15-03-2012 11:26 Daniel A. Osman, MD, breast cancer surgeon, program director, Miami Breast Cancer Conference, discusses the Miami Breast Cancer Conference (MBCC), which took place at the Fontainebleau Miami Beach hotel, in Florida, March 14-17, 2012. During the span of the MBCC the central theme of the meeting has been to make everything you learn instantly applicable. As the conference enters its 29th year, this thesis remains true with a focus on the use of genomics and personalized medicine. The esteemed presenter Charles M. Perou, PhD, discussed the topic of personalized medicine in his presentation on sequencing-based genomics. Perou led research in 2002, shortly after the genome was mapped, that discovered 5 biologically different subtypes of breast cancer. These subtypes have led to enhanced prognoses and treatments for breast cancer patients, which has helped herald a new era in breast cancer management.

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Dr. Osman on the 29th Miami Breast Cancer Conference - Video

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Self-experimentation is a venerable tradition in science.

London surgeon John Hunter deliberately gave himself gonorrhea (and inadvertently, syphilis) in 1767 and suffered from effects of the diseases in his old age.

Now Michael Snyder has joined their ranks.

The geneticist didn't risk life and limb, but he did sacrifice his privacy inviting colleagues to sequence his DNA and track tens of thousands of markers in his blood over a period of 14 months, when he was sick and when he was well, ultimately crunching billions of measurements on the molecular details of his body.

Some of the results came as big, and not very welcome, surprises, uncovering, among other things, that he was at risk for Type 2 diabetes, and capturing the precise moments when the disease took hold in his body.

Snyder, who heads the genetics department at Stanford University's medical school, says the work is more than just a curiosity. He thinks that his experiment, published Thursday in the journal Cell, offers a taste of what medicine may be like someday for everyone.

Physicians talk often about "personalized medicine": the idea that therapies should be tailored to each patient's unique genetic and medical profile. Doctors already practice a sort of personalized medicine when they "type" a tumor to find the most effective chemotherapy drug. Someday, scientists like Snyder say, it will be a routine part of prevention too.

But if the gantlet his team ran is any indication, that day isn't upon us yet.

First, the researchers sequenced Snyder's genome the 6 billion letters of his DNA blueprint several times over, to assess his risk for various conditions. (And they sequenced Snyder's mother's genome as well, to learn which genes he got from each parent.) They drew Snyder's blood regularly to see how proteins, RNA and a swath of other chemicals in his body increased or decreased when he was in good health and bad his "omics" profile. They monitored his immune system and other health measures.

"Your genome shows what you're predisposed for. Your 'omics' profile tells you what's really going on," Snyder said. "This is a whole new level."

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Geneticist's 'personalized medicine' study focuses on himself

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13-03-2012 21:42 Dr Oz on the latest regenerative medicine

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Dr Oz Regenerative Medicine - Video

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16-03-2012 11:56 Craig Venter, president and founder of the J. Craig Venter Institute, spoke to the California Institute for Regenerative Medicine governing board on January 17th, 2012, about the future of personalized medicine in which genomics, the study of genes and their function, is applied to pinpoint specific treatments for patients.

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Craig Venter | CIRM Spotlight on Genomics - A Step to Personalized Medicine - Video

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A NEW stem cell therapy treatment to develop new bones for patients with bone loss and new skin for recipients of plastic surgery has been developed, doctors from Shanghai No.9 People's Hospital announced yesterday.

In the procedure, medical staff use a special machine to collect stem cells from a patient's blood. The stem cells adhere to a base made of a special biological material.

The stem cells are then transplanted into the patient's body, where they grow into either new bones or skin tissue, while the base is absorbed by the human body.

"So far the practice has been successful in treating patients with bone and skin loss," said Dr Dai Kerong from Shanghai Jiao Tong University's translational medicine institute at Shanghai No.9 hospital. "The stem cell technology will be used to develop corneas for blind people as well as treating heart attack and stroke patients by developing new heart and cerebral tissue."

The technology is patented in China and abroad and will be licensed within one or two years, according to Dai.

China has established 51 translational medicine centers to boost the introduction of laboratory research into clinical use.

The complicated procedures and documentation required often prevent doctors from introducing lab success into clinical practice.

Dai said one reagent developed by No. 9 hospital's doctors for in vitro fertilization received a license in Europe within six months and has been used in clinical practice "while this would take at least five years in China."

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Eastday-Big stem cell breakthrough

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15-03-2012 13:24 Video created as class project by JTC-345 students featuring Dr. Gene Kelly, CSU faculty member and Associate Director for Research and Development at the School of Global Environmental Sustainability.

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COLORADO STATE UNIVERSITY - Enviance March Madness Contest - Gene Kelly - Video

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SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

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

Contact: Jennifer Ganton jganton@ohri.ca 613-798-5555 x73325 Ottawa Hospital Research Institute

A team of researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) has been awarded $367,000 from the Canadian Institutes of Health Research (CIHR) and $75,000 from the Stem Cell Network to lead the first clinical trial in the world of a stem cell therapy for septic shock. This deadly condition occurs when an infection spreads throughout the body and over-activates the immune system, resulting in severe organ damage and death in 30 to 40 per cent of cases. Septic shock accounts for 20 per cent of all Intensive Care Unit (ICU) admissions in Canada and costs $4 billion annually. Under the leadership of Dr. Lauralyn McIntyre, this new "Phase I" trial will test the experimental therapy in up to 15 patients with septic shock at The Ottawa Hospital's ICU.

