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The portion of people in Britain with detectable antibodies to the coronavirus fell by roughly 27 percent over a period of three months this summer, researchers reported Monday, prompting fears that immunity to the virus is short-lived.

But several experts said these worries were overblown. It is normal for levels of antibodies to drop after the body clears an infection, but immune cells carry a memory of the virus and can churn out fresh antibodies when needed.

Some of these headlines are silly, said Scott Hensley, an immunologist at the University of Pennsylvania.

Declining antibody levels after the acute infection has resolved is the sign of a normal healthy immune response, Dr. Hensley said. It doesnt mean that those people no longer have antibodies. It doesnt mean that they dont have protection.

The research also raised some fears about the ability of vaccines to help populations reach herd immunity, the point at which enough people would be immune to the coronavirus to thwart its spread.

Its too early to know how long immunity to the new coronavirus lasts, and whether people can be reinfected many months to a year after a first bout with the virus. Still, experts said worries about vaccines, too, are unwarranted.

The vaccine doesnt have to mimic or mirror the natural infection, said Shane Crotty, a virologist at the La Jolla Institute for Immunology. Certainly I wouldnt be alarmist about these data.

The new results indicate the prevalence of coronavirus antibodies in the broader population but not in specific individuals. Several studies looking at antibody levels in individuals have shown that after some initial decline, the levels hold steady for at least four to seven months.

The British report is based on three rounds of antibody blood tests carried out in 350,000 randomly selected people from June 20 to Sept. 28. The participants tested themselves at home for antibodies using finger-prick assays that deliver a yes-or-no result, much like a pregnancy test.

Over the three-month period, the proportion of people with detectable antibodies in their blood dropped to 4.8 percent from 6 percent, the researchers reported. The smallest decline was among people ages 18 to 24 and the biggest in those over age 75.

Looking at the data a different way, about 73 percent of people who had antibodies early on still produced a positive result months later, noted Dr. Antonio Bertoletti, a virologist at Duke NUS Medical School in Singapore. Thats not such a dramatic decline.

Antibodies also represent only one arm of the immune response, albeit the one that can most easily be measured. There are at least three other branches of the immune system that can fend off illness, so antibody levels dont present the full picture.

Its not the whole immune response, said Dr. Paul Elliott, an epidemiologist at Imperial College London who heads the project.

When the body encounters a pathogen, it rapidly produces antibodies that recognize the invader. Once the acute infection resolves, the levels decline as they must for purely practical reasons.

Our lymphatic system, where immune cells are, only has a finite amount of space, Dr. Hensley said.

Depending on the test used, the small amount of antibodies still circulating in the blood may not be enough for a positive signal. The test used in the study has a sensitivity of 84.4 percent, well below that of lab-based tests that hover around 99 percent. That means it may miss anyone who has low antibody levels.

For example, people with mild to no symptoms may have produced fewer antibodies than those with severe illness. Most of the people with positive results were ill in March or April, at the peak of the outbreak in Britain, but about 30 percent did not recall having any Covid-19 symptoms. Even a small decrease in the amount of antibodies may drop their levels below the limit of detection.

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Were saying the antibody response has declined below the threshold of detection, Dr. Elliott said. This is not a surprise to anyone who works in the field.

Data from monkeys suggests that even low levels of antibodies can prevent serious illness from the virus, if not a re-infection. Even if circulating antibody levels are undetectable, the body retains the memory of the pathogen. If it crosses paths with the virus again, balloon-like cells that live in the bone marrow can mass-produce antibodies within hours.

A very small number of people may not make any antibodies. But even those people may have immune cells called T cells that can identify and destroy the virus. The vast majority of people infected with the coronavirus develop lasting cellular responses, according to several recent studies.

T cells are unlikely to prevent infection, but they may at least prevent serious illness by blunting the attack, Dr. Crotty said. Given all that, he said, interpreting low antibody levels to mean that immunity disappears, or that coronavirus vaccines will not be effective is wrong.

For example, the human papillomavirus elicits a terrible immune response and lousy antibodies, he said. But the vaccine with a single immunization elicits fantastic antibodies that are 99 percent protective in people for 10-plus years, just a complete night-and-day difference.

Vaccines can also be designed to provoke much stronger responses than the natural infection, he added.

Though criticizing many of the interpretations of it, experts said the new studys results are an interesting glimpse into the prevalence of antibodies at a population level.

The same research team is also testing hundreds of thousands of people for presence of the virus. Together, Dr. Elliott said, the studies offer a really powerful tool for policymakers to gauge the size of a countrys epidemic.

Link:
Why You Shouldnt Worry About Studies Showing Waning Coronavirus Antibodies - The New York Times

Winteralways gets us thinking about doing our best to ward off bugs and colds and this year, immunity is on our minds more than ever.

The immune system is a lot more complex than we often give it credit for a fascinating network of cells, organs, proteins and tissues with a very important job: to protect the body from outside invaders, like bacteria, viruses and parasites.

Its working away in the background continuously and many different factors play a role in how it functions, including number of things in our day-to-day lifestyles.

While avoiding bugs (with good hand-washing, etc) is one of the single most important things for keeping winter bugs at bay, our own habits and lives can also play a part in supporting our immune system as well as possibly doing it no favours at all.

Heres five ways you might be sabotaging your immune system

1. Smoking:

Its common knowledge smoking has a harmful effect on many different areas of the body, and the delicate balance of the immune system is no different.

Smoking increases inflammation in the body, which can eventually lead to chronic inflammatory disorders, such as heart disease, asthma and arthritis explains Emily Rollason, senior nutritionist at Holland & Barrett (hollandandbarrett.com).

Smoking can also reduce absorption and usage of certain nutrients that are beneficial for immune system support, such as Vitamins B12, C and D; in fact, its well known that smokers have higher requirements for these nutrients.

Rollason says quitting smoking is not only beneficial for your heart and lungs, but also vital to ensure your body can make a good recovery when it encounters a winter bug. Speak to a healthcare professional if you are looking to quit, as they can talk to you about ways they can support you through the process.

Quitting smoking can help your body to make a better recovery after colds and flus

2. Not getting enough sleep:

Missing out on good quality sleep is something that affects us in more ways than we realise. Getting the right amount of sleep is extremely important, particularly when it comes to the adaptive immune response, says Rollason.

Rollason explains that the adaptive response is basically when the body stores a memory of any previous invading pathogens, in order to help fight it off again in the future. The cells required for these processes are regulated and activated during sleep.

The body follows a natural internally regulated sleep and wake cycle, known as the circadian rhythm, and theres evidence to support that many cells in the immune system also follow this rhythm, with certain cells peaking during nocturnal sleep, Rollinson adds.

She adds that our bodies also burn lots of energy when combatting or recovering from illness, so sleep is really important in helping to fight off any bugs you encounter throughout the day.

3. Not eating a healthy balanced diet:

Everything we eat and drink has an effect on our body, and while its fine to treat yourself every now and then, regularly gorging on junk food does little to help our immune system, advises Dr Joshua Berkowitz, medical director at IV Boost (ivboost.uk).

Berkowitz says we should be eating nutritious food with lots of fresh seasonal fruit and vegetables.

Prioritise a balanced diet full of whole foods, with five to seven portions of vegetable and fruit per day, adds Rollinson, and factor in a good balance of good protein, quality carbohydrates and some healthy fats from good sources too.

Berkowitz also says: I recommend reducing sugar intake, as this increases inflammation in the body, which can slow down the immune system.

Emily Rollason, senior nutritionist at Holland & Barrett

4. Being deficient in vitamin D:

Vitamin D, also know as the sunshine vitamin, is an essential nutrient for healthy immune functioning, yet many of us are unknowingly running low.

Despite its name, vitamin D acts more like a hormone in the body, rather than a vitamin, says nutritionist Isabel Tarrant.

It works to activate key immune cells, known as T cells, which play a crucial role in fighting infections. The vitamin also supports immune functioning by regulating anti-microbial compounds and helping clear harmful bacteria from immune cells.

As most of our vitamin D comes from sunlight, government guidelines suggest people in the UK take a daily supplement during autumn and winter months, when there isnt enough sun to meet our needs.

Dr Joshua Berkowitz, of IV Boost UK

5. Poor gut health:

The gut is a very important part of the immune system, and theres increasing evidence to suggest we shouldnt overlook the power of our gut microbiome.

We have approximately 100 trillion live bacteria living inside of us, equating to 2kg of our body weight, says Tarrant. This friendly bacteria is essential for our health, and is involved in the smooth functioning of lots of different bodily processes, from the digestive and immune systems to your mood, brain health and skin.

Tarrant explains that gut bacteria produce metabolites, such as short chain fatty acids, which play a crucial role in regulating our T-cells, the key peace-keeper cells of our immune system. Gut bacteria also produce compounds which support the healthy functioning of white blood cells, known as macrophages, Tarrant adds, which are key for fighting off infections and harmful germs.

With stress and anxiety at a high at the moment, its easy for your gut health to suffer. Poor diet, high sugar and alcohol intake, excessive antibiotic usage, poor sleep and stress can all contribute to an imbalance in gut bacteria and an increase in negative bacteria, known as dysbiosis.

The good news is theres lots you can do to help improve your gut microbiome too and variety is key here. Try eating a more fibrous diet, advises Tarrant. Go for colourful plant foods to ensure you are consuming a diverse range of fibres, such as carrots, yellow peppers, berries, aubergine, spinach, red cabbage, beetroot, broccoli, legumes, nuts and seeds.

Prebiotics are another great way to promote a healthy gut too. These are live friendly bacteria, which can be found in foods such as sauerkraut, live yogurt, kombucha, kefir and tempeh. Alternatively, there are a range of probiotic supplements on the market to promote a healthy gut.

Consider your sleep and stress levels too. Emerging evidence shows a powerful bi-directional relationship between the gut and the brain, known as the gut-brain axis, and stress can cause havoc to the balance of positive and negative bacteria in your gut, says Tarrant.

Try to manage your stress levels by gentle walks in nature, meditation, yoga or talking to a friend. Promoting a healthy gut is all about lifestyle and wellbeing as a whole, which are key to supporting a healthy immune system this winter.

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Five ways you might be secretly sabotaging your immune system - The Irish News

Andrew Ellsworth, MD, Prairie Doc Published 9:28 p.m. CT Oct. 29, 2020

Andrew Ellsworth, MD(Photo: Submitted)

Indeed, there is a lot we can worry about in the world today. It can be so easy to let those problems invade our thoughts as we try to get some sleep.Ideally, our bedrooms are sanctuaries of peace and quiet and places of rest. But televisions, phones, computers, and other devices bring the world and its problems to our beds, and this is not healthy.

Sleep is one of the best ways to help keep our immune system strong to fight off infection and illnesses. And now more than ever, it is important to give our bodies the best chance at fighting off a cold, flu, and disease.Adults need seven to eight hours of sleep every night, while teenagers and elementary children need nine to ten hours.

Regular exercise is one way to help us sleep better. It is best to exercise during the day rather than right before bedtime. We sleep better if we avoid eating large meals within two to three hours of going to bed. But this doesnt mean we must go to bed hungry. We can reach for a small healthy snack like carrot sticks or apple slices.It can also help to keep a regular schedule and have a bedtime ritual, such as brushing our teeth after that final snack.

