Archive for the ‘Gene Therapy Research’ Category

NEW YORK, Aug. 6, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, announced today the appointment of Douglas W. Losordo, MD, FACC, FAHA, as Chief Medical Officer of the Company. Dr. Losordo is a leader in cell therapy research and a renowned cardiologist. Most recently, Dr. Losordo was Vice President, New Therapies Development, Regenerative Medicine and Baxter Ventures at Baxter International.

Dr. Losordo is well regarded for his career-long efforts to develop novel therapeutics and as a scientist he obtained over $35 million in National Institutes of Health funding for discovering and developing new therapeutic concepts in the laboratory, providing the basis for clinical studies. He has led first in human studies in multiple gene and adult stem cell therapies in patients with cardiovascular diseases, including therapies now in Phase 3 testing. He is a highly sought after speaker, having given over 200 international lectures. He is an associate editor of Circulation Research, the basic science journal of the American Heart Association and serves on the editorial boards of a number of scientific journals.

"I am excited to join NeoStem in its pursuit of promising cell therapies, including a product candidate using CD34+ cells to repair ischemic tissue, taking us a step closer to true disease modification or reversal, instead of relegating patients to symptom palliation," said Dr. Losordo. "The Company is hard at work to unlock the future of cell therapies, a shared goal to which I have also devoted my professional career."

Andrew L. Pecora, MD, FACC, the Company's outgoing Chief Medical Officer, will assume the role of Chief Visionary Officer of NeoStem, where he will continue to assist in building a leading global cell therapy company. Dr. Pecora will also continue in his role as Chief Medical Officer of Progenitor Cell Therapy ("PCT"), NeoStem's contract development and manufacturing subsidiary, and Chief Scientific Officer of Amorcyte, LLC, NeoStem's subsidiary developing a cell therapy to preserve heart muscle function after a severe heart attack, as well as remain a member of NeoStem's Board of Directors.

Dr. Andrew Pecora said, "The Company has made a sound investment in Dr. Losordo who is an extremely talented and well-respected physician researcher in the cell therapy field. I look forward to collaborating with Dr. Losordo as the Company continues to identify and evaluate regenerative medicine opportunities."

Dr. Robin L. Smith, Chairman and CEO of NeoStem, said "We are extremely fortunate to have Doug Losordo join our leadership team. Doug will no doubt complement the stellar medical regime that Andrew Pecora has built, as well as help us move forward in our efforts to develop novel proprietary cell therapy products and platform technologies."

Dr. Losordo is an adjunct professor of medicine at Northwestern University in Chicago, Illinois. From 2006 to 2011, he was the director of the Feinberg Cardiovascular Research Institute and the Eileen M. Foell Professor of Heart Research at Northwestern University's School of Medicine and director of the Program in Cardiovascular Regenerative Medicine at Northwestern Memorial Hospital. From 2004 to 2006, he was a Professor of Medicine at Tufts University School of Medicine and Chief of Cardiovascular Research at St. Elizabeth's Medical Center in Boston. He is board-certified in internal medicine, cardiovascular disease, and interventional cardiology. Dr. Losordo's major research interests encompass angiogenesis/vasculogenesis, progenitor/adult stem cells, tissue repair/regeneration, and vascular biology. He received his medical degree from the University of Vermont.

About NeoStem, Inc.

NeoStem, Inc. is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy product, as well as operating a contract development and manufacturing organization that provides services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue-generating service provider business provides the Company with capabilities for cost effective in-house product development and immediate revenue and cash flow generation.

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

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NeoStem Appoints Douglas W. Losordo as Chief Medical Officer

HOUSTON, Aug. 7, 2013 /PRNewswire/ -- Gene by Gene, Ltd., the world's first company to develop consumer DNA testing products for ancestry and genealogy applications, announced today the acquisition of Arpeggi, Inc., a StartUp Health- and GE-backed company that develops solutions for genome sequencing, data management and computational analysis.

The combined company will enable the acceleration of an innovative suite of more affordable genetics testing and diagnostics services available to consumers, researchers and healthcare providers.

"The acquisition of Arpeggi's technology and world-class team of data and technology experts will enable us to accelerate Gene by Gene's plan to make next-generation DNA sequencing and clinical genomics accessible and affordable to all," said Max Blankfeld, Managing Partner of Gene by Gene. "We are on a mission to transform healthcare by dramatically speeding up the process, and reducing the costs, of genetic tests, which today are often far too expensive for the average consumer."

Founded in 2012, Arpeggi develops solutions for genome sequencing, data management and computational analysis. In April, the company released GCAT - Genome Comparison and Analytic Testing, a free community driven platform for evaluating the performance of next-generation sequencing (NGS) data analysis methods. The platform has gained tremendous traction and was recently showcased at Bio-IT World and the Clinical Genome Conference. Arpeggi has developed proprietary sequencing tools, designed for scale, that enable accurate, fast, and cost-effective analysis of genomes. This year, Arpeggi was selected as one of 14 startups, out of 400 applicants, to join the StartUp Health and GE Entrepreneurship Program to help grow, commercialize and scale new innovative healthcare technologies.

"We are thrilled by the acquisition of Arpeggi and excited to continue to help Gene by Gene on its mission to lead the rapidly advancing genetics testing and sequencing market," said Unity Stoakes, cofounder and President of StartUp Health. "This acquisition represents a significant combination of technologies, expertise and infrastructure that we believe will make an important impact on the future of the genomics sector and how many people have access to these innovations."

Rafael Torres, Senior Managing Director, GE Ventures- Healthcare said, "The deluge of data generated from genomic testing and the ability to store, analyze and interpret it efficiently has been a bottleneck for organizations focused on large scale sequencing. Arpeggi's solution provides an infrastructure that helps human genomic and bioinformatics companies get the most out of their data. We're proud to have Arpeggi involved with our Entrepreneurship Program with StartUp Health and cannot wait to see themfurther advance DNA testing through the marriage of science and technology."

