Archive for the ‘Gene Therapy Research’ Category

WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM).

"There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner.

Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for Regenerative Medicine (CIRM) commented, "Cell-based therapies represent a fundamentally new way to treat or cure disease, but developing a new therapy is costly, time consuming and fraught with uncertainty. Our paper takes a practical approach to clarifying the path to market."

"Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" provides detailed information on options for communicating with the FDA at different stages; the official communications tied to each stage of development; and the most common reasons regulatory applications are delayed. The article can be accessed at: http://stemcellstm.alphamedpress.org/content/early/recent

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

About ARM: The Alliance for Regenerative Medicine is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 120 members and is the leading global advocacy organization in this field. In March 2012, ARM launched a sister organization in Europe -- the Alliance for Advanced Therapies. For more information go to http://www.alliancerm.org.

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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell ...

NEW YORK, Oct. 17, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that it will redeem all outstanding shares of its Series E 7% Senior Convertible Preferred Stock ("Series E Preferred Stock").

On October 10, 2012, the Company gave notice to its Series E Preferred Stockholders that it is redeeming all of the outstanding shares of Series E Preferred Stock for an aggregate redemption price of $3.4 million, $2.5 million of which was funded by money placed into escrow when the Series E Preferred stock was issued in November 2010.

"We are pleased that we have been able to redeem this $10 million investment in full over a two year period. Equal to our focus on cell therapy product development and expanding our PCT contract development and manufacturing operations, we are committed to improving our balance sheet. Through the redemption of the Series E Preferred Stock, we will remove a significant overhang and simplify NeoStem's capital structure. The redemption of the Series E Preferred Stock is another example of a step taken by us to improve Common Stockholder value," said Dr. Robin Smith, Chairman and CEO of NeoStem. "We look forward to continued execution on our near term business strategy, including the forthcoming closing of the divestiture of our Erye China pharmaceutical subsidiary."

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing ("CDMO") business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

A new study comparing risk factors for Alzheimers disease has found that having a high amount of beta amyloid plaques in the brain is associated with greater mental decline in healthy, older people than carrying a gene thought to increase peoples risk for the disease.

According to study author Yen Ying Lim, at the University of Melbourne in Victoria, Australia, prior research has shown that carrying the Alzheimers gene, called the APOE 4 allele, and plaques have both been associated with increased risk of cognitive decline and the eventual development of Alzheimers disease. The gene also increases the risk of plaques.

Therefore, Lim and her colleagues originally thought that having both the gene and a high amount of plaques together would result in greater cognitive decline.

However, the data suggested that while both plaques and the gene were associated with decline in healthy people, the main driver of this decline was the amyloid plaque, Lim told FoxNews.com.

In a study of 141 healthy people with an average age of 76, the researchers found people who had more plaques at the start of the study had up to 20 percent greater cognitive decline over the next year and a half than those who had fewer plaques.

While people who carried the Alzheimers gene also showed greater decline than people without the gene, the gene did not affect the decline in memory caused by the plaques.

Though the evidence indicates plaques may be a more important factor in determining Alzheimers risk or other brain-related diseases, there are challenges to scanning people for plaques rather than the APOE 4 allele.

The main challenge is cost scans are very expensive, and the number of scanners are very few, Lim said. Further, this is the first time such a relationship between amyloid and cognitive decline has been observed.

If the results are replicated in future studies, Lim added, it could help direct future researchers on how to potentially treat or prevent Alzheimers disease.

It provides us with a platform to begin to investigate whether in healthy people with high levels of plaques, pharmaceutical therapies designed to halt or alter plaque accumulation can prevent the disease from progressing to the more severe stages, Lim said.

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Brain plaques may be worse than carrying Alzheimer's gene

Public release date: 17-Oct-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, October 17, 2012SELEX is a rapid, efficient, and iterative high-throughput method for screening large libraries of molecules to identify those with the potential to be developed as drug compounds or research tools. Advances in SELEX technology that have enabled screening in live cells, called Cell-SELEX, are explored in a comprehensive Review article published in BioResearch Open Access, a bimonthly peer-reviewed open access journal from Mary Ann Liebert, Inc. The article is available free on the BioResearch Open Access website.

Cell-SELEX uses live cells as targets for binding of molecules called aptamers, comprised of short chains of nucleic acids. Aptamers share many of the qualities that have made antibodies such successful drugs, but offer additional advantages such as stability, short length, and ease of manufacturing. Shoji Ohuchi, University of Tokyo, Japan, examines the ongoing progress in developing and refining this useful process for drug compound screening in the Review article "Cell-SELEX Technology."

"This review summarizes the progress and application of Cell-SELEX technology, providing an excellent resource for beginners to the field and experts alike," says Editor-in-Chief Jane Taylor, PhD, MRC Centre for Regenerative Medicine, University of Edinburgh, Scotland.

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About the Journal

BioResearch Open Access is a bimonthly peer-reviewed open access journal that provides a new rapid-publication forum for a broad range of scientific topics including molecular and cellular biology, tissue engineering and biomaterials, bioengineering, regenerative medicine, stem cells, gene therapy, systems biology, genetics, biochemistry, virology, microbiology, and neuroscience. All articles are published within 4 weeks of acceptance and are fully open access and posted on PubMedCentral. All journal content is available on the BioResearch Open Access website.

About the Publisher

Mary Ann Liebert, Inc. is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Assay and Drug Development Technologies, Tissue Engineering, Stem Cells and Development, Human Gene Therapy and HGT Methods, and AIDS Research and Human Retroviruses. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc. website.

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Progress in Cell-SELEX compound screening technology reviewed in BioResearch Open Access

Public release date: 17-Oct-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, October 17, 2012Among adults who use social media such as Facebook, YouTube, Twitter, and blogs for political purposes, 42% are under the age of 30. A case study of the controversial Budget Repair Bill in Wisconsin explored whether young adults who use social media are more likely to engage in offline protests, and the results are published in an article in Cyberpsychology, Behavior, and Social Networking, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free online on the Cyberpsychology, Behavior, and Social Networking website.

