StemCell Therapy

Reprinted with the kind permission of Cort Johnson and Health RisingMost people with chronic fatigues syndrome (ME/CFS) and fibromyalgia (FM) know the consequences of poor sleep the fatigue and pain, the difficulty concentrating, the irritability and more. Sleep is when our body rejuvenates itself; no sleep no rejuvenation. Given how important sleep is to our health, its no surprise that poor sleep is the first symptom many ME/CFS and FM doctors focus on.The effects of poor sleep go beyond just feeling bad, though. It turns out that poor sleep can have significant effects on our immune system effects, interestingly, which are similar to whats been found in the immune systems of people with ME/CFS and FM. Theres no evidence yet that ME/CFS and FM are sleep disorders that the problems ME/CFS and FM patients face are caused by poor sleep but depriving the body of sleep can cause one immunologically, at least, look like someone with these diseases.Why Sleep Is Important for Health: A Psychoneuroimmunology Perspective-Michael R. Irwin. Annu Rev Psychol. 2015 January 3; 66: 143172. doi:10.1146/annurev-psych-010213-115205.Irwin begins his review on sleep and immunology by noting the explosion in our understanding of the role sleep plays in health over the past decade. First, Irwin demolishes the idea that sleep studies are effective in diagnosing insomnia or sleep disturbances other than sleep apnea. Far more effective than a one or two-night sleep study is a home based sleep actigraph study which estimates sleep patterns and circadian rhythms over time and is coupled with a sleep diary.In fact, Irwin points out that the diagnosis of insomnia in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) is based solely on patient reports of difficulties going to sleep, maintaining sleep, having non-restorative sleep (common in ME/CFS) and problems with daytime functioning (fatigue, falling asleep, need to nap). (Problems with daytime functioning are actually required for an insomnia diagnosis.)Several effective sleep questionnaires exist including the Insomnia Severity Index, which assesses sleep quality, fatigue, psychological symptoms, and quality of life and the Pittsburgh Sleep Quality Index, a 19-item self-report questionnaire that evaluates seven clinically derived domains of sleep difficulties (i.e., quality, latency, duration, habitual efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction).Assess Your Sleep QualityThe Immune System and SleepThe immune system is vast and incredibly complex and has its own extensive set of regulatory factors, but is itself regulated by two other systems, the HPA axis and the sympathetic nervous system. Both are involved in the stress response and both are affected in ME/CFS and FM. One the HPA axis is blunted in ME/CFS, while the other the sympathetic nervous system is over-activated.Poor sleep, it turns out activates both system. The HPA axis is generally thought to be blunted, not activated, in the morning in ME/CFS patients, but the sympathetic nervous system (SNS), on the other hand, is whirring away at night (when it should be relaxing) in both FM and ME/CFS. (Having our fight or flight system acting up at night is probably not the best recipe for sleep.)Sympathetic nervous system activation, in fact, was the only factor in one Australian study which explained the poor sleep in ME/CFS. The authors of a recent FM/autonomic nervous system study went so far as to suggest that going to sleep with FM was equivalent to undergoing a stress test (!). Heart rates, muscle sympathetic nervous activation, and other evidence of an activated sympathetic nervous system response made sleep anything but restful for FM patients. In fact, the authors proposed sleep problems could be a heart of fibromyalgia.

Many questions have involved the roles pathogens play in ME/CFS and FM. Thats intriguing given the almost universally poor sleep found in the disorders and role recent studies indicate that sleep plays priming the immune systems pump to fight off invaders. During sleep, pathogen-fighting immune cells move to the lymph nodes where they search for evidence of pathogens. If pathogens are present, those immune cells mount a furious (and metabolically expensive) immune response.

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Is Poor Sleep Pummeling the Immune System in ME/CFS and Fibromyalgia? A Vicious Circle Examined - ProHealth

RURAL REPORTER

Last updated12:12, September 4 2017

LIC

A good looker, and the best performing bull at LIC is Sierra, a kiwicross bull. The 7-year-old bull might have 100,000 daughters in the next few years.

Father's Day was on Sunday, and many families got together,but there wasone super dad who foundit a struggle meeting all his offspring.

Sierra, one of LIC's top bulls, has fathered 1700 daughters (milking dairy cows).

"We expect that he will have 12,000 more daughters entering the national herd this year, and predict a further 100,000 over the next few years," said Simon Worth, LIC's livestock selection manager.

Farmers needed top quality genetics to get their cows producing top quality heifers in New Zealand and internationally.He said LIC owned24 of the top 30 artificial breeding (AB) bulls in the country, including Sierra - its top kiwicross bull.

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"Bulls like Sierra are shaping the future of dairying in New Zealand. Our bulls provide three out of every four cows in the country, contributing $300 million towards the economy each year," said Dave Hale, LIC's national artificial breeding manager.

During the peak dairy cow mating season in spring LIC collectedsemen from its 73 elite bulls seven days a week, at itsNewstead farm near Hamilton.

Up to five million semen straws will be processed between now and Christmas, with the co-op's exclusive long last liquid semen diluent (LIC proprietary technology) enabling one bull ejaculate to average 7000 fresh semen straws for insemination.

Straws are sentfresh to a team of 775 AB technicians all over the country, for insemination into cows as early as that same afternoon. Top AB technicians inseminate up to 10,000 cows a year, or200-300 a day.

On the peak day in spring 120,000 semen straws are dispatched nationally, internationally the co-op exports one million frozen straws worldwide year-round.

"While only seven years old, Sierra is definitely one of our super dad bulls. Without them Kiwis probably wouldn't have their morning lattes," said Hale.

-Stuff

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Artificial breeding bulls in demand as farmers improve genetics - Stuff.co.nz

Maryland Heights, MO September 1, 2017 (STL.NEWS)Mercy Clinic Primary Care has opened a new practice with three doctors, Jason Hand, MD, Fred Balch, DO and Justin Starke, MD and family nurse practitioner Jill Aberdeen Kolchinsky, FNP. The office is temporarily located in Maryland Heights at 12445 Dorsett Road and will move to its permanent location on the Mercy Hospital St. Louis campus later this fall.

Drs. Balch and Starke are new to Mercy Clinic but familiar with St. Louis area as they both grew up in the area and completed internal medicine residencies at Mercy Hospital St. Louis.

Dr. Balch was raised in St. Charles, Missouri, and graduated from Francis Howell High School.

Did you always know you wanted to be a doctor?Interestingly, I actually went into college with the intent of studying to be a veternarian. It was after my first or second year of undergrad that I realized human medicine was actually more of a true calling. In reality though, I was exposed to the medical field even at a very young age as my mom was an emergency room nurse.

What drew you to internal medicine?For me, there are very few medical specialties that require the depth of knowledge and experience to diagnose and manage such a vast array of acute and chronic medical conditions. It is this Jack-of- all-trades aspect of internal medicine that drew me to it. I chose primary care because of the patient-physician relationship. I get the humbling experience of meeting and forming long-lasting relationships with people from all walks of life, different backgrounds and experiences, as well as different personalities.