The entire Arpeggi team and technology platform will be incorporated into Gene by Gene. Additionally, Arpeggi's founders will join Gene by Gene's management team, effective immediately. Arpeggi's Nir Leibovich was named Gene by Gene's Chief Business Officer, Jason Wang was named Chief Technology Officer and David Mittelman, Ph.D was named Chief Scientific Officer.

Gene by Gene's Doron Behar, M.D., Ph.D. was also named Chief Medical Officer. Gene by Gene's Blankfeld and Bennett Greenspan continue to serve as the company's Managing Partners.

Financial terms of the transaction were not disclosed.

About Gene by Gene Ltd.

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Gene by Gene Acquires Arpeggi, a StartUp Health- and GE-Backed Company, to Build World's Leading Genetic Testing and ...

Perth scientists have made a gene discovery that could improve the survival of bowel cancer patients by making their chemotherapy more effective.

The research, published in the prestigious British Journal of Cancer, has identified genes involved in a process known as "notch signalling" which is switched on by bowel cancer and makes tumours grow faster.

But the WA Institute for Medical Research said it was possible that doctors could use special drugs to intercept this process.

A study led by institute deputy director Peter Leedman examined colorectal tumour tissues from 441 consenting patients having surgery and chemotherapy to treat their cancers at Sir Charles Gairdner Hospital.

Researcher Patrick Candy said notch signalling in the colon was normally low in healthy adults but studies on colon cancer cell-lines had shown that when tumours learnt how to switch on the process they became much more resistant to chemo- therapy.

"The WAIMR team looked for the first time at notch signalling in human colon cancer patients and we saw a very dramatic result," Dr Candy said. "For example, one protein we studied, SOX9, showed patients had an eightfold higher risk of death when it was found at high levels.

"Our work is leading to the point where medical professionals may be able to test levels of these notch proteins and use it to decide whether notch inhibitory drugs might be helpful in making chemotherapy treatment work better."

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Gene points to better bowel cancer treatment

Aug. 6, 2013 By studying a gene in yeast, a team of scientists has found that modifications to histones -- proteins associated with DNA -- can control whether or not a gene is allowed to function and may be important in maintaining the genes' "expression potential" so that future cells behave as their parent cells did. The research was led by Lu Bai, an assistant professor of biochemistry, molecular biology, and physics at Penn State University, in collaboration with David Stillman at the University of Utah. The discovery, which may have implications for the study of diseases such as cancer, will be published in a print edition of the journal Proceedings of the National Academy of Sciences.

Bai explained that gene expression -- the process by which certain genes are regulated or turned "on" or "off" -- is one of the most fundamental processes in the life of any biological cell. Different programs of gene expression -- even when cells have the same DNA -- can lead to different cellular behavior and function. For example, even though a human muscle cell and a human nerve cell have identical DNA, they behave and function very differently. Misregulation of gene expression can affect cell fitness and lead to diseases. "Gene expression tends to vary from cell to cell," Bai said. "Misregulation may happen in a small fraction of cells, and these cells may cause disease later on. Therefore it is important to study gene regulation at the single-cell level."

Using a fluorescent video of cell division, Bai and her team were able to observe how a gene called HO was expressed in single yeast cells over multiple cell divisions. Normally, the expression of HO allows budding yeast to change sex -- from "male" to "female" and vice versa. "Interestingly, HO expression -- and thus sex change -- is supposed to occur only in 'mother' cells but not the newly budded 'daughter' cells," Bai explained. After observing the video, team members found that HO was expressed in 98 percent of the mother cells but also in 3 percent of the daughter cells. "The vast majority of both the mother cells and the daughter cells responded as they were supposed to," Bai said. "But, in a small percentage of the cells, the gene regulation went wrong."

The pressing question for Bai's team then was, why did the HO gene regulation fail in a small population of cells -- in 2 percent of the mother cells and 3 percent of the daughter cells? She discovered that the answer seems to lie in histones, a major protein complex associated with DNA. "We found that changes in histone configurations affect the fraction of cells in which the HO expression was misregulated. In addition, we found that, in some conditions, the HO expression can 'remember' itself: If HO is turned on in one cell, it is more likely to be turned on in its progeny cells. We showed that this short-term memory of the HO expression seems to be inherited through histone modifications," Bai said. She added that further study of gene expression, specifically at the level of individual cells, can have important implications for disease research.

In addition to Bai and Stillman, other researchers who contributed to this study include Qian Zhang, Youngdae Yoona, Juan Antonio Raygoza Garay, and Michael M. Mwangi from Penn State; Yaxin Yu and Emily J. Parnell from the University of Utah; and Frederick R. Cross from the Rockefeller University.

The research was funded by the National Institutes of Health.

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The above story is based on materials provided by Penn State. The original article was written by Katrina Voss.

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Protein changes are discovered that control whether a gene functions are discovered

Could You Survive An Electric Car Apocalypse? -- AFTER/DRIVE
So how does one go about relearning how to love cars? Let #39;s pretend it #39;s all over, and electric cars won. What now? Can you love something that sounds like a...

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Medical Advancements in Genetic Engineering Journal OMICS Publishing Group
This video belongs to Genetic Engineering which is a techinque of controlled manipulation of genes to change the genetic makeup of cells and move genes acros...

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Medical Advancements in Genetic Engineering Journal OMICS Publishing Group - Video

6 August 2013 Media Release:

Local Communities want stricter GE controls

Rally for Democracy the People of Nelson are planning to rally next Saturday 10 August to tell the National Government that we want our democracy back.

For immediate release from beautiful Nelson, the first New Zealand city to be declared Genetic Engineering (GE) Free, by the Nelson City Council in 2001.