In the article entitled "Killing the Bill Online?: Pathways to Young People's Protest Engagement via Social Media ," Timothy Macafee, University of Wisconsin-Madison, compared the relationship between information-seeking behaviors online versus expressive engagement online (defined as using social media as a "soapbox" to share personal views and political events and issues) and actual participation in political protests.

"Individuals use social media primarily for informational and expressive purposes," Macafee concludes. College students used social media to gain information related to the protests in this case study, but that activity did not affect their offline behavior; whereas, "expressive" political social media use encouraged offline protest participation.

"Using social media for information gathering has quite different implications for real world behavior than does use of social media to express oneself (through blogs, tweets, etc.)," says says Brenda K. Wiederhold, PhD, MBA, BCIA, Editor-in-Chief of Cyberpsychology, Behavior, and Social Networking, from the Interactive Media Institute, San Diego, CA. "As young people utilize social media for information gathering more than traditional means, such as television or newspapers, those wishing to influence opinion and individual behavior should pay heed."

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About the Journal

Cyberpsychology, Behavior, and Social Networking is an authoritative peer-reviewed journal published monthly in print and online that explores the psychological and social issues surrounding the Internet and interactive technologies. Complete tables of content and a sample issue may be viewed online on the Cyberpsychology, Behavior, and Social Networking website.

About the Publisher

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Are young people who join social media protests more likely to protest offline too?

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced the initiation of a phase II clinical trial evaluating ADCETRIS (brentuximab vedotin) as a front-line therapy for patients age 60 or older with newly diagnosed Hodgkin lymphoma (HL). The trial is designed to assess the efficacy and tolerability of ADCETRIS as a monotherapy for older HL patients who have received no prior treatment. Seattle Genetics is the leader in the field of antibody-drug conjugates (ADCs) and ADCETRIS is an ADC directed to CD30 for relapsed HL and systemic anaplastic large cell lymphoma (sALCL).

The current standard of care for the treatment of front-line HL is a combination of multiple chemotherapeutic agents and has not changed in more than three decades. Some older HL patients are not able to tolerate the significant side effects associated with these regimens, and there is a significant need to identify effective and tolerable treatment options for these patients, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer at Seattle Genetics. We believe the response rate associated with single-agent use of ADCETRIS in the relapsed HL setting supports the evaluation of single-agent ADCETRIS in older patients who have received no prior therapy.

The phase II single-arm, open-label clinical trial will evaluate the efficacy and tolerability of ADCETRIS as front-line monotherapy in patients age 60 or older with HL. The trial is enrolling patients who are newly diagnosed and have received no prior HL treatment. The primary endpoint of the trial is to assess the objective response rate (ORR), with key secondary endpoints of safety and tolerability, duration of response, complete remission (CR) rate and progression-free survival (PFS). The study is expected to enroll up to 20 patients at multiple centers in the United States.

More information about the trial, including enrolling centers, will be available by visiting http://www.clinicaltrials.gov.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

ADCETRIS is not approved for use outside the United States. The marketing authorization application for ADCETRIS in relapsed or refractory HL and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted for review by the European Medicines Agency (EMA) in June 2011. In July 2012, the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion for the conditional approval of ADCETRIS, supporting an approval decision in the European Union.

Seattle Genetics and Millennium are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

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Seattle Genetics Announces Initiation of Phase II Trial of ADCETRIS® as Front-line Therapy for Hodgkin Lymphoma ...

Published: Oct. 16, 2012 at 8:30 PM

EVANSTON, Ill., Oct. 16 (UPI) -- U.S. scientists say they've discovered how to control the shape of nanoparticles that can move DNA through the body to treat cancer and other diseases.

A gene therapy technique utilizing nanoparticles is significant in that it does not use a virus to carry DNA into cells, as some gene therapy strategies relying on viruses have posed health risks, researchers at Northwestern University and John Hopkins University reported.

"These nanoparticles could become a safer and more effective delivery vehicle for gene therapy, targeting genetic diseases, cancer and other illnesses that can be treated with gene medicine," John Hopkins material science Professor Hai-Quan Mao said.

Mao, who has been developing non-viral nanoparticles for gene therapy for a decade, said a major breakthrough is the ability to "tune" the particles in three shapes, resembling rods, worms and spheres, which mimic the shapes and sizes of viral particles.

The nanoparticles carry healthy snippets of DNA within protective polymer coatings and are designed to deliver their genetic payload only after they have moved through the bloodstream and entered the target cells, prompting the cells to produce functional proteins that combat disease.

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Nanoparticles seen as gene therapy advance

With all the publicity about the miraculous effects of stem cell therapy, the Department of Health (DOH) should prepare itself for the possibility that the new procedure would be performed by unqualified, and completely clueless, people.

I passed a beauty parlor recently and saw a huge poster on its door announcing the arrival of stem cell therapy. I was instantly reminded of botched breast enhancement and nose jobs performed by salon personnel who seemed to think it was as easy to learn complicated surgical procedures as it was to train to cut hair or do manicures and pedicures.

The DOH should start warning the public not to fall for these special offers just because they are available at giveaway rates.

Modern lifestyle problem

Experts have repeatedly talked about problems brought about by modern lifestyles. Changing diets and stress are two of the best known. Dr. Jaime G. Ignacio, section chief of gastroenterology at Veterans Hospital and head of the Digestive Malignancy Council of the Philippine Society of Gastroenterology, said constipation could be one of the consequences of the combination of these two factors.

Speaking at an event hosted by Boehringer Ingelheim, maker of Dulcolax (generic name Bisacodyl), a formulation for constipation relief, Ignacio, who, as a gastroenterologist is a specialist in digestive system disorders, defined the problem as having fewer than three bowel movements in a week (normal ranges from three times a week to three times a day).

He said constipation itself was not a disease but it could sometimes be a symptom of something serious, like colorectal cancer. But he said about 95 percent of cases were acuteoccurring suddenly and lasting for only a short periodresulting from some sudden lifestyle or hormonal changes, the taking of medication, lack of exercise, etc.

Ignacio said acute was easy to treat, with products like Dulcolax to solve the problem. But, if left unattended, acute constipation could lead to a chronic or long-term condition, which was the more worrisome, and would need medical attention.

