Seattle Genetics, Inc. (SGEN - Free Report) announced that the FDA has lifted the clinical hold on two phase I trials of its candidate, vadastuximab talirine (SGN-CD33A; 33A).

Vadastuximab talirine is an early stage candidate that is being developed for the treatment of acute myeloid leukemia (AML).

The partial clinical hold was implemented in Dec 2016 to evaluate the potential risk of liver toxicity in patients treated with vadastuximab talirine, who underwent a stem cell transplant either before or after the treatment.

Seattle Genetics outperformed the Zacks classified Medical-Biomedical/Genetics industry year to date. The stock jumped almost 27.1% during this period while the industry gained 6.9%.

The clinical hold on vadastuximab talirine was resolved through an analysis of the clinical data from over 300 patients treated to date and evaluated by an independent committee of clinical experts, collaborative interactions with the FDA and protocol amendments designed to further enhance patient safety.

Consequently, Seattle Genetics will resume two phase I trials of vadastuximab talirine. The first trial will be a combination treatment with standard of care, or 7+3, chemotherapy in newly diagnosed younger AML patients. The second is monotherapy and combination treatment with hypomethylating agents in both newly diagnosed and relapsed AML patients.

Meanwhile, the company continues to enroll patients in the phase III CASCADE study in frontline older AML patients and in a phase I/II study in frontline high-risk myelodysplastic syndrome (MDS).

Zacks Rank & Key Picks

Seattle Genetics currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in the health care sector include Heska Corp. (HSKA - Free Report) , Sunesis Pharmaceuticals (SNSS - Free Report) and Celgene Corp. (CELG - Free Report) . While Heska sports a Zacks Rank#1 (Strong Buy), Sunesis Sciences and Celgene carry a Zacks Rank #2 (Buy). You can seethe complete list of todays Zacks #1 Rank stocks here

Heskas earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 291.54%.

Sunesis loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 30 days. The company recorded positive earnings surprises in three of the last four quarters, the average being 0.54%.

Celgenes earnings estimates increased from $6.52 to $6.60 for 2017 and from $8.15 to $8.16 for 2018, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 5.08%.

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Seattle Genetics (SGEN): FDA Lifts Hold on Trial of AML Drug - Zacks.com

NEW YORK (GenomeWeb) Oxford Genetics said today that it has signed a worldwide distribution agreement with CLS Cell Lines Service to combine CLS's cell lines with Oxford's current menu of bio-therapeutic research products and services.

The agreement gives Oxford's customers access to over 400 mammalian cell lines which can be used in the firm's custom cell line engineering and development services.

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Oxford Genetics to Distribute CLS Cell Lines Service Products - GenomeWeb

Laura Muir broke Doina Melintes 32-year-old European indoor championship record on Saturday on her way to 1500m gold in Belgrade. Photograph: Andrej Isakovic/AFP/Getty Images

When a bleary-eyed British team gathered at Belgrades Nikola Tesla airport on Monday morning after equalling their best result at a European Indoor Championships, Neil Black, the UK Athletics performance director, was asked just how high Laura Muirs star might soar. His response was short yet striking. She is a once-in-a-generation athlete.

Given the 23-year-old Muirs 1500m and 3,000m gold medals in Belgrade were the first and second of her career, that might sound overly dramatic but the evidence of the past eight months suggests Black was merely stating the obvious.

It is not only that Muir has set five British records and two European records at distances ranging from 1,000m to 5,000m since August. It is the way she has done it. Long solo runs from the front or lung-busting sprint finishes it does not matter. The result is the same: the living daylights are thrashed out of her opponents as well as the clock.

The next challenge, as Muir says, is coping with the step up in competition and pressure at this summers world championships in London. Not that she is concerned she wants to double up in the 1500m and 5,000m. You cant go winning medals and breaking records and not go raising expectations, she says. Ill take it all in my stride.

The IAAF president, Sebastian Coe, a keen onlooker in Belgrade, believes the European indoor gold will act as a springboard to greater glories for Muir just like it did for him back in 1977. This will have boosted her a lot, he said. My first championship medal was an 800m indoors 40 years ago in San Sebastin. Mo Farah made his breakthrough indoors, as did Colin Jackson.

Two years ago Laura wasnt making the right decisions on the track but she has grown in maturity. Now she feels she is not going to get beaten and, most importantly, her rivals dont think so either. Its a pretty good moment to get into a purple patch with the world championships coming up.

Coe is also impressed with Muirs mental toughness after several early career disappointments, most acutely at the world indoors in Sopot and the Commonwealth Games in Glasgow in 2014, where she fell short of the medals many expected from her. There was also frustration at the Rio Olympics in the 1500m final when she tried to go with Genzebe Dibaba on what turned out to be a 57-second third lap and found her medal hopes burned up by lactic acid.

Muir responded to that setback by running 3min 55.22sec a week later the 16th fastest time in history on a list dominated by former Eastern bloc and Chinese athletes who were around when state-sponsored doping was prevalent and she has not been beaten since. More impressive still, she has continued to improve while combining running 40-50 miles a week with work placements during a veterinary degree at the University of Glasgow.

