Archive for the ‘Gene Therapy Research’ Category

BOTHELL, Wash. (AP) -- Drug developer Seattle Genetics Inc. said Tuesday the Food and Drug Administration has accepted its application to market the lymphatic cancer treatment Adcetris for some additional uses.

The Bothell, Wash., company is seeking approval for Adcetris to be used in treating patients who had previously taken the drug, stopped and then saw their disease progress or relapse. It also wants approval for Adcetris to be used in treatments that extend beyond 16 cycles of the therapy.

Seattle Genetics expects the FDA to make a decision by Sept. 14.

The company said research showed that Adcetris was generally tolerated well by patients taking it for retreatment, and nine of 23 patients who could be evaluated saw complete remission. The drug also was tolerated well when used for an extended duration.

Adcetris is the company's only marketed product, and it already is approved to treat two types of lymphoma.

Seattle Genetics shares climbed more than 2 percent, or 86 cents, to $38.19 in Tuesday morning trading, while broader indexes rose slightly. The stock has climbed more than 60 percent so far this year and hit a 52-week high of $39 last month.

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FDA accepts Seattle Genetics Adcetris application

WALTHAM, Mass.--(BUSINESS WIRE)--

Interleukin Genetics,Inc. (ILIU) today issued financial and operational results for the first quarter ended March 31, 2013.

Revenue for the quarter ended March31, 2013 was $487,000, compared to $678,000 for the same period in 2012. The decrease is primarily attributable to decreased genetic testing revenue recognized from genetic tests processed as a result of sales through the Amway Global sales channel.

Research and development expenses were $160,000 for the three months ended March 31, 2013, compared to $446,000 for the same period in 2012. The decrease is primarily attributable to lower compensation, consulting and clinical trial costs. In the first quarter of 2013 our Chief Scientific Officer had fully transitioned to his role as Chief Executive Officer and, accordingly, related compensation costs were classified as part of selling, general and administrative expenses in the 2013 period whereas such costs had previously been classified as research and development expenses.

Selling, general and administrative expenses were $1.0 million for the three months ended March 31, 2013, compared to $1.1 million for the same period in 2012. The decrease is primarily attributable to decreased patent related legal fees and corporate legal and accounting fees as well as lower sales commissions paid to Amway Global as part of our Merchant Channel and Partner Store Agreement partially offset by higher compensation and consulting expenses.

The Company reported a net loss of $1.2 million, or $(0.03) per basic and diluted common share, for the first quarter of 2013, compared to $1.4 million or $(0.04) per basic and diluted common share for the same period in 2012.

As of March31, 2013, the Company had cash and cash equivalents of $1.1 million. As of March 31, 2013, the Company had drawn the full $14.3 million under credit facilities with Pyxis Innovations Inc., an affiliate of Alticor. This facility currently becomes due on March 31, 2014.

The Company expects that its current resources are adequate to maintain current and planned operations only through May 31, 2013. The Companys independent registered public accounting firm has included an explanatory paragraph in their opinion in connection with the 2012 audit, relating to the Company's ability to continue as a going concern. The Company has retained a financial advisor and is actively seeking additional funding. If the Company cannot obtain additional funding on acceptable terms, it may be required to discontinue operations and seek protection under U.S. bankruptcy laws.

The Company will not host a conference call/webcast today, but may determine to host a call and webcast later this month depending on the outcome of its fundraising efforts.

About Interleukin Genetics Interleukin Genetics, Inc. (ILIU) develops and markets a line of genetic tests under the Inherent Health brand. The products empower individuals to prevent certain chronic conditions and manage their existing health and wellness through genetic-based insights with actionable guidance. Interleukin Genetics leverages its research, intellectual property and genetic panel development expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. The Company markets its tests through partnerships with health and wellness companies, healthcare professionals and other distribution channels. Interleukin Genetics flagship products include its proprietary PST genetic risk panel for periodontal disease and tooth loss susceptibility sold through dentists, and the Inherent Health Weight Management Genetic Test that identifies the most effective diet and exercise program for an individual based on genetics. Interleukin Genetics is headquartered in Waltham, MA and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratories Improvements Act (CLIA). For more information please visit http://www.ilgenetics.com.

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Interleukin Genetics Reports First Quarter 2013 Financial Results

SEATTLE, WA--(Marketwired - May 15, 2013) - Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company, today announced its first quarter 2013 financial results and corporate developments.

"The national rollout of our ForeCYTE Breast Health Test is proceeding well and we are pleased with the response we are getting from the physician community and from patients," stated Dr. Steven Quay, chairman, CEO and president. "We were particularly pleased to have completed an agreement with Millennium HealthCare, Inc., which provides primary care physician practices, physician groups and healthcare facilities of all sizes with cutting edge medical devices focused primarily on preventive care through early detection.Millennium has initially submitted an order for 10,000 ForeCYTE Breast Health collection kits for distribution to its network of physicians' offices in the New York Metro area and Northern New Jersey. We anticipate signing up additional distributors this year and continuing to build our internal sales and marketing team."