Reduce caffeine and alcohol consumption, especially near bedtime.And when stressed, we can prepare for better sleep if we take time to relax by gentle stretching, meditation, prayer, or deep breathing.

We can help ourselves by changing our behaviors, but if we experience persistent heartburn or reflux, restless legs, snoring, daytime fatigue, or use the bathroom frequently at night, its time to visit the doctor for assistance.

Finally, it helps to keep the bedroom comfortable, quiet, dark, and cool.Despite all their conveniences, consider removing those electronic devices from the bedroom. Screen time before bed, whether watching television, phones or laptops is a large and growing reason for insomnia. The bright light from screens tricks our minds into thinking it is daytime so be sure to use the night filter to decrease the amount of light they emit. And, since our bedroom is meant for sleeping, why not set a firm time to turn off all the devices for the day.

You better get up; people die in their sleep. Thats what my dad would say when he was trying to get me out of bed as a teenager. While true, the reverse is also valid, people can die from problems stemming from lack of sleep. So, lets get some sleep and stay healthy out there people!

Andrew Ellsworth, M.D. is part of The Prairie Doc team of physicians and currently practices family medicine in Brookings. Prairie Doc is broadcast on SDPB most Thursdays at 7 p.m. CT.

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Sleep is one of the best ways to keep immune system strong - Argus Leader

SEATTLE, Oct. 28, 2020 /PRNewswire/ --A COVID-19 immune response study has revealed new findings that suggest that treatments aimed at arresting the infection at the stage of moderate severity may be most effective. The symptoms of COVID-19 vary widely, from very mild to severe conditions requiring ICU care. Researchers comprehensively studied a large number of patients during the week following a COVID-19 diagnosis, and found that mild COVID-19 is very distinct from the moderate or severe forms of disease, which appear surprisingly similar.

For both moderate and severe COVID-19 cases, the team found that there is a sort of tug-of-war taking place, in which inflammation is promoting a stronger immune response, yet many of the key nutrients required for building that response are depleted. This leads to unusual and dysfunctional immune responses.

A paper describing these findings has been accepted by Cell, and appeared online today. The study was led by the Institute for Systems Biology (ISB) and Swedish in Seattle, with help from Merck (known as MSD outside the United States and Canada), BARDA, and several other institutions and companies (listed below).

"These findings have practical implications for treatment of patients with COVID-19. Since patients with moderate illness have not yet developed end organ damage, our data suggest that early in the disease course would be the best time to intervene with various treatment options to prevent the immune, protein and metabolite derangements seen with more severe disease," said Dr. Jason Goldman of Swedish, who is the clinical lead for the study. "Our translational data align with data from randomized control trials, which have shown greater benefits from antiviral therapies given early. These data also provide intriguing hypotheses about the targeting of host-directed therapies, or even nutritional supplementation."

The research team examined serial blood draws from 139 COVID-19 patients of all severities, from patients recovering at home to critically ill patients and in the ICU. From each blood sample, they measured thousands of proteins and metabolites to capture the environment of the circulating immune system. They also measured thousands of genes and proteins from individual immune cells. Finally, they utilized novel computational methods to merge all of these observations together to provide an integrated view of COVID-19 infection during the week following initial diagnosis.

"This is what we mean by 'systems biology' -- thoroughly measure every component of the whole system, and then use computational methods to reassemble it back together again," said ISB President Dr. Jim Heath, who was the scientific lead of the study.

"The resources provided from this work could provide high value in developing new therapies that might target metabolite starvation, immune dysfunction, or blood clotting, each of which we see emerge at the level of moderate disease," said Dr. Yapeng Su, an ISB research scientist and lead author on the study.

"This important and comprehensive study, in which Merck has been proud to participate, demonstrates the power of an integrated systems biology approach to dissect the complexity of molecular and cellular responses in patients suffering from COVID-19," said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. "As we had hoped, the analysis defines a possible point of intervention in the progression of COVID-19 disease, which may in the near term permit the development of more effective, targeted therapeutics."

The COVID-19 Immune Response Study is made up by ISB, Swedish, Merck, Stanford University, Fred Hutchinson Cancer Research Center, Adaptive Biotechnologies, Bloodworks Northwest, Gilead, Isoplexis, Metabolon, Nanostring, Olink, Providence Molecular Genomics Laboratory, Scisco Genetics and 10x Genomics.

Funding for this project comes from Merck and the Biomedical Advanced Research and Development Authority (BARDA), the Wilke Family Foundation, the MJ Murdock Charitable Trust, the Swedish Medical Center Foundation, the Parker Institute for Cancer Immunotherapy, Gilead, Novartis, Amazon Web Services, Omeros, the Washington State Andy Hill CARE Fund, the Department of Defense, and the National Institutes of Health.

About ISB Institute for Systems Biology (ISB) is a collaborative and cross-disciplinary non-profit biomedical research organization based in Seattle. We focus on some of the most pressing issues in human health, including brain health, cancer, sepsis and aging, as well as many chronic and infectious diseases. Our science is translational, and we champion sound scientific research that results in real-world clinical impacts. ISB is an affiliate of Providence, one of the largest not-for-profit health care systems in the United States. Follow us online at http://www.isbscience.org, and on Facebookand Twitter.

About Swedish Founded in 1910, Swedish, affiliated with the Providence health system, is the largest nonprofit health provider in the Greater Seattle area. Swedish is comprised of five hospital campuses (First Hill, Cherry Hill, Ballard, Edmonds and Issaquah); ambulatory care centers in Redmond and Mill Creek; and a network of more than 115 primary care and specialty-care clinics located throughout the Greater Puget Sound area. Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiovascular care, cancer care, neuroscience, orthopedics, high-risk obstetrics, pediatric specialties, organ transplantation and clinical research. In 2019, Swedish provided $228 million in community benefit programs, including $22 million in free and discounted care in Western Washington.

Contact: Joe Myxter 206.732.2157

SOURCE Institute for Systems Biology

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COVID-19 Immune Response Study Could Lead to More Effective Treatments - PRNewswire

New study finds coronaviruses are masters of mimicry, reproducing their host's immune proteins to remain invisible and help promote infection.

Colorized scanning electron micrograph of a VERO E6 cell (blue) heavily infected with SARS-COV-2 virus particles (orange). Image credit: NIAID

Imitation is the sincerest form of flattery, and in nature, it also serves a practical purpose. Many plants and animals use mimicry to trick both prey and predators, but it takes on a deadly form when viruses employ similar strategies.

Viruses have adapted an arsenal of elegant and ever-changing strategies to evade detection by the immune system, one of which is to produce mimics of human immune proteins, such as cytokines, chemokines, and their receptors, that play a vital role in the bodys immune response. This allows them to promote infection and remain unseen and therefore unchecked by the hosts body.

Mimicry is a more pervasive strategy among viruses than we ever imagined, said Sagi Shapira assistant professor of systems biology at Columbia University Vagelos College of Physicians and Surgeons. Its used by all kinds of viruses, regardless of the size of the viral genome, how the virus replicates, or whether the virus infects bacteria, plants, insects, or people.

Shapira is part of a team of scientists who published a new study in the journal Cell Systems, which demonstrates that coronaviruses like SARS-CoV-2 are adept at this, imitating human immune proteins that have implications in severe cases of COVID-19.

Using powerful computers and a program similar to 3D facial recognition software to match viral proteins with their immune protein mimics, the team scanned more than 7,000 viruses and over 4,000 hosts and uncovered 6 million instances of viral mimicry.

While this underscored the phenomenons prevalence, the team was surprised to find that some families of viruses, such as Papilloma and retroviruses, use it less than others. The coronavirus family on the other hand was found to exhibit a high level of diversification and structural promiscuity in the human proteins they mimic, with over 150 protein examples identified in the current study.

Interestingly, these include many proteins that control blood coagulation or activate plasma proteins called complements, which help target pathogens for destruction and increase inflammation in the body.

We thought that by mimicking the bodys immune complement and coagulation proteins, coronaviruses may drive these systems into a hyperactive state and cause the pathology we see in infected patients, said Shapira.

In a separate paper published in Nature Medicine, the Columbia researchers found evidence that functional and genetic dysregulation in immune complement and coagulation proteins are associated with severe COVID-19 disease. They found that people with macular degeneration (which is associated with enhanced complement activation) were more likely to die from COVID-19, that complement and coagulation genes are more active in COVID-19 patients, and that people with certain mutations in complement and coagulation genes are more likely to be hospitalized for COVID-19.

Since that paper first appeared this spring in a preprint, other researchers have also found links between complement and COVID severity and several clinical trials of complement inhibitors have been initiated. Shapira says the investigation of viral protein functions and mimicry suggests that learning about underlying virus biology could be one way to gain insights into how viruses cause disease and who may be at greatest risk.

Viruses have already figured out how to exploit their hosts, Shapira says. By studying viruses we can not only reveal fundamental principles in biology but also how they perturb cellular homeostasis and cause pathology. The hope is that one day we may be able to use this knowledge to fight back.

Beyond COVID-19, the information were gathering about how individual viral proteins workacross all viruses on Earthmay one day be leveraged as building blocks in medical and agricultural interventions.

Reference: Gorka Lasso, et al. A Sweep of Earths Virome Reveals Host-Guided Viral Protein Structural Mimicry and Points to Determinants of Human Disease, Cell Systems (2020). DOI: 10.1016/j.cels.2020.09.006

Adapted from press release provided by Columbia University Irving Medical Center

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Coronaviruses mimic immune proteins and hide in plain sight - Advanced Science News

Read: The pandemic is in uncharted territory

Jelic was among the doctors treating COVID-19 patients in New York in the spring, when hundreds of people were turning up at the citys hospitals everyday unable to breathe. Patients were crammed into hallways; doctors were overworked. Normally, Jelic says, she might have seen eight or 10 patients in a day. In April, she and two fellows were responsible for 60, any of whom might crash and need to be intubated.

Lack of knowledge about the virus constrained what doctors did. Hospitals initially favored ventilation in part because doctors feared that high-flow therapy oxygen could aerosolize the virus and spread it to staff who didnt have adequate supplies of personal protective equipment. (Now, of course, we know that the virus can be spread through aerosols generated from just normal talking and exhaling.) In some cases, aggressive intubation might have done more harm than good in patients who didnt need it. Doctors stopped putting every patient on a ventilator once they realized the benefits of less invasive oxygen therapy and even turning patients onto their bellies, also known as proning.

Because COVID-19 can, like many conditions, manifest so differently from person to person, knowing which patients might benefitor be hurtby a treatment is a key part of the learning curve. There isnt a one-size-fits-all treatment, says Nicholas Caputo, a doctor at Lincoln Hospital in the Bronx, who was one early advocate of proning. Ventilation is one example of a treatment that can help or hurt depending on the patient. Another is dexamethasone, a steroid that suppresses the immune system. The drug has been shown to reduce mortality in patients with severe COVID-19, whose immune systems have become hyperactive, but might harm patients with milder cases whose immune systems are still trying to clear the virus.