The treatment involves mesenchymal stem cells, also called mesenchymal stromal cells or MSCs. Like other stem cells, they can give rise to a variety of more specialized cells and tissues and can help repair and regenerate damaged organs. They also have a unique ability to modify the body's immune response and enhance the clearance of infectious organisms. They can be found in adult bone marrow and other tissues, as well as umbilical cord blood, and they seem to be easily transplantable between people, because they are more able to avoid immune rejection.

There has been a great deal of interest in using MSCs to treat disease, with most research so far focused on heart disease, stroke, inflammatory bowel disease and blood cancers. Hundreds of patients with these diseases have already been treated with MSCs through clinical trials, with results suggesting that these cells are safe in these patients, and have promising signs of effectiveness. MSCs are still considered experimental however, and have not been approved by Health Canada as a standard therapy for any disease.

In recent years, a number of animal studies have suggested that MSCs may also be able to help treat septic shock. For example, a recent study by Dr. Duncan Stewart, CEO and Scientific Director of OHRI (and also a co-investigator on the new clinical trial) showed that treatment with these cells can triple survival in a mouse model of this condition.

"Mesenchymal stem cell therapy appears promising in animal studies, but it will require many years of clinical trials involving hundreds of patients to know if it is safe and effective," said Dr. Lauralyn McIntyre, a Scientist at the OHRI, ICU Physician at The Ottawa Hospital, Assistant Professor of Medicine at uOttawa and a New Investigator with CIHR and Canadian Blood Services. "This trial is a first step, but it is a very exciting first step."

As with all "Phase I" trials, the main goal of this study is to evaluate the safety of the therapy and determine the best dose for future studies. The 15 patients in the treatment group will receive standard treatments (such as fluids, antibiotics and blood pressure control), plus a planned intravenous dose of 0.3 to 3 million MSCs per kg of body weight. The MSCs will be obtained from the bone marrow of healthy donors and purified in the OHRI's Good Manufacturing Practice Laboratory in the Sprott Centre for Stem Cell Research. The researchers also plan to evaluate 24 similar septic shock patients who will receive standard treatments only (no MSCs). All patients will be rigorously monitored for side effects, and blood samples will be taken at specific time points to monitor the cells and their activity. This trial will not be randomized or blinded and it will not include enough patients to reliably determine if the therapy is effective. It will be conducted under the supervision of Health Canada and the Ottawa Hospital Research Ethics Board, and will have to be approved by both of these organizations before commencing.

"The OHRI is rapidly becoming known as a leader in conducting world-first clinical trials with innovative therapies such as stem cells," said Dr. Duncan Stewart, CEO and Scientific Director of OHRI, Vice-President of Research at The Ottawa Hospital and Professor of Medicine at uOttawa. "This research is truly pushing the boundaries of medical science forward, and is providing the citizens of Ottawa with access to promising new therapies."

"The Canadian Institutes of Health Research (CIHR) is very pleased to support this clinical trial," said Dr. Jean Rouleau, Scientific Director of the CIHR Institute of Circulatory and Respiratory Health. "The work of Dr. McIntyre and her colleagues will not only add to our growing knowledge of the benefits of stem-cell therapies, but will hopefully lead to treatments that can help save the lives of patients where currently, our treatment options are less than optimal."

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Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock

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OTTAWA A team of Ottawa researchers has been awarded $442,000 to test the worlds first experimental stem-cell therapy aimed at patients who suffer from septic shock, a runaway infection of the bloodstream thats notoriously difficult to treat.

The federal grant will allow researchers from the Ottawa Hospital Research Institute to use mesenchymal stem cells, found in the bone marrow of healthy adults, to treat as many as 15 patients with septic shock.

The deadly infection occurs when toxic bacteria spreads rapidly throughout the body and over-activates the immune system, leading to multiple organ failure and death in up to 40 per cent of cases.

One in five patients admitted to intensive-care units suffers from septic shock, making it the most common illness among a hospitals sickest of the sick.

Existing treatments focus on early diagnosis and intervention before organs start to fail. Patients with septic shock require aggressive resuscitation measures, large doses of intravenous antibiotics and, often, ventilators to help them breathe.

Yet because the infection can creep up on patients rapidly and cause unpredictable complications, death from septic shock remains relatively common.

The experimental therapy aims to use donor stem cells, grown and purified at the Ottawa laboratory, to dial down the bodys hyperactive immune response and reduce the cascade of inflammation that leads to organ failure.

Early results from animal studies even raise the possibility that mesenchymal cells could eliminate the bacteria that causes septic shock, although the impact on humans is not yet known.

Its a unique feature of the stem cells, said Dr. Lauralyn McIntyre, the intensive-care physician who is leading the trial. Certainly no other therapy in the past, other than antibiotics, has impacted the bacterial load in the system.