Corporate Highlights

First Quarter 2013 Financial Results

Revenues for the three months ended March 31, 2013, were $182,670, which included $13,440 of product revenue from the sale of MASCT Systems and $169,230 of diagnostic testing service revenue from the ForeCYTE breast health tests. This compares with total revenues of $54,713 for the first quarter ended March 31, 2012. The year-over-year increase in total revenue was driven by the national rollout of the ForeCYTE test in January 2013.

Gross profit for the three months ended March 31, 2013, was $116,206. This compares to gross profit of $27,709 for the quarter ended March 31, 2012.

Net loss for the quarter ended March 31, 2013, was $1.9 million, or $(0.14) per share, compared with net loss of $1.1 million, or $(0.09) per share, for the first quarter ended March 31, 2012. The increase in net loss was primarily attributable to an increase in general and administrative expense of $963,420, including increased expenses related to the national launch of the ForeCYTE test.

Total operating expenses were $2.1 million for the three months ended March 31, 2013, consisting of G&A expenses of $1.6 million, selling expenses of $272,575 and research and development expenses of $220,192.This compares to total operating expenses of $1.1 million for the three months ended March 31, 2012, consisting of G&A expenses of $601,452, selling expenses of $70,435 and research and development expenses of $417,990.The increase in G&A expenses of $963,420, from the first quarter of 2012 to the first quarter of 2013, is attributed to the launch of the Company's MASCT System, ForeCYTE test and ArgusCYTE test and the related growth in expenses to hire additional staff and expand the Company's operations.Atossa expects that its G&A expenses will continue to increase as it adds additional employees and incurs additional costs as a publicly traded company. Additionally, G&A costs are expected to rise as the Company increases headcount to coordinate the production and manufacture of the MASCT System, and the expected increase in service revenue.Selling expenses increased $202,140 from the first quarter of 2012 to the first quarter of 2013 as a result of hiring additional sales and marketing personnel and incurring additional marketing expenses directly and to the Company's distributor for the national launch of the ForeCYTE test.Research and development expenses decreased by $197,798 from the first quarter of 2012 to the first quarter of 2013 as a result of completion of the development of the ForeCYTE test and ArgusCYTE test in 2012 and as a result of Atossa's focus in 2013 on the national launch of ForeCYTE.

At March 31, 2013, Atossa had cash and cash equivalents of $1.4 million.

About Atossa Genetics, Inc.

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Atossa Genetics Reports First Quarter 2013 Results and Operating Highlights

BRIDGEWATER, N.J.--(BUSINESS WIRE)--

Senesco Technologies, Inc. (Senesco or the Company) (OTC QB: SNTI), announced today that a poster presentation will be delivered at the 16th Annual Meeting of the American Society of Gene & Cell Therapy. The conference will be held May 15-18th, 2013 at the Salt Palace Convention Center in Salt Lake City, Utah. The Company will present during the Cancer-Targeted Gene & Cell Therapy: Viral Vector / siRNA-Mediated Therapies Session, which will begin Thursday, May 16, at 4:00 p.m. The poster presentation, entitled Combination Therapy with Novel Nanoparticle, SNS01-T, and Bortezomib Results in Synergistic Cytotoxicity In Vitro and In Vivo in Multiple Myeloma, will be delivered by Catherine Taylor, who is from Senesco CSO John Thompsons research laboratory at the University of Waterloo in Ontario, Canada.

About SNS01-T

SNS01-T is a novel approach to cancer therapy that is designed to selectively trigger apoptosis in B-cell cancers such as multiple myeloma, and, mantle cell and diffuse large B-cell lymphomas. Senesco is the sponsor of the Phase 1b/2a study that is actively enrolling patients at Mayo Clinic in Rochester, MN, the University of Arkansas for Medical Sciences in Little Rock, the Mary Babb Randolph Cancer Center in Morgantown, WV, and the John Theurer Cancer Center at Hackensack University Medical Center in Hackensack, NJ. http://www.clinicaltrials.gov/ct2/show/NCT01435720?term=SNS01-T&rank=1

About Senesco Technologies, Inc.

Senesco, a leader in eIF5A technology, is running a clinical study with its lead therapeutic candidate SNS01-T, which targets B-cell cancers by selectively inducing apoptosis by modulating eukaryotic, translation, initiation Factor 5A (eIF5A), which is believed to be an important regulator of cell growth and cell death. Accelerating apoptosis may have applications in treating cancer, while delaying apoptosis may have applications in treating certain inflammatory and ischemic diseases. Senesco has already partnered with leading-edge companies engaged in agricultural biotechnology and biofuels development, and is entitled to earn research and development milestones and royalties if its gene-regulating platform technology is incorporated into its partners products.