What made you want to join Mercy?Having the privilege of doing my internal medicine training at Mercy Hospital St. Louis, I was able to witness first hand the top-notch care that Mercy provides. The specialists, nursing staff and administration are fantastic and truly go above and beyond to assure that patient care is a number one priority.

Dr. Starke was born and raised in the St. Louis area and graduated from St. Louis Priory School. Outside of the office, Starke enjoys cooking and spending time with his wife, son and is excited to soon welcome a baby girl.

Did you always know you wanted to be a doctor?I knew I wanted to be a doctor the moment I realized I would never become a professional athlete, which was probably around age 7.

What drew you to the internal medicine?I was drawn to internal medicine and primary care, in particular, because I love managing a broad scope of medical problems, but also welcome the chance to excel in preventative medicine, working to keep patients out of the hospital and doctors office as much as possible.

What made you want to join Mercy?I was drawn to Mercy by the incredible team-work mentality that recognizes and encourages all employees to work toward the ultimate goal of delivery excellent patient care. Having worked in the residency program for three years I got to witness and be a part of this first-hand.

source; Mercy Clinic Primary Care, published on STL.NEWS by St Louis Media, LLC

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Mercy Clinic Primary Care has opened a new practice - STL News - STL.News

Light, fat, and commensals

The gut microbiota facilitates energy harvest from food and transfers it into fat storage. Working in mice, Wang et al. found that an epithelial cell circadian transcription factor, NFIL3, is involved in regulating body composition through lipid uptake. Flagellin and lipopolysaccharide produced by certain microbes tuned the amplitude of oscillation of NFIL3 through innate lymphoid cell (ILC3) signaling, STAT3, and the epithelial cell clock. Such interactions may help to explain why circadian clock disruptions in humans, arising from shift work or international travel, frequently track with metabolic diseases, including obesity, diabetes, and cardiovascular disease.

Science, this issue p. 912

The intestinal microbiota has been identified as an environmental factor that markedly affects energy storage and body-fat accumulation in mammals, yet the underlying mechanisms remain unclear. Here we show that the microbiota regulates body composition through the circadian transcription factor NFIL3. Nfil3 transcription oscillates diurnally in intestinal epithelial cells, and the amplitude of the circadian oscillation is controlled by the microbiota through group 3 innate lymphoid cells, STAT3 (signal transducer and activator of transcription 3), and the epithelial cell circadian clock. NFIL3 controls expression of a circadian lipid metabolic program and regulates lipid absorption and export in intestinal epithelial cells. These findings provide mechanistic insight into how the intestinal microbiota regulates body composition and establish NFIL3 as an essential molecular link among the microbiota, the circadian clock, and host metabolism.

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The intestinal microbiota regulates body composition through NFIL3 and the circadian clock - Science Magazine

Myriad Genetics (NASDAQ: MYGN) and Varex Imaging (NASDAQ:VREX) are both medical companies, but which is the better investment? We will compare the two businesses based on the strength of their dividends, valuation, institutional ownership, earnings, analyst recommendations, risk and profitability.

Valuation & Earnings

This table compares Myriad Genetics and Varex Imagings revenue, earnings per share (EPS) and valuation.

Varex Imaging has higher revenue, but lower earnings than Myriad Genetics.

Analyst Ratings

This is a breakdown of recent ratings and target prices for Myriad Genetics and Varex Imaging, as provided by MarketBeat.com.

Myriad Genetics presently has a consensus target price of $20.38, suggesting a potential downside of 32.64%. Varex Imaging has a consensus target price of $33.50, suggesting a potential upside of 7.48%. Given Varex Imagings stronger consensus rating and higher probable upside, analysts plainly believe Varex Imaging is more favorable than Myriad Genetics.

Institutional & Insider Ownership

91.8% of Varex Imaging shares are owned by institutional investors. 6.2% of Myriad Genetics shares are owned by insiders. Strong institutional ownership is an indication that endowments, large money managers and hedge funds believe a stock will outperform the market over the long term.

Profitability

This table compares Myriad Genetics and Varex Imagings net margins, return on equity and return on assets.

Summary

Myriad Genetics beats Varex Imaging on 6 of the 10 factors compared between the two stocks.

Myriad Genetics Company Profile

Myriad Genetics, Inc. is a molecular diagnostic company. The Company is engaged in the discovery, development and marketing of transformative molecular diagnostic tests. The Company operates through two segments: diagnostics and other. The diagnostics segment provides testing and collaborative development of testing that is designed to assess an individuals risk for developing disease later in life, identify a patients likelihood of responding to drug therapy and guide a patients dosing to enable optimal treatment, or assess a patients risk of disease progression and disease recurrence. The other segment provides testing products and services to the pharmaceutical, biotechnology and medical research industries, research and development, and clinical services for patients, and also includes corporate services, such as finance, human resources, legal and information technology. Its molecular diagnostic tests include myRisk Hereditary Cancer, BRACAnalysis CDx and COLARIS.

Varex Imaging Company Profile

Varex Imaging Corporation is a supplier of medical X-ray tubes and image processing solutions. The Companys segments include Medical and Industrial. The X-ray imaging system manufacturers use the Companys components for medical imaging, cargo screening and border security, to detect, diagnose and protect. The Medical business segment designs, manufactures, sells and services X-ray imaging components for use in a range of applications, including radiographic or fluoroscopic imaging, mammography, special procedures, computed tomography, radiation therapy and computer-aided detection. The Industrial business segment designs, manufactures, sells and services products for use in security and industrial inspection applications, such as cargo screening at ports and borders and non-destructive examination in a range of applications.

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Myriad Genetics (MYGN) and Varex Imaging (VREX) Financial Survey - The Ledger Gazette

A recent Duke University study sheds new light on intestinal health and disease.

The study, called Genomic Dissection of Conserved Transcriptional Regulation in Intestinal Epithelial Cells, published Tuesday in PLOS Biology journal.

Scientists identified an ancient network of genes shared between humans and other vertebrates that make up the intestine.

These results indicate that the intestines of humans and fishes share more in common than once presumed, making it possible to look into the guts of fish and other related animals to learn about the origins of human intestinal conditions, said Dr. John Rawls, the senior author of the study.

Some of the shared genes have previously been linked to diabetes, inflammatory bowel diseases and obesity. Rawls, associate professor of molecular genetics and microbiology at Dukes School of Medicine, said the researchers believe they discovered what may turn those genes on and off.

Our research has uncovered aspects of intestinal biology that have been well-conserved during vertebrate evolution, suggesting they are of central importance to intestinal health, Rawls said in a news release from Duke. By doing so, we have built a foundation for mechanistic studies of intestinal biology in non-human model systems like fish and mice that would be impossible to perform in humans alone.

The use of animals in human intestinal research is nothing new. But genome-wide data generated from zebrafish, stickleback fish, mice and humans identified the extent the genes were shared among the species.