He said constipation should be treated as soon as the problem had lasted for four or more days.

Constipation is part of modern living. [Like other diseases] prevention is the key. Safe and effective treatment is available [if needed], Ignacio stressed.

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Beauty salon ‘offers’ stem cell therapy

ScienceDaily (Oct. 16, 2012) A landmark paper identifying genetic signatures that predict which patients will respond to a life-saving drug for treating congestive heart failure has been published by a research team co-led by Stephen B. Liggett, MD, of the University of South Florida.

The study, drawing upon a randomized placebo-controlled trial for the beta blocker bucindolol, appears this month in the international online journal PLoS ONE. In addition to Dr. Liggett, whose laboratory discovered and characterized the two genetic variations, Christopher O'Connor, MD, of Duke University Medical Center, and Michael Bristow, MD, PhD, of ARCA biopharma and the University of Colorado Anschutz Medical Campus, were leading members of the research team.

Dr. Stephen Liggett, who joined USF just four months ago to lead the University's Center for Personalized Medicine and Genomics, was a senior author of the paper.

The analysis led to a "genetic scorecard" for patients with congestive heart failure, a serious condition in which the heart can't pump enough blood to meet the body's needs, said Dr. Liggett, the study's co-principal investigator and the new vice dean for research and vice dean for personalized medicine and genomics at the USF Morsani College of Medicine.

"We have been studying the molecular basis of heart failure in the laboratory with a goal of finding genetic variations in a patient's DNA that alter how drugs work," Dr. Liggett said. "We took this knowledge from the lab to patients and found that we can indeed, using a two-gene test, identify individuals with heart failure who will not respond to bucindolol and those who have an especially favorable treatment response. We also identified those who will have an intermediate level of response." The research has implications for clinical practice, because the genetic test could theoretically be used to target the beta blocker to patients the drug is likely to help. Equally important, its use could be avoided in patients with no likelihood of benefit, who could then be spared potential drug side effects. Prospective studies are needed to confirm that bucindolol would be a better treatment than other classes of beta blockers for a subset of patients with health failure.

Dr. Liggett collaborated with medical centers across the United States, including the NASDAq-listed biotech company ARCA biopharma, which he co-founded in Denver, CO. This genetic sub-study involved 1,040 patients who participated in the Beta-Blocker Evaluation of Survival Trial (BEST). The researchers analyzed mortality, hospital admissions for heart failure exacerbations and other clinical outcome indicators of drug performance.

"The results showed that the choice of the best drug for a given patient, made the first time without a trial-and-error period, can be accomplished using this two-gene test," Dr. Liggett said.

The genetic test discovered by the Liggett team requires less than 1/100th of a teaspoon of blood drawn from a patient, from which DNA is isolated. DNA is highly stable when frozen, so a single blood draw will suffice for many decades, Dr. Liggett said. And since a patient's DNA does not change over their lifetime, as new discoveries are made and other tests need to be run, it would not be necessary to give another blood sample, he added.

This is part of the strategy for the USF Center for Personalized Medicine and Genomics. The discovery of genetic variations in diseases can be targeted to predict three new types of information: who will get a disease, how the disease will progress, and the best drug to use for treatment.

"In the not too distant future, such tests will become routine, and patient outcomes, and the efficiency and cost of medical care will be impacted in positive ways. We also will move toward an era where we embrace the fact that one drug does not fit all," Dr. Liggett said. "If we can identify by straightforward tests which drug is best for which patient, drugs that work with certain smaller populations can be brought to the market, filling a somewhat empty pipeline of new drugs."

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Two-gene test predicts which patients with heart failure respond best to beta-blocker drug

16.10.2012 - (idw) Schweizerischer Nationalfonds SNF

Jacques Fellay receives the National Latsis Prize 2012

The medical researcher Jacques Fellay is studying the human genome in search of genetic variations that influence how the body reacts to a virus and to the drugs fighting it. He is to be awarded the National Latsis Prize 2012 for his research. Jacques Fellay is a "bridge builder" and an advocate of translational research, a discipline that allows the results of basic research to be transferred to medical practice. Always on the borderline between laboratory and hospital, he is of the opinion that, in order to discover medically useful solutions, an exchange between the two worlds is needed.

Jacques Fellay applies this thinking in his own research, which is conducted at the intersection of genomics and infectious diseases and for which he receives the National Latsis Prize 2012. The information stored in our genes can be of great value for developing new treatments.

Different responses to drugs At the beginning of the millennium, the treatment of HIV patients - persons who were infected with the virus that causes AIDS - still involved serious, undesired side-effects. Jacques Fellay, then a doctoral student of Amalio Telenti in Lausanne, discovered the existence of genetic variations that influence the individual's response to antiretroviral drugs: some patients have a higher concentration of drugs in the blood than others, which in turn increases the risk of a toxic reaction. Knowledge of their genetic profile now makes it easier to predict harmful effects and adjust the treatment accordingly.

During a four-year stay at Duke University in the United States, Jacques Fellay became interested in the genetic material of people who are carriers of the hepatitis C virus. He discovered that the genetic make-up of the patient played a significant role in the success of antiviral treatments, which are only effective in 50 percent of the cases. Today, these genetic predictors of the response to drugs are taken into account by doctors when they choose a treatment.

Fighting viral diseases At the same time, Fellay kept on studying the HIV virus. He identified three genes that enable certain patient populations to exercise better immune control over the disease. This could be a crucial step towards the development of a vaccine.

Since 2011, as the holder of an SNSF professorship and head of his own lab at the Faculty of Life Sciences at EPF Lausanne, Jacques Fellay has kept on searching for features of the human genome that make it possible to counter viral diseases. Together with his team, he is studying mutations that occur in HIV when fought by the immune system and investigating the genetic variations of infected persons that might be the cause of this.

Worth 100,000 Swiss francs, the National Latsis Prize is one of the most prestigious scientific awards in Switzerland. Each year, the Swiss National Science Foundation presents the prize on behalf of the Latsis Foundation to researchers of up to 40 years of age in recognition of their special contribution to science in Switzerland.