Like other stem cells, mesenchymal cells can turn into a variety of more specialized cells and tissues that help repair and regenerate damaged organs. And because mesenchymal cells are derived from adults, they sidestep the ethical issues arising from the destruction of human embryos needed to make embryonic stem cells.

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Ottawa researchers receive grant to test stem-cell therapy for septic shock

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OTTAWA A team of Canadian researchers has been awarded $442,000 to test the world's first experimental stem-cell therapy aimed at patients who suffer from septic shock, a runaway infection of the bloodstream that's notoriously difficult to treat.

The federal grant will allow researchers from the Ottawa Hospital Research Institute to use mesenchymal stem cells, found in the bone marrow of healthy adults, to treat as many as 15 patients with septic shock.

The deadly infection occurs when toxic bacteria spreads rapidly throughout the body and over-activates the immune system, leading to multiple organ failure and death in up to 40 per cent of cases.

One in five patients admitted to intensive-care units suffers from septic shock, making it the most common illness among a hospital's sickest of the sick.

Existing treatments focus on early diagnosis and intervention before organs start to fail. Patients with septic shock require aggressive resuscitation measures, large doses of intravenous antibiotics and, often, ventilators to help them breathe.

Yet because the infection can creep up on patients rapidly and cause unpredictable complications, death from septic shock remains relatively common.

The experimental therapy aims to use donor stem cells, grown and purified at the Ottawa laboratory, to dial down the body's hyperactive immune response and reduce the cascade of inflammation that leads to organ failure.

Early results from animal studies even raise the possibility that mesenchymal cells could eliminate the bacteria that causes septic shock, although the impact on humans is not yet known.

"It's a unique feature of the stem cells," said Dr. Lauralyn McIntyre, the intensive-care physician who is leading the trial. "Certainly no other therapy in the past, other than antibiotics, has impacted the bacterial load in the system."

As with other stem cells, mesenchymal cells can turn into a variety of more specialized cells and tissues that help repair and regenerate damaged organs. And because mesenchymal cells are derived from adults, they sidestep the ethical issues arising from the destruction of human embryos needed to make embryonic stem cells.

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Canadian researchers receive grant to test stem-cell therapy for septic shock

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Al-Omran, who is an associate professor and consultant vascular surgeon at KSU, is widely published in many respectable peer-reviewed journals such as the New England Journal of Medicine, PNAS, JBC, Circulation and Nature Communication.

"This is an important initial step in implementing this innovative treatment for cardiovascular diseases. The treatment is still experimental and in the animal phase, so the next step is to move from the experimental phase to application on patients through more research processes that will take several years," Al-Omran told Arab News, underscoring the significance of this research.

Al-Omran explained the idea behind this research was conceived about seven years ago when he was in his general surgery training at University of Toronto working with breast cancer patients.

This question launched the research that Al-Omran and Verma undertook where they experimented on mice by removing the BRCA1 gene and administering Doxorubicin.

Al-Omran, who is focused on risk reduction and prevention of cardiovascular diseases despite being a surgeon, added: "Cardiovascular diseases is the leading cause of death worldwide, and this research will pave the way for developing therapies that treat and prevent these diseases. This will also be potentially useful for prevalent conditions such as hypertension and diabetes among others."

When asked about the future of research in Saudi Arabia, Al-Omran lauded King Saud University for its strategic research programs such as the Research Chairs Program, International Twinning Program, and Attracting Outstanding Faculty and Researchers Program.

She added this patent is the embodiment of the university's vision of harnessing the benefits of international collaboration in research and education that will ultimately speed up information and technology exchange and the transfer of medical discoveries from the laboratory bench to patients' bedside.

"More than 50 percent of our postgraduate medical trainee and students abroad are already enrolled in formal research programs such as Master's and Ph.D, programs alongside their clinical training," said Al-Omran.

He said he intends to continue his research on the BRCA1 gene in order to move on from the experimental phase to the application of the therapy on patients after going through the necessary experiments and ethical approval.

Arab News 2012

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Leading Business Intelligence on the Middle East & North Africa

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SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions through its ongoing acquisition of the assets of SG Austria, realizes the important role for Cell-in-a-Box technology, and what it offers the medical community, and aims today to discuss the potential it will serve as a treatment option for a variety of solid tumors.

As discussed previously, the Cell-in-a-Box technology involves the encapsulating, or encasing of live cells in a specially created cotton-based capsule. The cell-type chosen, in the case of cancer treatment it is a cytochrome P450 expressing cell, is chosen for the disease and then is ultimately placed beside or within the target tumor while the cells remain inside the capsule. For cancer, once a patient receives the drug to be converted, the encapsulated cells transform this into an active chemotherapeutic. As a result, a high concentration of the drug is provided locally to the tumor.

Although the original human clinical trials were limited to pancreatic cancer tumors, later work showed the Cell-in-a-Box encapsulation technology has great potential for use in other solid tumors. The work also pointed toward encapsulated cells expressing more than one drug-activating enzyme as being of potential value in treating other cancers, indicating the possibility of combination drug therapies targeted by one or more encapsulated cell product(s) being placed in or near the tumor to cause a high level of chemotherapy at the site its intended for.