Read: Immunology is where intuition goes to die

Doctors have also learned to watch out for COVID-19s more unusual symptoms. The disease has been linked to kidney failure; those patients might need dialysis. Its also linked to blood clots; patients who show warning signs might need blood thinners. Seeing more cases of COVID-19 has also allowed doctors to refine details like the size of tubing used with ECMO, an artificial-lung technology for the sickest patients who arent doing well on ventilators.

A lot of this experience has been shared in real time and informally. J. Eduardo Rame, a cardiologist at Thomas Jefferson University Hospitals, helps convene a regular Zoom forum where doctors discuss the latest, such as how to use ECMO. Experiential learning, as Rame puts it, has been vital for sharing information about a new disease. But doctors are also trained to rely on data and randomized, controlled trials, not anecdotes. Were nowhere near the inflection point where we can have medical care dictated by evidence, Rame says, which puts doctors in a strange position. For now, they have experience to go on, which is better than nothing. But its not data.

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The Simple Rule That Could Keep COVID-19 Deaths Down - The Atlantic

From boosting immune system to lowering high blood pressure: Know the health benefits of spinach  |  Photo Credit: iStock Images

New Delhi: Spinach is loaded with vitamins, minerals and powerful antioxidants, making it a superstar among green leafy vegetables. This superfood has been shown to benefit health in several ways, from boosting the immune system to preventing heart disease and cancer. The leafy green is also a great addition to your weight loss diet as its very low in calories.

Whats more, this nutritious, versatile vegetablecan be consumed raw or cooked. Keep reading as we list some amazing health benefits that spinach can offer.

Spinach is one of the most nutritious foods that you can eat on the planet. However, the vegetable may cause some adverse effects in some people - such as those who are prone to kidney stones. The vegetable may also interfere with blood-thinning medication since its high in vitamin K1. Hence, individuals who are at risk of having kidney stones and those taking blood thinners may consult with their doctors or healthcare providers before eating large amounts of spinach.

Disclaimer: Tips and suggestions mentioned in the article are for general information purpose only and should not be construed as professional medical advice. Always consult your doctor or a dietician before starting any fitness programme or making any changes to your diet.

Get the Latest health news, healthy diet, weight loss, Yoga, and fitness tips, more updates on Times Now

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From boosting immune system to lowering high blood pressure: Know the health benefits of spinach - Times Now

Radioprotective bacteria

A common symptom of radiation treatment for cancer is gastrointestinal disruption. The damage caused can become so severe and debilitating that it interrupts treatment. Guo et al. noticed that mice surviving experimental radiation exposure had distinctive taxonomic representation in their gut microbiota. A similar correlation was also observed in a small group of human subjects. Further experiments in mice revealed that some strains of bacteria produced high levels of short-chain fatty acids, which seemed to be dampening inflammatory responses and alleviating the damage caused by reactive oxygen species released by the radiation. A metabolomics analysis also implicated a role for tryptophan metabolic pathways in radiation survivorship.

Science, this issue p. eaay9097

The toxicity of high-dose ionizing radiation is associated with the induction of both chronic and acute radiation syndromes that occur after partial or total body radiation and can be further characterized into hematopoietic, gastrointestinal, and cerebrovascular syndromes. The intestine is the major target of radiation and the biggest niche for gut microbiota. Although there are sporadic descriptive studies showing a potential correlation between the gut microbiota and radiation-induced damage, the detailed underpinnings of this relationship remain obscure. In addition, medical intervention to counteract radiation injury is still a global challenge despite decades of rigorous research.

Over the last decade, numerous investigations have demonstrated highly diverse gut microbiota between individuals and significant correlations of gut microbiota with multiple diseases. Gut microbes, as well as microbe-derived metabolites represented by short-chain fatty acids (SCFAs) and tryptophan metabolites, have essential roles in regulating host metabolism and immunity. The imbalance or dysbiosis of a microbial community is associated with potential diseases, risks, or even to the clear onset of clinical symptoms. We have previously corroborated the biological importance of gut microbiota and certain bacteria (e.g., Lachnospiraceae) together with SCFAs in attenuating colitis and obesity. It has also been reported that SCFAs and tryptophan metabolites can reduce proinflammatory cytokines such as tumor necrosis factor-, interleukin-6, and interferon- and promote the anti-inflammatory cytokines, all of which are vital mediators of radiation-induced damage. These findings raise the possibility that the gut microbiota and metabolites play a key role in the regulation of disease susceptibility after radiation challenge.

We found that a small percentage of mice could survive a high dose of radiation and live a normal life span. These elite-survivors harbored a distinct gut microbiome that developed after radiation. Taking advantage of this finding, we used a combination of fecal engraftment and dirty cage sharing to demonstrate that the microbiota from elite-survivors provided substantial radioprotection in both germ-free and conventionally housed recipients, characterized by enhanced survival and ameliorated clinical scores. An unbiased microbiome analysis identified Lachnospiraceae and Enterococcaceae as the most enriched bacteria in elite-survivors. Monoassociation analysis provided direct evidence for the protective role of Lachnospiraceae and Enterococcaceae in promoting hematopoiesis and attenuating gastrointestinal damage. Clinical relevance in humans was supported by an analysis of leukemia patients who were exposed to whole-body radiation. The elevated abundance of Lachnospiraceae and Enterococcaceae was associated with fewer adverse effects in a highly statistically significant fashion. Treatment with SCFAs, especially propionate, rendered mice resistant to radiation, mediated by attenuation of DNA damage and reactive oxygen species release both in hematopoietic and gastrointestinal tissues. Further, an untargeted metabolomics study revealed a realm of metabolites that were affected by radiation and selectively increased in elite-survivors. Among these, two tryptophan pathway metabolites, 1H-indole-3-carboxaldehyde (I3A) and kynurenic acid (KYNA), provided long-term radioprotection in vivo.

Our findings emphasize a crucial role for the gut microbiota as a master regulator of host defense against radiation, capable of protecting both the hematopoietic and gastrointestinal systems. Lachnospiraceae and Enterococcaceae, together with downstream metabolites represented by propionate and tryptophan pathway members, contribute substantially to radioprotection. This study sheds light on the pivotal role that the microbiota-metabolite axis plays in generating broad protection against radiation and provides promising therapeutic targets to treat the adverse side effects of radiation exposure.

Gut microbes, especially Lachnospiraceae and Enterococcaceae along with bacteria-derived metabolites represented by SCFA (propionate) and tryptophan pathway members (I3A and KYNA), tune host resistance against high doses of radiation by facilitating hematopoiesis and gastrointestinal recovery.

Ionizing radiation causes acute radiation syndrome, which leads to hematopoietic, gastrointestinal, and cerebrovascular injuries. We investigated a population of mice that recovered from high-dose radiation to live normal life spans. These elite-survivors harbored distinct gut microbiota that developed after radiation and protected against radiation-induced damage and death in both germ-free and conventionally housed recipients. Elevated abundances of members of the bacterial taxa Lachnospiraceae and Enterococcaceae were associated with postradiation restoration of hematopoiesis and gastrointestinal repair. These bacteria were also found to be more abundant in leukemia patients undergoing radiotherapy, who also displayed milder gastrointestinal dysfunction. In our study in mice, metabolomics revealed increased fecal concentrations of microbially derived propionate and tryptophan metabolites in elite-survivors. The administration of these metabolites caused long-term radioprotection, mitigation of hematopoietic and gastrointestinal syndromes, and a reduction in proinflammatory responses.

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Multi-omics analyses of radiation survivors identify radioprotective microbes and metabolites - Science

Facts, not fear: KENS 5 is tracking the latest numbers from the coronavirus (COVID-19) pandemic in San Antonio and across Texas.

SAN ANTONIO We're tracking the latest numbers from the coronavirus pandemic in San Antonio and across Texas. Here are the latest numbers reported by Bexar and surrounding counties:

How Bexar County is trending

We've tracked how many coronavirus cases have been confirmed in Bexar County from the time officials began reporting cases in March 2020. The graphic below shows the number of cases since June and charts those daily case numbers along a 7-day moving average to provide a more accurate picture of the overall coronavirus case curve in our area and the direction we're trending amid the pandemic.

On Thursday, San Antonio Mayor Ron Nirenberg reported 201 additional coronavirus cases in Bexar County, calling this "a critical moment in the course of this pandemic."

It's the second straight day with at least 200 more cases in the county, as the total number of novel coronavirus diagnoses reaches 65,423. However, no new deaths were reported; 1,250 county residents have died from COVID-19 complications in all.

Nirenberg said Metro Health is also stepping up efforts to contain the virus's spread via additional testing sites (all of which can be found here) and greater outreach from community health teams.

Meanwhile, hospitalizations related to the virus decreased ever so slightly on Thursday, to 223. That's down two from Wednesday. The number of patients on ventilators (38) and in intensive care (80) is also down from Wednesday.

Coronavirus in Texas

The number of Texans who have tested positive for the coronavirus since the pandemic began grew by 6,826 on Thursday, according to the Texas Department of State Health Services.

6,430 of those are new diagnoses over the last 24 hours, while another 396 cases stem from a number of backlogs in several counties. More details can be found at the top of this page.

In all, at least 886,820 Texans have contracted COVID-19.

State health authorities also reported 119 additional virus-related deaths on Thursday. At least 17,819 Texans have passed away from COVID-19 complications.

Meanwhile, COVID-19-related hospitalizations in Texas decreased for the first time in five days, with 5,587 Texans receiving treatment for COVID-19 symptoms63 fewer patients overall than on Wednesday. The bigger picture, however, shows a troubling trend; October has brought a reversal of flatlining numbers as hospitalizations have spiked in recent weeks for the Lone Star State. In the last seven days, the number of Texas hospitalizations have gone up by 13%; since Oct. 1, they've gone up by 75%.

Health officials warn that the state is currently in another surge. Experts attribute the spike in COVID-19 numbers to "pandemic fatigue."

The state estimates that 772,350 Texans have recovered, while 98,775 Texans remain ill with COVID-19.

Meanwhile, the Texas Education Agency updated its online coronavirus database to show that there have been 26,127 cumulative cases among staff and students across the state through Oct. 23. More information can be found here.

The TEA releases new data on school cases every Thursday.

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The symptoms of coronavirus can be similar to the flu or a bad cold. Symptoms include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell sore throat, congestion or runny nose, nausea or vomiting and diarrhea, according to the Centers for Disease Control.

Most healthy people will have mild symptoms. A study of more than 72,000 patients by the Centers for Disease Control in China showed 80 percent of the cases there were mild.

But infections can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death, according to the World Health Organization. Older people with underlying health conditions are most at risk.

But infections can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death, according to the World Health Organization. Older people with underlying health conditions are most at risk.

Experts determined there was consistent evidence these conditions increase a person's risk, regardless of age:

The CDC believes symptoms may appear anywhere from two to 14 days after being exposed.

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Coronavirus Tracker: Mayor Nirenberg says community has reached 'critical moment' in the pandemic while reporting 201 more cases - KENS5.com

Basel, October 30, 2020 Novartis today announced the receipt of marketing authorization from Japans Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe ("FBRI") to manufacture and supply commercial Kymriah (tisagenlecleucel) for patients in Japan. This approval makes FBRI the first and only approved commercial manufacturing site for CAR-T cell therapy in Asia.