Coe said: I love the way shes done it. Its quite tough when youve chosen the most difficult sport in the world to master and probably one of the most difficult degree courses at the same time. Shes juggling all the plates I take my hat off to her.

A large part of her success is down to genetics which, according to her coach, Andy Young, give her the right blend of slow and fast twitch muscles that make her dangerous at all distances from 800m upwards. Ive never seen someone with that sort of capability. I used to train with Paula Radcliffe when I was at Loughborough and she obviously had a huge engine but she didnt have a turn of speed. Kelly Holmes had that huge turn of speed but not the engine Laura has both.

Then there is her physical robustness, which means Muir tolerates and thrives in hard training sessions without her body breaking down, and her work ethic. As Young puts it: When she arrived she didnt like going into the red zone, the pain zone. She was always running within herself. But over the last couple of years weve developed that and she now gives it everything.

Some at British Athletics remain to be convinced Muir should double up at London. Young insists the world championships schedule is perfect as it involves running her favourite event, the 1500m, on the first, second and fourth days, and then a two-day break before the 5,000m heats. She wants to start racking up the medals, said Young. She wants world championship medals, she wants Olympic medals.

It will not be easy. In the 1500m she will face the world-record holder Dibaba, who seems back at her best after a mixed 2016 during which the Ethiopians coach, Jama Aden, was arrested by Spanish police on suspicion of doping after EPO was found in the hotel they and others were staying in. In the 5,000m another Ethiopian, Almaz Ayana, will be a danger.

In the current climate all athletes who set fast times are automatically under suspicion, along with their coaches. Young stresses that Muir is powered by little more than a good diet and the odd chocolate recovery shake. Laura also takes iron because she struggled with that, and sometimes magnesium, but she doesnt like taking tablets, he said. When she first started she wouldnt even take paracetamol or ibuprofen when the legs got sore or for a headache. Its not her way. And its not my way either.

Read more from the original source:
Laura Muir has mentality and genetics to live up to 'once-in-a-generation' tag - The Guardian

March 7, 2017 - by Laura Lloyd Search for similar articles by keyword: [Wheat]

Team from Spain completes first genetic, phenotypic and geographic adaptation study. Photo by Adobe Stock.

Among the studys goals was to establish a statistical relationship between certain genetic variables and the phenotypic characteristics they determine. A phenotype is defined as the appearance of an organism resulting from the interaction of genotype and environment. The phenotypic traits under study included the different varieties of durum wheats flowering time, biomass, drought resistance, foliar architecture, photosynthesis, protein, yield and yield components.

The study sought to establish which genetic characteristics were decisive in the expression of particular phenotypic traits that indicated both genetic improvement and adaptation of crops in environmental conditions associated with global climate change.

The study divided durum wheat into five genetic subpopulations one composed only of modern cultivars and another four closely related to their geographic origins in the eastern Mediterranean, eastern Balkans and Turkey, Western Balkans and Egypt and the Western Mediterranean. Durum wheat grown in the Mediterranean ecosystem, where weather conditions are moderately dry and sunny, is mostly used to make pasta and semolina. Domesticated thousands of years ago in the Fertile Crescent, durum spread widely, developing diverse landraces, or crop cultivars developed through traditional farming practices over a lengthy period of time or lacking influence from modern agricultural practices, the study authors said.

The rest is here:
Scientists analyze Mediterranean durum genetics - World Grain

The ready availability of genetic testing has created a contradictory set of challenges.

(Disclosure/reminder: Im Chief Medical Officer of DNAnexus, a genetic data management company.)

On the one hand, there are data suggesting that some patients dont modify their behavior even after genetic testing indicates they might be at increased risk for a condition, such as lung cancer or skin cancer, a risk that could be mitigated through deliberate behavior change. (I recommend this 2016 Atlantic piece on the subject, by law and policy professor Timothy Caulfield, for his wise emphasis on social context, though Im less persuaded by the published meta-analysis that motivated the commentary.)

But Ive been at least as struck by what seems in many ways to the be opposite problem: the use of specious genetic tests to motivate behavior change, such as the use of genetically informed diets or genetically informed exercise programs (or both), solutions an increasing number of consumer genetics companies seem to promote.

Although a robust scientific link between the genetic results and the indicated intervention is generally lacking, many individualswhether patients or elite athletesseem to find the idea that their recommendations are based on cutting-edge genetic science compelling. In a very real sense, this is genetics as placebo.

Credit: Twenty20

There are many examples demonstrating the impact of placebo on athletic performance, for example, in both trained (see here, here, here) and untrained (here) athletes. Its not a stretch to imagine that athletes who believe genetics can offer them a distinct advantage might perform better if they believe their training program is driven by genetics.

Its also entirely believable that patients with a particular faith in geneticsfor example, those who have self-selected by seeking out such testingmight be more likely to adhere to a wellness regimen represented as the customized output of genetic evaluation.