Most chemotherapy drugs affect both normal and cancerous tissue, which is why they are so toxic to naturally fast-growing cells in the body, such as hair follicles and intestinal cells. By using encapsulated cytochrome P450 expressing cells to convert the drug locally and then placing them close to or in a tumor, much less active drug is available to cause harm to healthy normal cells and instead its localized high concentration remains in the tumor region, irrespective of solid tumor type being treated, and thereby can increase elimination of the tumor cells.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, added, The work that continues to be advanced by SG Austria expands the possible use of the Cell-in-a-Box technology beyond pancreatic cancer. When combined with the potential downstream affect on micro metastases through use of encapsulated cells, we can realistically imagine being able to treat cancers across a broad spectrum. Our goal is to minimize normal cell and tissue damage, reduce the life-threatening side effects, and yet bring about elimination of a persons cancer. Over the past year and through today, we have continued to research new ways to improve on the quality and quantity of the products we will be driving forward, including the pancreatic cancer treatment, all of which are designed to increase the quality of our lives through effective use of live cell encapsulation.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX.PK - News) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties. Results, events and performances could vary from those contemplated. These statements involve risks and uncertainties which may cause actual results, expressed or implied, to differ from predicted outcomes. Risks and uncertainties include product demand, market competition, and Nuvilexs ability to meet current or future plans. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

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Completed Clinical Trial Further Indicates Cell-in-a-Box® Encapsulation Technology Has the Potential to Treat a Wide ...

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Editor's Choice Academic Journal Main Category: Heart Disease Also Included In: Genetics;Medical Devices / Diagnostics Article Date: 16 Mar 2012 - 9:00 PDT

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Using a gene analysis tool called the Cardiochip, the researchers examined a specific gene variant associated with inflammation and heart disease. The chip was designed by Brendan J. Keating, Ph.D., co-author of the study and a researcher in the Center for Applied Genomics at The Children's Hospital of Philadelphia.

Even though researchers are aware of the association between inflammation and atherosclerosis - a disorder in which fat, cholesterol, and other fatty deposits build up in the walls of arteries - they have been unable to find an inflammatory agent that causes the diseases, until now. In addition, researchers did not know whether a drug targeted at reducing inflammation might treat the disease.

The team focused on the signaling protein interleukin-6 receptor (IL6R). IL6R is found in the blood and increases inflammatory responses.

Keating explained:

The meta-analysis study was conducted by the IL6R Mendelian Randomization Analysis Consortium, and international team of investigators led by Dr. Juan Pablo Casas, Professor Aroon. D. Hingorani, and Dr. Daniel I. Swerdlow, all of University College London, UK.

The researchers examined data from 40 previous studies that involved almost 133,500 individuals from Europe and the United States. Mendelian randomization is a research technique that utilizes knowledge of genes and biological mechanisms in order to figure out the likely effects of a new medication before a clinical trial is conducted, with its potential risk of adverse effects and high cost.

In the same issue of The Lancet, an associated report conducted by the IL6R Genetics Consortium and Emerging Risk Factors Collaboration, discovered that a genetic variant of the IL6R gene, which carries the code for the IL6R protein, decreases inflammation and therefore reduces the risk of heart disease.

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Gene Chip May Help Prevent Heart Disease

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A team of Stanford researchers has unveiled the most detailed biological profile of a human being done so far: a peek at one man's genetic foundation, along with snapshots, taken dozens of times over the course of a year, of the millions of proteins and other molecules that are in constant flux in his body.

In a stroke of shocking good luck - for the scientists, if not necessarily the patient - the profile subject developed Type 2 diabetes during the study, allowing researchers to follow in real time the molecular changes that took place as the illness progressed.

It also allowed the subject, Stanford geneticist Michael Snyder, to catch his diabetes early and stop it, most likely months or even years before he would have been diagnosed without the genetic profiling.

"This is the first time someone's actually analyzed the genome of a healthy person, predicted disease risk, and then by following him, actually saw a disease develop," said Snyder, who in addition to being the subject of the study was the senior author.

Snyder's profile and an analysis of the results were published today in the journal Cell. Snyder, chairman of the genetics department at Stanford, is not named in the published study because of privacy rules, but he volunteered to identify himself.

The research provides some of the first proof that detailed genetic profiling - beyond just DNA sequencing - could be used someday not just to predict an individual's chances of developing disease, but also to identify the smallest molecular changes that show when a person starts to become ill, said experts in personalized medicine.

The first human genome - a map of all of the DNA in a human cell - was announced in 2000. Seven or eight years later geneticists began mapping the genomes of specific individuals. Such personal genomic sequencing is expected to become widely available this year, at a cost of several thousand dollars.

Using genetic information to help diagnose and treat patients is still a very new field, although it's growing rapidly. Certain key genes have been found to greatly increase the risk of breast cancer, for example, or the deadly Huntington's disease, and doctors will regularly test for those genes when someone is diagnosed with an illness or when a close family member is known to have a disease.

But for most people, DNA sequencing and other biological profiling isn't yet useful - subjects would end up with a lot of unwieldy information that is mostly beyond modern scientific understanding or far too expensive to analyze.