Behind our efforts to reimagine medicine with CAR-T cell therapy lies a commitment to build a manufacturing network that brings treatment closer to patients, commented Steffen Lang, Global Head of Novartis Technical Operations. The expertise and infrastructure of FBRI, a world-leading manufacturing organization, allows us to bring CAR-T manufacturing to Asia. With the Japan MHLW commercial manufacturing approval, the recent capacity expansion in the US and our ongoing efforts to optimize and evolve our processes, we are well-positioned to deliver this potentially curative treatment option to more patients around the world.

Novartis has the largest geographical CAR-T cell therapy manufacturing network in the world, including seven CAR-T manufacturing facilities, across four continents. Commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US Food and Drug Administration (FDA) recently approved a further increase in manufacturing capacity.

Kymriah is the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL)1. Kymriah, approved in both indications by the Japan MHLW in 2019, is currently the only CAR-T cell therapy approved in Asia. Clinical manufacturing began at FBRI in 2019 and will continue alongside commercial manufacturing.

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, a strategic alliance between industry and academia, which was first-of-its-kind in CAR-T research and development.

About Novartis Commitment to Oncology Cell & Gene Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis has a deep CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.

Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of Novartis commitment to CAR-T cell therapy. Kymriah is currently approved for use in at least one indication in 26 countries and at more than 260 certified treatment centers, with the ambition for further expansion to help fulfill the ultimate goal of bringing CAR-T cell therapy to every patient in need.

The Novartis global CAR-T manufacturing footprint spans seven facilities, across four continents. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain. Commercial and clinical trial manufacturing is now ongoing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, New Jersey, USA, as well as at the contract manufacturing sites at Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut fr Zelltherapie und Immunologie) facility in Leipzig, Germany, and now FBRI in Kobe, Japan. Manufacturing production at Cell Therapies in Australia and Cellular Biomedicine Group in China is forthcoming.

ImportantSafety information from the Kymriah SmPC

EU Name of the medicinal product:

Kymriah 1.2 x 106 6 x 108 cells dispersion for infusion

Important note: Before prescribing, consult full prescribing information.

Presentation: Cell dispersion for infusion in 1 or more bags for intravenous use (tisagenlecleucel).

Indications: Treatment of pediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse posttransplant or in second or later relapse. Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Dosage and administration:

B-cell patients: For patients 50 kg and below: 0.2 to 5.0 x 106 CAR-positive viable T-cells/kg body weight. For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T-cells (non-weight based).

DLBCL Patients: 0.6 to 6.0108 CAR-positive viable T-cells (non-weight based).

Pretreatment conditioning (lymphodepleting chemotherapy): Lymphodepleting chemotherapy is recommended to be administered before Kymriah infusion unless the white blood cell (WBC) count within one week prior to infusion is 1,000 cells/L. The availability of Kymriah must be confirmed prior to starting the lymphodepleting regimen.

Precautions before handling or administering Kymriah: Kymriah contains genetically modified human blood cells. Healthcare professionals handling Kymriah should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.

Preparation for infusionThe timing of thaw of Kymriah and infusion should be coordinated. Once Kymriah has been thawed and is at room temperature (20C 25C), it should be infused within 30minutes to maintain maximum product viability, including any interruption during the infusion.

Administration Kymriah should be administered as an intravenous infusion through latexfree intravenous tubing without a leukocyte depleting filter, at approximately 10 to 20mL per minute by gravity flow. If the volume of Kymriah to be administered is 20mL, intravenous push may be used as an alternative method of administration.

All contents of the infusion bag(s) should be infused.

Clinical assessment prior to infusion: Kymriah treatment should be delayed in some patient groups at risk (see Special warnings and precautions for use).

Monitoring after infusion: Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities. Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of CRS and/or neurological events. After the first 10 days following the infusion, the patient should be monitored at the physicians discretion. Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.

Elderly (above 65 years of age): Safety and efficacy have not been established in B-cell patients. No dose adjustment is required in patients over 65 years of age in DLBCL patients.

Paediatric patients: No formal studies have been performed in paediatric patients with B-cell ALL below 3 years of age. The safety and efficacy of Kymriah in children and adolescents below 18 years of age have not yet been established in DLBCL. No data are available.

Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV): There is no experience with manufacturing Kymriah for patients with a positive test for HIV, active HBV, or active HCV infection. Leukapheresis material from these patients will not be accepted for Kymriah manufacturing.

Contraindications: Hypersensitivity to the active substance or to any of the excipients of Kymriah. Contraindications of the lymphodepleting chemotherapy must be considered.

Warnings and precautions: Reasons to delay treatment: Due to the risks associated with Kymriah treatment, infusion should be delayed if a patient has any of the following conditions: Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions or hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), significant clinical worsening of leukaemia burden or rapid progression of lymphoma following lymphodepleting chemotherapy. Blood, organ, tissue and cell donation: Patients treated with Kymriah should not donate blood, organs, tissues or cells.

Active central nervous system (CNS) leukaemia or lymphoma: There is limited experience of use of Kymriah in patients with active CNS leukaemia and active CNS lymphoma. Therefore the risk/benefit of Kymriah has not been established in these populations. Risk of CRS: Occurred in almost all cases within 1 to 10 days post infusion with a median time to onset of 3 days and a median time to resolution of8 days. See full prescribing information for management algorithm of CRS. Risk of neurological events: Majority of events, in particular encephalopathy, confusional state or delirium, occurred within 8 weeks post infusion and were transient. The median time to onset of neurological events was 8 days in B-cell ALL and 6 days in DLBCL; the median time to resolution was 7 days for B-cell ALL and 13 days for DLBCL. Patients should be monitored for neurological events. Risk of infections: Delay start of therapy with Kymriah until active uncontrolled infections have resolved. As appropriate, administer prophylactic antibiotics and employ surveillance testing prior to and during treatment with Kymriah. Serious infections were observed in patients, some of which were life threatening or fatal. After Kymriah administration observe patient and ensure prompt management in case of signs of infection Risk of febrile neutropenia: Frequently observed after Kymriah infusion, may be concurrent with CRS. Appropriate management necessary. Risk of prolonged cytopenias: Appropriate management necessary. Prolonged cytopenia has been associated with increased risk of infections. Myeloid growth factors, particularly granulocyte macrophage colony stimulating factor (GM CSF), not recommended during the first 3 weeks after Kymriah infusion or until CRS has been resolved. Risk of secondary malignancies: Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer and should be monitored lifelong for secondary malignancies. Risk of hypogammaglobulinemia or agammaglobulinemia: Infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be managed per age and standard guidelines. In patients with low immunoglobulin levels preemptive measures such as immunoglobulin replacement and rapid attention to signs and symptoms of infection should be implemented. Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment was not studied. Vaccination with live virus vaccines is not recommended at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah. Risk of tumor lysis syndrome (TLS): Patients with elevated uric acid or high tumor burden should receive allopurinol or alternative prophylaxis prior to Kymriah infusion. Continued monitoring for TLS following Kymriah administration should also be performed. Concomitant disease: Patients with a history of active CNS disorder or inadequate renal, hepatic, pulmonary or cardiac function are likely to be more vulnerable to the consequences of the adverse reactions of Kymriah and require special attention. Prior stem cell transplantation: Kymriah infusion is not recommended within 4 months of undergoing an allogeneic stem cell transplant (SCT) because of potential risk of worsening GVHD. Leukapheresis for Kymriah manufacturing should be performed at least 12weeks after allogeneic SCT. Serological testing: There is currently no experience with manufacturing Kymriah for patients testing positive for HBV, HCV and HIV. Screening for HBV, HCV and HIV, must be performed before collection of cells for manufacturing. Hepatitis B virus (HBV) reactivation, can occur in patients treated with medicinal products directed against B cells and could result in fulminant hepatitis, hepatic failure and death. Prior treatment with anti CD19 therapy: There is limited experience with Kymriah in patients exposed to prior CD19 directed therapy. Kymriah is not recommended if the patient has relapsed with CD19 negative leukaemia after prior anti-CD19 therapy. Interference with serological testing: Due to limited and short spans of identical genetic information between the lentiviral vector used to create Kymriah and HIV, some commercial HIV nucleic acid tests (NAT) may give a false positive result. Sodium and potassium content: This medicinal product contains 24.3 to 121.5mg sodium per dose, equivalent to 1 to 6% of the WHO recommended maximum daily intake of 2g sodium for an adult. This medicinal product contains potassium, less than 1mmol (39mg) per dose, i.e. essentially potassium free. Content of dextran 40 and dimethyl sulfoxide (DMSO): Contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL. Each of these excipients are known to possibly cause anaphylactic reaction following parenteral administration. Patients not previously exposed to dextran and DMSO should be observed closely during the first minutes of the infusion period.

Interaction with other medicinal products and other forms of interaction

Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah.

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females: Pregnancy status for females of reproductive potential should be verified prior to starting treatment with Kymriah. Consider the need for effective contraception in patients who receive the lymphodepleting chemotherapy. There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with Kymriah.

Pregnancy: There are no data from the use of Kymriah in pregnant women. It is not known whether Kymriah has the potential to be transferred to the foetus via the placenta and could cause foetal toxicity, including B cell lymphocytopenia. Kymriah is not recommended during pregnancy and in women of childbearing potential not using contraception. Pregnant women should be advised on the potential risks to the foetus. Pregnancy after Kymriah therapy should be discussed with the treating physician. Pregnant women who have received Kymriah may have hypogammaglobulinaemia. Assessment of immunoglobulin levels is indicated in newborns of mothers treated with Kymriah.

Breast feeding: It is unknown whether Kymriah cells are excreted in human milk, a risk to the breast fed infant cannot be excluded. Women who are breast feeding should be advised of the potential risk to the breast fed infant. Breast-feeding should be discussed with the treating physician.

Fertility: There are no data on the effect of Kymriah on fertility.

Effects on ability to drive and use machinesDriving and engaging in hazardous activities in the 8 weeks following infusion should be refrained due to risks for altered or decreased consciousness or coordination.

Adverse drug reactions:

B-Cell ALL patients and DLBCL patients:

Very common (10%): Infections - pathogen unspecified, viral infections, bacterial infections, fungal infections, anaemia, haemorrhage, febrile neutropenia, neutropenia, thrombocytopenia, cytokine release syndrome, hypogammaglobulinaemia, decreased appetite, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, anxiety, delirium, sleep disorder, headache, encephalopathy, arrhythmia, hypotension, hypertension, cough, dyspnoea, hypoxia, diarrhoea, nausea, vomiting, constipation, abdominal pain, rash, arthralgia, acute kidney injury, pyrexia, fatigue, oedema, pain, chills, lymphocyte count decreased, white blood cell count decreased, haemoglobin decreased, neutrophil count decreased, platelet count decreased, aspartate aminotransferase increased.