Nelson and Tasman communities want their councils to be able to set their own rules for stricter controls on the outdoor use of Genetically Modified organisms (GMOs) in the Nelson Tasman region, and want the National government to respect local democratic processes.

Local ratepayers are wary of EPA approved GE field trials in this region, having had to bear a large part of the enormous costs of cleaning up the agricultural chemical contaminated site at Mapua. Local councils have a responsibility to ratepayers to minimize risks of future contamination costs from the outdoor use of GMOs in our region.

We are pleased to see that the President of Local Government, Lawrence Yule, recognizes that some councils have taken steps to create an additional tier of protection against the risks of outdoor use of GMOs because their ratepayers want a more precautionary approach than central government requires, said The People of Nelson spokesman Seager Mason.

"Nelson City was the first council in NZ to achieve the distinction of being a symbolic GE free Zone, and our council is maintaining a watching brief on the good work of other councils to create enforceable Regional Exclusion Zones for all outdoor use of GMOs.

We want Nelson City to strengthen its existing valuable GE free status- we object to threats by Amy Adams, current Minister of the Environment, to undermine local council autonomy and jurisdiction for controlling GMOs."

"We commend our local MP Nick Smith, the former Minister for the Environment, who provided written clarification in August 2010 for local councils, confirming that local authorities can regulate or prevent the outdoor use of GMOs, using the RMA."*

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Local Communities want stricter GE controls

Approximately $300 billion is wasted each year on drugs that do not work in people who carry certain genes, according to experts. These people never receive the full benefit from these drugs, while others experience dangerous side effects.

In order to treat individuals who have had many failures with drugs, some doctors are turning towards personalized medicine - which provides a method by which doctors can customize medication regimens so that they are effective from the start.

What role does genetics have in pain? Research shows that genetic factors account for a substantial proportion of all elements contributing to a patients response to drugs (others include age, sex, weight, general health and liver function).

Genes provide your body with instructions for making enzymes, which help break down drugs in your system, allowing your body to benefit from the medicine. Differences in your enzymes can affect how your body metabolizes a drug and how long the drug stays your body - and thus, how well drugs may work in an individual.

In particular, common pain medications require activation by an enzyme called CYP2D6 to become effective. Approximately half of patients have genes that alter the function of CYP2D6. Testing for these gene alterations allows for changes to dosage regimens in order to compensate for altered metabolisms - and optimizes the safety and efficacy of pain medications.

Without knowing an individuals specific genetic code, physicians may often need to go through months of trial-and-error prescribing to find the right drug and dose. Physicians are often baffled when a drug will work for one person but not for another with the same diagnosis. The fact of the matter is that physicians really do not know how to predict drug effectiveness or toxicity because everyone is different. Genetic testing helps assess drug responsiveness. An individuals genes can be a map that serves as a guide for physicians.

What is Pharmacogenetic Testing (PGT)? A simple saliva test can evaluate an individuals ability to metabolize or process drugs. Pain medications such as hydrocodone, oxycodone, diazepam and morphine utilize the CYP2D6 enzyme in order to metabolize the drug. As a drug gets metabolized, it is broken down into harmless pieces and eventually cleared. The activity of your clearance system is based on your genetic code. Once tested, this knowledge about an individuals unique drug metabolizing system can help guide physicians.

What is the purpose of PGT? Physicians would like to be able to anticipate how one may respond to a drug instead of relying on a trial-and-error process. By knowing the specific way one may break-down drugs, a physician can tailor treatment according to an individuals unique metabolism and immediately find the right drug. Not only will this information help physicians predict which drug will best treat pain, a physician will also be able to predict the effective dose and potential for toxicity. In theory, this knowledge has the potential to save time, money and lives.

Pharmacogenetic testing (PGT), specifically, is exceedingly important for the proper management of pain because finding the precise drug and dose for each patient is so critically important. The groundbreaking development of PGT testing provides more individualized drug treatment for patients while also reducing adverse effects.

What if someone is an ultra-rapid metabolizer? Ultra-rapid metabolizers break down medications really fast. Individuals who often receive medications that do not work or frequently need double doses of medication in order to relieve pain may be ultra-rapid metabolizers.

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Could genetic testing help doctors treat pain more effectively?

Genetics - Trident @ the Aggie, Fort Collins

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Ambry Genetics Corp., a seller of tests for genetic risks of breast cancer, accused Myriad Genetics Inc. of misusing its patents to intimidate and chill competition in the market.

Myriad sued Ambry and another closely held company, Houston-based Gene By Gene Ltd., in July, claiming their tests infringe its patents for the testing process and synthesized DNA. The tests look at genes known as BRCA to determine if there is a hereditary risk of developing breast or ovarian cancers.

Myriad, based in Salt Lake City, filed the suits after the companies began offering competing tests hours after a U.S. Supreme Court ruling that invalidated some of Myriads patents on genes linked to the diseases. Richard Marsh, Myriads general counsel, said Ambry and Gene by Gene were using the companys patented processes.

Myriad continues a practice of using sharp and overreaching practices to wrongfully monopolize the diagnostic testing of human BRCA1 and BRCA2 genes in the United States and to attempt to injure any competitor who dares to challenge Myriads monopoly, Aliso Viejo, California-based Ambry said in a counterclaim filed yesterday.

Ambry said Myriad is sending threatening letters to doctors with false allegations meant to confuse genetic counselors. The antitrust contentions, which are only against Myriad and not the other patent owners, were part of a filing in which Ambry responded to the Myriad claims.

Ambry said the patents are invalid, based on the high courts ruling in the Myriad case and a March 2012 decision involving diagnostic tests.

In addition to Myriad, the other owners of the patents -- the University of Utah, the University of Pennsylvania, the Hospital for Sick Children in Toronto and Endorecherche Inc. -- also joined in the suits.