Dr. Colin Lickwar, a co-author of the study, mapped out each species activity level for all of the genes and the location of specific genetic sequences or regulatory elements that flipped those genes on and off, the university reported.

The project was supported by Duke University and the National Institutes of Health.

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Human, fish intestine gene study may show what turns illnesses on ... - News & Observer

A new Duke study suggests that typhoid fever invades human cells with the help of cholesterol.

After analyzing the genomes of cells that were particularly susceptible to typhoid infection, the team centered their research around the protein VAC14. They ultimately found that cells producing less VAC14 had more cholesterol in their cell membranes and were also more likely to become infected by invading bacteria.

This genetic difference affects the level of VAC14 in your cell, said Dennis Ko, assistant professor of molecular genetics and microbiology and senior author of the paper. VAC14 is involved in lipid signaling, but we didnt know how that connected to salmonella [bacteria] invasion.

He explained that the first part of the experiment was dedicated to pinpointing which genes were associated with an increase in infection of Salmonella typhi, the bacteria that causes typhoid fever.

By exposing cells taken from hundreds of volunteers to the bacteria, the group determined which genes may make cells more conducive to bacterial invasion. Ko compared this work to a needle-in-the-haystack scenario, since there are many possible genes that could play a role in the infection process.

After isolating VAC14 as a significant gene for Salmonella infection, Monica Alvarez, a graduate student and lead author of the study, identified that cells producing less VAC14 had more bacteria attached to their membranes.

In other words, the team's findings showed that VAC14 was affecting the first step of bacterial invasion, as salmonella must first attach to the cell membrane and use a molecular needle to inject the viral molecules into the cell, Ko explained.

That was important, because it told us that the initial binding was the step involved, he said. Thats when we remembered that salmonella had been previously shown to bind directly to cholesterol as part of this initial attachment process.

To further test this theory, the researchers turned to Sarah Dunstan, who studies typhoid fever susceptibility in Vietnam. Compiling the DNA information for about 1,000 Vietnamese patients, Ko and the team again found that the VAC14 gene was tied to the risk of Salmonella infection.

After confirming VAC14's importance, the team next looked at how this process played out in a zebrafish model. They centered their tests around the hypothesis that decreasing the levels of cholesterol would lead to less Salmonella invasion.

Zebrafish are a phenomenal animal model system because they are optically transparent making them ideal for imaging studies, Alvarez wrote in an email.

The zebrafish were first treated with ezetimibea drug that lowers cholesterol levelsand then exposed to the typhoid fever bacteria. Alvarez found that the fish treated with the cholesterol-lowering drug had improved survival rates and also cleared the bacteria from their system with more efficiency.

Both Ko and Alvarez noted that their success in zebrafish may not be entirely predictive for humans but were optimistic about the initial results. They said they hoped to move to a different animal to show that the treatment may be more broadly useful.

The reason we still have to be cautious is because its a zebrafishnot a person, not a mouse, its a zebrafish, Ko said. And we were delivering the bacteria through an injection, so people usually get salmonella infection because they eat something thats taintedso the route of delivery isnt quite the same.

He explained that the exact mechanism behind VAC14s ability to affect the amount of cholesterol in the cell is still unknown. There is also a potential to apply these findings to other diseases and examine whether other pathogens are similarly affected by cholesterol.

The ultimate goal in terms of a utility standpoint would be to be able to say, yeah, we started these initial observations based on cell biology, and we were able to take it to animal models and then eventually, we wanted to see whether or not they had any usefulness in people, Ko said.

Originally posted here:
Cholesterol is linked to increased risk of typhoid fever, Duke study shows - Duke Chronicle

Researchers say that certain variations of the TOMM40 gene, located on the 19th chromosome outlined above, are heavily associated with developing Alzheimer's disease. Credit: National Center for Biotechnology Information, U.S. National Library of Medicine

The notorious genetic marker of Alzheimer's disease and other forms of dementia, ApoE4, may not be a lone wolf.

Researchers from USC and The University of Manchester have found that another gene, TOMM40, complicates the picture. Although ApoE4 plays a greater role in some types of aging-related memory ability, the researchers believe that TOMM40 may pose an even greater risk for other types.

TOMM40 and APOE genes are neighbors, adjacent to each other on chromosome 19, and they are sometimes used as proxies for one another in genetic studies. At times, scientific research has focused chiefly on one APOE variant, ApoE4, as the No. 1 suspect behind Alzheimer's and dementia-related memory decline. The literature also considers the more common variant of APOE, ApoE3, neutral in risk for Alzheimer's.

USC researchers believe their new findings raise a significant research question: Has TOMM40 been misunderstood as a sidekick to ApoE4 when it is really a mastermind, particularly when ApoE3 is present?

"Typically, ApoE4 has been considered the strongest known genetic risk factor for cognitive decline, memory decline, Alzheimer's disease or dementia-related onset," said T. Em Arpawong, the study's lead author and a postdoctoral fellow in the USC Dornsife College of Letters, Arts and Sciences' Department of Psychology.

"Although prior studies have found some variants of this other gene TOMM40 may heighten the risk for Alzheimer's disease, our study found that a TOMM40 variant was actually more influential than ApoE4 on the decline in immediate memorythe ability to hold onto new information," Arpawong explained.

Studies have shown that the influence of genes associated with memory and cognitive decline intensifies with age. That is why the scientists chose to examine immediate and delayed verbal test results over time in conjunction with genetic markers.

"An example of immediate recall is someone tells you a series of directions to get somewhere and you're able to repeat them back," said Carol A. Prescott, the paper's senior author and professor of psychology at USC Dornsife and professor of gerontology at the USC Davis School of Gerontology. "Delayed recall is being able to remember those directions a few minutes later, as you're on your way."

The study was published in the journal PLOS ONE on Aug. 11.

Tracking memory loss

The team of researchers from USC and The University of Manchester used data from two surveys: the U.S. Health and Retirement Study and the English Longitudinal Study of Ageing. Both data sets are nationally representative samples and include results of verbal memory testing and genetic testing.

The research team used verbal test results from the U.S. Health and Retirement Survey, collected from 1996 to 2012, which interviewed participants via phone every two years. The researchers utilized the verbal memory test scores of 20,650 participants, aged 50 and older who were tested repeatedly to study how their memory changed over time.

To test immediate recall, an interviewer read a list of 10 nouns and then asked the participant to repeat the words back immediately. For delayed recall, the interviewer waited five minutes and then asked the participant to recall the list. Test scores ranged from 0 to 10.

The average score for immediate recall was 5.7 words out of 10, and the delayed recall scoring average was 4.5 words out of 10. A large gap between the two sets of scores can signal the development of Alzheimer's or some other form of dementia.

"There is usually a drop-off in scores between the immediate and the delayed recall tests," Prescott said. "In evaluating memory decline, it is important to look at both types of memory and the difference between them. You would be more worried about a person who has scores of 10 and 5 than a person with scores of 6 and 4."

The first person is worrisome because five minutes after reciting the 10 words perfectly, he or she can recall only half of them, Prescott said. The other person wasn't perfect on the immediate recall test, but five minutes later, was able to remember a greater proportion of words.