Common (1 to 10%): Haemophagocytic lymphohistiocytosis, leukopenia, pancytopenia, coagulopathy, lymphopenia, infusion-related reactions, graft versus host disease, hypoalbuminaemia, hyperglycaemia, hyponatraemia, hyperuricaemia, fluid overload, hypercalcemia, tumor lysis syndrome, hyperkalaemia, hyperphosphataemia, hypernatraemia, hypermagnesaemia, dizziness, peripheral neuropathy, tremor, motor dysfunction, seizure, speech disorder, neuralgia, ataxia, visual impairment, cardiac failure, cardiac arrest, thrombosis, capillary leak syndrome, oropharyngeal pain, pulmonary oedema, nasal congestion, pleural effusion, tachypnea, acute respiratory distress syndrome, stomatitis, abdominal distension, dry mouth, ascites, hyperbilirubinaemia, pruritus, erythema, hyperhidrosis, night sweats, back pain, myalgia, muscolosceletal pain, influenza-like illness, asthenia, multiple organ dysfunction syndrome, alanine aminotransferase increased, blood bilirubin increased, weight decreased, serum ferritin increased, blood fibrinogen decreased, international normalized ratio increased, fibrin D dimer increased, activated partial thromboplastin time prolonged, blood alkaline phosphate increased, prothrombin time prolonged.

Uncommon: B-cell aplasia, ischaemic cerebral infarction, flushing, lung infiltration.

Packs and prices: Country-specific.

Legal classification: Country-specific.

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

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References

1.Kymriah (tisagenlecleucel) Summary of Product Characteristics (SmPC), 2018.

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Novartis Media RelationsE-mail: media.relations@novartis.com

Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com

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Novartis expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia - GlobeNewswire

NEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L. It also provided a financial report for the first quarter ended September 30, 2020.

Mesoblast Chief Executive Dr Silviu Itescu stated: We believe the immunomodulatory properties of remestemcel-L position this potential therapy at the forefront of treatment for severe and life-threatening inflammatory conditions, including COVID-19 acute respiratory distress syndrome (ARDS) and steroid-refractory acute graft versus host disease (SR-aGVHD). We are pursuing an accelerated approval pathway for remestemcel-L in the treatment of children with SR-aGVHD, and a parallel approval pathway for COVID-19 ARDS if the randomized controlled Phase 3 trial is positive.

Children with Steroid-Refractory Acute Graft Versus Host DiseaseIn August, the Oncologic Drugs Advisory Committee (ODAC)1 of the United States Food and Drug Administration (FDA) voted 9:1 that the available data from a single-arm Phase 3 trial and evidence from additional studies support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD. Despite the overwhelming ODAC vote, in September the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.

Mesoblast believes that remestemcel-L meets the criteria for accelerated approval as there are currently no approved treatments for this life-threatening condition in children under 12. Mesoblast has formally requested a Type A meeting with the FDA to discuss a potential accelerated approval of the Biologics License Application (BLA) for remestemcel-L for the treatment of SR-aGVHD in children, with an additional randomized controlled study in patients 12 years and older as a post-approval requirement. Mesoblast expects this meeting will occur in November.

Adults with COVID-19 ARDSAs cases of COVID-19 surge in the United States and globally, deaths continue to increase from ARDS in ventilator-dependent patients as a result of an overactive immune response in the lungs to COVID-19. It is now evident that in both adults and children COVID-19 causes severe inflammation of other organ systems in addition to the lungs, including the heart, brain and kidneys. The immunomodulatory mechanism of action of remestemcel-L may be beneficial in the treatment of ARDS as well as in involvement of other organ systems.

Indeed, nine of 12 ventilator-dependent adult patients with COVID-19 ARDS who received two doses of remestemcel-L under emergency compassionate use at New Yorks Mt Sinai Hospital were successfully discharged within a median of 10 days. Additionally, two COVID-19 infected children with multisystem inflammatory syndrome (MIS-C) who received remestemcel-L for severe heart failure fully recovered heart function and were discharged within 30 hours of the second dose.

To confirm these pilot data, remestemcel-L is being evaluated for its potential to reduce mortality in a Phase 3 randomized controlled trial of up to 300 ventilator-dependent adults with moderate or severe COVID-19 ARDS. The dosing regimen in the Phase 3 is the same as in the pilot trial. Trial enrollment across more than 20 hospitals in the United States has surpassed 50% of the total 300 patient target. The trials first 135 patients will complete 30 days of follow up during October, after which the independent Data Safety Monitoring Board (DSMB) will perform an interim analysis of the trials primary endpoint of all-cause mortality within 30 days of randomization. The DSMB is expected to inform Mesoblast in early November on whether the trial should proceed as planned, or should stop early. A further interim analysis is planned after 60% of the trial has been enrolled.

Crohns DiseaseAccording to recent estimates, more than three million people (1.3%) in the United States alone have inflammatory bowel disease, with more than 33,000 new cases of Crohns disease and 38,000 new cases of ulcerative colitis diagnosed every year.2-4 Despite recent advances, approximately 30% of patients are primarily unresponsive to anti-TNF agents and even among responders, up to 10% will lose their response to the drug every year. Up to 80% of patients with medically-refractory Crohns disease eventually require surgical treatment of their disease,5 which can have a devastating impact on quality of life.

A randomized, controlled study of remestemcel-L delivered by an endoscope directly to the areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohns disease and ulcerative colitis has commenced at Cleveland Clinic. Mesoblasts objective is to confirm the potential for remestemcel-L to induce luminal healing and early remission in a wider spectrum of diseases with severe inflammation of the gut, in addition to SR-aGVHD. The investigator-initiated study at Cleveland Clinic is the first in humans using local cell delivery in the gut, and will enable Mesoblast to compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo-controlled trial in patients with biologic-refractory Crohns disease where remestemcel-L was administered intravenously.

Chronic Heart FailureIn the United States alone, of more than 6.5 million patients with chronic heart failure, there are more than 1.3 million patients with advanced stage of the disease.6 The objective of treatment with Mesoblasts allogeneic cellular product candidate REVASCOR is to reduce or reverse the severe inflammatory process in the damaged heart of these patients, and thereby prevent or delay further progression of heart failure or death. In an earlier randomized placebo-controlled 60-patient Phase 2 trial, a single intra-myocardial injection of REVASCOR at the dose administered in the subsequent Phase 3 trial prevented any hospitalizations or deaths over three years of follow-up in patients with advanced chronic heart failure. Results from Mesoblasts randomized placebo-controlled Phase 3 trial in patients with advanced forms of New York Heart Association Class II or Class III disease are expected during Q4 CY2020.

Chronic Low Back PainThere is a significant need for a safe, efficacious and durable treatment in patients with chronic low back pain due to severely inflamed degenerative disc disease, affecting over 3.2 million patients in the United States and approximately 4 million in the EU5.7 Results from a Phase 3 randomized placebo-controlled trial evaluating Mesoblasts product candidate in patients with chronic low back pain due to degenerative disc disease are expected during Q4 CY2020. In parallel, Mesoblast and its partner Grnenthal GmbH are collaborating on the clinical protocol for a confirmatory Phase 3 trial in Europe.

Cash Flow Report for the First Quarter FY2021Cash on hand at the end of the quarter was US$108.1 million. Over the next 12 months, Mesoblast may have access to an additional US$67.5 million through existing financing facilities and strategic partnerships.

Total Operating Activities excluding product inventory resulted in net cash usage of US$23.0 million in the quarter ended September 30, 2020. In addition, $5.2 million was invested in RYONCIL (remestemcel-L) commercial inventory in anticipation of product launch for either children with SR-aGVHD or COVID-19 patients with moderate to severe ARDS.

About MesoblastMesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid-refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

1.This vote includes a change to the original vote by one of the ODAC panel members after electronic voting closed.2.CDC Facts and Figures 2015.3.Globaldata Pharmapoint 2018.4.Dahlhamer JM, MMWR Morb Mortal Wkly Rep. 2016;65(42):11661169.5.Crohns and Colitis Foundation6.AHAs 2017 Heart Disease and Stroke Statistics7.Decision Resources: Chronic Pain December 20158.TEMCELL HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Update on Remestemcel-L For the Treatment of COVID-19 ARDS and Steroid-Refractory Acute GVHDQuarterly Activity Report - BioSpace

OCEANSIDE, Calif., Oct. 29, 2020 /PRNewswire/ --Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today publication on the NIH clinical trials website1 of its newly initiated trial aiming to validate a blood-based diagnostic for predicting suicide risk.

The Campbell Score, which is a patent-pending method of quantifying inflammatory-associated biological markers, has previously been shown in pilot investigator-initiated studies to correlate with propensity for suicide. Based on positive feedback from collaborators, the Company decided to initiate a formal clinical trial to validate correlations between the Campbell Score and established psychiatric assessment tools of suicidal propensity. Currently the only means of quantifying predisposition to suicide is based on psychological, question-based techniques. These tests are highly subjective and biased based on desire of questionee to avoid being labeled as "crazy."

"I am thankful for Timothy Dixon and the team at TSOI for working to establish a biological basis of suicide as a disease and not a choice," said Kalina O'Connor, Director of the Campbell Neurosciences Division of the Company. "Rigorous scientific validation of the Campbell Score, will be the first step in establishing a foundation for a paradigm shift in the way that suicide is approached."

Therapeutic Solutions International has previously filed patents for diagnosing people at high risk of suicide and intervening using immunotherapy and stem cell based approaches.

"According to the World Health Organization, suicide is the #2 cause of death for people between the ages of 15 and 29,"2 said Famela Ramos, Director of Business Development of the Company. "I am honored to be involved with a company that not only is working on developing the first objective means of quantifying suicidal thoughts, but also is the first to believe that taking one's life occurs because of a biochemical abnormality and not "taking the easy way out."

"The Campbell Score is named after Kathleen Campbell, the mother of Kalina O'Connor who was victim of suicide. We strive in her name, and the name of the multiple victims of suicide, to lay down the scientific basis, and intellectual property foundation, for repositioning suicide from a stigma to a bona fide medical condition," said Timothy Dixon, President and CEO of Therapeutic Solutions International.

About Therapeutic Solutions International, Inc.Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/ and Campbell Neurosciences at https://www.campbellneurosciences.com

1https://clinicaltrials.gov/ct2/show/NCT046068752https://www.who.int/mental_health/prevention/suicide/suicideprevent/en/

ir@tsoimail.com

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Therapeutic Solutions International Launches Clinical Trial to Validate First Blood Based Predicator of Suicidal Ideation: The Campbell Score -...

By FELICITY DARVILLE

As October comes to an end, I wanted to recognise a group that deserves just as much attention as other NGOs celebrating important causes this month.

The Bahamas Alliance for the Blind and Visually Impaired (BABVI) recognises October as Blindness Awareness Month. This year, BABVI celebrates 30 years in existence and 23 years as a legal entity for the blind in The Bahamas.

The fact that members of the alliance are blind or visually impaired have not stopped them from being active this month despite the restrictions of the pandemic.

In fact, members have been more active on social media than ever before. This was in keeping with this years theme: Our Vision Still Strong; Pandemic or Not!

BABVI president Ken Rolle said the organisation launched an aggressive campaign via social media platforms centred on eye care tips, breaking barriers in blindness, and living with blindness.

There were also media house interviews, talk show appearances and presentations to civic organisations via Zoom. Since Ken has been president, he has brought a lot of young people to the alliance and they, in turn, have been using their social media platforms to promote their cause.

