearthed the cache of fossils in the Middle Awash region of Ethiopia.

They describe the finds, which belong to the species Australopithecus anamensis, in the journal Nature.

Australopithecus is an important ancient genus of humanlike creatures, or hominids.

Our own genus, Homo, is widely thought to have evolved from this group. So the relationship of Australopithecus to even earlier bipedal hominids is crucial to understanding where we all ultimately come from.

When placed together with other fossils from the same general area of Ethiopia, the 4.1-million-year-old anamensis specimens appear to establish an evolutionary succession between earlier and later species... human fossil fill lineage

Evolution follows few of the possible paths to antibiotic resistance

Bacteria gain resistance from only a handful of 120 possible five-step mutational paths in a key gene

Darwinian evolution follows very few of the available mutational pathways to attain fitter proteins, researchers at Harvard University have found in a study of a gene whose mutant form increases bacterial resistance to a widely prescribed antibiotic by a factor of roughly 100,000. Their work indicates that of 120 harrowing, five-step mutational paths that theoretically could grant antibiotic resistance, only about 10 actually endow bacteria with a meaningful evolutionary advantage.

The research is published in the journal Science.

"Just as there are many alternate routes one might follow in driving from Boston to New York, one intrinsic property of DNA is that very many distinct mutational paths link any two variants of a gene," says lead author Daniel M. Weinreich, a research associate in Harvard's Department of Organismic and Evolutionary Biology. "Although this fact has been recognized for at least 35 years, its implications for evolution by natural selection have remained unexplored. Specifically, it is of great interest to determine whether natural selection regards these many mutational paths equivalently."

Weinreich and colleagues generated a series of mutants found along all 120 possible mutational trajectories involving the gene coding for the enzyme beta-lactamase, which in altered form can serve to inactivate antibiotics including penicillin and cefotaxime. Analyzing how well each variant protected host Escherichia coli cells against treatment with various concentrations of antibiotic, the scientists found that only a very small fraction of these pathways confer ever-increasing resistance in pathogenic microbes, and are therefore relevant to natural selection.

Resistance-granting mutations of beta-lactamase occur in a five-step process, with the 120 possible mutational paths representing all the possible ways in which these five point mutations can occur. Fully 102 of the 120 trajectories are inaccessible to natural selection because they create intermediates that are no more fit than the original gene, and of the remaining 18 Weinreich and colleagues observed that only about half actually had a significant probability of evolutionary occurrence.

"To be followed by an evolving population, natural selection requires that antibiotic resistance increase with each mutation," Weinreich says. "In contrast, most mutational paths of the enzymatic variant we examined fail to continuously increase resistance. Importantly, this is not a reflection of the fact that many more mutations reduce biological function than improve it, because in the present case each mutational path is composed exclusively of mutations known jointly to improve resistance."

Weinreich argues that this finding likely applies to most protein evolution, not just the beta-lactamase enzyme.Although many mutational paths lead to favored variants, only a very small fraction are likely to result in continuously improved fitness and therefore be relevant to the process of natural selection.

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U.S. states battle for slice of biotech pie

U.S. states squared off against each other on Monday in a battle to capture jobs and revenue generated by the burgeoning biotechnology industry.

A report released at the BIO 2006 conference here showed U.S. employment in biosciences reached 1.2 million in 2004. That was slightly more than a 1 percent increase since 2001, with workers earning an lucrative average annual wage of $65,775.

"These are good, well-paying jobs," said Walter Plosila, a vice president at Battelle Technology Partnership Practice, which co-sponsored the report.

The report also found that states are spending billions of dollars to support bioscience research and development. State governments are also using investment funds and tax incentives to attract large industry anchors, instead of solely focusing on launching and growing new bioscience ventures... read

Biotech progress overlooked

At 30, America's biotech industry is growing, becoming more stable and nearing the elusive break-even point.

Since America's first biotech company, Genentech Inc., was formed April 7, 1976, it has developed into a $50 billion-a-year industry, with annual revenue growth that has ranged in the past three years from 16 to 19 percent.

At roughly 5 years old, Arizona's emerging biotech and bioscience industries show surprising signs of vitality and growth. The number of Arizona bioscience companies is growing, grant funding is sharply up and related employment grew 12 percent from 2000 to 2004 to about 72,000 total jobs.

Work on new drugs drew a record level of grants from the National Institutes of Health. Grants to researchers in the state rose 30 percent from 2001 to 2004 and now total more than $160 million.