Forward-Looking Statements

Certain statements included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from such statements expressed or implied herein as a result of a variety of factors, including, but not limited to: the Companys ability to continue as a going concern; the Companys ability to recruit patients for its clinical trial; the ability of the Company to consummate additional financings; the development of the Companys gene technology; the approval of the Companys patent applications; the successful implementation of the Companys research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Companys products; the timing and success of the Companys preliminary studies, preclinical research and clinical trials; competition and the timing of projects and trends in future operating performance, the quotation of the Companys common stock on an over-the-counter securities market, as well as other factors expressed from time to time in the Companys periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with the Companys periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

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Senesco Announces Presentation on Combination Therapy with Novel Nanoparticle, SNS01-T, and Bortezomib Results in ...

STAMFORD, Conn.--(BUSINESS WIRE)--

Alliance for Cancer Gene Therapy, Inc. (ACGT), http://www.acgtfoundation.org, https://twitter.com/acgtfoundation, and https://www.facebook.com/acgtfoundation, today announced that it will be hosting an inaugural Foundation Symposium Gene and Cell Therapy For Cancer on Thursday, May 16, from 6:00 p.m. to 8:00 p.m., Ballroom B, at the 16th Annual American Society of Gene and Cell Therapy Meeting, May 15-18, Salt Palace Convention Center, in Salt Lake City, Utah. The Symposium will be co-chaired by Xandra O. Breakefield, PhD, Massachusetts General Hospital, and Savio L.C. Woo, PhD, Mount Sinai School of Medicine.

This ACGT-sponsored Symposium will present state-of-the-art lectures by leading investigators in four exceptionally promising areas of scientific research and translational development in gene and cell therapies for cancer. Over the past decade, the power of gene and cell therapies has been harnessed into novel bio-therapeutics for the treatment of many different cancers that are both effective and safe.

We are honored to partner with ASGCT and to feature some of the worlds most renowned scientists, physicians and researchers in the field of cell and gene therapy, said Barbara Netter, ACGT President and Co-Founder.

Speakers and Topics Include:

ACGT is the only not-for-profit in the U.S. dedicated solely to cancer cell and gene therapies for all types of cancer. 100% of contributions go directly to research. ACGT has funded 41 grants from public donations since its founding in 2001 totaling almost $25 million for both basic research and clinical translation. Seventeen ACGT funded research projects have been approved for human clinical trials, 11 of which are underway. To donate, please visit http://www.acgtfoundation.org or call 203.358.8000.

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Alliance for Cancer Gene Therapy to Host Inaugural Foundation Symposium at the 16th Annual American Society of Gene ...

ALLENDALE, N.J. and WASHINGTON, May 13, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS), a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized contract development and manufacturing organization, announced today that PCT has entered into a Cell Therapy Processing Customer Agreement with MedStar Georgetown University Hospital in Washington, D.C. to provide autologous and allogeneic cellular therapy services for cellular products provided by MedStar Georgetown University Hospital ("MGUH") and deliver resulting cellular therapy products to MGUH for patient care.

In April, Georgetown's Lombardi Comprehensive Cancer Center, part of MedStar Georgetown University Hospital, and the John Theurer Cancer Center, part of Hackensack University Medical Center ("HackensackUMC") in Hackensack, N.J., announced the establishment of an oncology affiliation arrangement between them to enhance patient access to innovative clinical trials, and is a significant step towards developing a clinical, translational and basic science cancer research consortium.

In its agreement with PCT, MedStar Georgetown University Hospital will use the services of PCT for processing and storage of peripheral blood progenitor cells, donor leukocytes, bone marrow and cord blood, as well as requested assaying and storage of cellular therapy product, and retrieval and transportation logistics.

"Akin to our relationship with HackensackUMC, whose engagement of PCT began over thirteen years ago, we look forward to developing a strong association with Georgetown," said Robert A. Preti, Ph.D., President and Chief Scientific Officer of PCT. "Our agreements with HackensackUMC and MedStar Georgetown University Hospital enable us to continue to play a vital part in patient care for cancers and other hematologic disorders, and to continue to provide cell products to our entire client base. Since its founding, PCT has provided cell therapy products for infusion into over 6,000 patients."

Dr. Robin L. Smith, NeoStem's Chairman and Chief Executive Officer, stated that, "NeoStem is committed to supporting and enabling the development of emerging cell therapy products. We, as well as our clients, are developing innovative therapies using the cells of our body to treat chronic diseases such as cancers, autoimmune conditions and cardiovascular disease. We are thrilled to be working with prestigious institutions such as MedStar Georgetown University Hospital and HackensackUMC to support their bone marrow transplant programs. PCT's exceptional client retention rate validates the management's commitment to Quality and Service as we look forward to future growth with our clients outside of the United States."