To prevent bias in the study's results, the researchers excluded participants who reported that they had received a likely diagnosis of dementia or a dementia-like condition, such as Alzheimer's. They also focused on participants identified as primarily European in heritage to minimize population bias. Results were adjusted for age and sex.

One key innovation of the study is that the researchers used statistical methods to create scores that represent level and decline in delayed recall, separate from level and decline in immediate recall from the repeated assessments of memory. Most of the prior studies have used a total sum score for the two, a score from a single time-point or combined recall scores with other measures of cognition to investigate overall cognitive decline. By separating these components of recall, researchers had a better chance of detecting and explaining how genes affect each of these abilities differently.

The researchers compared the U.S. data to the results of an independent replication sample of participants, age 50 and up, in the English Longitudinal Study of Aging from 2002 to 2012. Interviews and tests were conducted every two years.

Genetic markers for memory

To investigate whether genes associated with immediate and delayed recall abilities, researchers used genetic data from 7,486 participants in the U.S. Health and Retirement Study and 6,898 participants in the English Longitudinal Study of Ageing.

The researchers examined the association between the immediate and delayed recall results with 1.2 million gene variations across the human genome. Only one, TOMM40, had a strong link to declines in immediate recall and level of delayed recall. ApoE4 also was linked but not as strongly.

"Our findings indicate that TOMM40 plays a larger role, specifically, in the decline of verbal learning after age 60," the scientists wrote. "Further, our analyses showed that there are unique effects of TOMM40 beyond ApoE4 effects on both the level of delayed recall prior to age 60 and decline in immediate recall after 60."

Unlike ApoE4, the ApoE3 variant is generally thought to have no influence on Alzheimer's disease or memory decline. However, the team of scientists found that adults who had ApoE3 and a risk variant of TOMM40 were more likely to have lower memory scores. The finding suggests that TOMM40 affects memoryeven when ApoE4 is not a factor.

The team suggested that scientists should further examine the association between ApoE3 and TOMM40 variants and their combined influence on decline in different types of learning and memory.

"Other studies may not have detected the effects of TOMM40," Prescott said. "The results from this study provide more evidence that the causes of memory decline are even more complicated than we thought before, and they raise the question of how many findings in other studies have been attributed to ApoE4 that may be due to TOMM40 or a combination of TOMM40 and ApoE4."

Explore further: Education does not protect against cognitive decline

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Which genetic marker is the ring leader in the onset of Alzheimer's disease? - Medical Xpress

Side effects are a very real consequence to some medication and they could be telling you something you may not know. According to mygeneRX, your genetics have a direct effect on how your body processes medication, this metabolism, in turn, may lead to severe side effects.

A DNA sample of a simple cheek swab can now be accurately profiled to determine your risk of side effects, which will allow you to adjust dosages and avoid certain medications altogether.

According to medical experts, personalised medicine will be the future of medicine as we know it. Personalised medicine is focused on tailoring treatment for the individual. According to mygeneRx, in order for the medication to have the desired effect and then be expelled from the body, proteins called enzymes break down the medication. Some individuals enzymes work more efficiently than others other people dont possess certain enzymes at all.

ALSO READ:Scientist may be able to reverse DNA and ageing

Medications act as inhibitors or inducers of enzymes affecting how the medication works and at what dosages.

According to mygeneRX, simple, non-invasive and affordable genetic testing analyses the genotypes associated with responsiveness to a range of medications, and gives your healthcare practitioner the knowledge to tailor your treatment accordingly. It means greater confidence in taking and prescribing medication.

A body that metabolises certain medications slower may need reduced dosages, whereas a body that has a rapid metabolism might require stronger dosages for the medication to have the desired outcome.

According to mygeneRX, Dr Danny Meyersfeld, a molecular biologist and the founder of DNAlysis biotechnology, says it is critical to understand the genetic make-up of a patient in relation to the prescription of medicine. If healthcare practitioners were to use genetics, heres what they could learn about prescribing the common painkiller codeine.

ALSO READ:Pupils enjoy National Science Week

Typically, the body produces an enzyme called CYP2D6 that breaks down the drug into its active ingredient, morphine, which provides pain relief. Yet up to 10% of patients have genetic variants that produce too little of the enzyme, so almost no codeine gets turned into morphine.

These people get little or no help for their pain. Similarly, about 10% of the population has too many copies of the gene that produces the enzyme, leading to overproduction. For them a little codeine can quickly turn to too much morphine, which can lead to a fatal overdose and side effects such as constipation, dizziness, drowsiness, nausea and vomiting, says Meyersfeld.

Typically, patients with cardiovascular diseases are on different medications such as blood thinners, beta blockers and statins, and with each one, the risk of adverse medicine interaction significantly increases. A genetic test for cardiac patients for drug response has shown to be more effective in guiding treatment decisions or improving outcomes.

He said mygeneRx tests for more than 150 medications including cardiovascular, psychiatry and pain management. It can be ordered online and the cheek swab is done in the privacy of your own home. According to mygeneRX, it is a simple process with substantial benefits.

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How your DNA can prevent medicine side effects - Centurion Rekord

A team of UC San Francisco researchers will receive $11.7 million over four years from the National Institutes of Health (NIH) to launch a new Program in Prenatal and Pediatric Genomic Sequencing (P3EGS) at UCSF. The program is aimed at pursuing equity in the implementation of genomic precision medicine for children and families in the San Francisco Bay Area.

Genomic precision medicine is a broad effort to connect the vast amounts of genetic sequencing data that have been collected in the past decades with information about human population health in order to understand why individuals respond differently to sickness and medical treatment, and to apply this knowledge toward developing more precise diagnostics and therapies targeted to the needs of particular patients and groups.

To advance equity in precision medicine within the Bay Area, the P3EGS team will recruit 1,100 families with children with potential prenatal or pediatric genetic disorders drawn from a diverse set of backgrounds, including medically underserved communities. P3EGS will not only provide state-of-the-art genomic assessments to these families, but also provide genetic counseling, develop software to aid in displaying and communicating genetic data in community clinics, and study the long-term benefits of providing genetic sequencing for these families and children as well as identify the barriers they face in accessing care.

The effort leverages the outstanding clinical, genomics, informatics, bioethics, health economics, and medical anthropology expertise that together form a robust genomics infrastructure at UCSF. The P3EGS team will be helmed by four leading members of the Institute for Human Genetics (IHG) at UCSF:

Neil Risch, PhD, the director of the UCSF Institute for Human Genetics, notes that P3EGS will be among the first users of the newly approved UCSF Whole Exome Sequencing service hosted by the Genomic Medicine Initiative, which he co-directs with Kwok.

Patients will be recruited from the diverse communities served by UCSF Benioff Childrens Hospital Oakland, UCSF Benioff Childrens Hospital San Francisco, UCSF Betty Irene Moore Womens Hospital, and Zuckerberg San Francisco General Hospital (ZSFGH).