This phenomenon seems like an expression of what medical anthropologist (and one of my favorite undergraduate instructors) Arthur Kleinman called the Explanatory Model. The basic idea is that different people have different views of illness and disease, and the physician or healer needs to understand and acknowledge the patients model to optimize the therapeutic relationship.

Consider NIH director Francis Collins, for instance. After genetic testing suggested he was at increased risk for diabetes, he immediately altered his diet and exercise regimenpresumably because he strongly connected with the idea of genetic risk. Collins reaction isnt unique; Ive encountered a number of individuals whove apparently been motivated to change their lifestyle after getting curiosity-driven genetic testing.

The thing is, from a medical perspective, the logic is lacking, or at least soft; most people would presumably benefit from a healthier lifestyle, whether genetic testing reveals a particular predisposition or not. Collins, a physician-scientist, shouldnt have needed genetic testing to motivate lifestyle changes. Yet apparently, it took genetic testing because that deeply resonated with his explanatory model of illness.

As an aside, its important to recognize that patients are not the only ones who may find themselves beguiled by the charms of genetic data. A recent, powerful Stat article described a dubious genetic test used to help doctors select the optimal opioid for patients; the reporter, Charles Piller, memorably captures how the analysis was perceived by an enthusiastic physician:

Tests of how his patients would respond to particular drugs validate his clinical judgment most of the time, [the physician] said. When they dont, he ignores the results.

This seems like another version of genetics as placebomaking the doctor feel better about his diagnosisrather than genetics as discriminating science.

Ive also seen a similar phenomenon in biopharma companies that aspire to use biomarkers (not necessarily genetic) to guide decision-making during early drug development. Ive been surprised by how often biomarkers or other early signals are embraced when seem to support the decision the team wants to make (generally advancing a drug), but ignored or rationalized away when they go in the wrong direction. Of course context is always important in interpreting specific results, but its striking how early signals can be selectively employed in drug development decisions to inject the imprimatur of science into a confusing and often highly political process.

Returning our focus to patients, some might ask, whats so wrong about using genetic testing to motivate behavior change in those who are susceptiblewho in essence advertise their susceptibility by seeking out genetic testing? If the testing is legitimateas presumably Collins wasthen perhaps it will provide the motivation needed to pursue a healthy lifestyle. And even if the relationship between testing and therapeutic recommendation is scientifically dubious, it might still motivate the recipient to eat healthier, exercise more or perform at a higher level. It would be ironic, certainly, if the primary benefit of many genetic tests proves to be behavioral, but whats the harm, especially if its paid for by consumers?

The problem is that even if there are short-term successes, they may come at the unacceptable cost of eroding trust in the underlying science, a consequence that might ultimately undermine what genetics could one day deliver.

My fear is that validated genetics gets overwhelmed by hucksterism, and patients who might benefit from genetics will get turned off, and reject critically important advice. Just as unsupported belief in the science could lead to overly enthusiastic adoption today (such as using genetics to guide diet), its not hard to envision this ending badly, besmirching the reputation of genetics and leading to the concerning possibility that down the line, expectations of disappointment might dissuade potential users of genetic testing in the future.

But inevitably, Im more optimistic than concerned.

First, I hope is that even in a sea of unsupported wellness claims (eat this, not that; train this way, not that), it will still be possible to discern legitimate medical advice (take extreme measures to avoid the sun and see your dermatologist frequently if you carry particular mutations predisposing to melanoma, say) that could save someones life. Ideally, this rigorous vetting will come from the community itself, as it has in a number of other examples cardiologist and former FDA Chief Health Informatics Officer Taha Kass-Hout frequently cites.

Second, I hope that responsible, critical scientists continue to pursue links between genetics and behavior, including diet, exercise and human performance (the pioneering work of Stanford cardiologist Euan Ashley falls squarely into the last category, for examplealso discussed on this recent Tech Tonics podcast).

Thirdmuch as I argued in the New York Times when the human genome was first sequenced, nearly two decades agoI suspect the rigorous pursuit of genetics will perhaps paradoxically reveal the limits of reductionism, highlight that genetics is not everything and emphasize the need for more integrative approaches to vexing population health problems.

Or, as Dennis Ausiello, Joseph Martin and I put it in 2000, in the American Journal of Medicine,

As Goldstein and Brown recently noted, paraphrasing Magritte, a gene sequence is not a drug, and although the development of rational therapy for a disease may require an understanding of its molecular basis, the path from mechanistic understanding to clinical treatment is often difficult to define and hard to predict. Proteins often behave differently in test tubes than in cells, and cells behave differently in culture than as part of a vital organism. Finally, a patients experience of disease reflects more than simply an underlying biologic defect. It is, to quote Eric Cassell, a process inextricably bound up with the unfolding story of this particular patient. Thus, the critical question we are now struggling with as physicians and physician-scientists is how to avail ourselves of the advances in molecular biology without losing sight of our primary goalthe care and treatment of our patients.

Clearly, this struggle continues.

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Precision Credulity: How Specious Genetic Tests Might Motivate Real Behavior Change - American Enterprise Institute