"What they did (at Stanford) is much more interesting from a scientific basis than a practical basis," said Dr. David Witt, a medical geneticist at Kaiser San Jose. "And that gets to the heart of personalized medicine: It's not ready for prime time."

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Stanford gene researchers see diabetes develop

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15-03-2012 12:52 Personalized Medicine: trends and prospects for the new science of genetic testing and molecular diagnostics Overview of new working paper -- Mapping the Future of Genetic Testing and Molecular Diagnostics: A payer's perspective on integrating personalized care into clinical practice Review of results of survey of consumers and physicians about genetic testing Deneen Vojta, UnitedHealth Group

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Personalized Medicine, UnitedHealth Group - Video

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15-03-2012 14:59 What is the relationship between implementation guidelines and reimbursement? Are payers the ultimate gatekeeper? Is it worth educating healthcare providers and patients? • Appropriate uses of genetic testing • Evidence-based guidelines and flexibility • Clinical management of new technology • Best practices (eg, breast cancer) Moderator: Robert Green, Harvard Medical School Robert McCormack, Veridex/J&J Thomas Musci, Novartis Diagnostics Greg Feero, Maine - Dartmouth Family Medicine Residency and NHGRI Deborah Heine, Claire Altman Heine Foundation

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Integrating new genetic testing technologies into clinical pathways - Video

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15-03-2012 16:33 This panel will consider the context for evidence, rather than the level of evidence, needed to move innovative technology into a clinical setting and how we will generate the needed evidence. Which evidence questions must be answered pre- market and which, if any, can be answered post-market? It will consider the often mismatched evidence requirements of patients, clinicians, test developers, regulators and payers. Collectively, we should define a burden of evidence that's appropriate for the balances of risk and speed that is appropriate in this space. This will require community-wide cooperation to collect and analyze data residing in many different places -- inside pharmaceutical companies, inside diagnostics companies and payers -- to measure outcomes and define the best use of diagnostics, and innovative methodologies to generate evidence (both in process and results). Moderator: Adam Berger, Institute of Medicine Patricia Deverka, Center for Medical Technology Policy Stanley Lapidus, SynapDx Susan Friedman, Facing Our Risk of Cancer Empowered David Clifford, PatientsLikeMe Roger Klein, University of South Florida Medical School

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Evidence - Video

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A team of Stanford researchers has unveiled the most detailed biological profile of a human being done so far: a peek at one man's genetic foundation, along with snapshots, taken dozens of times over the course of a year, of the millions of proteins and other molecules that are in constant flux in his body.

In a stroke of shocking good luck - for the scientists, if not necessarily the patient - the profile subject developed Type 2 diabetes during the study, allowing researchers to follow in real time the molecular changes that took place as the illness progressed.

It also allowed the subject, Stanford geneticist Michael Snyder, to catch his diabetes early and stop it, most likely months or even years before he would have been diagnosed without the genetic profiling.

"This is the first time someone's actually analyzed the genome of a healthy person, predicted disease risk, and then by following him, actually saw a disease develop," said Snyder, who in addition to being the subject of the study was the senior author.

Snyder's profile and an analysis of the results were published today in the journal Cell. Snyder, chairman of the genetics department at Stanford, is not named in the published study because of privacy rules, but he volunteered to identify himself.

The research provides some of the first proof that detailed genetic profiling - beyond just DNA sequencing - could be used someday not just to predict an individual's chances of developing disease, but also to identify the smallest molecular changes that show when a person starts to become ill, said experts in personalized medicine.

The first human genome - a map of all of the DNA in a human cell - was announced in 2000. Seven or eight years later geneticists began mapping the genomes of specific individuals. Such personal genomic sequencing is expected to become widely available this year, at a cost of several thousand dollars.

Using genetic information to help diagnose and treat patients is still a very new field, although it's growing rapidly. Certain key genes have been found to greatly increase the risk of breast cancer, for example, or the deadly Huntington's disease, and doctors will regularly test for those genes when someone is diagnosed with an illness or when a close family member is known to have a disease.

But for most people, DNA sequencing and other biological profiling isn't yet useful - subjects would end up with a lot of unwieldy information that is mostly beyond modern scientific understanding or far too expensive to analyze.

"What they did (at Stanford) is much more interesting from a scientific basis than a practical basis," said Dr. David Witt, a medical geneticist at Kaiser San Jose. "And that gets to the heart of personalized medicine: It's not ready for prime time."

Original post:
Stanford man's genetic profile yields surprises

Recommendation and review posted by Bethany Smith

ScienceDaily (Mar. 15, 2012) A collaborative discovery involving Kansas State University researchers may improve animal health and save the U.S. pork industry millions of dollars each year.

Raymond "Bob" Rowland, a virologist and professor of diagnostic medicine and pathobiology, was part of the collaborative effort that discovered a genetic marker that identifies pigs with reduced susceptibility to porcine reproductive and respiratory syndrome, or PRRS. This virus costs the U.S. pork industry more than $600 million each year.

"This discovery is what you call a first-first," Rowland said. "This discovery is the first of its kind for PRRS but also for any large food animal infectious disease. I have worked in the field for 20 years and this is one of the biggest advances I have seen."