The prize will be awarded on 10 January 2013 at the Rathaus in Berne.

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Our genetic differences as means of treatment

ScienceDaily (Oct. 16, 2012) Evolution has not only controlled human development over millions of years, it also has an impact on modern humans. This is one of the conclusions of a study of Argentinian villagers in the Andes, where the water contains high levels of arsenic. A gene variant that produces efficient and less toxic metabolism of arsenic in the body was much more common among the villagers than among other indigenous groups in South or Central America.

The study was a collaborative effort by Karin Broberg from Lund University and Carina Schlebusch and Mattias Jakobsson from Uppsala University in Sweden.

"We know that many bacteria and plants have genes that increase resistance to arsenic, a highly toxic substance that is found in soil and water in many parts of the world. There has been no previous research on whether the people in these regions also have protective genes against arsenic," says Karin Broberg.

High levels of arsenic in drinking water are linked to a range of health problems. Increased child morbidity and an increased risk of cancer, heart disease and diabetes are some examples.

In many places this is a relatively new problem, for example in Bangladesh, where it arose in connection with new drilled wells. In the Andes, however, people have lived with drinking water containing arsenic for thousands of years, owing partly to high levels of the toxic substance in the bedrock and partly to consequences of mining since the pre-colonial era. Even 7 000-year-old mummies from northern Chile have been found to have high levels of arsenic in their hair and internal organs.

Occupational and environmental medicine researcher Karin Broberg has been studying the health impact of metals in the Andes for a long time.

"We found that the people up in the mountains in Argentina had unusually efficient metabolism of arsenic. This meant that the toxin left the body rapidly and less toxically instead of accumulating in tissue," she explains.

In the newly published study, the researchers have studied the genes of Atacameo Indian villagers in San Antonio de los Cobres in Argentina, who have lived in the area for multiple generations. Their genes were compared with those of various indigenous and Mestizo groups from Peru and indigenous groups from Colombia and Mexico. Over two thirds of the Argentinian villagers were found to carry a gene variant that accelerates the metabolism of arsenic, compared with half of the Peruvian villagers and only 14 per cent of the other indigenous groups.

There has been very little previous research on human evolutionary adaptation to environmental toxins. However, it is known that many of the genes that control the metabolism of poisons in the body have a large number of variants that occur with varying prevalence around the world. There may therefore be different adaptations among different populations, depending on what toxins they are exposed to in the local environment, according to Karin Broberg.

The study is a collaboration between researchers in Sweden, the US and Peru. They now hope to continue mapping genes that increase human tolerance of toxic substances.

Originally posted here:
Genetic protection against arsenic

NASHVILLE, Tenn., Oct. 16, 2012 /PRNewswire/ -- NextGxDx, a healthcare information technology company, today announced the release of its online genetic testing platform that curates information on the more than 10,000 genetic testing products currently offered by FDA and CLIA certified labs in the U.S. According to NextGxDx's research, the database is the most comprehensive catalog of all the genetic testing products available to U.S. healthcare providers. The company also found the number of available tests is tenfold greater than previously estimated by industry experts.

The company intends to help implement strategies that further clinical integration of genetic testing. The goal of the platform is to speed the process of diagnosing, and thus treating, patients with genetic diseases. The NextGxDx platform allows healthcare providers and hospitals to easily identify the appropriate genetic tests for their patients by searching the database by symptoms or browsing by clinical specialty. The platform also allows side-by-side comparison of tests, and the company's partnerships with laboratories across the country enable physicians to order tests directly from the NextGxDx website.

"Our research shows there are nearly ten times more genetic tests available today than commonly thought, and yet there has not been a centralized, well-curated, user-friendly platform to help healthcare providers find the right test for a patient. Our platform brings together all the disparate information about available genetic tests to help physicians find and order the best test the first time," said Mark Harris, Ph.D., founder and CEO of NextGxDx. "In addition to facilitating the diagnosis process, the technology we have developed will allow us to maintain the most accurate catalog of genetic testing products available."

NextGxDx explores the factors informing and shaping the industry in "The Genetic Testing Landscape: Finding the Needle in the Haystack" a white paper released today. The paper provides a comprehensive overview of the genetic testing industry, including the size of the industry, how genetic tests are used and how genetic information is communicated. It also outlines key strategies for the future of clinical integration of genetic testing and personalized medicine.

Among the paper's key findings:

"This report is designed to establish a robust analysis of genetic testing as it relates to the products currently available for clinical use," said Jud Schneider, Ph.D., scientific director of NextGxDx and author of the white paper. "As personalized medicine becomes a clinical reality, we think it's important for physicians to understand the scope and trajectory of the genetic testing industry and how it may impact their practices in the years ahead."

The white paper is currently available for free download on the NextGxDx website, http://www.NextGxDx.com.

About NextGxDx

NextGxDx is a healthcare information technology company that provides a web-based genetic diagnostics platform allowing hospitals and physicians to quickly and efficiently identify appropriate genetic tests and cross-reference multiple test providers. With the ability to research tests based on patient symptoms, instantly compare tests across laboratories, and determine existing institutional relationships, NextGxDx provides physicians with a single destination for discovering, comparing and ordering genetic tests. For more information, visit http://www.NextGxDx.com.

Media Contact: Erin Lawley 615-946-9914 erin@lovell.com

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NextGxDx Launches Comprehensive Genetic Testing Platform, Curating Information on More Than 10,000 Genetic Testing ...

October 16, 2012

April Flowers for redOrbit.com Your Universe Online

A new study suggests that the reason worker bees are such a highly skilled and specialized workforce is that the genes controlling their behavior are re-shuffled frequently, helping evolution build a better bee.

The new research from York University, published in the Proceedings of the National Academy of Sciences (PNAS), sheds light on how sterile worker bees evolved charismatic and cooperative behaviors. These behaviors include nursing young bees, collecting food for the colony, defending it against intruders, and dancing to communicate the location of profitable flowers to nest mates.