Funding for the P3EGS program is part of $18.9 million being awarding by the NIH this year toward research accelerating the use of genome sequencing in clinical care at six sites across the United States, called the Clinical Sequencing Evidence-Generating Research (CSER2) Consortium. The consortium is funded by the National Human Genome Research Institute (NHGRI) and the National Cancer Institute (NCI), both part of NIH, and it builds upon an earlier Clinical Sequencing Exploratory Research (CSER) Consortium, initiated in 2010, which included an award to Koenig and colleagues to study the ethics of informing family members of participants in cancer biobank research about unanticipated genetic findings.

The CSER2 awards are designed to support the development of methods needed to integrate genome sequencing into the practice of medicine, improve the discovery and interpretation of genomic variants, and investigate the impact of genome sequencing on health care outcomes. In addition, the funds are intended to generate innovative approaches and best practices to ensure that the effectiveness of genomic medicine can be applied to all individuals and groups, including diverse and underserved populations, and in health care settings that extend beyond academic medical centers.

The full press release about the CSER2 awards is available on the NHGRI website

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New UCSF Program Aims to Advance Equity in Genomic Medicine in the Bay Area - UCSF News Services

Brian J. O'Roak, Ph.D., assistant professor of molecular and medical genetics, OHSU, January 4, 2017. Credit: OHSU/John Valls

Autism spectrum disorder affects approximately one out of every 68 children in the United States. Despite expansive study, the origin and risk factors of the complex condition are not fully understood.

To better understand the root causes, an international team led by researchers at OHSU in Portland, Oregon has applied a new systematic analysis to a cohort of 2,300 families who have a single child affected with autism. The study focused on identifying and characterizing low-lying genetic mutations that may have been missed in previous research, given these mutations are only present in a fraction of the bulk DNA of an individual.

Known as postzygotic mosaic mutations, or PMMs, these genetic changes occur after the conception of the human zygote during the development cycle of a fetus. An individual will contain a mosaicor assortmentof mutated and non-mutated cells with the level of mosaicism depending on the time and location of the mutation's occurrence. This emerging class of genetic risk factors has recently been implicated in various neurologic conditions, however, their role in more complex disorders, such as autism, has been unclear.

Autism risk due to unexpected mosaic mutations

By comparing genetic sequencing data of these familiespart of the Simons Simplex Collection, a permanent repository of precisely characterized genetic samplesthe research team determined that approximately 11 percent of previously reported new mutations affecting a single DNA base, which were thought to have be present at the time of human conception, actually show evidence of the mutation occurring during the development process.

"This initial finding told us that, generally, these mosaic mutations are much more common than previously believed. We thought this might be the tip of a genetic iceberg waiting to be explored," said the study's principal investigator Brian O'Roak, Ph.D., an assistant professor of molecular and medical genetics in the OHSU School of Medicine.

To investigate this possibility, a custom approachleveraging next generation sequencing and molecular barcodes - was developed to both identify these low-level mutations, and also validate that they are, in fact, real and not technological artifacts. With this more sensitive method, the rate of potentially PMMs increased to 22 percent of the new mutations present in children.

The researchers then compared the rates of PMMs that result in different predicted effects on the genome in affected children and their unaffected siblings. This lead to an unexpected finding that so-called "silent" mosaic mutations were enriched in the affected children, contributing risk to approximately 2 percent of the individuals with autism in this cohort. These types of mutations are generally believed to be neutral, as they don't alter the genetic coding of proteins. However, the team found evidence that these mutations might actually be altering how genetic messages are stitched together.

The study also found preliminary evidence that mosaic mutations that alter the protein code of genes essential for development, or genes that resist mutations, are also enriched in individuals with autism. This contributes risk to an additional 1 to 2 percent of individuals with autism. Many of the PMMs occurred in some of the most highly validated autism risk genes identified to date, further suggesting that these mutations are contributing to autism genetic risk. Due to this, the research team believes that overall, mosaic mutations may contribute to autism risk in 3 to 4 percent of this cohort.

Understanding the timeline and location of mosaic mutations

Determining exactly when and where these mutations are occurring during development is challenging. The PMMs identified were present in 10 to 75 percent of the cells examined from the children's blood, suggesting that they likely occurred early in development. However, the exact timeline was not known.

By leveraging the unique family design of the Simons Simplex Collection cohort, O'Roak's team analyzed the parents' genomes and discovered that 6.8 percent of the supposedly "new" mutations present in children at conception could actually be traced back to a PMM that occurred early in the development of their parent. These mutations were generally present in 20 to 75 percent of the parents' blood cells, providing indirect evidence that many of the PMMs occurring in children did in fact happen very early during development and that they likely contribute mosaicism across the body, including in the brain.

"In addition to a need for broader research focused on the role that mosaicism plays in autism and related disorders, our data argue that physicians should be requiring more sensitive testing of both children and parents, when a new disorder-related genetic mutation is identified," O'Roak said. "These mutation can go from being in a few percent of the cells of a parent to 100 percent of the cells of a child. If present, at even low levels in the parents, the risk of additional children receiving this mutation is dramatically increased."

"Exonic mosaic mutations contribute risk for Autism Spectrum Disorder" published today in The American Journal of Human Genetics.

Explore further: Late-breaking mutations may play an important role in autism

More information: Deidre R. Krupp et al. Exonic Mosaic Mutations Contribute Risk for Autism Spectrum Disorder, The American Journal of Human Genetics (2017). DOI: 10.1016/j.ajhg.2017.07.016

See more here:
Study identifies new genetic risk factor for developing autism ... - Medical Xpress

Posted Aug. 30, 2017

The AVMA House of Delegates passed a new policy July 21 on "Therapeutic Use of Stem Cells and Regenerative Medicine."

According to the policy: "Regenerative medicine is defined as the use of biological therapies including platelet rich-plasma, pluripotent stem cells, and multipotent stem cells to effect therapeutic benefit in disease states. While regenerative medicine holds promise of improvements in the treatment of a variety of diseases, many of which lack adequately effective treatments, questions remain. The AVMA supports the continued scientific development of these modalities while at the same time encouraging its members to employ caution with respect to their use.

"While data continue to accumulate suggesting therapeutic benefit from regenerative medicine, published peer-reviewed studies definitively documenting benefit are still lacking for many diseases. Nor has a scientific consensus for stem cell type, stem cell origin, dosage, transfer media, or method of administration been developed for each disease being treated. Despite these scientific insufficiencies, the adoption of regenerative medicine in the veterinary profession has grown rapidly. Unfortunately, some therapies being propounded and the processes and equipment being sold have outpaced the science which supports them. Veterinarians have few guidelines and limited resources for differentiating valid and effective therapies from ones which have insufficient data supporting the processes and/or therapies. Therefore, it is incumbent upon veterinarians engaged in regenerative therapies to be well versed in the emerging science of the field in order to successfully select the specific therapeutic protocols, processes, equipment, and vendors most likely to result in clinical benefit for their patients."

The policy lists nine considerations for use of regenerative medicine by veterinarians.