Rowland and researchers Jack Dekkers from Iowa State University and Joan Lunney from the Agricultural Research Service discovered a genetic marker called a quantitative trait locus, or QTL, which is associated with porcine reproductive and respiratory syndrome virus susceptibility. This discovery is a first step in controlling and eliminating the virus.

The research recently appeared in the Journal of Animal Science. The project's beginning and future center around Kansas State University, Rowland said.

It begins at the university because Rowland is involved with an organization called the PRRS Host Genetics Consortium, or PHGC, which initiated and provided more than $5 million for the research. Rowland is co-director of the consortium, which is a collaboration among the United States Department of Agriculture, the National Pork Board and Genome Canada as well as universities and industry members. Rowland is also director of the USDA-funded PRRS Coordinated Agriculture Project, known as PRRS CAP.

"The PRRS Host Genetics Consortium takes fundamental science and turns it into utility," Rowland said.

Kansas State University's new Large Animal Research Center is the site of much of the project's experimental work. The researchers obtain multiple measurements -- including growth, weight gain, performance and virus measurements -- over time. They have collected samples from more than 2,000 pigs since they began the study in 2007, for a total of more than 100,000 samples that are stored or distributed to the consortium's collaborators.

The university shipped samples to the Agricultural Research Service for genomic DNA preparations to identify differences among more than 60,000 genes. The data was transferred to Iowa State University for genetic analysis that led to the discovery of the QTL.

The collaborators at Iowa State University created a common database so that all the data collected during the project can be accessed at multiple locations by researchers and the breeding industry for the next several decades.

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Animal health breakthrough: Research uncovers genetic marker that could help control, eliminate PRRS virus

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Editor's Choice Academic Journal Main Category: Lymphoma / Leukemia / Myeloma Also Included In: Cancer / Oncology;Genetics Article Date: 16 Mar 2012 - 9:00 PDT

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Ross Levine, M.D., lead author of the study, member of Memorial Sloan-Kettering's Human Oncology Pathogenesis Program, and a medical oncologist on the Leukemia Service at Memorial Sloan-Kettering, said:

We also want to use existing therapies more intelligently. It helps a great deal to know which subset of patients will actually benefit from intensive therapies, such as a higher dose of chemotherapy or a bone marrow transplant."

Currently, there are just a few known genetic biomarkers that clinicians rely on in order to predict outcome in individuals suffering with leukemia. Although these biomarkers provide helpful information for some patients with AML, for the majority it is hard to predict the chance for a cure.

The researchers used a method that incorporated information from a set of genes. This allowed them to categorize almost two-thirds of patients into clearly defined prognostic groups.

Dr. Levine, explained:

"Our goal was not to ask whether a certain gene or two raised or lowered risk, but to determine whether a combination of characteristics from a set of genes made it possible to precisely stratify patients according to risk."

The team examined blood or bone marrow samples from 502 individuals with AML who took part in a clinical trial conducted by Martin S. Tallman, M.D., Chief of Memorial Sloan-Kettering's Leukemia Service. The aim of the trial was to determine whether increasing the standard dose of chemotherapy would improve survival for individuals with AML under the age of 60.

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Leukemia Patients' Outcomes Predicted With Genetic Profiling

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PHILADELPHIA A growing body of evidence underscores the importance of human gut bacteria in modulating human health, metabolism, and disease. Yet bacteria are only part of the story. Viruses that infect those bacteria also shape who we are. Frederic D. Bushman, PhD, professor of Microbiology at the Perelman School of Medicine at the University of Pennsylvania, led a study published this month in the Proceedings of the National Academy of Sciences that sequenced the DNA of viruses -- the virome -- present in the gut of healthy people.

Nearly 48 billion bases of DNA, the genetic building blocks, were collected in the stools of 12 individuals. The researchers then assembled the blocks like puzzle pieces to recreate whole virus genomes. Hundreds to thousands of likely distinct viruses were assembled per individual, of which all but one type were bacteriophages viruses that infect bacteria -- which the team expected. The other was a human pathogen, a human papillomavirus found in a single individual. Bacteriophages are responsible for the toxic effects of many bacteria, but their role in the human microbiome has only recently started to be studied.

To assess variability in the viral populations among the 12 individuals studied, Bushman's team, led by graduate student Samuel Minot, looked for stretches of bases that varied the most.

Their survey identified 51 hypervariable regions among the 12 people studied, which, to the team's surprise, were associated with reverse transcriptase genes. Reverse transcriptase enzymes, more commonly associated with replication of retroviruses such as HIV, copy RNA into DNA. Of the 51 regions, 29 bore sequence and structural similarity to one well-studied reverse transcriptase, a hypervariable region in the Bordetella bacteriophage BPP-1. Bordetella is the microbe that causes kennel cough in dogs.

BPP-1 uses reverse transcriptase and an error-prone copying mechanism to modify a protein to aid in entering and reproducing in a wide array of viral targets. Bushman and colleagues speculate that the newly discovered hypervariable regions could serve a similar function in the human virome, and microbiome, by extension.