By examining the honey bee genome, the team noticed that the genes associated with worker behavior were found in the area of the genome known to have the highest rate of recombination, which is basically a shuffling of the genetic deck. Biology Professor Amro Zayed says that because of such shuffling, the bees can be strongly varied. For example the recombination in a queens ovaries means that her female offspring are likely to inherit mosaic chromosomes with different combinations of mutations.

This recombination allows specific mutations to be selected without regard to adjacent mutations.

If Im a good rower in a dragon boat with 49 poor rowers, I am going to lose all of my races. But if teams were shuffled after every race, Ill likely have a better chance of winning. I may even get to be in a boat with 49 good rowers just like myself, says Zayed. The same thing happens with mutations on a chromosome. Recombination makes the evolutionary fate of mutations independent of their surrounding neighbors, which enhances the process of natural selection..

Zayed and his team think they have solved one of the mysteries of the honey bees genome.

The honey bee has the highest rates of recombination in animals ten times higher than humans. Our study shows that this high degree of genetic shuffling has turned on the evolutionary faucet in parts of the bee genome responsible for orchestrating worker behavior, says postdoctoral research associate Clement Kent. This can allow natural selection to increase the fitness of honey bee colonies, which live or die based on how well their workers behave.

Source: April Flowers for redOrbit.com - Your Universe Online

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Genetics Plays Vital Role In Building Better Bees

Public release date: 15-Oct-2012 [ | E-mail | Share ]

Contact: Kat Snodgrass 202-962-4090 Society for Neuroscience

NEW ORLEANS New animal studies provide additional support for investigating stem cell treatments for Parkinson's disease, head trauma, and dangerous heart problems that accompany spinal cord injury, according to research findings released today. The work, presented at Neuroscience 2012, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health, shows scientists making progress toward using stem cell therapies to repair neurological damage.

The studies focused on using stem cells to produce neurons essential, message-carrying cells in the brain and spinal cord. The loss of neurons and the connections they make for controlling critical bodily functions are the chief hallmarks of brain and spinal cord injuries and of neurodegenerative afflictions such as Parkinson's disease and ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

Today's new findings show that:

Other recent findings discussed show that:

"As the fields of developmental and regenerative neuroscience mature, important progress is being made to begin to translate the promise of stem cell therapy into meaningful treatments for a range of well-defined neurological problems," said press conference moderator Jeffrey Macklis, MD, of Harvard University and the Harvard Stem Cell Institute, an expert on development and regeneration of the mammalian central nervous system. "Solid, rigorous, and well-defined pre-clinical work in animals can set the stage toward human clinical trials and effective future therapies."

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This research was supported by national funding agencies such as the National Institutes of Health, as well as private and philanthropic organizations.

Todd Bentsen, (202) 962-4086

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Realizing the potential of stem cell therapy

The Grekos hearing is scheduled to begin at 9 a.m. Tuesday. The location has changed to the Collier County Courthouse in room 4-D, according to a case filing Monday.

The hearing before J. Lawrence Johnson, an administrative law judge from Tallahassee, will begin at 9 a.m. The hearing is scheduled to last four days. The Collier County Courthouse is located at 3315 U.S. 41 E.

Photo by Allie Garza

Zannos Grekos

BONITA SPRINGS Bonita Springs physician Zannos Grekos, whose license is in jeopardy for controversial stem cell therapy, is getting his day before a judge.

Barring a last-minute delay or settlement, an administrative hearing is scheduled to begin Tuesday in Naples for the 47-year-old. He is fighting to get his license back in good standing from a suspension order, while the state Department of Health is pursuing more discipline and potentially revocation of his license.

Trained as a cardiologist, he's been licensed in Florida since 1996.

The trial-like proceeding, without a jury, is scheduled for four days before an administrative law judge. The proceeding is open to the public. The case against Grekos has garnered considerable media attention, including CNN and inquiries from European media.

A Texas father, Jimmy Bell, will be tracking what happens. Last year, he paid $57,000 upfront for his 5-year-old son, Jason, to undergo stem cell therapy to fight pulmonary hypertension. Despite pleas that his boy was weakening by the day, the treatment was never scheduled and Jason died. Bell received a $10,000 refund.

"He's taking advantage of people and it's more for personal gain," Bell said. "I'd like to see that stopped."

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State licensing hearing for Bonita Springs stem cell doctor to begin Tuesday

ScienceDaily (Oct. 15, 2012) Soybean cyst nematode (SCN) does hundreds of millions of dollars' worth of damage each year. Matt Hudson and Brian Diers, crop sciences researchers at the University of Illinois and Andrew Bent at the University of Wisconsin, think they may have found a way to strengthen plant resistance. The research has just been published in Science Express.

Diers and Hudson, with researchers at Wisconsin and the University of Nebraska, have been studying an area on chromosome 18 called Rhg1 (Resistance to H. glycines) that is known to be the location of the main source of SCN resistance. Rhg1 disrupts the formation and maintenance of potential nematode-feeding sites on plant roots.

Most SCN-resistant soybeans in the Midwest are bred to contain Rhg1, but no one knew the DNA sequence of the gene that was responsible for the resistance. Diers wanted to find it.

"You could say it's a billion-dollar gene because it's in many varieties, it's widely used, and it's protecting varieties against these nematodes," he explained.

Using fine mapping, which is a technique that involves mapping genes in a very constrained area, Diers narrowed the search down to a few gene candidates. At that point, Hudson and Bent got involved in the analysis.

By then, the soybean genome sequence had been completed, greatly facilitating their research. "It became possible to know which genes were within the genetic intervals that people had historically used to confer traits like nematode resistance," Hudson said.

"When we had the genome sequenced, most people were shocked by how many genes there were in regions that people considered to be one gene," he continued. "By doing these fine-mapping experiments, you could get it down to a smaller number of possible genes."

There was, however, one big problem: the soybean that had been sequenced was not nematode-resistant.

"So, however many genes there were in the Rhg1 interval, we knew that the gene that actually makes the plants nematode-resistant wasn't there," Hudson said.

They went back to the nematode-resistant line and sequenced the genome in the interval. When they finished, they saw something very unusual. Rather than finding a gene in the resistant line that was not present in the susceptible line or changes in a gene that was present in both, they saw that a group of four genes had been replicated several times.