The Georgetown Lombardi Comprehensive Cancer Center at MedStar Georgetown University Hospital is the Washington, D.C. metropolitan region's only comprehensive cancer center, a designation from the National Cancer Institute (NCI) demonstrating its scientific excellence and the capability to integrate multi-disciplinary, collaborative research approaches to focus on the problem of cancer.

The John Theurer Cancer Center at HackensackUMC is a nationally renowned, award-winning cancer center with a strong clinical program of excellence. HackensackUMC is ranked among the 50 best hospitals in the United States and the John Theurer Cancer Center is the highest ranked cancer center in New Jersey in the 2012-13 U.S. News & World Report Best Hospitals ranking.

About John Theurer Cancer Center at Hackensack University Medical Center

John Theurer Cancer Center at HackensackUMC is New Jersey's largest and most comprehensive cancer center dedicated to the diagnosis, treatment, management, research, screenings, preventive care, as well as survivorship of patients with all types of cancer.

Each year, more people in the New Jersey/New York metropolitan area turn to the John Theurer Cancer Center for cancer care than to any other facility in New Jersey. The 14 specialized divisions feature a team of medical, research, nursing and support staff with specialized expertise that translates into more advanced and focused care for all patients. The John Theurer Cancer Center provides comprehensive multidisciplinary care, state of the art technology, access to clinical trials, compassionate care and medical expertiseall under one roof. Physicians at the John Theurer Cancer Center are members of Regional Cancer Care Associates, one of the nation's largest professional hematology/oncology groups. For more information please visit jtcancercenter.org.

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NeoStem's Subsidiary, Progenitor Cell Therapy, to Provide Autologous and Allogeneic Cellular Therapy Services to ...

Public release date: 13-May-2013 [ | E-mail | Share ]

Contact: Tom Vasich tmvasich@uci.edu 949-824-6455 University of California - Irvine

UC Irvine Health researchers have helped discover that genes controlling circadian clock rhythms are profoundly altered in the brains of people with severe depression. These clock genes regulate 24-hour circadian rhythms affecting hormonal, body temperature, sleep and behavioral patterns.

Depression is a serious disorder with a high risk for suicide affecting approximately one in 10 Americans, according to the Centers for Disease Control, and is ranked as fourth of all diseases by the World Health Organization in terms of lifetime disability. Study findings provide the first evidence of altered circadian gene rhythms in brain tissue of people with depression and suggest a physical basis for many of the symptoms that depressed patients report.

The study which appears online this week in the Proceedings of the National Academy of Sciences involved researchers from UC Irvine Health, University of Michigan, UC Davis, Cornell University, the Hudson Alpha Institute for Biotechnology and Stanford University.

"Our findings involved the analysis of a large amount of data involving 12,000 gene transcripts obtained from donated brain tissue from depressed and normal people. We were amazed that our data revealed that clock gene rhythms varied in synchrony across six regions of normal human brain and that these rhythms were significantly disrupted in depressed patients. The findings provide clues for potential new classes of compounds to rapidly treat depression that may reset abnormal clock genes and normalize circadian rhythms," said Dr. William Bunney, Distinguished Professor of Psychiatry & Human Behavior at UC Irvine, and the study's senior author.

Circadian clock genes play an important role in regulating many body rhythms over a 24-hour cycle. Although animal data provide evidence for the circadian expression of genes in brain, little has been known as to whether there is a similar rhythmicity in human brain.

In the study, the researchers analyzed genome-wide gene expression patterns in brain samples from 55 individuals with no history of psychiatric or neurological illness and compared them to the expression patterns in samples from 34 severely depressed patients.

The investigators isolated multiple RNA samples from six regions of each brain and arranged the gene expression data around a 24-hour cycle based on time of death. Several hundred genes in each of six brain regions displayed rhythmic patterns of expression over the 24-hour cycle, including many genes essential to the body's circadian machinery.

In the end, they had a near-complete understanding of how gene activity varied throughout the day in the cells of the six brain regions they studied.

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Circadian clock gene rhythms in brain altered in depression, UC Irvine Health study finds

Finding of disrupted brain gene orchestration gives first direct evidence of circadian rhythm changes in depressed brains, opens door to better treatment

Newswise ANN ARBOR, Mich. Every cell in our bodies runs on a 24-hour clock, tuned to the night-day, light-dark cycles that have ruled us since the dawn of humanity. The brain acts as timekeeper, keeping the cellular clock in sync with the outside world so that it can govern our appetites, sleep, moods and much more.

But new research shows that the clock may be broken in the brains of people with depression -- even at the level of the gene activity inside their brain cells.