The Ambry case is University of Utah Research Foundation v. Ambry Genetics, 13cv640, The Gene By Gene case is University of Utah Research Foundation v. Gene By Gene LTD., 13cv643, both U.S. District Court for the District of Utah (Salt Lake City).

To contact the reporters on this story: Susan Decker in Washington at sdecker1@bloomberg.net; Catherine Larkin in Chicago at clarkin4@bloomberg.net

To contact the editor responsible for this story: Bernard Kohn at bkohn2@bloomberg.net

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Ambry Claims Myriad Is Monopolizing Breast Cancer Market

SEATTLE, WA--(Marketwired - Aug 6, 2013) - Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company, today announced that it will issue financial results and corporate highlights for the quarter ended June 30, 2013, following the close of market on Wednesday, August 14, 2013.

Management will host a conference call on Wednesday, August 14, 2013, at 4:45 pm Eastern time to review financial results and corporate highlights, including a slide presentation by Dr. Steven C. Quay, Chairman, Chief Executive Officer and President. Participating on the call in addition to Dr. Quay will be Kyle Guse, CFO and General Counsel, and Chris Destro, Vice President of Sales and Marketing. Following management's formal remarks, there will be a question and answer session.

To listen to the call by phone, interested parties within the U.S. may dial 866-652-5200 or 412-317-6060 for international callers. All callers should ask for the Atossa Genetics conference call. For your convenience, you may pre-register for the call by clicking here: http://dpregister.com/10031764.

The conference call and slides will also be available through a live webcast at http://www.atossagenetics.com.

A replay of the call will be available one hour after the end of the call through September 16, 2013, and can be accessed via Atossa's website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international). The replay conference ID number is 10031764.

About Atossa Genetics

Atossa Genetics, Inc. is focused on preventing breast cancer through the commercialization of patented, FDA-designated Class II diagnostic medical devices and, through its wholly-owned subsidiary, the National Reference Laboratory for Breast Health, Inc. (NRLBH), patented, laboratory developed tests (LDT) that can detect precursors to breast cancer up to eight years before mammography.

The NRLBH is a CLIA-certified high-complexity molecular diagnostic laboratory located in Seattle, Washington.

For additional information on Atossa, please visit http://www.atossagenetics.com. For additional information on the ForeCYTE test and the National Reference Laboratory for Breast Health, please visit http://www.nrlbh.com.

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Atossa Genetics to Announce Second Quarter 2013 Results on Wednesday, August 14, 2013

AMES, IA--(Marketwired - Aug 7, 2013) - NewLink Genetics Corporation (NASDAQ: NLNK) today reported consolidated financial results for the second quarter of 2013 and reviewed progress in its development programs.

NewLink reported a net loss for the second quarter 2013 of $7.1 million or $.28 per common share (based on 25.6 million weighted average shares outstanding), compared with $6.3 million, or $.31 per common share, for the second quarter 2012 (based on 20.7 million weighted average shares outstanding).

Total grant revenues for the second quarter 2013 were $232,000 compared with $590,000 for the second quarter 2012. Research and development expense for the second quarter 2013 was $5.0 million compared with $4.7 million for the second quarter 2012. General and administrative expense for the second quarter 2013 was $2.3 million compared with $2.2 million for the second quarter 2012.

NewLink ended the second quarter with cash, cash equivalents and certificates of deposit totaling $59.0 million and continues to expect to end the year with about $40 million in cash, cash equivalents and marketable securities.

"We presented an array of compelling clinical and preclinical data across our pipeline of novel immunotherapies at some of the most prominent cancer meetings this quarter. This included clinical data on NewLink's HyperAcute immunotherapies and our novel IDO pathway inhibitor, indoximod. In addition, preclinical data on NLG919, our second IDO pathway inhibitor were presented at ACCR," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. "Patient accrual remains on track for the many clinical trials currently underway, including enrollment in the Phase 3 IMPRESS trial for surgically resected pancreatic cancer. In addition, we have made significant progress in the Phase 2b/3 trial for patients with previously treated non-small-cell lung cancer and in Phase 2 trials in other settings. We look forward to reporting further progress with these programs in the months to come."

Second Quarter and Recent Accomplishments

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About NewLink Genetics Corporation

NewLink is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve treatment options for patients with cancer. NewLink's portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as a monotherapy or in combination with other treatment regimens. For more information please visit http://www.linkp.com. Patient information is available at http://www.pancreaticcancer-clinicaltrials.com.

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NewLink Genetics Corporation Reports Second Quarter 2013 Financial Results

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

Interleukin Genetics, Inc. (ILIU) announced today that it will host a conference call and Webcast on Wednesday, August 14, 2013 at 4:30 p.m. (ET) to provide a corporate update and discuss the Companys second quarter results.

To access the live call, dial 877-324-1976 (domestic) or 631-291-4550 (international). The live Webcast and replay access of the teleconference will be available on the Investors section of Interleukin Genetics, Inc.s Website at http://www.ilgenetics.com.

About Interleukin Genetics

Interleukin Genetics, Inc. (ILIU) develops and markets a line of genetic tests under the Inherent Health and PST brands.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, Mass. and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). For more information, please visit http://www.ilgenetics.com.

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Interleukin Genetics, Inc. Announces Conference Call to Discuss Second Quarter 2013 Results

ALISO VIEJO, Calif.--(BUSINESS WIRE)--

Ambry Genetics, the worldwide leader in hereditary cancer testing, announced today that it has filed an antitrust counterclaim against Myriad Genetics in response to the patent infringement lawsuit Myriad and other plaintiffs filed against Ambry on July 9, 2013, University of Utah Research Foundation, et al, v. Ambry Genetics Corporation, United States District for the District of Utah, Case No. 2:13-cv-00640-RJS.