They celebrated World Sight Day on Thursday, October 8, and International White Cane Day on October 15, pushing the message to friends, family members and followers to get their eyes tested and be conscious of the needs of blind and visually impaired people like them.

The month of celebrations culminated last night with the Vision 2020 Virtual Summit which featured presentations from BABVI members along with representatives from the Caribbean Council for the Blind; Disability Affairs Division; Department of Social Services; The Eye Care Services Department of Public Health and The Erin H Gilmour School for the Blind.

The Alliance remains the trailblazers in the country sensitising the general public on the importance of eye protection, sight preservation and blindness prevention, Ken said.

Additionally, the organisation is still focused on its mission and goals as outlined in the Constitution, employing members to remain vocal, advocating for the rights, dignity, and wellbeing of the blind in the Bahamian society.

This years Blindness Awareness Month highlights included three BABVI members: Jermaine Clarke, Rickia Pratt and Akemi Kenaz Thompson.

Jermaine Clarke is a husband and father of three. He has been blind for over 25 years. Despite this challenge, Jermaine is independent and is a daily provider for his family. He has been employed at the Salvation Armys mop factory for years now.

But thats not all Jermaine is a lumberjack. He is skilled at what he does and because of it, members of his community know who to call after a hurricane to help with clean up, or just to cut down overgrown trees in their yard.

For people without any disabilities, holding down two jobs is quite a feat. But being a lumberjack and a factory worker only scratches the surface of what this talented man can do. Jermaine also has skills in plumbing as well as auto mechanics.

So, his community members, family and friends call on him for all sorts of odd jobs. When he isnt getting his hands dirty and earning money, Jermaine turns to something he loves music.

His passion for music has blossomed into another career. Jermaine is a DJ who specialises in events like birthdays and weddings.

Challenge me to do something and I will find a way to do it, he said.

Anything to feed my family.

Ken called his BABVI colleague a great supporter of all of the organisations initiatives, and a true model of a man who is blind.

The spotlight is also on Rickia Pratt for Blindness Awareness month. Rickia has been visually impaired all her life. She attended the Salvation Army School for the Blind, where she graduated with 6 BJCs and 6 BGCSEs.

At the age of ten, Rickia developed a love for foreign languages. That love blossomed as she pursued tertiary education. She attended Eastern Washington University and successfully pursued a degree in foreign languages.

When Rickia returned home, her skills were put to good use. She made history by being the only person with disability to be accepted into the Ministry of Tourisms Foreign Language Cadet Programme in 2008. She was afforded the opportunity to attend a summer-abroad programme in Costa Rica, one of many places she has travelled to perfect the Spanish language.

Rickia is a seasoned liturgical dancer. She has been dancing from she was eight years old. Today, Rickia is an activist for local people with disabilities. Her personal motto is: All things are possible with hard work and determination.

The youngest to be highlighted this month is Akemi Kenaz Thompson. She is one of the bright stars at the Erin H Gilmour School for the Blind and Visually Impaired.

Now in her late teens, Akemi was diagnosed at birth with a condition called Hydrocephalus, which is a build-up of fluid within the cavities of the brain. Treatment was administered; however, by sixth grade, Akemis condition took a turn for the worse, leaving her with chronic visual impairment, mostly in her right eye.

Despite this, Akemi still continues to thrive and blossom, obtaining four BJCs due to her hard work and dedication to her studies.

She is now attending classes at RM Bailey Senior High School on a quest to obtain her BGCSEs, with a focus on English Language. Akemi has learned to navigate independently with low vision using the white cane, an essential tool for blind and visually impaired people all around the world.

A white cane primarily allows its user to scan their surroundings for obstacles or orientation marks. As an onlooker, it is important to take notice when you see the white cane, so that you can identify the user as blind or visually impaired and take appropriate care. This becomes very important when you are a motorist and someone is using the white cane and crossing the street, for example. For BABVI, white cane also symbolises self-reliance and accomplishment.

Akemi has a love for reading, traveling and experiencing new cultures. One day, she hopes to be a college graduate and she aspires to become an author. She is confident she can achieve her goals because of her strong support system her parents and three brothers.

Congratulations goes out to the Alliance as it celebrates another milestone in the organisations life, Ken said in an address to his members.

Remain resilient, press on towards your goals, persevere in these unprecedented times despite the emergency orders. As our theme suggests let your vision remain strong, pandemic or not!

For donations to help the causes of the blind and visually impaired, or for general information, BABVI can be contacted through the Disability Affairs Division, telephone 325-2252 or email babvi.101@gmail.com.

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FACE TO FACE: Shining a light on those living with blindness - Bahamas Tribune

There are many different types of retinal diseases, but almost all of them lead to damage of the retinal and vision loss. The retinal is a thin layer of tissue on the inside back wall of your eye, which contains millions of light-sensitive cells and nerve cells that receive and send visual information to the brain through the optic nerve. This is what enables you to see. If there are any problems with the retina, available treatment options will stop the progress of the disease and preserve and restore vision. But this is not always successful. Also Read - Working from home? You may be at risk of developing computer vision syndrome

Now researchers have uncovered a potential new strategy for treating eye diseases that affect millions of people around the world, often resulting in blindness. Many serious eye diseases including age-related macular degeneration, diabetic retinopathy and related disorders of the retina feature abnormal overgrowth of new retinal blood vessel branches, which can lead to progressive loss of vision. Its a phenomenon called neovascularization. Also Read - 5 everyday bad habits that are hurting your eyes

For the past decade and a half, eye doctors have been treating these conditions with drugs that block a protein, VEGF, thats responsible for spurring new vessel growth. Such drugs have improved the treatment of these conditions, but dont always work well and have potential safety issues. The current study, published in the journal Proceedings of the National Academy of Sciences, showed that a new approach that doesnt target VEGF directly is highly effective in mice and has broader benefits than a standard VEGF-blocking treatment. Also Read - Dont rub your itchy eyes: Try these effective home remedies instead

Researchers from Scripps Research Institute in the US were thrilled to see how well this worked in the animal model. There really is a need for another way to treat patients who do not respond well to anti-VEGF treatments, they say. For the findings, the research team conducted tests in a mouse model of retinal hypoxia and neovascularization, using a fragment of CITED2 that contains its functional, hypoxic-response-blocking elements. They showed that when a solution of the CITED2 fragment was injected into the eye, it lowered the activity of genes that are normally switched on by HIF-1a in retinal cells, and significantly reduced neovascularization. Moreover, it did so while preserving, or allowing to re-grow, the healthy capillaries in the retina that would otherwise have been destroyed researchers call it vaso-obliteration in this model of retinal disease.

In the same mouse model, the researchers tested a drug called aflibercept, a standard anti-VEGF treatment. It helped reduce neovascularization but did not prevent the destruction of retinal capillaries. However, reducing the dose of aflibercept and combining it with the CITED2 fragment yielded better results than either alone, strongly reducing neovascularization while preserving and restoring retinal capillaries. CITED2s ability to combine these two benefits appears to represent a key advance, the researchers concluded. The researchers now hope to develop the CITED2-based treatment further, with the ultimate goal of testing it in human clinical trials.

(With inputs from IANS)

Published : October 28, 2020 10:31 pm | Updated:October 29, 2020 9:28 am

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Retinal diseases often lead to blindness, but a new treatment shows promise - TheHealthSite

Glaucoma is an eye condition that can cause damage to the optic nerve. This nerve is essential for your eye health. If it becomes damaged, it can cause permanent vision loss and, in some cases, it may even lead to blindness.

Glaucoma is typically caused by high pressure inside your eyes. However, diabetes can also be a risk factor for glaucoma.

In this article, well take a closer look at the link between diabetes and glaucoma, and the steps you can take to help protect your eye health.

Your eyes continuously produce a clear fluid known as the aqueous humor that fills the inside of your eye. New fluid constantly replaces the older fluid, which leaves your eye through a meshwork drainage field and channels.

If something obstructs this drainage mechanism, the natural pressure inside your eye known as your intraocular pressure (IOP) can increase. If your IOP increases too much, it can damage the fibers of your optic nerve.

As damage to this nerve progresses, you may begin losing sight in your eye, especially in your peripheral vision.

There are two primary types of glaucoma: open-angle and closed-angle.

According to a 2017 study, diabetes may raise your risk of open-angle glaucoma by approximately 36 percent. Closed-angle glaucoma does not seem to have a known connection with diabetes.

Diabetic retinopathy, which is a complication of diabetes and the most common form of diabetic eye disease, can increase your risk of glaucoma.

Diabetic retinopathy usually affects people who have had diabetes for a long time. The risk of this condition increases with:

With diabetic retinopathy, changes in your glucose levels can cause the blood vessels in your retina to weaken and become damaged. This can eventually lead to glaucoma.

The leading theory is that when the blood vessels in your retina become damaged, it can cause abnormal blood vessels to grow in your eye, known as neurovascular glaucoma. These blood vessels can block your eyes natural drainage system. When this happens, it can cause your eye pressure to increase, which can lead to glaucoma.

Another theory as to how diabetic retinopathy increases the risk of glaucoma points to high blood sugar as the direct cause. According to this theory, high blood sugar can cause an increase in a specific glycoprotein, called fibronectin, to form in your eye. Having more fibronectin in your eye may block your eyes natural drainage system, which can lead to glaucoma.

Glaucoma typically doesnt have any symptoms, especially in the early stages. Because glaucoma causes gradual changes in your vision, you might not notice any symptoms until its more advanced. If left untreated, glaucoma can lead to severe vision loss or blindness.

If you do have symptoms of glaucoma, the symptoms will vary depending on the type of glaucoma and how advanced the disease is.

Symptoms may include:

This type of glaucoma is a medical emergency and requires immediate treatment. Symptoms may include:

Symptoms may include:

Because glaucoma often doesnt have symptoms in the early stages, its important to get regular eye exams. This is especially important if you have any risk factors, including diabetes.

According to the Centers for Disease Control and Prevention (CDC), people with diabetes should get a dilated eye exam every year. Having your eyes dilated can help your eye doctor to more easily check for optic nerve damage or other issues.

During your eye exam, your doctor will also measure the pressure in your eyes. Depending on your risk, you might need other tests, such as checking for areas of vision loss, measuring the thickness of your cornea, and looking at the angle at which your eye drains fluid.

If you receive a glaucoma diagnosis, prescription eye drops are usually the first treatment option.

If the eye drops dont help reduce the pressure buildup in your eye, your doctor may suggest medication or surgery.

Surgery options for glaucoma include:

Depending on your diabetes management and other risk factors, you may be at a higher risk of developing other eye issues, too.

Short-term spikes in your blood sugar, which can happen when youre changing your treatment, can cause swelling or high fluid levels in your eye. This can cause temporary blurry vision. This will likely go away once your blood sugar stabilizes.

Long-term elevated blood sugar levels can damage the blood vessels in your eye and lead to conditions, such as:

If you have diabetes, its very important to protect your eye health, as well as your general health. To lower your risk of glaucoma and other eye issues with diabetes, be sure to:

Diabetes can increase your risk of several eye diseases, including glaucoma.