Its the first direct evidence of altered circadian rhythms in the brain of people with depression, and shows that they operate out of sync with the usual ingrained daily cycle. The findings, in the Proceedings of the National Academy of Sciences, come from scientists from the University of Michigan Medical School and other institutions.

The discovery was made by sifting through massive amounts of data gleaned from donated brains of depressed and non-depressed people. With further research, the findings could lead to more precise diagnosis and treatment for a condition that affects more than 350 million people worldwide.

Whats more, the research also reveals a previously unknown daily rhythm to the activity of many genes across many areas of the brain expanding the sense of how crucial our master clock is.

In a normal brain, the pattern of gene activity at a given time of the day is so distinctive that the authors could use it to accurately estimate the hour of death of the brain donor, suggesting that studying this stopped clock could conceivably be useful in forensics. By contrast, in severely depressed patients, the circadian clock was so disrupted that a patients day pattern of gene activity could look like a night pattern -- and vice versa.

The work was funded in large part by the Pritzker Neuropsychiatric Disorders Research Fund, and involved researchers from the University of Michigan, University of Californias Irvine and Davis campuses, Weill Cornell Medical College, the Hudson Alpha Institute for Biotechnology, and Stanford University.

The team uses material from donated brains obtained shortly after death, along with extensive clinical information about the individual. Numerous regions of each brain are dissected by hand or even with lasers that can capture more specialized cell types, then analyzed to measure gene activity. The resulting flood of information is picked apart with advanced data-mining tools.

Lead author Jun Li, Ph.D., an assistant professor in the U-M Department of Human Genetics, describes how this approach allowed the team to accurately back-predict the hour of the day when each non-depressed individual died literally plotting them out on a 24-hour clock by noting which genes were active at the time they died. They looked at 12,000 gene transcripts isolated from six regions of 55 brains from people who did not have depression.

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Out of Sync: Body Clocks Altered at Cell Level in Depression

Should the government require companies to label food that contains genetically modified organisms?

Last November, California voters rejected a ballot initiative that would require such labeling, but bills that would do so were recently introduced in both the U.S. House and Senate. Invoking the right to know, a lot of people support those bills.

In the abstract, the argument for compulsory labeling seems exceedingly powerful. But there is a risk that a compulsory label for GM food would confuse, mislead and alarm consumers, potentially causing economic harm, not least to consumers themselves.

To see the problem, we need to step back a bit. The World Health Organization defines GMOs as organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally. As a result of the underlying technology, sometimes called recombinant DNA technology or genetic engineering, certain individual genes are transferred into one organism from another. GM food can potentially grow faster, taste better, resist diseases, lower reliance on pesticides, cost less and prove more nutritious.

In the U.S., GM food has become pervasive. Tomatoes, potatoes, squash, corn, sugar beets and soybeans frequently have GM ingredients. As much as 90 percent of corn, sugar beet and soybean crops are now genetically modified. In American supermarkets, genetically modified ingredients can be found in about 70 percent of processed foods. Among them are pizza, cookies, ice cream, salad dressing, corn syrup and chips. Should they all be labeled?

The argument for labeling GM foods would be compelling if they posed risks to human health. This is, of course, a scientific question, and most scientists now believe that GM food, as such, doesnt pose health risks. Last October, the American Association for the Advancement of Science spoke unequivocally. In its words, the science is quite clear: crop improvement by the modern molecular techniques of biotechnology is safe.

The American Medical Association has similarly proclaimed, The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies.

The World Health Organization, the National Academy of Sciences, and the Royal Society in the U.K. basically agree.

There would also be an argument for labeling if GMOs created ecological risks, rather than dangers to human health. But in 1988, the National Academy of Sciences concluded that the environmental hazards associated with GMOs are not essentially different from those associated with unmodified organisms. It found that assessment of the risks should be based not on whether the organism is genetically modified, but on the nature of the organism and the environment into which it is introduced.

The American Medical Association recently endorsed this finding.

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Don’t Mandate Labeling for Gene-Altered Foods

Mutations in genes that occur spontaneously may contribute to congenital heart disease in children, according to a new study.

These mutations which arise after conception, rather than being inherited from a parent may contribute to about 10 percent of cases of congenital heart disease in children, the study said.

Congenital heart disease is a group of heart defects (such as holes, or missing parts of the heart), and is the most common type of birth defect in the United States. About 40,000 babies are born each year with congenital heart disease.

While some chromosomal abnormalities (such as Down syndrome) and infections during pregnancy are known to cause congenital heart disease, the new study shows that spontaneous gene mutations during fetal development affect the development of brain and heart, and may lead to congenital heart disease in children with healthy parents.

In the study, researchers looked at the rate of spontaneous mutations in 362 children with severe congenital heart disease, 264 healthy children and parents of both groups.