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Strengthening a billion-dollar gene in soybeans

Dundee University experts said P34 played a key role in causing the disease punctate PPK, which gives sufferers dots of hard, thickened skin which can cause pain and discomfort.

Irwin McLean, professor of human genetics in the Centre for Dermatology and Genetic Medicine at the university, said: "We have not only found this gene but we have been able to figure out how it works, which is very important.

"When the gene is disrupted or knocked out, the cells in the skin grow too fast and this results in these hard, thick, painful lesions which can be quite debilitating. When the gene is working properly then the skin forms normally.

"Knowing about this gene and what it does makes it easier for us to diagnose this form of skin disease and look towards developing new therapies.

"The pathway where this gene functions is a possible drug target although it will need more work to identify how we can take advantage of that."

Punctate PPK is one of a whole family of PPK skin diseases, each of which are relatively rare. It is estimated to affect around one in every 15,000 people in the UK.

The find was made possible by the use of next generation sequencing technology, which allows researchers to screen large amounts of genome data in a short space of time.

"This is a notable step forward in diagnosing skin diseases and the genetic causes behind them as this is research that we simply could not have done just a few years ago, We are now able to spot faulty genes and track their behaviour far more effectively," said Mr McLean.

The research is published in the journal Nature Genetics.

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Scientists have identified a soybean gene responsible for making some varieties resistant to the cyst nematode, a pest responsible for $1 billion in annual crop losses.

The gene wards off nematodes by making an enzyme that starves the pest or acts as a natural pesticide, according to a paper released today in the journal Nature. The study is the first to identify the gene and its mechanism for creating resistance, said lead authors Melissa Mitchum of the University of Missouri in Columbia and Khalid Meksem of Southern Illinois University in Carbondale.

The soybean cyst nematode can cut crop yields 50 percent and cause $1 billion in losses in the $42.2 billion annual U.S. crop, making it the top soybean pathogen, Greg Tylka, a plant pathology professor at Iowa State University. Knowing which gene is responsible for natural resistance will help breeders identify the hardiest varieties and could lead to genetically modified soybeans with complete resistance, he said.

This could speed up breeding for soybean cyst nematode resistance by a quantum leap, Tylka, who wasnt involved with the Nature study, said today by telephone from Ames, Iowa. It will allow traditional breeding to be very precise.

The soybean cyst nematode starts life as a microscopic worm that burrows into soybean roots, where the female feeds and swells into a leathery, lemon-sized cyst full of eggs. The eggs are time released, hatching over the course of a decade or more, so rotation with other crops does little to eradicate the pests from a field, Tylka said.

Soybeans have been bred to resist the cyst nematode, an import from Asia, since it was first discovered in the U.S. in 1954, Tylka said. Resistant varieties remain imperfect, with damage occurring to varying degrees depending on the plant and the type of cyst nematode in the field, he said.

Identification of a second soybean gene for cyst nematode resistance is needed before plants can be created that offer complete resistance, Tylka said. In the near term, researchers may want to focus on how the newly discovered enzyme-producing gene confers resistance.

In addition to breeding soybeans for resistance to nematodes, Monsanto Co. (MON), the worlds biggest seed company, has an early-stage research project on a bean that is genetically modified to resist the pest, Sara E. Miller, a spokeswoman for the St. Louis-based company, said in an e-mail. Monsanto, which in 2008 made public its sequence of the soybean cyst nematode genome, also is developing a seed treatment to control nematodes, she said.

To contact the reporter on this story: Jack Kaskey in Houston at jkaskey@bloomberg.net

To contact the editor responsible for this story: Simon Casey at scasey4@bloomberg.net

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Soybean Gene Find May Ward Off $1 Billion Pest

MELBOURNE researchers may have found a way to block a gene that fuels the growth of tumours in about a quarter of stomach cancer cases, paving the way for a new treatment for one of the world's deadliest cancers.

Researchers from the Monash Institute of Medical Research found a gene that produces a protein called toll-like receptor 2 was overactivated in about 25 per cent of cancer patients, after noticing a similar trend in animals.

In the study published today in the journal Cancer Cell, they found the protein was causing tumour cells to grow, and that antibodies could counteract it in mice.

Senior researcher Brendan Jenkins said: "It was quite remarkable, over a 10-week period the antibodies actually stopped these tumours from growing."

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The antibody treatment is expected to move into human trials within the next couple of years, and would be offered in addition to existing treatments such as chemotherapy before and after surgery.

"We will identify patients who have increasing amounts of this protein, and treat them with the antibody together with the current standard treatment," Associate Professor Jenkins said.

"Our belief is that by doing that we can stop or slow down the growth of tumours, and reduce the chance they will spread to other parts of the body."

Associate Professor Jenkins said screening for the protein could also be used to capture stomach cancer in its early stages, allowing for more effective treatment.

He said the finding might be relevant to other cancers in which chronic inflammation could lead to the development of cancer, such as colon, liver and lung cancers.

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One cancer gene meets its match

ScienceDaily (Oct. 15, 2012) Preventing activity of a key enzyme in potatoes could help boost potato quality by putting an end to cold-induced sweetening, according to U.S. Department of Agriculture (USDA) scientists.

Cold-induced sweetening, which occurs when potatoes are put in long-term cold storage, causes flavor changes and unwanted dark colors in fried and roasted potatoes. But long-term cold storage is necessary to maintain an adequate supply of potatoes throughout the year.

Agricultural Research Service (ARS) scientists found that during cold storage, an enzyme called invertase causes changes in potato sugars -- more accumulation of sucrose and a corresponding increase in the amount of glucose and fructose in tubers stored at very low temperatures.

At the ARS Vegetable Crops Research Unit in Madison, Wis., plant physiologist Paul Bethke, geneticist Shelley Jansky, and technician Andy Hamernik used a recently developed technology to show that decreasing the activity of invertase is sufficient to enable cold storage of potatoes without compromising the appearance of potato chips or the growth characteristics of the potato plants.

