Archive for December, 2020

In a year upended by COVID-19, it seems like our immune systems have received more attention than ever before. But many unhealthy behaviors brought on by the pandemic make it harder for our bodies to fight off infections.Here are some tips on maintaining a balanced immune system that can protect you this winter:

The first line of defense is a healthy lifestyle. These factors can put you at risk:

Eating too much, or too little, can be harmful. Make sure that you include enough healthy foods in your diet, and avoid consuming too many items that are low in fiberor high in fat, salt and/or sugar. Unhealthy eating can contribute to the risk of developinghealth problems and even some illnesses:

No supplement will cure or prevent disease. However, aproper diet can help prepare the body to better fight disease.

"The thing about foods is that they combine a bunch of nutrients and vitamins into a complete package," said Sandra Darling, a preventive medicine physician at Cleveland Clinic."You can't extract one compound like antioxidant green tea and just take that one compound and expect to have benefits. It doesn't work like that."

Make sure to include fresh fruits and vegetables in your daily diet. Don't forget about whole grains and nuts.

Vitamin C can stimulate the production of white blood cells, which are key to fighting infections.Citrus fruits, strawberries, red bell peppers and kiwis are richin vitamin C.With such a variety to choose from, its easy to addfoods high in this nutrientto any meal. However, high doses of some vitaminscan be toxic, especially when taken regularly.

Beta carotenefunctions as anantioxidant, a compoundthathelps defend your cells from damage caused by potentially harmful molecules called free radicals. Eating a diet rich in antioxidants can help reduce risk of chronic diseases and boost health. Carrots, sweet potatoes, spinach, and broccoli contain high amounts of beta carotene. Vitamin A, which the body creates from beta carotene,helpsthe lungs work properly in addition to other benefits.

Studies have shown that compounds in garliccan boost the disease-fighting response of some types of white blood cells in the body when they encounter viruses. Eating it while you are sick can help decreasehow long you stay sick and reduce the severity of symptoms. Garlic can also lowerthe risk of becoming sick in the first place.

Ginger may help decrease inflammation andrelieve congestion. It may alsosoothe nausea and digestive issues. Don't focus too much on the particular foods or supplements, but make sure are getting a sufficient amount of all the necessary nutrients from healthy foods in your diet.

Health-promoting bacteria in the colon are also animportant part of the immune system, Darling said. Focus on high-fiber foods, and specifically foods that contain the type of fiber called inulin. Good sources of inulin include artichoke, asparagus, and chicory root. Yogurt contains live and active cultures or probiotics. Try to choose the low-fat plain kindrather than theflavored varieties that can be loaded with sugar.

Don't forget to drink plenty of water.Try to avoid snacking irregularly. If you do snack, choosefresh fruits and raw vegetables rather than foods that are high in sugar, salt or fat.

"Pack carrot sticks, pack almonds,"said Erin Michos, preventive cardiologist at the Johns Hopkins Hospital."I'm a snacker, so I'm not going to tell you not to snack. I am just going to say snack on things that are good for your body, that boost your immunity."

It's important to maintain yourweight within healthy ranges. One of the measures that can help in measuring and interpreting yourweight is body mass index(BMI).BMI from18.5 to 24.9 is considered to bewithinhealthy range. Fat cells are not justpassive reservoir of energy, but canactually secretehormones thatincrease inflammation making overweight people more vulnerable to diseases. Making meal plans and schedulingfood intakesin advance can help to keep weight under control, especially if you are working remotely.

Studies indicate that sleep plays a crucial role in the functioning of the immune system. Breathing and muscle activity slows down, freeing up energy for the body to fight off illness. Sleep is important forimprovingT cellfunctioning. T cellsrespond to viral infections and boost the immune function of other cells. Cytokines, a type of protein in theimmune system that target infections,are also produced and released during sleep.Studies have also shown that sleep even improves the effects of vaccines.

The American Academy of Sleep Medicine and the Sleep Research Society recommend that adults aged 1860 years sleep at least sevenhours each night. According to the Centers for Disease Control and Prevention, 1 in 3adults dont get enough sleep.