Although children in both groups had about the same number of spontaneous mutations, the locations of those mutations were markedly different in the two groups, according to the study that was published online in the journal Nature yesterday (May 12).

"The mutations in patients with congenital heart disease were found much more frequently in genes that are highly expressed in the developing heart," said study researcher Christine Seidman, a Howard Hughes Medical Institute investigator.

This finding provides insights for future research, and may someday lead to better treatment options, the researchers said.

Follow Bahar Gholipour@alterwired. Follow MyHealthNewsDaily@MyHealth_MHND, Facebook&Google+. Originally published on LiveScience.

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Spontaneous Gene Mutations Linked to Kids' Heart Defects

About 10 percent of congenital heart defects may come from spontaneous rather than inherited gene mutations, according to a study that offers new insight into a condition that can range from simple to severe.

Scientists investigated the DNA of 362 newborns with serious heart defects in families where neither the parents nor the childs siblings had cardiac illness. The research, reported online yesterday in the journal Nature, found hundreds of mutations that were only in the affected children.

Congenital heart defects occur in 8 out of every 1,000 newborns in the U.S., or more than 35,000 children yearly, according to the National Heart, Lung and Blood Institute. While the findings may not help prevent the condition, identifying the variants may one day aid doctors in individualizing treatments for the children, the researchers said.

One of the most important questions when a family has a child with congenital heart disease is why? said Edwin Kirk, a clinical geneticist at the Sydney Childrens Hospital, who wasnt involved in the study. Any research that helps us understand the answer hopefully one day will be something we can apply to answering the question for individual families.

Understanding the role of the variants may eventually help improve outcomes, said co-author Christine Seidman, director of the Cardiovascular Genetics Center at Brigham and Womens Hospital in Boston, in a statement.

After we repair the hearts of these children, some children do great and some do poorly, said Seidman, who is a researcher at the Howard Hughes Medical Institute in Chevy Chase, Maryland. Scientists have suspected this might be due to differences in the underlying disease causes, she said.

The researchers compared DNA from children with heart defects and in healthy babies. Both had about the same number of so-called de novo mutations, the non-inherited variants. The sick children, though, were much more likely to carry damaging mutations at two sites within a cellular pathway known to regulate genes key in heart development.

This is really a major contribution because it gives us some hard facts about the incidence of new mutations and the rates at which they may cause congenital heart disease, said David Winlaw, a pediatric cardiac surgeon at Childrens Hospital Westmead in Sydney, in a telephone interview. The great difficulty is knowing the relevance of a specific mutation.

The next step is to narrow down the list of genes known to be associated with congenital heart disease to a list thats known to be causative, he said.

This class of proteins that they have identified as being important for congenital heart disease are involved in that regulatory process, said Sydney Childrens Hospitals Kirk in a telephone interview. Thats new. There was some hint of it from a couple of rare syndromes, but for non-syndromic congenital heart disease, I dont think we had any hint that this was going to be important.

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Spontaneous Gene Mutations Tied to Child Heart Defects

Public release date: 13-May-2013 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, May 10, 2013 MOOCs FORUM (http://www.liebertpub.com/mooc), a new journal, is the only publication dedicated exclusively to the development, design, and deployment of the game-changing Massive Open Online Courses (MOOCs). Multidisciplinary in scope, this authoritative journal has a neutral bias. Its mandate is the critical evaluation of the MOOC components and modules that are essential in creating a global and sustainable system. The Journal will be published online, with open access options, and in print by Mary Ann Liebert, Inc., publishers (http://www.liebertpub.com).

The Editor-in-Chief of MOOCs FORUM is Nishikani (Nish) Sonwalkar, Sc.D. MOOCs FORUM content includes components and modules, roundtable discussions, interviews, case studies, model proposals, and perspectives from the leading stakeholders in the expanding and dynamic MOOCs community. Strategic thinking and re-evaluation will include ensuring the integrity for both creation and use. Existing economic models will be presented, and new models will be proposed. A robust blog will be a critical component of the Forum.

Dr. Sonwalkar is Co-Chair, EdTech Circle, MIT Enterprise Forum; Director of Research for the United States Distant Learning Association; and the Founder and Managing Director of Synaptic Global Learning, LLC. "The impetus to move our educational system to international excellence is urgent and ongoing," says Dr. Sonwalkar. "Yet the considerations relevant to the success of MOOCs have not been fully addressed. MOOCs FORUM is the catalyst for meaningful discussion and debate on the impact of these disruptive educational models."

"Education and technology have united to create MOOCs and the opportunity for unlimited and continuous global learning," says Mary Ann Liebert, President and CEO of the company that bears her name. "MOOCs FORUM is the new and authoritative space for all things MOOC."