Bethke and his colleagues are using molecular tools to improve understanding of what is controlling the process of cold-induced sweetening. Potatoes are sensitive to their environment and highly sensitive to low temperatures, and respond to these temperatures by producing certain sugars called "reducing sugars," primarily glucose and fructose. When chips or fries are made from these potatoes, they tend to be dark-colored and bitter. The scientists' research paper in Plant Physiology provides a proof of concept that the invertase enzyme is critically important in the process.

However, invertase's level of importance has never been clear, because there are other biochemical steps that might also contribute, according to Bethke.

Read more about this research in the October 2012 issue of Agricultural Research magazine: http://www.ars.usda.gov/is/AR/archive/oct12/fruits1012.htm

ARS is USDA's principal intramural scientific research agency, and the research supports the USDA priority of promoting international food security.

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Gene suppression can reduce cold-induced sweetening in potatoes

The pitter-patter of tiny feet could announce the arrival of tomorrow's landmine detectors lab mice genetically engineered by humans to sniff out TNT explosives.

The idea became reality in a New York City lab that already created and bred the special breed of mice. Such mice have a sense of smell 500 times better than normal at detecting DNT, a chemical cousin of TNT, and they may alert humans to the presence of landmines by possibly falling down in an epileptic seizure.

"Whatever their behavior is going to be, we think we will be able to track their change in behavior using a sort of microchip implanted under their skin that would indeed wirelessly report back to a computer," said Charlotte D'Hulst, a bioengineer at Hunter College, City University of New York.

The mice could go a long way toward saving human lives in a world where landmines kill 15,000 to 20,000 people every year, according to the United Nations. A Belgian nonprofit has already trained giant African pouched rats to sniff out landmine explosives in a matter of hours compared with days for humans using metal detectors.

But the rats require nine months of training based on banana food rewards. The genetically modified mice could prove faster to breed and would require much shorter training, D'Hulst said. She presented her research at the Neuroscience 2012 conference in New Orleans on Oct. 14.

"The major advantage of the approach is that we will have created animals with an inherent super sensitivity to DNT, which will make the training significantly quicker," D'Hulst told TechNewsDaily. "Mice are smaller, cheaper and very easy to breed in large numbers, so one could get more animals do the job simultaneously (about 500, for example)."

Recent research suggests the mice may fall down and undergo epileptic seizures in response to the smell of TNT the result of all the sensory neurons firing off in their hypersensitive noses and flooding the brain with signals. But whatever their response, researchers anticipate using the implanted microchips implanted microchips to detect whether the mice had found explosive material.

D'Hulst and her colleagues still need to test how the mice react to DNT in the lab and on the field. But she expects that the mice could be ready for action in five years if all goes well. [Genetically Engineered Cell Shoots Out First-Ever Biological Laser]

The MouSensor Project, funded by the National Institutes of Health, could also eventually lead to mice genetically modified with special noses for other jobs sniffing out tuberculosis in humans, identifying contaminated water, or perhaps helping rescue workers locate survivors of natural disasters.

Researchers created the special mice for the landmine detection job by injecting genetically modified DNA into a fertilized mouse egg, so that the embryos could be surgically implanted in a female mouse. The female mice were tricked into becoming "pseudopregant" by mating them with male mice who had undergone vasectomies to prevent them from breeding.

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Gene-Tweaked Mice Tailored to Sniff Out TNT

Re: your Oct. 14 editorial, The propositions:

The Star believes that agencies at the federal and state levels should make sure foods are safe and properly labeled, but they are not doing. So, it is now up to the people to take food safety matters into their own hands when it comes to genetic engineering and the resulting effect on our health and the health of our families.

Proposition 37 is neither complicated nor technical, and rather than properly managing genetic engineering, federal and state agencies are leaving it in the hands of the chemical companies to assure us that our food is safe when it comes to genetic engineering.

Proposition 37 requires labeling of products that contain first generation genetically modified organisms - plain and simple. If these chemical companies, big agriculture, etc., are so proud of their laboratory created, genetically modified food, we say they should be proud to put a label on them so we know what we are buying, or not.

We have a right to know what we are eating, just like the citizens of the 50 other countries that already label genetically engineered food.

- Cyndi and Jude Egold,

Moorpark

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Food labeling regulations

Public release date: 15-Oct-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, October 15, 2012In addition to the obvious benefit of eliminating the need for an injection, new vaccine delivery methods via the lungs offer particular advantages for protecting against infectious agents that enter the body through the respiratory track. A comprehensive review article that presents the current status, challenges, and opportunities of pulmonary vaccine delivery is published in Journal of Aerosol Medicine and Pulmonary Drug Delivery, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free online on the Journal of Aerosol Medicine and Pulmonary Drug Delivery website.

In "Pulmonary Vaccine Delivery: A Realistic Approach?" Wouter Tonnis and coauthors from University of Groningen and National Institute for Public Health and the Environment (Bilthoven), The Netherlands, describe the unique physiology and immune responsiveness of the respiratory track that make pulmonary vaccine delivery such an attractive alternative to traditional injections. Although pulmonary vaccination is still a young field, with much more research needed, evidence suggests administration of a vaccine to the lungs can induce a local immune response more effectively than conventional types of vaccine delivery, in addition to stimulating antibody production throughout the body. This could be especially important for combating pathogens that cause pulmonary diseases.

"The lung is an immunologic powerhouse that remains largely unexplored. Theoretically we should be able to avoid needles and simply inhale our vaccines," says Editor-in-Chief Gerald C. Smaldone, MD, PhD, Professor and Chief, Division of Pulmonary and Critical Care Medicine at SUNY-Stony Brook.

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About the Journal

Journal of Aerosol Medicine and Pulmonary Drug Delivery is an authoritative peer-reviewed journal published bimonthly in print and online. It is the Official Journal of the International Society for Aerosols in Medicine. The Journal is the only authoritative publication delivering innovative articles on the health effects of inhaled aerosols and delivery of drugs through the pulmonary system. Topics covered include airway reactivity and asthma treatment, inhalation of particles and gases in the respiratory tract, toxic effects of inhaled agents, and aerosols as tools for studying basic physiologic phenomena. Complete tables of content and a sample issue may be viewed on the Journal of Aerosol Medicine and Pulmonary Drug Delivery website.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Pediatric Allergy, Immunology, and Pulmonology, High Altitude Medicine & Biology, and Microbial Drug Resistance. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available online on the Mary Ann Liebert, Inc., publishers website.