"It appears there's natural selective pressure for rapid variation for these classes of bacteriophages, which implies there's a corresponding rapidly changing environmental factor that the phage must be able to quickly adapt to," says Minot. Possible reasons for change, say the authors, include evading the immune system and keeping abreast of ever-evolving bacterial hosts a kind of mutation-based host-pathogen arms race. Whatever the case, Minot says, such variability may be helping to drive evolution of the gut microbiome: "The substrate of evolution is mutation."

Evolutionary analysis of the 185 reverse transcriptases discovered in this study population suggests that a large fraction of these enzymes are primarily involved in generating diversity. Now, Minot says, the challenge is to determine the function of the newly discovered hypervariable regions, and understand how their variability changes over time and in relationship to disease.

"This method opens a whole new world of 'diversity-generating' biology to discover what these clearly important systems are actually doing," he says.

In addition to Bushman and Minot, co-authors are Stephanie Grunberg (Department of Microbiology); Gary Wu (Division of Gastroenterology); and James Lewis (Department of Biostatistics and Epidemiology), all from Penn.

The research was supported by grants from the National Institutes of Health, Pennsylvania Department of Health, and the Crohn's and Colitis Foundation of America.

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Genetic Variation in Human Gut Viruses Could be Raw Material for Inner Evolution, Perelman School of Medicine Study ...

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By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) Dealing with incidental findings uncovered in whole-genome and whole-exome sequencing studies has been a contentious issue in the move to bring next-generation sequencing into the clinic.

A paper published today in Genetics in Medicine finds that physicians generally agree that those findings should be returned to adult patients, especially when medical intervention is possible. They differ, however, in their opinions on whether the findings should be returned to pediatric patients.

"This is the first study to ask specialists in genetics and laboratory medicine about the conditions they would like to see returned to clinicians who order genome sequencing," Robert Green, a geneticist at Brigham and Women's Hospital and Harvard Medical School and co-leader of the study, said in a statement. "It was heartening that the majority of specialists agreed that many incidental findings should be returned."

Co-led by Green and Howard Jacob, director of the human and molecular genetics center at the Medical College of Wisconsin, the researchers surveyed 16 genetics specialists on their recommendations for returning genetic information.

The specialists were questioned about whether they would return known pathogenic mutations, mutations that were likely to be pathogenic, and variants to known disease genes but with unknown consequences, from 99 genetic conditions and disease predisposition genes.

Around 80 percent of the specialists agreed on the return of known pathogenic mutations for 64 different diseases, and all of them agreed on the return of results for 21 different conditions for things like cancer risk and other diseases where there is the potential for medical intervention.

Opinions differed however, on returning results to children. For instance, while all the participants agreed that known variants conferring risk for hereditary breast and ovarian cancer should be returned to adults, only 75 percent thought that information should be shared with children.

Additionally, there was less agreement about what to do with findings that predicted risk for diseases for which there are no treatments, such as Huntington's disease or Alzheimer's.

Around 60 percent of the specialists said that known mutations in the genes for Huntington's disease should be returned to adults, but only 31 percent thought those findings should be returned to children. Half thought that mutations to APOE, which suggests a predisposition to Alzheimer's, should be returned to adults, while 25 percent said that the finding should be returned to children.

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Incidental Findings from Sequencing Studies Should be Returned, Say Genetics Specialists

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

Contact: Phyllis Edelman pedelman@genetics-gsa.org 301-351-0896 Genetics Society of America

Bethesda, MD March 15, 2012 -- A new research report appearing in the March 2012 issue of the journal Genetics shows why the development of a cure and new treatments for HIV has been so difficult. In the report, an Australian scientist explains how he used computer simulations to discover that a population starting from a single human immunodeficiency virus can evolve fast enough to escape immune defenses. These results are novel because the discovery runs counter to the commonly held belief that evolution under these circumstances is very slow.

"I believe the search for a cure for AIDS has failed so far because we do not fully understand how HIV evolves," said Jack da Silva, Ph.D., author of the study from the School of Molecular and Biomedical Science at the University of Adelaide in Adelaide, Australia. "Further insight into the precise genetic mechanisms by which the virus manages to so readily adapt to all the challenges we throw at it will, hopefully, lead to novel strategies for vaccines and other control measures."

To make this discovery, da Silva used computer simulation to determine whether, under realistic conditions, the virus could evolve as rapidly as had been reported if the virus population started from a single individual virus. This was done by constructing a model of the virus population and then simulating the killing of virus-infected cells by the immune system, along with mutation, recombination and random genetic changes, due to a small population size, affecting viral genes. Results showed that for realistic rates of cell killing, mutation and recombination, and a realistic population size, that the virus could evolve very rapidly even if the initial population size is one.

"A cure for HIV/AIDS has been elusive, and this report sheds light on the reason," said Mark Johnston, Ph.D., Editor-in-Chief of the journal Genetics. "Now that we know HIV rapidly evolves, even when its population size is small, we may be able to interfere with its ability to evolve so we can get the most out of the treatments that are developed."

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ABOUT GENETICS: Since 1916, Genetics has covered high quality, original research on a range of topics bearing on inheritance, including population and evolutionary genetics, complex traits, developmental and behavioral genetics, cellular genetics, gene expression, genome integrity and transmission, and genome and systems biology. Genetics, the peer-reviewed, peer-edited journal of the Genetics Society of America is one of the world's most cited journals in genetics and heredity.