Insufficient sleep makes it more likely one willcatch the common cold or the flu. A study showed that people whosleep less than six or seven hours per night have a higher risk of infection in a short term.

Researchshows creating a good sleep routineis essential for a good nightsleep and helping your immune system. Limit the amount of caffeine and alcoholyou consume before bed. Alcohol can make you sleepy, but can affect your sleep cycle. Caffeine can cause you to you feel wired, making it hard to fall asleep. Darling recommends avoiding electronic screens for at least 60 minutes before sleep.

Create a sleep schedule. Havingconsistent cues before bed can playa large role in your nighttimeroutine. Brushing your teeth, readinga bookand other activities can give your body signsit's time foryou to wind down for the day.

Moderate exercise improves cardiovascular health, lowers blood pressure andhelps control body weight. It also promotescirculation of the cells and substances of the immune system, which allows them to move through the body freely and do their job efficiently. It may reduce inflammation and help your immune cells regenerate regularly.

Unfortunately, only about 1 in 5 adults and teens get enough exercise to maintain good health, according to American Heart Association.Here is how lack of activity can affect the body and lower your immune response:

Moderatephysical activityis recommended during the pandemic and can also combat obesity, heart disease and diabetes. Health experts recommend a moderate-intensity exercise routine, two to three times a week,for up to 45-minutesfor good immune health. Try to aim for at least 150 minutes of moderate exercise per week, or 30 minutes, five days a week. Maintaining continued exercise routinemight be particularly essential for the elderly.

However, avoid pushing yourself too hard for too long.Prolonged (more than 1.5 hours) intense exerciseperformed without food intake can temporarilysuppress your immune system,providing the opportunity for infections to take hold. To determine whether the exercise is moderate or vigorous, you can use the "talk test."

"When you're doing a moderate activity like brisk walking, you can talk but you can't sing," Darling said."And then if you are doing vigorous physical activity, likeswimming laps, or jogging or playing tennis, you would not be able to talk or sing."

As the pandemic continues, many people have been experiencingvarious levels of continued stress. Nearly 8 in 10 adults say the coronavirus pandemic is amajor source of stress in their life.

Stress causes your body to release cortisol, the body's primary stress hormone. Increased cortisol levels in the bloodstream can cause inflammation, which altershow your body's immune system responds toinfections. Moreover, long-term inflammation promotes imbalances in immune cell function and can evensuppress immune response. Children and the elderly are particularly vulnerable to the effects of stresson immune system.

According to Johns Hopkins Medicine,controlling your stress is key to improving your immune system. Here's a look the impact stress has on the body:

Once you know your triggers workloads, kids or relationships you can makesmall changes can help manageyour stress levels. Here are a few modification to help reduce your stress:

If you can't minimize stress, make sure to have acoping mechanism that works for you, says Michos, the preventive cardiologist from Johns Hopkins. Some of the activitiesthat may help you manage your stress includemeditation, exercise, journaling, yoga, and other mindfulness practices. Stay away from adverse coping mechanisms like smoking or drinking too much alcohol. Smoking can actually weaken your body's defenses.

Ifyoure experiencing a mental health crisis or having thoughts of suicide, go to an emergency room, call the National Suicide Prevention Lifeline at 1-800-273-8255or visit the National Alliance on Mental Illness site,nami.org,for additional resources.

Overall, maintaining a balanced diet, getting enough sleep, engaging in regular physical activity, and keeping stress down are some of the most important ways to help keep your immune system healthy and reduce your chances of infection and disease. Take it easy, take a walkand put down those smokes.

However, don't go overboard. Too muchimmune response can causeimmune system to malfunction as well.

"You've probably heard about autoimmune diseases like lupus or rheumatoid arthritis, or even in COVID, where the immune system might go overdrive," Michos said."So, we don't wanthyperimmunity either. What you're talking about is trying to have overall balance, so everything is working in check."

It's also important to keep wearing mask in public, maintaining social distancing and sanitizinghands before touching face. These measures will help you to avoid exposure to novel coronavirus and flu viruses, among others.