Yet despite the strides Arizona has made toward becoming a major biotech hub, it remains unmentioned in national reports on biotech... continue

Novel Device Shows Great Potential in Detecting Oral Cancer

Researchers supported by the National Institute of Dental and Craniofacial Research, part of the National Institutes of Health, report today their initial success using a customized optical device that allows dentists to visualize in a completely new way whether a patient might have a developing oral cancer.

Called a Visually Enhanced Lesion Scope (VELScope), this simple, hand-held device emits a cone of blue light into the mouth that excites various molecules within our cells, causing them to absorb the light energy and re-emit it as visible fluorescence. Remove the light, and the fluorescence of the tissue is no longer visible.

Because changes in the natural fluorescence of healthy tissue generally reflect light-scattering biochemical or structural changes indicative of developing tumor cells, the VELScope allows dentists to shine a light onto a suspicious sore in the mouth, look through an attached eyepiece, and watch directly for changes in color. Normal oral tissue emits a pale green fluorescence, while potentially early tumor, or dysplastic, cells appear dark green to black.

Testing the device in 44 people, the results of which are published online in the Journal of Biomedical Optics, the scientists found they could distinguish correctly in all but one instance between normal and abnormal tissue. Their diagnoses were confirmed to be correct by biopsy and standard pathology... read

ASU Biodesign chief Poste sets challenges

As a drug-company executive for 17 years, George Poste knew the perils of slumping sales: less money for research, slower growth and possible layoffs.

Now, as head of the Biodesign Institute at Arizona State University, Poste wants his staff to face the same consequences.

Under him, each researcher must generate $225 in federal or private grants for each square foot of space he or she occupies or lose lab space and maybe points in a performance review. It's not the typical accountability measure in academe, but Poste makes no apologies.

"That is tragically the Darwinian model," Poste said. Those who can't compete shouldn't be carried by other researchers or the university, he said. "(Otherwise) it's a form of academic welfare. Dispense with it."

At 61 and headlong into a third career, Poste leads the most high-profile, ambitious effort launched at ASU under President Michael Crow. The Biodesign Institute is the flagship of ASU's effort to become a world-class research institution, applying its findings in biology, chemistry, physics, computing and other areas to better human health.

It recently opened a second building costing $79 million that will house up to 500 employees near the eastern edge of the Tempe campus.

Perhaps more than anyone, Poste embodies Crow's effort to inject corporate values and incentives into the university setting. He wants measurable results: grants, patents, high rankings, prestige.

"If you are competitive, you have a reputation," he said. "People want to work for the Fortune 500 companies. They want to play for the best sports teams."

A British native and naturalized U.S. citizen, Poste was lured out of retirement in north Scottsdale nearly three years ago to take the job. He came with experience as a research director, an adviser to the Defense Department on bioterrorism issues, and an author and speaker on genetics, health policy and personalized medicine.

He brings to the job a tireless curiosity, a penetrating intellect, and a force of will that wins admirers but comes off as arrogance to some faculty... biodesign chief George Poste

Lowly fly is selling point in a bio-high-tech world

Presenters here for a conference promoting Arizona's biotechnology industry this week said the state has many things to offer the emerging industry — including state-of-the art flies for research.

For nearly 100 years, Drosophila, known as fruit flies to most of us, have done much of the heavy lifting in genetic studies, said Therese Ann Markow of the Arizona Research Lab. Markow is a Regent's Professor in the University of Arizona department of ecology and evolutionary biology.

Markow spoke Tuesday at a breakout session at BioSouthwest 2006, this year's edition of Arizona's statewide biotechnology conference, held at the Doubletree Hotel Tucson at Reid Park.

Markow said UA scientists have completed gene sequencing on two fruit-fly species and are working on others.

Drosophila, which are available from the UA's Tucson Drosophila Stock Center, are useful in many types of medical research, including studies of mental retardation, she said.

"Believe it or not," Markow said, "these little flies can learn."
She said that made them useful for studying human retardation.

Among the human-disease research being done using Drosophila, she said, is work on a number of fatal neurodegenerative diseases, including Huntington's disease. Although they may all look the same to most people, Markow said some of the flies have the ability to eat things that would be toxic to others. In many cases, those differences — mutations — can help in understanding human biology.

She said fruit flies, first used for genetic research in the early 1900s, have remained popular because they are easy to raise, have a small chromosome number and are not subject to the same regulations that govern work with vertebrate species... read

InNexus Biotechnology to Present at BIO 2006

Dr. Morgan, President and Chief Executive Officer of InNexus Biotechnology, Inc., an innovative antibody-driven drug development company based on SuperAntibody™ Technologies, will be presenting at the BIO 2006 Annual International Convention Business Forum. The presentation will take place on Wednesday, April 12th at 12:00PM in Room A of McCormick Place South Convention Center, Level 3, Exhibit Hall A.