Ambry's antitrust counterclaim alleges that:

Ambry Genetics was the first commercial laboratory to launch hereditary cancer panels using next generation sequencing in 2012 with their comprehensive BreastNext, OvaNext, ColoNext and CancerNext products. With hundreds of clinics and institutions utilizing these panels, Ambry has established itself as the scientific leaders in inherited cancer panel testing. Following the Supreme Courts landmark June 13, 2013 decision in AMP et al v. Myriad Genetics, et al., Ambry included BRCA1 and BRCA2 diagnostic testing to its suite of panels.

Being sued for patent infringement a month after the Supreme Court ruled 9-0 unanimously against Myriad is just wrong, said Chief Executive Officer, Charles Dunlop. As alleged in our counterclaim, Myriad Genetics is also wrongfully depicting Ambrys variants of unknown significance (VUS) statistic to be as high as 30% when it actually is approximately 5% for BRCA1/2 diagnostic testing. Tactics like this have no place in the medical field, especially cancer, as it will take a collaborative, industry wide effort to further understand the disease and find cures.

About Ambry Genetics

Ambry Genetics is a College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified commercial clinical laboratory with headquarters in Orange County, California. Since its founding in 1999, it has become a leader in providing genetic services focused on clinical diagnostics and genomic services, particularly in sequencing and array services. Ambry has established a reputation for unparalleled service and for over a decade has been at the forefront of applying new technologies to the clinical molecular diagnostics market and to the advancement of disease research. To learn more about testing and services available through Ambry Genetics, visit http://www.ambrygen.com.

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Ambry Genetics Sues Myriad Genetics for Violating Federal Antitrust Laws

Nov. 2, 1995 - Aug. 4, 2013

Almost a decade after becoming the first patient with Batten disease to undergo gene replacement therapy, Zachary Balog died at home Sunday in Cranberry. He was 17.

"We're very proud of Zach, of the fight that he fought," said his father, Steve Balog, who called his son a "pioneer" for the experimental treatment he underwent at Weill Cornell Medical Center in New York City in June 2004.

Batten disease, also referred to as Spielmeyer-Vogt-Sjogren-Batten disease, is a rare neurodegenerative disorder that affects roughly 2 to 4 births out of every 100,000 in the United States.

Like other victims of the disease, for the first few years of his life Zach seemed like a normal, healthy child.

"As a child, he loved 'Barney' and 'Blue's Clues.' He loved construction vehicles," his mother, Susan Balog, said, adding, "and his favorite foods were pizza and chicken nuggets."

When he was 4, he began experiencing seizures, soon accompanied by other common symptoms of Batten's, like poor balance and deteriorating eyesight and speech abilities.

Batten's is one of 40 or 50 known types of lysosomal disorders. In such diseases, the enzymes that typically break down or eliminate materials like fats and proteins are missing, so these substances build up in brain, eye, skin, and muscle cells. The buildup is what causes the gradual loss of eyesight, along with motor and cognitive skills.

The disorder is autosomal recessive, so both parents must be carriers of the recessive gene. Their offspring must inherit the gene from both parents, meaning he or she has a one in four chance of developing the disease.

The Balogs have a younger son, Joshua, 15, who is a carrier but does not have the disease.

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Obituary: Zachary Ordy Balog / Cranberry youth battled rare disease

Newswise Neurosurgeons at the University of California, San Diego School of Medicine and UC San Diego Moores Cancer Center are among the first in the world to utilize real-time magnetic resonance imaging (MRI) guidance for delivery of gene therapy as a potential treatment for brain tumors. Using MRI navigational technology, neurosurgeons can inject Toca 511 (vocimagene amiretrorepvec), a novel investigational gene therapy, directly into a brain malignancy. This new approach offers a precise way to deliver a therapeutic virus designed to make the tumor susceptible to cancer-killing drugs.

With chemotherapy, just about every human cell is exposed to the drugs potential side-effects. By using the direct injection approach, we believe we can limit the presence of the active drug to just the brain tumor and nowhere else in the body, said Clark Chen, MD, PhD, chief of stereotactic and radiosurgery and vice-chairman of neurosurgery at UC San Diego Health System. With MRI, we can see the tumor light up in real time during drug infusion. The rest of the brain remains unaffected so the risk of the procedure is minimized.

Toca 511 is a retrovirus engineered to selectively replicate in cancer cells, such as glioblastomas. Toca 511 produces an enzyme that converts an anti-fungal drug, flucytosine (5-FC), into the anti-cancer drug 5-fluorouracil (5-FU). After the injection of Toca 511, the patients are treated with an investigational extended-release oral formulation of 5-FC called Toca FC. Cancer cell killing takes place when 5-FC comes into contact with cells infected with Toca 511.

Inevitably, almost all glioblastoma patients fail currently available therapy. The challenge, in part, is knowing if current drugs are actually penetrating the tumor. This MRI-guided approach will help us deliver this drug into the tumor directly to see if the drug is working, said Santosh Kesari, MD, PhD, principal investigator and director of neuro-oncology at Moores Cancer Center. This approach may lead to new treatment options for patients battling several other types of brain cancers.

Previous efforts using gene therapy to treat brain cancer were largely limited by the inability to deliver the drug into the brain. Under normal conditions, the brain is protected by the blood-brain barrier but this natural defense mechanism also prevents drugs from reaching the cancer cells in patients with brain tumors. Fortunately, 5-FC crosses the blood-brain barrier, and direct injection of Toca 511 into the tumor provides a means to selectively generate chemotherapy within the tumor mass.

To ensure that the adequate amount of Toca 511 is delivered to the region of the tumor, neurosurgeons at UC San Diego Health System utilize state-of-the art MRI guidance, called ClearPoint, to monitor the delivery and injection processes in real time. The MRI-guided process provides visual confirmation that the desired amount of drug is delivered into the tumor and provides physicians the ability to make adjustments to optimize the location of drug delivery.