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Can vaccines be delivered via the lungs instead of by injection?

Public release date: 15-Oct-2012 [ | E-mail | Share ]

Contact: Anita Srikameswaran 412-578-9193 University of Pittsburgh Schools of the Health Sciences

PITTSBURGH, Oct. 15, 2012 An increased risk of autism spectrum disorders (ASD) could result from an accumulation of many small, common genetic variations rather than large-effect, rare changes in the genetic code, according to a multicenter team led by researchers at the University of Pittsburgh School of Medicine. Their findings, published today in Molecular Autism, provide new insights into the genetic factors that underlie the neurodevelopmental condition.

Scientists have debated about the genetic contributions that lead to ASD in families where only one individual is affected, called simplex, versus those that have multiple affected family members, called multiplex, said senior author Bernie Devlin, Ph.D., associate professor, Department of Psychiatry, University of Pittsburgh School of Medicine.

"Our team compared simplex, multiplex and unaffected families using sophisticated quantitative genetic techniques," he said. "In families where only one child has an ASD, 40 percent of the risk is inherited while in families with more than one affected child, the risk rises to 60 percent."

For the project, the team examined thousands of DNA samples from families in the Simons Simplex Collection, in which one child but no parent or sibling had an ASD; the Autism Genome Project, in which more than one child had an ASD; and unaffected families enrolled in the HealthABC Program.

In addition to reviewing nearly 1 million gene variations, called single nucleotide polymorphisms (SNPs), to look for inheritance patterns associated with ASD, they also ran computer simulations to plot family trees using 1,000 SNPs that appear to impact the risk of ASD.

"These small gene changes can add up even though individually they do little harm," Dr. Devlin said. "This might explain why parents who do not have autism traits can have children who do."

Other research has shown that autism and related disorders also can arise from spontaneous variations in parental genes prior to conception as well as rare mutations of larger effect that are passed on, he noted. The multiple inheritance patterns could help explain the range of symptoms in the disorder.

The team included researchers from Yale University, the University of Michigan, University of California Los Angeles, Emory University, Harvard University and others. The effort was funded by grants from the Simons Foundation and National Institutes of Health grant MH057881.

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Additive effect of small gene variations can increase risk of autism spectrum disorders

MOUNTAIN VIEW, Calif., Oct. 15, 2012 /PRNewswire/ --In a new theoretical study, 23andMe, the leading personal genetics company, developed a mathematical model which shows that family history and genetic tests offer different strengths. The study results suggest that both family history and genetics are best used in combination to improve disease risk prediction. The full results of the study have now been published online in the journal PLOS Genetics.

Family history is most useful in assessing risks for highly common, heritable conditions such as coronary artery disease. However, for diseases with moderate or low frequency, such as Crohn's disease, family history accounts for less than four percent of disease heritability and is substantially less predictive than genetic factors in the overall population. The study results indicate single nucleotide polymorphism (SNP)-based genetic tests can reveal extreme likelihood ratios for a relatively large percentage of individuals, thus providing potentially valuable evidence in differential diagnoses.

"Both family history and genetics are important tools for assessing an individual's risk for disease," 23andMe CEO and co-founder Anne Wojcicki said. "We believe it will become increasingly important for individuals and physicians to know both family history and genetic profile to provide optimal healthcare."

Lead author and 23andMe scientist Chuong Do, Ph.D, worked with 23andMe senior medical director Uta Francke, M.D., and principal scientists David Hinds, Ph.D., and Nicholas Eriksson Ph.D. to make a comprehensive comparison of family health histories and genetic testing to assess risk for 23 different conditions. These conditions included coronary artery and heart diseases, type 1 and 2 diabetes, prostate cancer, Alzheimer's disease, breast cancer, lung cancer, Crohn's and celiac disease, ovarian cancer, melanoma, bipolar disease and schizophrenia among others.

The analysis confirms that family history is most useful for highly common, heritable conditions and for single-gene (Mendelian) disorders with high penetrance, where the specific genetic cause is not yet known. For relatively common diseases that may have many contributing genetic and environmental factors, such as coronary artery disease, knowing that your father had the disease is helpful at predicting whether or not you might be at risk for the same condition.

For less common diseases involving many weak genetic, such as Crohn's disease, knowing family history seldom helps in making a risk prediction, in part, because these diseases are uncommon enough that they would rarely show up in the immediate family health history. When family histories are uninformative, genetic testing may still reveal the genetic variants that would put an individual at a higher or lower risk for the condition. For example, Crohn's disease might not show up in a family history, but the risk prediction from a genetic test can be relatively more informative.

"These results indicate that for a broad range of diseases, already identified SNP associations may be better predictors of risk than their family history-based counterparts, despite the large fraction of missing heritability that remains to be explained," stated lead researcher Chuong Do, Ph.D. "They also suggest that in some cases, individuals may benefit from supplementing their family medical history with genetic data, in particular, as genetic tests are improving and more risk factors are discovered."

"This study addresses the false division between these two diagnostic tools, genetic testing versus family health histories, where the approaches have traditionally been portrayed as competing alternatives," explained Uta Francke, M.D., senior medical director. "Physicians rely on a variety of tools such as a stethoscope or a thermometer both are useful in their own way. Similarly, family health histories and genetics both offer different but equally valuable information to inform patient care."

"Using genetic testing or SNP-association based methods to estimate risk for some rare complex diseases is as good as family histories can be at estimating risk for common heritable conditions," Dr. Francke continued, "and for individuals who don't have access to their family health history, genetic testing can alert them to risks they wouldn't be aware of otherwise."

The authors use their theoretical model to demonstrate the limits of predictive testing while also outlining specific areas where genetic tests have the potential to be medically useful. These results, which provide a cautiously optimistic outlook on the future of genetic testing, contrast with the conclusions reached in an independent study published earlier this year in Science Translational Medicine.

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23andMe Compares Family History and Genetic Tests for Predicting Complex Disease Risk