MOOCs FORUM will examine adaptive and intelligent systems; universal design and policy; sustainable revenue models; the role of key faculty; mass customization of education; next generation of educational technology; integrity of accreditation; development of meaningful standards; clarification of misconceptions; international consideration and security; as well as differences between open and traditional online education.

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Visit the MOOCs FORUM website to participate and sign up for email alerts (http://www.liebertpub.com/mooc).

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MOOCs FORUM journal debuts summer 2013

Public release date: 13-May-2013 [ | E-mail | Share ]

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

New Rochelle, NY, May 13, 2013New approaches to applying noninvasive imaging tests such as computed tomography (CT), magnetic resonance (MR), and positron emission tomography (PET) may play a bigger role in evaluating and managing patients with diabetes. Advances in noninvasive imaging technology can assess important changes in fat composition and distribution in the body that may affect the metabolic complications and diseases associated with diabetes, including cardiovascular disease and cancer. A forward-looking Review article on "Obesity and Diabetes: Newer Concepts in Imaging" in Diabetes Technology & Therapeutics (DTT), a peer-reviewed journal from Mary Ann Liebert, Inc., publishers, highlights these emerging advances. The article is available free on the Diabetes Technology & Therapeutics website at http://www.liebertpub.com/DTT.

Kavita Garg, MD, Samuel Chang, MD, and Ann Scherzinger, PhD, University of Colorado Denver School of Medicine, Aurora, describe how sophisticated imaging techniques can be used to quantify body fat in different locations in the body. It can also help distinguish between different types of fat, which can have different effects on metabolism and pose different disease risks. In their Review article, the authors suggest that noninvasive imaging tests may be able to replace the need for biopsies, aid in early disease detection, and identify not only structural but also functional abnormalities in tissues such as heart muscle before a disorder becomes symptomatic.

"Currently, imaging techniques are not routinely done in people with diabetes," says Viswanathan Mohan, MD, WHO Collaborating Centre for Non-Communicable Diseases Prevention and Control and IDF Centre for Education, Gopalapuram, Chennai, India, in his accompanying Editorial, "Has the Time Come for Routine Imaging Studies in Diabetes?" With the changing profile of the complications of diabetes and increased incidence of diseases related to diabetes and diabetes therapies, "the article by Garg et al. is a trend-setter because this could change the way we routinely screen for these conditions in people with diabetes."

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About the Journal

Diabetes Technology & Therapeutics is a monthly peer-reviewed journal that covers new technology and new products for the treatment, monitoring, diagnosis, and prevention of diabetes and its complications. Led by Editor-in-Chief Satish Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver, the Journal covers topics that include noninvasive glucose monitoring, implantable continuous glucose sensors, novel routes of insulin administration, genetic engineering, the artificial pancreas, measures of long-term control, computer applications for case management, telemedicine, the Internet, and new medications. Tables of content and a sample issue may be viewed on the Diabetes Technology & Therapeutics website at http://www.liebertpub.com/DTT.

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 Journal of Aerosol Medicine and Pulmonary Drug Delivery, Metabolic Syndrome and Related Disorders, Childhood Obesity, and Population Health Management. 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., publishers website at http://www.liebertpub.com.

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How can advanced imaging studies enhance diabetes management?

When a national organization of genetic specialists took a stab at clarifying one of the biggest issues facing the integration of DNA sequencing into medicine in March, the bold guidelines seemed destined to stir up a hornets nest of controversy.

The recommendations suggested that patients who have their genomes sequenced should be told of select incidental findingsgenetic risk factors for conditions unrelated to the reason they got their DNA sequenced in the first place. In a major departure from current norms in the nascent field of genome sequencing, the group said patients should not have a choice about which risks they wanted to know. And risks for diseases that do not strike until adulthood were also to be disclosed to childrens parents, counter to the longstanding idea that it is important to preserve an open futuremeaning doctors should wait until the patients are old enough to decide for themselves whether they would like to know their risk of breast cancer, for example.

Now, the responsecall it a backlash, call it a healthy debatehas begun, even as the guidelines begin to have an impact on the kind of testing being offered to patients. A critique was published last week in the journal Trends in Biotechnology. Meanwhile, two companies have announced they are adopting the guidelines, though with an opt-out provision.

Dr. Robert C. Green, a medical geneticist at Brigham and Womens Hospital who co-led the working group that drafted the recommendations adopted by the American College of Medical Genetics and Genomics, said that he expected a vigorous public discussion about the guidelines and thinks the debate will benefit the field. But he added that he is surprised at how quickly things are already moving forward.

Some of the recommendations from professional organizations have taken 10 years to actually start being practiced, Green said. In this case, within weeks, two commercial labs announced they would integrate the new panel of genetic risk factors into their sequencing tests, which include mutations that cause rare heart problems or cancers. All of the conditions on the list are for serious illnesses that are clinically useful, meaning that patients can take measures to prevent disease, detect it early, or decrease their risk.