SOURCE Healthline.com; John Hopkins Medicine; Mayo Clinic; Stress.org and USA TODAY research

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How to strengthen your immune system this winter - USA TODAY

Vitamin D is certainly enjoying its moment in the sun. Not only has the vitamin been highlighted lately for its potential role in COVID-19 severity, but now new research suggests it may be linked to a healthier gut microbiomea critical part of your immune system function, hormone regulation, and bone health.

Published in the journal Nature Communications, the research looked at data from 567 men participating in a larger study on osteoporotic fracture risk.

Researchers used rRNA sequencing to identify the types of bacteria present in stool samples, and compared it to vitamin D levels in blood serum samples. Those researchers found that participants with more active vitamin D also had higher overall microbiome diversitywhich is considered essential for better gut health.

So, whats the connection? According to senior study author Deborah Kado, M.D., director of the Osteoporosis Clinic at UC San Diego Health, its all about a substance called butyrate. If you have a healthy gut, Kado said, your beneficial bacteria produce more butyrate, which is basically the by-product made when fibers are broken down by those happy bacteria. Butyrate leads to an increase of vitamin D. So, the more you have, the more D you absorb.

But heres the catch: The word active is more important than it might seem, because you can be getting enough vitamin D from sunlight and supplements (the National Institutes of Health recommends 600 international units [IU] per day), but if your body isnt metabolizing that, you wont get the benefits the vitamin providessuch as building and maintaining bones, increasing lean body mass, boosting aerobic fitness, and improving your immune systemaccording to Kado.

The good news is that its likely you can boost how much vitamin D youre absorbing through healthy habits, she told Runners World.

Gallery: 13 Healthy Foods That Boost Your Memory, According to Nutritionists (Eat This, Not That!)

It seems plausible that we can make lifestyle changes to maximize our gut bacterial health that will, in turn, help our overall health.

In addition, as your gut function improves, your vitamin D absorption will, too.

There are many aspects of good health that can optimize vitamin D signaling, Kado said. The easiest is ensuring you get plenty of fresh fruits and vegetables of many different colors in your daily diet. Not only will this provide important vitamins and minerals, but will also promote a nourishing environment for healthy gut bacteria.

Although the study results only included older menand Kado cannot say for certain that women and younger people would have similar outcomesshe does believe that based on previous research, its likely everyone would experience the same association between vitamin D and gut health.

The takeaway? Feed your gut rightand that includes regular exercise, research findsand youll strengthen that vitamin D absorption.

The health of the bacteria in our gut relate to being able to maximize vitamin D metabolism in our bodies, Kado said, and thats important for a range of health benefits, including osteoporosis and immune function.

Try 200+ at home workout videos from Mens Health, Womens Health, Prevention, and more on All Out Studio free for 14 days!

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You Might Not Absorb as Much Vitamin D as You ThinkHere's How to Maximize the Process - msnNOW

WRIGHT-PATTERSON AIR FORCE BASE, Ohio The COVID-19 pandemic has led to implementation of unprecedented physical distancing strategies crucial to limiting the spread of the virus. While the most immediate threat from COVID-19 is the physical health of those infected, the pandemic will also have wide-ranging effects on the social and mental health of others living through the crisis.

Social isolation occurs when an individual does not have adequate opportunities to interact with others. Physical distancing and isolation can present certain challenges, such as spending days or weeks at home with limited resources, stimulation, and social contact.

According to the Centers for Disease Control and Prevention, social isolation can threaten health, and regular social interactions and having a strong personal network are important to a persons mental and physical health, resilience, and longevity. Health concerns stemming from social deprivation include high blood pressure, sleeplessness or less restful sleep, anxiety, depression, and thoughts of suicide. In addition, lack of human interaction may increase hormone levels that contribute to inflammation and weakened immunity, thereby increasing the risk of diseases.

Although it remains critical that we follow physical distancing requirements to combat the spread of COVID-19, it is equally important that we remain socially connected with our family, friends, colleagues, and community to prevent the negative health outcomes caused by being socially isolated and lonely. The following are some strategies for feeling more socially connected during this time.