AVMA to deliberate on assistance animals, stem cells (June 1, 2017)

FDA finalizes guidance on cell-based products in animals (July 15, 2015)

Stem cells in theory & practice (Feb. 15, 2011)

Go here to read the rest:
Policy addresses therapeutic use of stem cells, regenerative medicine - American Veterinary Medical Association

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Developments in Regenerative Medicine: FDA Announces Plans to ... - JD Supra (press release)

Valeria Canto-Soler at work in the lab at the Gates Center for Regenerative Medicine.

When Valeria Canto-Soler, Ph.D., was a biology student in Argentina, she dreamed of a career studying elephants and other African wildlife in their natural habitat.

But life took her on a different journey. In July, Canto-Soler joined the Department of Ophthalmology and the Gates Center for Regenerative Medicine as the Doni Solich Family Endowed Chair in Ocular Stem Cell Research.

I like to joke about it, she says. Instead of spending my life studying animals in the wilds of Africa, Im in a dark room sitting in front of a microscope.

After an international search, Canto-Soler also was named director of CellSight, the Ocular Stem Cell and Regeneration Research Program, in partnership with the Gates Center and the Department of Ophthalmology. She also will be an Associate Professor of Ophthalmology at the CU Anschutz School of Medicine.

This $10 million ocular stem cell and regeneration program initiative began with a $5 million grant from the Gates Frontiers Fund to research the potential for stem cells to treat age-related macular degeneration, the leading cause of blindness in people ages 50 and older.

I dreamed of launching a stem cell research program like this for years, she says. The leadership at both the Gates Center and the Department of Ophthalmology has the same vision that I have. Working together, we can make it happen.

Canto-Soler grew up in Mendoza, Argentina, a city on the eastern side of the Andes Mountains. Similar to Denver in that its nestled in the foothills, Mendozas close proximity to the mountains gave her the opportunity to hike, explore and marvel at the natural wildlife she encountered.

But when it came to a career choice, it was more difficult for her to decide how to direct her love of nature and biology. In contrast to the U.S., students in Argentina have to decide on a career early.

Its a very important decision and there are very few chances for you to change your mind after that, she says.

As a young biology student, Canto-Soler found herself drawn to the study of the human nervous system and how the sense organs work.

Year by year, I felt more and more fascinated by the biology of the human body, she says. In the last two years of biology school, I started to work in a lab studying the nervous system. That defined my future.

Canto-Soler earned a B.S. in Biology from the University of Cordoba School of Natural Sciences, Cordoba, Argentina in 1996. In 2002, she completed a Ph.D. in Biomedical Sciences at the Austral University School of Medicine in Buenos Aires.

After she earned her Ph.D., Canto-Soler had the opportunity to explore new vistas. She was accepted as a Fellow with the Retinal Degenerations Research Center in the Department of Ophthalmology at Johns Hopkins University School of Medicine in Baltimore. She worked with renowned scientist Ruben Adler, MD, at the Wilmer Eye Institute.

I was so excited the focus of his research was the development of the eye, Canto-Soler says. It was perfect for me.

She thought her fellowship would provide her the knowledge and experience she could take back to Argentina, but she found new challenges to keep her in the U.S. When her mentor, Dr. Adler, died in 2007, she took over his role at Wilmer to continue their work.

In 2014, Canto-Soler and her team created a miniature human retina in a petri dish, using human stem cells. The mini retinas had functioning photoreceptor cells capable of sensing light. This cutting-edge research opened up the potential to take cells from a patient who suffers from a particular retinal disease, such as macular degeneration, and use them to generate mini retinas that would recapitulate the disease of the patient; this allows studying the disease on a human context directly, rather than depending on animal models.

This research could lead to personalized medicine and drug treatments for specific patient needs. At CellSight, Canto-Soler will work with clinicians and members of the Gates Center to create patient registries and cell banking. She hopes her research will someday result in cell-based treatments; retinal patches, for example, which could be transplanted into a patients eye, possibly curing blindness.

Once you transplant a retinal patch, the cells have to establish all the right connections with the patients own retinal cells in order to process the information and produce a visual image, she says. No one really knows how to do that yet.

But shes confident the clinicians from the Department of Ophthalmology, and the researchers at CellSight and the Gates Center, will work together to make the dream a reality.

Im definitely a dreamer, Canto-Soler says. I never imagined we could generate human mini retinas in a petri dish. And to see that happen made me a believer. I believe our scientific dreams can come true if we pursue them in the right way.

The letters and emails she receives from those who have family members or friends suffering from sight problems or blindness inspire her. Theyre also looking for answers.

Its what gets me motivated to come to work every day, she says. Im excited to think about how we could help people and the impact that would make in their lives.

Continue reading here:
Canto-Soler joins team at Gates Center for Regenerative Medicine to develop cell-based treatments - CU Anschutz Today (press release)

The US Food and Drug Administration (FDA) intendsto investigate the use of unproven stem cell therapies being offered in the country'sclinics.

Tighter enforcement from the FDA comes as an inspection at StemImmune Inc based in San Diego, California, revealed the use of potentially dangerous treatments administered to vulnerable cancer patients.

Only a small number of stem cell treatments are currentlyFDA approved, including use of bone marrow transplants in cancer patients and cord blood for specific blood-related disorders.However stem cell treatments using only the patient's own cells are not subject to the same level of regulation as drugs if the cells are only 'minimally manipulated'.

FDA commissioner Dr Scott Gottlieb said in a statement:'The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially wont allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.'

Five vials,each containing 100 doses of the live Vaccinia Virus Vaccine, were seized from StemImmune Incby US marshals on25August 2017.

The vaccine, which is usedagainst smallpox, and is not commercially available was combined with stem cells derived from body fat to create an unapprovedtherapy. The concoction was injected directly into tumours of cancer patients at California Stem Cell Treatment Centres in Rancho Mirage and Beverly Hills.

The effects of the vaccine in immunocompromised cancer patients have the possibility to cause severe complications such as inflammation and swelling of the heart and surrounding tissues.

In a separate case, awarning letter was also sent to chief scientific officerKristin Comellaat US Stem Cell Clinic in Sunrise, Florida, after three patients with macular degeneration were blinded following the use of unapproved stem cell injections into their eyes, in a sponsored study (see BioNews 893). The letter lists a number of non-compliance to procedures and 'significant deviations' to current good manufacturing practice and good tissue practice.

'Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk,' Dr Gottlieb commented. 'I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch a safety reporting programme.'

Professionals in the field blame the past lack of FDA attention for the widespread problem and are calling for stringent regulation. ProfessorLeigh Turner, fromthe Centre for Bioethics at the University of Minnesota, told CNN: 'This is a space where the FDA could have taken action four or five years ago as far as making this a policy priority.'