Participants in this clinical trial must be 18 years or older; have a single, recurrent Grade 3 or 4 glioma; and have had prior surgery, radiation, and chemotherapy. The MRI-based procedure is minimally invasive and all participants of the study were discharged from the hospital one day after surgery and resumed their normal daily activity.

The Phase 1 trial is evaluating the safety and tolerability of Toca 511 in combination with Toca FC (5-FC, extended-release tablets), and is being developed by San Diego-based Tocagen Inc.

For more information about this clinical trial at Moores Cancer Center, please call Brad Brown at 858-822-5377 or email bdbrown@ucsd.edu

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UCSD Among First to Inject Brain Cancer Drug with MRI

Public release date: 5-Aug-2013 [ | E-mail | Share ]

Contact: Shaun Mason smason@mednet.ucla.edu 310-206-2805 University of California - Los Angeles

Researchers at UCLA's Jonsson Comprehensive Cancer Center have successfully combined cellular therapy and gene therapy in a mouse-model system to develop a viable treatment strategy for breast cancer that has spread to a patient's brain.

The research, led by Carol Kruse, a professor of neurosurgery and member of the Jonsson Cancer Center and the UCLA Brain Research Institute, was published Aug. 1 in the journal Clinical Cancer Research.

Breast cancer is the most common form of cancer in women, and metastasis is a major cause of health deterioration and death from the disease. Managing metastasis is difficult for several reasons: The circulatory network known as the bloodbrain barrier prevents many anti-cancer drugs from reaching areas of the brain to which cancer has spread, and metastases have a tendency to spring up in multiple brain locations simultaneously, making current treatments such as radiation challenging.

Cellular therapy is a type of immunotherapy that uses T cells, the foot soldiers of the immune system, that have been sensitized in the laboratory to kill breast cancer cells. These sensitized T cells are injected into the parts of the brain to which cancer has spread. The research shows that the T cells can move through tissue and recognize and directly kill the tumor cells.

With the gene therapy, genetically modified cancer cells are killed by a drug called 5-flurocytosine (5-FC). To get the gene into the cancer cells, the researchers first insert it into a virus that can infect the tumor cells. After the virus has infected the cells, non-toxic 5-FC is given to the patient. Tumor cells infected by the virus convert the non-toxic drug to a toxic form that kills the cancer cells. Dr. Noriyuki Kasahara, a professor in the department of medicine at UCLA, developed the gene therapy method in his laboratory.

While the two methods alone each show efficacy in mouse models, the greatest reduction in metastatic brain tumor size occurred when the cellular and gene therapies were combined, the researchers said.

"There is a significant lack of federally funded research addressing translational studies on brain metastases of systemic cancers, even though metastatic brain tumors occur 10 times more frequently than primary brain tumors in humans," Kruse said. "These patients have a dismal prognosis because the brain represents a 'sanctuary site' where appropriate access by many chemotherapeutics is ineffective. Our research addresses this unmet need."

Both experimental therapies are being tested individually in ongoing clinical trials for primary malignant brain tumors; this presents a unique opportunity for the rapid translation of these technologies from the laboratory to the clinic for breast and other types of cancer that metastasize to the brain, the researchers said.

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New therapy strategy could help treat cancer that has spread from breast to brain

Thanks to gene therapy, a boy born without an immune system can now play in the yard.

Jameson Golliday, in his bubble stroller, reaches out to brother Shawn (Courtesy Jennifer Golliday)

I met two-year-old Jameson Golliday on a patch of lawn in Bloomington, Illinios. He had blue eyes, dark hair, and wore a striped shirt, shorts, and Crocs. He followed his mother, Jennifer, 31, as she pushed a wheelbarrow around the yard, picking up sticks. The neighbors were burning lawn debris and fly ash was swirling in the sky, big fluffy flakes, falling lightly all around us. Jamesons brother, Shawn, 5, was wearing a Star Wars t-shirt and tossed a plastic sword to his grandfather. There was the bat-bat of plastic, and things quickly turned Galactic.

Jamie and his motherretreated to a quiet spot in the yard. She lets him run free in the backyard, but he cant play with other children or touch high-contact surfaces such as playground equipment.

Its super sad, Jennifer told me. He sees kids off in the distance and points at them. I know he wants to interact.

Jamie was born with X-SCID, or "bubble boy disease,"which means he has no immune system. At birth he had no mature T-cells, the rugged soldiers of the immune system that sense and fight infections, due to mutations in the IL-2 gene on his X-chromosome, which rendered the gene non-functional.

David Vetter was the most famous bubble boy. In the 1970s and 1980s he lived in a bubble, using only items sterilized with 140-degree ethylene oxide gas. Doctors tried a bone marrow transplant from his sister to introduce working T-cells into his system. But the Epstein-Barr virus was sleeping in the marrow, and it triggered the growth of many tumors. Vetter died at age 12.

When Jamie was born he had a small cough, but unlike most colds, it didnt go away, not for a year. His mom noticed a bump on his hip one day, which turned out to be a cluster of B-cells unsuccessfully trying to fight an infection. This clustering looked like cancer, and caused doctors to diagnose Jamie with diffuse B-cell lymphoma, which is very uncommon in infants. Later tests revealed Jamies illness for what it wasX-SCID.

In April 2012, not long after Jamies diagnosis, Jennifer and Jamie, then 1, took a medical jet to Cincinnati Childrens Hospital, so that Jamie could participate in a trial for gene therapya treatment that wasnt available in David Vetters time. Jennifer improvised a bubble stroller out of a rain tarp and a baby stroller, to transport him back and forth between the hospital and the Ronald McDonald House where they stayed in Cincinnati. Inside, he wore a surgical mask.

Doctors drew some of Jamies bone marrow, and dosed it with a virus carrying the IL-2 gene. The virus serves as a tiny pilot, carrying the payload of the IL-2 gene into his cells, installing it in his genome. That gene builds a protein called a cytokine, which sends a signal telling T-cells to mature. Weeks after Jamie received his shiny new IL-2 gene, a blood test showed 13 mature T-cells per microliter, where before hed had none.