Diabetic retinopathy, which is a complication of diabetes, can result in damage to the blood vessels in your retina. This can cause abnormal blood vessels to grow in your eye, which can block your eyes natural drainage system and eventually lead to glaucoma.

Because glaucoma often has no symptoms, especially in the early stages, its important to get annual eye exams if you have diabetes.

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Glaucoma and Diabetes: Is There a Connection? - Healthline

A new Christchurch art exhibition will give people with blindness or low vision the chance to experience the work with a number of pieces that you can 'touch' and 'feel'.

The Touching Sight exhibition showcases new work by three contemporary Christchurch artists.

"Each of the artists who've contributed to Touching Sight work in different mediums, and we've brought them together for a playful exhibition that celebrates different ways of making and seeing art," said art gallery curator Melanie Oliver.

Being unable to see doesn't need to be a barrier to appreciating visual art, the exhibition includes some works that people can touch and feel.

Photographer Conor Clarke (Ngi Tahu) has worked with participants from the blind and low vision community to make a series of large, touchable photographs that represent landscapes described as they remember them.

Emma Fitts has made brightly coloured, voluminous sculptural textiles, inspired by the form, colour and composition of twentieth-century paintings.

Oliver Perkins's paintings are the result of restless experimentation in the studio.

These works challenge our contemporary understanding of abstraction and how it can represent or reflect our experience.

"We have a reference room at the heart of Touching Sight that includes audio descriptions of each work. They don't describe things in the way a sighted person would, but in a way that would let someone with low vision understand and appreciate them.

"We've tried to talk about things like colour for someone who may never have actually seen one before how do you do that? We've brought in the other senses as much as we can, things like texture and feeling," Oliver said.

"And the title of the exhibition also comes into play, because some of the artworks have been specially crafted so that visitors can touch them and experience art in a way that people don't often get to."

Touching Sight runs from October 31 2020 to February 21 2021 at Christchurch Art Gallery.

There will also be an artist floortalk, where visitors can join the three artists and curator Melanie Oliver for a conversation about their projects.

Touching Sight is one of several exhibitions in the Gallery's All Art All Summer season, designed to make everyone feel welcome this summer.

The season will launch officially on 5 December 2020.

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New Christchurch Art Gallery exhibition aims to include those with blindness or low vision - New Zealand Herald

Newswise Mass Eye and Ear is proud to announce the successful conclusion of its historic campaign, Bold Science. Life-Changing Cures. which raised $252M from philanthropy to advance research to treat and cure diseases of vision, hearing, and the head and neck.

The campaign was led by co-chair Wyc Grousbeck, Boston Celtics CEO and Lead Owner and former Chairman of Mass Eye and Ear. Grousbeck was elected Chairman of the Foundation and Board of Directors of the Massachusetts Eye and Ear in 2010, and stepped down from the position earlier this year. He will continue to serve as a trustee and contribute to advancing Mass Eye and Ears mission, with a lasting legacy that includes two endowed chairs and a gene therapy research center he and his family established.

The campaigns finale culminated in a virtual celebration as part of the hospitals annual Sense-ation! Gala on Wednesday, October 28, 2020 at 7:30 PM EST. This years gala was held online due to the COVID-19 pandemic, and was hosted by longtime Mass Eye and Ear friends, Billy Costa, (Co-Host of KISS 108s Matty in the Morning and NESNs Dining Playbook) and founding gala chair Joey McIntrye (New Kids on the Block).

[Watch the entire 11th Annual Sense-ation Gala!]

Bold Science. Life-Changing Cures. Ends with Enduring Legacy

The Bold Science. Life-Changing Cures. campaign was launched with the goal of expediting cures for blindness, deafness and diseases of the head and neck by investing in three key areas: people, programs and places (our facilities). Through this campaign, the generosity of donors and organizations infused significant financial resources into Mass Eye and Ears cutting-edge research programs, and supported the facilities needed by the leading physicians and scientists in Ophthalmology and Otolaryngology-Head and Neck Surgery to conduct their world-class work.

The campaign resulted in a powerful and far-reaching impact on research at Mass Eye and Ear by faculty, including:

Additionally, new Research Centers were launched in gene therapy, tinnitus, and head and neck cancer and two world-class surgical training laboratories were built.

The campaign also will leave a lasting legacy of fourteen endowed Chairs for leading physicians and scientists that will remain for generations. The endowment of a Chair provides financial support for researchers, allowing them to focus on their efforts to develop treatments and cures.

Wyc Grousbeck Honored for Dedication to Mass Eye and Ear During 10 years as Chairman

Grousbeck, who served as Board Chairman at Mass Eye and Ear for the past decade, was honored at this years Sense-ation! Gala for his many contributions. During his tenure, he led the organization through remarkable growth, both clinically and as a world-renowned research center. Mass Eye and Ear surgical volume doubled and the number of clinical locations grew from 9 to 21 throughout the region. Grousbecks leadership played critical roles in two highly successful mergers: Schepens Eye Research Institute joining Mass Eye and Ear in 2012 and Mass Eye and Ear joining Mass General Brigham (formerly Partners HealthCare) in 2018. He also initiated and served as co-chair of the Bold Science. Life-Changing Cures. campaign.

Wycs leadership during the campaign has been nothing short of magnificent; he has showed us anything is possible, said John Fernandez, President of Mass Eye and Ear. When we first reached our $100M goal in the campaign, Wyc called on us to double that amount by 2020. With Wycs guidance, we were able to exceed that ambitious goal by more than $50M by the campaigns end.

Grousbeck first became involved with Mass Eye and Ear because his family has been touched by blindness, and since then, they have been devoted to research and educational initiatives relating to blindness and other vision-related conditions for many years.

Grousbeck and his familys philanthropic support established the Grousbeck Center for Gene Therapy at Mass Eye and Ear as well as the Grousbeck Family Chair in Gene Therapy, held by Luk H. Vandenberghe, PhD. Additionally, Wyc and his wife, Emilia Fazzalari, funded the Fazzalari-Grousbeck Chair in Otolaryngology-Head and Neck Surgery held by Tessa Hadlock, MD. Most recently, they seeded Dr. Vandenberghes work to develop an experimental and novel genetic vaccine for COVID-19.

Grousbeck was a driving force around establishing the first Sense-ation Gala 11 years ago, which brought celebrities, musicians, philanthropists, and scientists together to help raise funds for Mass Eye and Ear research and patient care. The gala to date has raised more than $12M for the Mass Eye and Ear Curing Kids Fund.

About Mass Eye and Ear

Massachusetts Eye and Ear, founded in 1824, is an international center for treatment and research and a teaching hospital of Harvard Medical School. A member ofMass General Brigham, Mass Eye and Ear specializes in ophthalmology (eye care) and otolaryngologyhead and neck surgery (ear, nose and throat care). Mass Eye and Ear clinicians provide care ranging from the routine to the very complex. Also home to the world's largest community of hearing and vision researchers, Mass Eye and Ear scientists are driven by a mission to discover the basic biology underlying conditions affecting the eyes, ears, nose, throat, head and neck and to develop new treatments and cures. In the 20202021 Best Hospitals Survey,U.S. News & World Reportranked Mass Eye and Ear #4 in the nation for eye care and #6 for ear, nose and throat care.For more information about life-changing care and research at Mass Eye and Ear, visit our blog,Focus, and follow us onInstagram,TwitterandFacebook.

Originally posted here:
Mass Eye and Ear Capital Campaign Concludes with $252 Million Raised to Advance Research and Patient Care - Newswise

By Carmen Heredia Rodriguez, Kaiser Health News

Norma Crosby remembers when she relied on blind faith to cast her vote.

The 64-year-old Texan was born virtually without sight, a side effect of her mother catching rubella while pregnant with her. Friends and relatives stood beside her and filled out her ballot at polling precincts for more than half of her voting life. Then, accessible voting machines rolled out around the year 2000, enabling her to vote in person on her own.

Now, the COVID-19 pandemic makes going to the polls a risky proposition for Crosby. She also has a condition called sarcoidosis that requires her to take immunosuppressant drugs, she said. However, the state does not have a mail-in voting system that accommodates Crosbys visual impairment.

It communicates to me that Im not valued as much as other citizens, said Crosby, president of the National Federation of the Blind of Texas, that Im a second-class citizen.

A projected 7 million Americans who are eligible to vote in the presidential election live with visual impairments, according to researchers from Rutgers university. For those, like Crosby, who also deal with illnesses that place them at a higher risk of falling seriously ill with COVID-19, voting this year will be especially difficult.

The pandemic exposed glaring holes in absentee and mail-in voting systems around the nation. In some jurisdictions, voters who have whats known as print disabilities conditions that make it difficult to process printed content, such as blindness, low vision or learning or physical disabilities could not cast a ballot remotely without asking for help, thereby compromising their privacy.

Outcry and lawsuits from disability advocates prompted at least 11 states to update their mail-in and absentee ballot systems in an attempt to accommodate these voters. Some changes enable voters to use text-reading software with their ballots and submit them online through a secure portal.

However, some states have been slow to address these needs. In Iowa, voters cannot vote confidentially using the mail-in system because the state requires the use of paper ballots. Texas residents like Crosby must find someone to fill out their ballot and mail it in or take it to the sole drop box in the county all during a pandemic that has required people to physically distance themselves to stay safe.

We should not have to choose, said Chris Danielsen, director of public relations for the National Federation of the Blind, between endangering our health and going to the polls in person, or not voting at all.

Several federal laws affirm the right of all people, regardless of disability, to vote in an accessible manner. The Americans with Disabilities Act, passed in 1990, requires state and local governments to make the voting process user-friendly to voters of various abilities. This includes providing accessible parking spaces and placing voting machines where people using wheelchairs have enough space to move and at a height reachable by all.

In 2002, Congress passed the Help America Vote Act. The law built on the previous legislation by requiring every polling place to have at least one voting machine available during federal elections that accommodates a range of disabilities. These gadgets vary in features by manufacturer, but they can include touch screens, buttons labeled in Braille and audio capabilities. Voters using them must have the same privacy and independence enjoyed by people who dont have such challenges.

However, states largely retained the power to decide how to comply with these federal mandates, said Lisa Schur, co-director of the Program for Disability Research at Rutgers. The result, she said, is an uneven patchwork that voters with disabilities must navigate.

With COVID-19 creating a reason to avoid in-person voting, some states, such as Texas, still failed to take steps to make it possible for a voter with visual or print impairments to fill out a mail-in ballot without assistance. The state government is also embroiled in a lawsuit regarding its decision to limit ballot drop-off boxes to one per county.

Harris County, where Houston is located, covers more than 1,700 square miles and is home to 4.7 million people. The distance becomes an added hardship for voters who opted to vote remotely and would prefer to drop off their ballot to make sure it is counted.

The state declined to comment due to the pending litigation.

Iowa also has fallen short in making systemic changes to improve access, according to disability advocates. Like Texas, the state provides only paper ballots for voters wishing to vote absentee.

Scott Van Gorp, president of the National Federation of the Blind in Iowa, said he initially felt resigned to his lack of privacy when he started voting. He was born three months early, leaving him with little more than light perception for sight. As a college student in the 1990s, Van Gorp rallied his friends to help him cast his vote.