Read more from the original source:
FDA crackdown on unproven stem cell therapies - BioNews

President and Scientific Director, Ontario Institute for Cancer Research and Director, P3G (Public Population Project in Genomics)President and Scientific Director, Ontario Institute for Cancer Research Scientific Director, P3GDr. Thomas J. Hudson is president and scientific director of the Ontario Institute for Cancer Research. He is implementing the institutes strategic plan, working with cancer research institutions across Ontario to leverage existing strengths. The plan focuses on prevention, early diagnosis, cancer targets and new therapeutics. Its innovation platforms include imaging and interventions, bio-repositories and pathology, genomics and high-throughput screening, and informatics and biocomputing. Dr. Hudson is recruiting more than 50 internationally recognized principal investigators.Dr. Hudson was the founder and Director of the McGill University and Genome Quebec Innovation Centre and Assistant-Director of the Whitehead/MIT Center for Genome Research. Dr. Hudson is internationally renowned for his work in genomics. At the Whitehead Institute, Dr. Hudson led the effort to generate dense physical and gene maps of the human and mouse genomes. He is a leader in the development and applications of robotic systems and DNA-chip based methodologies for genome research. In June 1996, he founded the Montreal Genome Centre based at the McGill University Health Centre Research Institute. In 2003, this group expanded to become the McGill University and Genome Quebec Innovation Centre. Dr. Hudson and his team were founding members of the International Haplotype Map Consortium. Dr. Hudsons interests in human genetic diseases focus on the dissection of complex genetic diseases. Disease projects in Dr. Hudsons laboratory included the search for genes predisposing to lupus, inflammatory bowel disease, coronary artery disease, asthma, diabetes and colon cancer. The laboratory also used the DNA-chip technology to characterize breast and ovarian cancer.

In 2007, Dr. Hudson was appointed to the rank of professor (status-only) in the Department of Molecular Genetics at the University of Toronto. He taught in the departments of Human Genetics and Medicine at McGill University and practiced medicine at the McGill University Health Centre Montreal General Hospital.

Dr. Hudson is a fellow of the Royal Society of Canada. He was one of the co-founding members of P3G and is currently serving as its scientific director. He is editor-in-chief of the journal Human Genetics.

The recipient of numerous awards, Dr. Hudson has received the 2005 Achievement of the Year in Healthcare from Macleans magazine, the 2005 Award for Research in Immunology by the Canadian Society for Allergy and Clinical Immunology, the Andr-Dupont 2002 Young Investigator Award given by Quebecs Clinical Research Club, an Investigator Award from the Canadian Institutes of Health Research, a Burroughs-Wellcome Clinician-Scientist Award, The 2002 Prix de la Sant from the Armand-Frappier Foundation, the 2001 Young Scientist Award by the Genetics Society of Canada, the 2000 Scientist of the Year by Radio-Canada, and the 1999 Canadas Top 40 Under 40.

http://oicr.on.ca/person/oicr-investigator/tom-hudson

Visit link:
HudsonAlpha Institute for Biotechnology

Your May 17 article about genetic engineering [Facts, Fears and the Future of Food] is so chock-full of glib falsehoods that I hardly know where to begin. I would have far more respect for the science behind biotechnology if it didnt depend so heavily on half-truths, double standards, unwarranted assumptions, blurred distinctions and conflicts of interest.

Jack Britt says that the same microorganisms move genes between species both in nature and in genetic engineering, and therefore the methods are the same. This is half true. In the latter, various techniques are employed to either bypass or weaken the natural immunity of the organism being manipulated, often literally forcing the DNA into the cells in ways that would never occur in nature. Stating that many organisms are naturally GMO, and therefore implying that we have carte blanche to do whatever we wish, isnt just a stretch, its a whopper.

Britt and Leah McGrath emphasize the precision of these techniques. Again, this is a perversion of the truth. In fact, this is merely a precision of abstractions, because the living organism is then going to move these genes around in ways that cant possibly be controlled or predicted. The only way to even begin to achieve complete control or precision would be to kill the organism, which would obviously be counterproductive. A technology that treats living organisms as though they were dead has extremely questionable scientific validity, not to mention morality.

Both the tone and title of the article perpetuate the same old scientific myths about biotechnology: The facts are with the scientists, the fears (beliefs) are with the uninformed public, and the future of food requires the widespread adoption of these techniques. The public is misinformed, largely because news media like the Xpress have allowed themselves to be used as soapboxes by academic cheerleaders for corporate interests.

As long as we continue to assume that:1. The deterministic gene weve been taught in school and through the media is real.2. The kind of science we now have (which is mostly technology rather than science proper) is the only science possible. And3. Everything a scientist says is scientific by definition,

we will continue to make catastrophic mistakes.

Substantive criticisms of biotechnology do exist, but for some reason, they almost never find their way into the mass media. The opposition only seems weak because its strongest arguments are ignored.

Andy Shaw Easton, Md.

Editors note: Freelance writer Nick Wilson responds in part:I thank you for your passionate response. I appreciate criticism and view it as an opportunity to learn through grappling with different perspectives. Ultimately, Im more than happy to admit my past errors if I come to a new understanding that falls more in line with what I believe to be true. If it comes to my awareness that I have put forth falsehoods, Id absolutely like to remedy that. This is to say that my perspectives are evolving, not fixed. Its important to me to keep learning and growing in the pursuit of truth.

Link:
Letter: Perpetuating 'scientific' myths about biotechnology - Mountain Xpress

As Boulders biotech community continues to thrive and grow, theJennie Smoly Caruthers Biotechnology Buildingdebuted its state-of-the-art E-Wing on Monday.

The 56,340-square-foot E-Wingwill feature next-generation active learning spaces where students learn by doing rather than by being lectured, as well as laboratory space wherecurrent and future faculty in the BioFrontiers Instituteand the Department of Chemicaland Biological Engineering will be able tocontinue their groundbreaking research.

Mondays ribbon-cutting event honored Colorado-based philanthropists John and Anna Sie, whose generous $2 million gift will allow for the creation of an industry co-location space on the E-Wings second floor. The space will be leased to industry partners, allowing local and national biotech companies to bring scientists and resources on-site in order to work side-by-side with university students and researchers.

CU Boulder Chancellor Philip DiStefano and Tom Cech, Nobel Laureate and director of the BioFrontiers Institute, were on hand to officially open the Yuan Yung-Foo Interdisciplinary Bioscience Research Neighborhood and thanked the Sies for their continued support of BioFrontiers and the universitys research mission.

The Sies, whose philanthropic generosity is well known in the state of Colorado and around the world, have provided stalwart support for the BioFrontiers Institute for many years and in many ways, said Cech, a Distinguished Professor of chemistry and biochemistry at CU Boulder. We are truly grateful for their most recent commitment to providing much-needed research facilities where our talented researchers, students and industry partners work together to unravel the complexities of biology with an ultimate goal of enhancing human health and welfare.

Anna and John are among CUs most generous donorstheir gifts are always transformational, DiStefano said. "With their support, we are achieving our vision to become a leader in addressing the humanitarian, social and technological challenges of the 21st century."

Construction on the $32 million E-wing broke ground in March 2016, aided by $15 million in funding from the state of Colorado.