Link:
How to Cure a Bubble Boy

The University of Queenslands Dr Lee Hickey and research team have discovered a gene that provides resistance to leaf rust in some barley variety adult plants.

The University of Queensland's Dr Lee Hickey led a team that discovered that the gene Rph20 provides resistance to leaf rust in some barley variety adult plants.

Leaf rust is a fungal disease that could destroy almost a third of the nation's barley crop, said Dr Hickey, a research fellow at UQ's Queensland Alliance for Agriculture and Food Innovation.

The discovery will enable selective breeding of barley that will provide genetic protection to the disease.

This will result in much lower chemical use, reduced crop losses, and a more reliable grain supply.

Dr Hickey said the crop disease could also leave Aussie beer drinkers thirsty as the country's primary use of barley was to make beer, as well as stock feed.

But for areas like North Africa and Southwest Asia it is a food staple, he said.

Dr Hickey teamed up with scientists from the Queensland Department of Agriculture, Fisheries and Forestry, the University of Sydney and Uruguay's Instituto de Investigacion Agropecaria.

Using field trials in Australia and Uruguay, the team was able to identify the specific gene.

They then developed a diagnostic DNA marker to determine the presence of the gene.

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A new gene to stop barley leaf rust

Public release date: 5-Aug-2013 [ | E-mail | Share ]

Contact: Phyllis Brown phyllis.brown@ucdmc.ucdavis.edu 916-734-9023 University of California - Davis Health System

(SACRAMENTO, Calif.) -- UC Davis researchers have identified how and where in the genome a cancer chemotherapy agent acts on and 'un-silences' the epigenetically silenced gene that causes Angelman syndrome, a rare neurodevelopmental disorder characterized by severe intellectual disability, seizures, motor impairments, and laughing and smiling.

The agent, Topotecan, is a topoisomerase inhibitor, part of a class of drugs that in earlier research has been found to un-silence the Angelman gene, suggesting that it might be therapeutic for the condition, which affects approximately 1 in 25,000, or approximately 150,000 people worldwide. But how it acts has not been known.

Topotecan is primarily used to treat metastatic cancers, including ovarian cancer, cervical cancer and small-cell lung cancer, by preventing cells from dividing and causing their death.

The research, published online today in Proceedings of the National Academy of Sciences (PNAS), found that the drug stabilizes the formation of strands of RNA that create RNA-DNA hybrids called 'R-loops,' in the Ube3a region of the gene15q11-q13. The gene is implicated in other neurodevelopmental disorders, including autism. About 1 percent of cases of autism are linked to duplications in 15q11-q13 or "Dup15q," children that over-express Ube3a.

"Now we have a molecular mechanism for a proposed drug for a disease, so we can understand how it works and begin to tweak it to develop therapies," said lead study author Weston Powell, a third-year medical student in the Physician Scientist Training Program in the UC Davis School of Medicine.

Angelman syndrome is caused by the loss of a maternally inherited Ube3a gene at the 15q11-q13 locus, which is expressed in brain neurons. Loss of the same chromosomal region inherited from the male parent causes another neurodevelopmental condition, Prader-Willi syndrome, best known for its sufferers' obsessive-compulsive behavior and insatiable appetites which, if left unchecked, can lead to morbid obesity.

DNA is like a twisted rope, Powell explained, which opens as the enzyme polymerase travels down one thread of the rope to produce an RNA copy of the DNA strand. Normally the RNA leaves the DNA, but sometimes the RNA instead sticks to one piece of DNA, and an 'R-loop' is formed. These hybridized DNA-RNA loops create tension, preventing the DNA from having the characteristic flexibility that allows it to form its spiral helix or twisted-rope shape. R-loops themselves are a relatively recent discovery, and researchers have just begun to understand how they function.

While the discovery of the effect of Topotecan is important, future investigations will determine how and whether the drug may have therapeutic applications for Angelman syndrome, the researchers said.

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How a cancer drug unties knots in the chromosome that causes Angelman and Prader-Willi syndromes

Public release date: 2-Aug-2013 [ | E-mail | Share ]

Contact: Meng Zhao eic@nrren.org 86-138-049-98773 Neural Regeneration Research

Interleukin-18 promoter gene polymorphisms may be associated with ischemic stroke pathogenesis, and the 607C allele increases ischemic stroke risk in the Han Chinese population. The frequency distribution of genetic polymorphisms varies among different populations, races, and living environments. A recent study by Haiping Wang and colleagues from Qingdao University Medical College demonstrates that the 13T/C (rs11024595) polymorphism, in the 5-flanking region of the serum amyloid A gene, shows no correlation with ischemic cerebrovascular disease. However, the C allele of the 607C/A (rs1946518) polymorphism in the interleukin-18 gene promoter is a strong risk factor for ischemic cerebrovascular disease in the Han population of northern China. In addition, the A allele is likely protective for ischemic cerebrovascular disease. These findings published in the Neural Regeneration Research (Vol. 8, No. 20, 2013) are considered to identify molecular genetic mechanisms involved in cerebrovascular disease pathogenesis.

###

Article: " Ischemic stroke susceptibility gene in a Northern Han Chinese population," by Haiping Wang1, Shujuan Shi2, Wenjing Yan1, Yan Song3, Jingjing Zhan4, Chen Zhang1, Haiji Wang3 (1 Department of Neurology, Affiliated Hospital of Qingdao University Medical College, Qingdao 266003, Shandong Province, China; 2 Health Care Office, Affiliated Hospital of Qingdao University Medical College, Qingdao 266003, Shandong Province, China; 3 Department of Gerontology, Affiliated Hospital of Qingdao University Medical College, Qingdao 266003, Shandong Province, China; 4 Department of Internal Medicine Ward 1, Jiao Nan People's Hospital, Jiaonan 266400, Shandong Province, China)

Wang HP, Shi SJ, Yan WJ, Song Y, Zhan JJ, Zhang C, Wang HJ. Ischemic stroke susceptibility gene in a Northern Han Chinese population. Neural Regen Res. 2013;8(20):1881-1891.