The world’s largest biotechnology event, BIO 2006, will be held April 9-12, 2006 in Chicago and hosts more than 18,000 industry executives from around the globe, and as an organization, represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations.

Decoding the Genetics of Common Disease

Ten years after he returned to his native Iceland to build a biopharma company, Kari Stefansson says deCODE Genetics’ intense search for genes underlying common diseases is not only pushing promising new drug candidates into the clinic but is also revealing new insights into the very basis of common disease.

In a keynote address at Bio-IT World’s Life Sciences Conference + Expo Tuesday, Stefansson acknowledged, “There’s great enthusiasm for human genetics, but it has yet to deliver anything of great significance.” But he believes that “the genetics of common disease is the genetics of gene expression.”

Since 1996, deCODE has launched research programs to study 50 common diseases, mapping and isolating susceptibility genes for 30 diseases and turning nine of those into drug discovery and development programs. Three drugs are already in the clinic, a number Stefansson says will increase to five before the end of 2006.

Complex traits are confounded by environmental factors. Cases of lung cancer in Iceland are invariably triggered by smoking, but 10–15 percent of cancer deaths cluster in families, suggesting a genetic susceptibility that doesn’t penetrate until subject to an environmental trigger.

DeCODE’s search for the genetic causes of common disease have revealed several common themes. DNA sequence variants that predispose an individual to common disease rarely fall in the gene coding sequence; typically influence gene expression, e.g. alternative splicing; almost always provide a good drug target; and allow for the “intelligent design of clinical trials.”

DeCODE’s data mining relies on three key criteria – phenotype, genealogy, and genome data. “Genealogy is important in quality control and is the key to success in genome-wide association studies,” said Stefansson. Stefansson proudly noted how his personal genealogy tree extends back 1000 years to one Egil Skallagrimmson – “A great poet, great warrior, and said to be the ugliest man alive.”

Testing Times
DeCODE’s genotyping programs typically involve screens of 300–500,000 SNPs, but that raises the statistical problem of multiple testing. DeCODE’s standard practice is to test any Icelandic gene variants in a second population. “Every single discovery we report is done after we have replicated it in at least several other populations,” said Stefansson... read

Cervical cancer vaccine holds up

A vaccine protecting against two types of viruses that cause cervical cancer has demonstrated unusual staying power, new research shows.

In a follow-up study to a randomized clinical trial, researchers found antibody levels in the study subjects remained steadfast for up to four and a half years. Researchers say the results confirm the success and safety of the vaccine Cervarix, which is designed to guard against two cancer-causing human papillomaviruses, HPV 16 and 18.

"This is the most significant advance in cancer prevention in the last 50 years," said lead author Diane Harper, director of Gynaecologic Cancer Prevention Research at Dartmouth Medical School. "We now have a vaccine that's 100 percent effective," she added.

She also emphasized the vaccine does not prevent cancer -- it prevents the virus that causes cervical cancer, the second most common malignant disease in women worldwide.

The research, conducted by Harper and several investigators, appears online Thursday in the British journal Lancet.

Around 800 women from the original clinical trial were included in the follow-up, conducted between 2003 and 2004. The women, who come from 32 sites around the world, represent a racially and ethnically diverse group, possibly the only global study with a planned longterm follow-up, Harper said.

Not only did the vaccine still appear strong after four years, the women encountered no vaccine-related diseases, Harper said. In other studies of HPV vaccines, the duration of effect, as it's called, was only three years. In general, vaccine duration varies greatly: some are needed only once-in-a-lifetime, and others last 10 years, as with tetanus. Researchers do not yet know the booster requirements for cervical cancer vaccines, or if boosters are even required.

Two cervical cancer vaccines are currently being developed: GlaxoSmithKline's Cervarix, which targets only HPV 16 and 18, and Merck's Gardasil, which prevents HPV 16, 18, 6 and 11; the latter two viruses cause genital warts. Cervarix could be released on the market as early as spring 2007, months after Gardasil's expected debut in fall 2006, Harper said.

HPV 16 and 18, in the same family of viruses as skin warts, are contracted through sexual activity, although genital contact alone can also spread the virus. These viruses are also very common: 80 percent of people will have an HPV genital infection in their lifetime. To develop cervical cancer, the virus must stay in the cervix long enough to change its cell structure.... cervical cancer vaccine