ABOUT GSA: Founded in 1931, the Genetics Society of America (GSA) is the professional membership organization for scientific researchers, educators, bioengineers, bioinformaticians and others interested in the field of genetics. Its nearly 5,000 members work to advance knowledge in the basic mechanisms of inheritance, from the molecular to the population level. The GSA is dedicated to promoting research in genetics and to facilitating communication among geneticists worldwide through its conferences, including the biennial conference on Model Organisms to Human Biology, an interdisciplinary meeting on current and cutting edge topics in genetics research, as well as annual and biennial meetings that focus on the genetics of particular organisms, including C. elegans, Drosophila, fungi, mice, yeast, and zebrafish. GSA publishes Genetics, a leading journal in the field and a new online, open-access publication, G3: Genes|Genomes|Genetics. For more information about GSA, please visit http://www.genetics-gsa.org. Also follow GSA on Facebook at facebook.com/GeneticsGSA and on Twitter @GeneticsGSA.

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Computer simulations help explain why HIV cure remains elusive

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AMES, Iowa, March 15, 2012 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK - News), today announced that financial results for the company's fourth quarter and year ended December 31, 2011 will be released after the market closes on Thursday, March 29, 2012. The NewLink management team will host a conference call discussing the company's financial results and recent developments on Thursday, March 29, 2012 at 5:00 p.m. (EDT). The call can be accessed by dialing (877) 303-6919 (domestic) or (253) 237-1194 (international) five minutes prior to the start of the call and providing the passcode 62462759. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international), providing the passcode 62462759. The replay will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the NewLink website at http://investors.linkp.com/. A replay of the webcast will be archived on the company's website for two weeks following the call.

About NewLink Genetics Corporation

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. 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 with an objective to harness multiple components of the innate immune system to combat cancer, either as a monotherapy or in combination with current treatment regimens, without incremental toxicity. NewLink's lead product candidate, HyperAcute Pancreas cancer immunotherapy is being studied in a Phase 3 clinical trial in surgically-resected pancreatic cancer patients (patient information is available at http://www.pancreaticcancer-clinicaltrials.com). This clinical trial is being performed under a Special Protocol Assessment with the U.S. Food and Drug Administration. NewLink and its collaborators have completed patient enrollment for a Phase 1/2 clinical trial evaluating its HyperAcute Lung cancer immunotherapy product candidate for non-small cell lung cancer and a Phase 2 clinical trial for its HyperAcute Melanoma cancer immunotherapy product candidate. NewLink also is developing d-1-methyltryptophan, or D-1MT, a small-molecule, orally bioavailable product candidate from NewLink's proprietary indoleamine-(2, 3)-dioxygenase, or IDO, pathway inhibitor technology. Through NewLink's collaboration with the National Cancer Institute, NewLink is studying D-1MT in various chemotherapy and immunotherapy combinations in two Phase 1B/2 safety and efficacy clinical trials. For more information please visit http://www.linkp.com.

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NewLink Genetics Announces 2011 Fourth Quarter and Year-End Conference Call and Webcast

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Newswise Infants with Batten disease, a rare but fatal neurological disorder, appear healthy at birth. But within a few short years, the illness takes a heavy toll, leaving children blind, speechless and paralyzed. Most die by age 5.

There are no effective treatments for the disease, which can also strike older children. And several therapeutic approaches, evaluated in mouse models and in young children, have produced disappointing results.

But now, working in mice with the infantile form of Batten disease, scientists at Washington University School of Medicine in St. Louis and Kings College London have discovered dramatic improvements in life span and motor function by treating the animals with gene therapy and bone marrow transplants.

The results are surprising, the researchers say, because the combination therapy is far more effective than either treatment alone. Gene therapy was moderately effective in the mice, and bone marrow transplants provided no benefit, but together the two treatments created a striking synergy.

The research is reported online in the Annals of Neurology.

Until now, this disease has been refractory to every therapy that has been thrown at it, says senior author Mark Sands, PhD, professor of medicine and of genetics at the School of Medicine. The results are the most hopeful to date, and they open up a new avenue of research to find effective therapies to fight this devastating disease.

The combination therapy did not cure the disease, the scientists caution, but mice that received both treatments experienced significant, lasting benefits.

Mice that got gene therapy and a bone marrow transplant lived nearly 18.5 months, more than double the lifespan of untreated mice with the disease. (Healthy laboratory mice live about 24 months.) And for a significant portion of their lives, motor skills in mice that got both therapies were indistinguishable from those in normal, healthy mice.

While bone marrow transplants carry significant risks, especially in children, the researchers say they may be able to combine gene therapy with another treatment to achieve the same results. This same approach potentially could be used to treat other forms of Batten disease.

Batten disease is an inherited genetic disorder that strikes fewer than five of every 100,000 U.S. children but is slightly more common in northern Europe. There are several forms of the disease, diagnosed at different ages, and all are related to the inability of cells to break down and recycle proteins.

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Combination Treatment in Mice Shows Promise for Fatal Neurological Disorder in Kids

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