Contact:

Meng Zhao eic@nrren.org 86-138-049-98773 Neural Regeneration Research http://www.nrronline.org/

Full text: http://www.sjzsyj.org:8080/Jweb_sjzs/CN/article/downloadArticleFile.do?attachType=PDF&id=659

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Ischemic stroke susceptibility gene in a Northern Han Chinese population

by Jon Hamilton, NPR

August 5, 2013

A gene that affects the brain's dopamine system appears to have influenced mothers' behavior during a recent economic downturn, researchers say.

At the beginning of the recession that began in 2007, mothers with the "sensitive" version of a gene called DRD2 became more likely to strike or scream at their children, the researchers say. Mothers with the other "insensitive" version of the gene didn't change their behavior.

But once it appeared that the recession would not become a full-fledged depression, the "sensitive" mothers became less likely than "insensitive" mothers to engage in harsh parenting.

"You have the same genes, and with a different environment it's a completely different story," says Irwin Garfinkel, a professor of contemporary urban problems at Columbia University. "I think that's the most amazing part of what we found."

Garfinkel and four other researchers published the results in the Proceedings of the National Academy of Sciences.

The surprising finding came about because Garfinkel and the other researchers happened to be studying "fragile" families in 20 large cities when the 2007 recession began. One of the things they were tracking was reports of harsh parenting, including spanking, hitting or screaming at a child, he says.

Previous research had found that harsh parenting is more common during economic hard times, so Garfinkel says that's what researchers expected to see during the 2007-2009 period, often called the Great Recession.

The team was puzzled by the reports that harsh parenting, despite rising initially, actually declined as the recession got worse. Dohoon Lee, an assistant professor of sociology at New York University, suggested that the mothers' genes might offer an explanation.

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Gene may influence moms' behavior

Scientists noticed an increase in harsh parenting during the recession by parents with the so-called 'Orchid Gene.'

Researchers say a specific gene might make parents more likely to abuse their children during tough times, according to a study published Monday in Proceedings of the National Academy of Sciences.

The DRD2 Taq1A gene, called the "orchid/dandelion gene" by researchers who study it, is a "sensitive" one, meaning that its effects are driven by the environment. The gene controls the release of dopamine, a hormone that regulates behavior in the brain and is often associated with cocaine and other drug use.

[STUDY: Child Abuse Rises When Economy Sags]

During good times, the roughly 50 percent of the population that have this gene is actually less likely to use "harsh parenting" tactics such as spanking, slapping, shouting and threatening their children. But during the recession, researchers noticed a general uptick in harsh parenting in 20 cities nationwide. Surprisingly, that increase was driven almost exclusively by parents who had this gene.

"In bad environments, people with this gene are more likely to do impulsive, aggressive things," says Irwin Garfinkel, a Columbia University researcher and co-author of the paper.

It's called the orchid/dandelion hypothesis because like orchids, people with the gene need a specific, positive environment to thrive, Garfinkel says. "Dandelions," on the other hand, are more stoic and were better able to handle adverse economic conditions without resorting to harsh parenting. Though "dandelions" did still use harsh parenting techniques, the rate at which they did so did not increase or decrease during the recession.

The orchic/dandelion hypothesis is not a new one: Researchers have previously suggested that the gene may be involved in causing despair, fear and aggression, but could also be related to feelings of resilience and empathy.

"The same gene that makes you look vulnerable in a bad situation makes you do better in a good environment. In a good environment, an orchid flourishes and is beautiful," he says. "But some of us, we're dandelions -- we might not thrive, but we can survive in all environments."

[READ:Little Known on How Primary Care Docs Can Prevent Child Abuse]

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A Gene May Cause Impulsive Behavior During Bad Economic Times

A gene known as DRD2 affects the brain's dopamine system and is known to be associated with aggressive behavior.

A gene that affects the brain's dopamine system appears to have influenced mothers' behavior during a recent economic downturn, researchers say.

At the beginning of the recession that began in 2007, mothers with the "sensitive" version of a gene called DRD2 became more likely to strike or scream at their children, the researchers say. Mothers with the other "insensitive" version of the gene didn't change their behavior.

But once it appeared that the recession would not become a full-fledged depression, the "sensitive" mothers became less likely than "insensitive" mothers to engage in harsh parenting.

"You have the same genes, and with a different environment it's a completely different story," says Irwin Garfinkel, a professor of contemporary urban problems at Columbia University. "I think that's the most amazing part of what we found."

Garfinkel and four other researchers published the results in the Proceedings of the National Academy of Sciences.

The surprising finding came about because Garfinkel and the other researchers happened to be studying "fragile" families in 20 large cities when the 2007 recession began. One of the things they were tracking was reports of harsh parenting, including spanking, hitting or screaming at a child, he says.

Previous research had found that harsh parenting is more common during economic hard times, so Garfinkel says that's what researchers expected to see during the 2007-2009 period, often called the Great Recession.

The team was puzzled by the reports that harsh parenting, despite rising initially, actually declined as the recession got worse. Dohoon Lee, an assistant professor of sociology at New York University, suggested that the mothers' genes might offer an explanation.

The team focused on the DRD2 gene because the dopamine system affects how people feel, and that particular gene is known to be associated with aggressive behavior. They looked at genes only from mothers because it would have been more expensive and more difficult to include fathers.

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Harsh In Hard Times? A Gene May Influence Mom's Behavior

Hallo Science Genetic Engineering

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