Even though the companies have decided to allow patients to decline to learn the information, Green said it was a fantastic start.

I think as clinicians order this, they may see that its not troubling the patients who opt inand they maybe discover some lifesaving information, Green said. I think it will reassure the field.

As of May 1, GeneDx announced that it will integrate the panel of gene mutations into some of its tests, although it would allow patients to decline receiving the information. A second company, Ambry Genetics, is also integrating the panel of genes associated with the two dozen conditions into its sequencing results, and will allow patients to opt out.

The opt-out provision reflects a main component of the critique published last week by two ethicists from Stanford University School of Medicine, which asserts that saying patient wishes not to learn certain genetic information should be over-ridden by physicians for the patients own good is weakly supported in modern clinical ethics.

The Stanford ethicists also question the reasoning of Greens working group, which suggested that it would be expensive and logistically onerous for laboratories and genetic counselors to implement the extra testing only conditionally, depending on the patients desire.

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Should patients be told of unexpected risk factors lurking in their DNA?

Washington, May 23 (ANI): Scientists have identified four new genetic variants associated with an increased risk of testicular cancer.

The study was conducted by researchers at the Perelman School of Medicine at the University of Pennsylvania.

The discovery of the genetic variations could ultimately help researchers better understand which men are at high risk and allow for early detection or prevention of the disease.

Katherine L. Nathanson, MD, associate professor in the division of Translational Medicine and Human Genetics within the department of Medicine, said that certain chromosomal regions are tied into testicular cancer susceptibility, and represent a promising path to stratifying patients into risk groups-for a disease known to be highly heritable.

Tapping into 3 genome-wide association studies (GWAS), the researchers, including Peter A. Kanetsky, PhD, MPH, an associate professor in the department of Biostatistics and Epidemiology, analyzed 931 affected individuals and 1,975 controls and confirmed the results in an additional 3,211 men with cancer and 7,591 controls.

The meta-analysis found that testicular germ cell tumor (TGCT) risk was significantly associated with markers at four loci-4q22, 7q22, 16q22.3, and 17q22, none of which have been identified in other cancers.

Additionally, these loci pose a higher risk than the vast majority of other loci identified for some common cancers, such as breast and prostate.

The study has been published in Nature Genetics. (ANI)

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4 new genetic risk factors for testicular cancer identified

SUNDAY, May 12 (HealthDay News) -- Twelve new genetic regions associated with an increased risk of testicular cancer have been identified by researchers in two studies.

One study identified four regions and the other identified eight regions, bringing to 17 the total number of genetic regions associated with testicular cancer. The studies were published online May 12 in the journal Nature Genetics.

Testicular cancer is the most common type of cancer diagnosed in young American men.

The findings could eventually help scientists better understand which men are at high risk and enable early detection or possibly even prevention of the disease, the researchers said.

The team, including Peter Kanetsky, an associate professor of biostatistics and epidemiology at the University of Pennsylvania Perelman School of Medicine, identified four of the 12 new genetic regions after analyzing the genomes of more than 13,000 men.

None of the four regions has been linked to other cancers. They pose a higher risk than other regions identified for some common cancers, such as breast and prostate cancer, according to a school news release.

Testicular cancer is highly inheritable. A man whose father or son has testicular cancer has a four to six times higher risk of developing the disease than a man with no family history. The risk is up to 10 times higher if the man also has a brother with testicular cancer.

-- Robert Preidt

Copyright 2013 HealthDay. All rights reserved.

SOURCE: University of Pennsylvania Perelman School of Medicine, news release, May 12, 2013

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Scientists Discover More Genetic Clues to Testicular Cancer

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Myriad Genetics is up sharply since reporting a strong quarter last week, and traders are betting on more gains ahead.

Nearly 4,000 August 33 calls traded in a strong buying pattern this morning, led by a print of 3,001 contracts that went for $3.75, according to optionMONSTER's Heat Seeker system. These are clearly fresh purchases, as the volume was well above the strike's open interest of 1,656 contracts before the session began.

MYGN is up fractionally at $33.19 in midday trading. The shares gapped up from the $28 level after the medical-diagnostics company posted earnings and revenues estimates while raising guidance last Tuesday.

Today's long calls , which lock in the price where the stock can be bought no matter how far it might rise, are looking for MYGN to rally roughly 11 percent or more by expiration in mid-August. But these calls, which will track the share price closely because they are already in the money , will rapidly lose value if the stock doesn't rise. (See our Education section)

Overall option volume in the name today is already almost 6 times its full-session average. Calls outnumber puts by 16 go 1, a reflection of the bullish sentiment.

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