I kept thinking, Thats not a secret ballot. Why?

In a written statement, a spokesperson for the Iowa secretary of state said it has made efforts to even the field by creating a large-print voter registration form and how-to videos on using accessible voting machines at polling locations. It cannot unilaterally make a change to improve accessibility without legislative approval, he added.

Election officials in several other states, though, including the battlegrounds of Nevada, Pennsylvania and Michigan, adopted changes this year to their mail-in ballot systems to accommodate people with visual disabilities.

In Maine, voters with impairments can request, fill out and submit their votes electronically through a new online platform. The ballots are compatible with various types of screen-reader software and will be counted through the same system used for absentee and overseas military voters.

This option became available in early October after the state was notified of confidentiality issues with paper ballots and sued by disability advocates.

Kristen Muszynski, a spokesperson for Maines secretary of state office, said some of the plaintiffs named in the lawsuit helped test the system. Litigation is now on hold, she said, and she is hopeful the new voting option will help resolve some of the issues.

Were hopeful that the word is starting to get out, Muszynski said.

A few jurisdictions around the nation offer Braille ballots. However, said Douglas Kruse, co-director of the Program for Disability Research at Rutgers, voters may still need someone to help them fill one out and submit it. These ballots would also need to be counted separately, compromising the voters privacy.

One of the few states that have not needed to make drastic changes to accommodate voters with disabilities during the pandemic is Oregon, where mail-in ballots have been the primary form of voting for years.

Voters with disabilities can access and fill out ballots electronically using assistive technology like screen readers and sip-and-puff systems through which a person with limited mobility controls the device using their breath and a straw to vote. Then, the ballots must be mailed in.

Sean Carlson, 42, president of the Portland Central Chapter of the National Federation of the Blind, said he has never encountered issues while voting in his home state. He and his colleagues are focused on bringing awareness to the importance of having a say in our democracy, he said.

It should not be that if someone has a disability that they should be locked out of that process.

For now, Norma Crosby, who lives outside Houston, plans to vote in person, and she will need to bring a sighted friend to make sure she maintains social distance. After all, she cant see whether other people are wearing masks.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Election Ballots Aren't Accessible to People With Low Vision - The Mighty

There are cases for re-electing President Trump that make sense in their own terms. If your top priorities are tax cuts, immigration restriction, or conservative judges, for example, Trump has proven a remarkably reliable vehicle for achieving those ends. Other cases reflect a willful blindness to reality. Far from draining the swamp, for example, Trump has turned himself into the capital's premier swamp-dweller.

But most voters in the middle care about practical results, and from health care to infrastructure to trade, Trump's efforts have been largely feckless and incompetent. Even discounting the glaring failure of his response to COVID-19, an area where plenty of peer countries have not exactly covered themselves with glory, the administration has a very thin record of accomplishment to run on.

There's one area, though, where Trump can argue he has genuinely distinguished himself from prior administrations, Democratic and Republican, in a way that should matter deeply to the American people. Trump ran in both the primaries and the general election as the man who would keep America out of unnecessary wars and who would end the ones we were in. He hasn't ended any of our wars yet, but Trump is in fact the first president since Jimmy Carter not to have sent American troops into a new conflict.

So it's at least worth hearing out the idea: Is Trump the peace candidate?

The claim, made most prominently by Modern Age editor and The Week contributor Daniel McCarthy, rests on three arguments. First, as noted, Trump did not involve America in any new conflicts. For a normal nation, this would not be an extraordinary accomplishment but for America, it might be. Military intervention has long-since become a way of life in American foreign policy. Even Barack Obama, who was elected on a promise not to get involved in "stupid wars," was convinced to intervene in Libya, with catastrophic results, and it was only at the last moment that he pulled back from a comparable effort in Syria. By contrast, Trump, while he appointed super-hawks like Mike Pompeo and John Bolton to be his advisors, declined to be talked into war with Iran. Shouldn't he get credit for that?

Second, while Trump is the last person anyone would call diplomatic, he has been a promiscuous globe-trotter in search of peace deals. He long advocated a rapprochement with Russia, initiated personal diplomacy with North Korea for the first time at the presidential level, and, most notably, facilitated peace agreements between Israel and three Arab states the United Arab Emirates, Bahrain, and Sudan with the potential for more to come. If this is not the record of a peace-maker, what is it?

The third argument is the most important, because it speaks to overall philosophy, not generally considered this president's strong point. But if Trump has a theory of the world, it is that you should make deals that benefit yourself. Applied to foreign policy, this suggests the goal of American foreign policy should not be to improve other countries or to advance some values we hold dear, but to get the best possible deals for America. So if, for example, we can woo North Korea away from confrontation (and out of a pro-Chinese alignment) by soft-pedaling concerns about human rights or missile development, why not do it?

Is that peace? If so, Trump has a case. But I don't think it's peace.

For one thing, while it's true that Trump did not start a war with Iran, he did take a high-risk gamble in assassinating terrorist mastermind General Qassem Soleimani, and the fact that the gamble has so far paid off doesn't invalidate how risky it was at the time, nor the fact that, in that instance, he did listen to his extremely hawkish advisors. Moreover, Trump pulled out of the nuclear deal that was one of Obama's notable accomplishments, which has, predictably, led Iran to move further toward nuclear potential while shredding any American diplomatic leverage. While Trump has not started any new wars, one of his first acts was to dramatically escalate America's involvement in Saudi Arabia's near-genocidal war in Yemen, a war so unpopular that he had to veto a bi-partisan war-powers resolution to keep fighting. Meanwhile, from North Korea to China to Venezuela, Trump has been as promiscuous with his threats as he has been with his praise of foreign dictators. If he has rarely backed those threats up with military action, that is not a sign of a dove but of a paper tiger.

As for diplomacy, while Trump has claimed to want better relations with Russia, it's hard to discern any actual improvement there. Instead, America has torn up arms agreements with Russia in the hopes of adding China to them, a gambit which failed, leaving the future of New Start in serious question. The same can be said about North Korea, where Trump's bold diplomatic opening has led nowhere. Chalk these failures up to conflict between Trump and his subordinates, or to Russian and North Korean determination to pursue their own interests, or what have you regardless, a stated eagerness for better relations is not the same thing as achieving them, and the achievement is what's lacking.

The only area where Trump can legitimately point to peacemaking is between Israel and some of its erstwhile adversaries. But it's important to understand what underwrites this peace. In the case of the Gulf States, it was mutual fear of Iran stoked by Obama's nuclear deal that led to a behind-the-scenes working relationship with Israel. And what made it possible to bring that relationship into the open is the weakness of the Palestinian position, and their consequent inability to shape events in the Arab world. Trump surely revealed that weakness by moving the American embassy to Jerusalem, so the world could see that nothing much happened in consequence. If he contributed beyond this, it was by being prepared to ask less than most American presidents would of either party, and to offer more. How is that "America First?"

Which leads me to my largest objection to the characterization of Trump as the peace candidate. It's not just that Trump hasn't actually reduced America's military commitments, or ended any of our ongoing conflicts, or improved American relations with any other powers. It's not just that his idea of a good deal is one that benefits America's defense contractors while leaving us more beholden to allies who can offer us little in exchange for our support. It's that the conception of peace implied by this characterization is too thin to deserve the term. Peace is not merely the absence of current conflict. It is the establishment of relations with other powers on a basis that makes conflict less likely over the long term.

That is an idea that strikes me as entirely beyond President Trump's comprehension, convinced as he is that life is a constant zero-sum struggle for dominance. Of course, that's one way to characterize international relations as well perhaps the most realistic one in our fallen world. But it's one that declares "peace" an impossibility, the only hope being either global hegemony, or a dynamic balancing between different powers punctuated by conflict. If the former is no longer realistic (and I agree it's not), then America needs more than ever a shrewd, knowledgeable statesman at the helm, capable of discerning where our true interests lie and maneuvering to advance them as peacefully and cooperatively as possible. A statesman who will only threaten when necessary, but whose threats are always taken seriously.

If that sounds like Trump to you, then I've got a heck of a deal on a swamp to sell you.

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Is Trump the candidate of peace? - The Week Magazine

(PRESS RELEASE) BOSOTON A medication frequently used to treat diabetic macular edema, which is the most common cause of blindness in people with diabetes, is less effective when used to treat the condition in Black patients, new study results show. Led by researchers at Boston Medical Center, the study demonstrated that Black patients were significantly less likely than white patients to show short-term visual improvement after both a single injection and a series of three injections with the drug bevacizumab (Avastin), the most common treatment in the U.S. for diabetic macular edema. Published in the American Journal of Ophthalmology, the results underscore the need to increase diversity in participation in clinical trials for the treatment of diabetic macular edema in order to develop treatments that are effective for all patients.

This is the first study looking at race as a factor in the treatment of diabetic macular edema, a condition that results from fluid build-up around the macula, producing blurry and distorted vision. Diabetic macular edema is caused by diabetic retinopathy, a complication of diabetes that is the leading cause of blindness among working-age adults in the U.S. Of the approximately 7.7 million Americans who have diabetic retinopathy, it is estimated that 775,000 of those individuals also have diabetic macular edema, which is the leading cause of vision loss for those with diabetes.

The three medications that are most commonly used to treat diabetic macular edema aflibercept, bevacizumab, and ranibizumab were initially developed to treat age related macular degeneration (AMD), which is the number one cause of blindness in older patients and a condition that primarily affects white individuals. After these medications were found to be effective for AMD, they were then studied for the treatment of diabetic eye disease, which disproportionately affects Black patients.

The results from our study show a gap in treatment for Black individuals with diabetic macular edema, despite the fact that they are more heavily impacted by this disease, said Manju Subramanian, MD, an ophthalmologic surgeon at Boston Medical Center and the studys senior and corresponding author. When clinical research trials dont include enough diversity, it will not provide comprehensive data about the efficacy across different racial and ethnic groups, which as we can see, results in disparities in care.

For this study, the researchers focused on bevacizumab (Avastin), given that it is a first-line treatment for diabetic macular edema. They used data from electronic medical records of patients treated for the condition at Boston Medical Center 314 received one injection of the medication, and 151 received the series of three injections of the same medication. After the first injection, 26.71 percent of Black patients compared to 39.39 percent of Hispanic and 50 percent of White patients experienced improved visual acuity. For those who received three injections, 33.82 percent of Black patients compared to 54.76 percent of Hispanic patients and 58.54 percent of white patients experienced improvements in their visual acuity.

According to the U. S. Department of Health and Human Services Office of Minority Health, African American and Black adults are 60 percent more likely to have been diagnosed with diabetes than white, non-Hispanic adults. Evidence points to a variety of factors that play a role in the increased diabetes incidence in Black Americans, including biological risk factors, lower access to health care, and socioeconomic status.

Black individuals represent 13.4 percent of the US population but carry at least twice the prevalence of diabetic macular edema compared to white individuals, and should be represented in future research accordingly, said Subramanian, also an associate professor of ophthalmology at Boston University School of Medicine.

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Common Treatment for Diabetic Macular Edema Not Effective in Black Individuals - InvisionMag