For more information on the E-Wing, visit the BioFrontiers Institutes website.

More here:
Biotechnology building debuts state-of-the-art E-Wing - CU Boulder Today

Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced the release of two abstracts on its drug neratinib that will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress, which will be held September 8 12 in Madrid, Spain. Abstracts are available to the public online on the ESMO website: http://www.esmo.org.

Abstract #1490: Neratinib after trastuzumab-based adjuvant therapy in early stage HER2-positive breast cancer:5-year analysis of the Phase III ExteNET trial.The abstract will be presented as a proffered paper oral session on Friday, September 8.

Abstract #177P:Effects of neratinib on health-related quality of life in early stage HER2-positive breast cancer.The abstract will be displayed as a poster on Monday, September 11.

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer.

U.S. Approval of Neratinib (NERLYNX)

Neratinib was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

Indication

NERLYNX is a tyrosine kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance.More information on the Puma Patient Lynx program can be found at http://www.NERLYNX.com or 1-855-816-5421.

The full prescribing information for NERLYNX is available at http://www.NERLYNX.com. The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

Important Safety Information

There are possible side effects of NERLYNX. Patients must contact their doctor right away if they experience any of these symptoms. NERLYNX treatment may be stopped or the dose may be lowered if the patient experiences any of these side effects.

Diarrhea

Diarrheais a common side effect ofNERLYNX. The diarrhea may be severe, and you may get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 cycles (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea:

Contact your healthcare provider right away if you have severe diarrhea or if you have diarrhea along with weakness, dizziness or fever.

Liver Problems

Changes in liver function tests are common with NERLYNX. The patients doctor will do tests before starting treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. NERLYNX treatment may be stopped or the dose may be lowered if your liver tests show severe problems. Symptoms of liver problems may include tiredness, nausea, vomiting, pain in the right upper stomach area (abdomen), fever, rash, itching or yellowing of your skin or whites of your eyes.

Pregnancy

Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. NERLYNX can harm your unborn baby. Birth control should be used while a patient is receiving NERLYNX and for at least 1 month after the last dose. If patients are exposed to NERLYNX during pregnancy, they must contact their healthcare provider right away.

Common side effects in patients treated with NERLYNX

In clinical studies, the most common side effects seen in patients taking NERLYNX were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis (dry or inflamed mouth, or mouth sores), decreased appetite, muscle spasms, dyspepsia, changes in liver blood test results, nail problems, dry skin, abdominal distention, weight loss and urinary tract infection.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 orhttp://www.FDA.gov/medwatch. Patients and caregivers may also report side effects to Puma Biotechnology at 1-844-NERLYNX (1-844-637-5969).

Please see Full Prescribing Information, available at http://www.NERLYNX.com.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. NERLYNX (neratinib) is approved for commercial use by prescription in the United States as extended adjuvant therapy for early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed as NERLYNX. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the commercialization of NERLYNX and the continued development of its other advanced drug candidates directed at the treatment of HER2-positive breast cancer. The Company believes that NERLYNX has clinical application in the potential treatment of several other cancers that over-express or have a mutation in HER2.

Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the benefits of NERLYNX and neratinib, the Companys clinical trials and the announcement of data relative to those trials. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Companys actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has only recently commenced commercialization and shipment of its only FDA approved product; the Companys dependence upon the commercial success of NERLYNX (neratinib); the Companys history of operating losses and its expectation that it will continue to incur losses for the foreseeable future; risks and uncertainties related to the Companys ability to achieve or sustain profitability; the Companys ability to predict its future prospects and forecast its financial performance and growth; failure to obtain sufficient capital to fund the Companys operations; the effectiveness of sales and marketing efforts; the Companys ability to obtain FDA approval or other regulatory approvals in the United States or elsewhere for other indications for neratinib or other product candidates; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support the Companys drug candidate claims; even if approved, the risk that physicians and patients may not accept or use the Companys products; the Companys reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates; risks pertaining to securities class action, derivative and defamation lawsuits; the Companys dependence on licensed intellectual property; and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170830006310/en/

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Puma Biotechnology Announces Publication of Abstracts for ESMO 2017 - Markets Insider

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Shares last traded at $93.95 barely above $87.37, the 50 day moving average and which is well above the 200 day moving average of $61.78. The 50 day moving average went up by +7.53% whereas the 200 day average was up by +52.06%. 820K shares changed hands by the end of trading on Friday. Overall, volume was down 80.71% under the stocks normal daily volume.

Traders are more bullish on Puma Biotechnology Inc of late looking at the fall in short interest. The firm had a fall in short interest between July 31, 2017 and August 15, 2017 of -0.12%. Short interest decreased 7,361 over that timeframe. The days to cover decreased to 6.0 and the percentage of shorted shares was 0.17% on August 15.

Here is the rundown on market activity for Puma Biotechnology Inc (NASDAQ:PBYI). Richard Paul Bryce, SR VP, CLINICAL RESEARCH & DEV sold $435,500 worth of shares at an average price of $87.10 on July 3rd. Bryce now owns $2,546,543 of stock as recorded in a recent Form 4 SEC filing.

Here are a few other firms who have also updated their positions. Janus Capital Management LLC divested its stake by shedding 2,714 shares a decrease of 0.1% from 12/31/2016 to 03/31/2017. Janus Capital Management LLC currently owns 2,209,599 shares worth $82,195,000. The total value of its holdings increased 21.0%. Rock Springs Capital Management Lp expanded its investment by buying 91,500 shares an increase of 96.8% as of 06/30/2017. Rock Springs Capital Management Lp claims 186,000 shares valued at $16,256,000. The value of the position overall is up by 362.5%.

Ghost Tree Capital, LLC reduced its holdings by selling 75,000 shares a decrease of 33.3% in the quarter. Ghost Tree Capital, LLC now holds 150,000 shares with a value of $13,110,000. The value of the position overall is up by 56.6%. As of the end of the quarter Graticule Asia Macro Advisors LLC had sold 6,200 shares trimming its holdings by 13.4%. The value of the investment in (PBYI) went from $1,726,000 to $3,514,000 a change of 103.6% quarter over quarter.

July 18 investment analysts at Credit Suisse maintained a stock rating of Outperform and raised the price target to $118.00 from $111.00.

In the market the company is trading up by 1.57% since yesterdays close of $92.5. In the last earnings report the EPS was $-8.14 and is expected to be $-8.68 for the current year with 37,205,000 shares outstanding. Analysts expect next quarters EPS to be $-2.09 and the next full year EPS is projected to be $-4.71.

Puma Biotechnology, Inc., launched on September 15, 2010, is a biopharmaceutical company that focuses on the development and commercialization of products for the treatment of cancer. The Company focuses on in-licensing the global development and commercialization rights to the three drug candidates, including PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Its neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer (NSCLC), and other tumor types that over-express or have a mutation in HER2..

Originally posted here:
Puma Biotechnology Inc (NASDAQ:PBYI) Stock Closed 7.5% Above Its 50 Day Average - Modern Readers