If you are struggling with chronic loneliness, hopelessness, anxiety, or depression, you are not alone. With professional support, you can improve your mental wellbeing and enjoy life again.

Professional counseling services are available for the AFMC workforce and their families.

Civilian employees may contact the Employee Assistance Program for free, confidential counseling services at 866-580-9078 or visit the EAP website at AFPC.af.mil/EAP.

Military members can contact their local mental health clinic for services. Military OneSource is another option for military and their families. For more information, call 800-342-9647 or visit militaryonesource.mil.

For more information on coping with social isolation and loneliness, visit the Civilian Health Promotion Services video library at USAFwellness.com. Substance Abuse and Mental Health Services Administration also has an informative PDF Taking Care of Your Behavioral Health with advice for managing social isolation under quarantine.

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Coping with social isolation | News | standard.net - Standard-Examiner

During a breast self-exam two months ago, I felt a lump. This month, the lump seems to have disappeared. My cousin, who had breast cancer, is suggesting I get it checked anyways. I'm nervous to go to the doctor because of COVID-19. Is it safe to get a mammogram and other breast cancer screenings, or is it OK to wait, even with a family history?

As a woman, you know your body better than anyone, including your health care provider, so taking time to do breast self-exam is important. Finding a lump in your breast can be scary and cause anxiety. And with the COVID-19 pandemic continuing, I can appreciate your concerns about safety.

Mayo Clinic is taking many precautions related to COVID-19, and we are committed to ensuring the safety of our patients and visitors. The risk of contracting COVID-19 from coming in for a screening, such as a mammogram, is very low. Though many people may tell you that waiting a week or two for a breast cancer screening will not cause significant issues, I believe that delaying screening or delaying seeking medical attention can make a difference in terms of treatment if cancer is detected.

Keep in mind that a self-exam of the breast can be difficult for some women, depending on their breast consistencies. Some women might have lumpy breasts, and it might be difficult to discern which lump is cancer and which one is not. So a breast self-exam is good, but it's not enough. In my opinion, it is important to see a health care professional for diagnosis.

It is also important to note that different ethnic groups get different kinds of breast cancer. Young African American women and Latinas more commonly get the aggressive form of breast cancer called triple-negative breast cancer. Unfortunately, there are not a lot of targeted treatments that can be used with these women. So if you are an African American or Latina woman, that is another reason for you to seek medical attention as early as possible.

If breast cancer is detected early, such as in stage 1 or stage 0, the likelihood is that the cancer is highly curable. But if you wait until the cancer starts to grow, especially if it starts to spread to the lymph nodes, then the cure rate is much lower. If it starts to spread somewhere else in the body, then it may become incurable. In addition, treatments for patients with stage 0 or stage 1 breast cancer are often simpler. These patients often only require surgery, radiation and endocrine therapy. Chemotherapy usually is required for patients with more advanced disease, with a larger tumor or lymph node involvement.

In the past few months, I have seen a few women who reported finding a lump in their breast back in February or March at the beginning of the pandemic. Due to their concerns about COVID-19, they decided to wait to seek medical attention. In one patient, the mass continued to grow. She now has cancer growing through her skin, and it has become difficult to treat. I would encourage you if you feel anything different in your breast compared to what it was previously to seek medical attention right away.

Depending upon your situation, in addition to the traditional mammogram, there also is tomosynthesis, which is the 3D mammogram that can provide clearer images for women with dense breast tissue. Additionally, your health care professional also might order a breast MRI, which is the most sensitive test and looks at all of the breast area, including regional lymph nodes around the breasts.

The other benefit to visiting a health professional sooner rather than later is to discuss your personal risk and what, if any, preventive measures might be valuable based on your family history.

There are ways that we can calculate the risk of breast cancer in each patient. Currently, there are multiple models used. Some of these models include Gail's model and another called the Tyrer-Cuzick model. These models take into account your age at menarche, how many children you have and if you had a previous breast biopsy. All of those things can be plugged into the calculation. Then it will come up with your estimated lifetime risk of breast cancer and the best screening mechanisms for you.

If you meet certain criteria, such as in the Gail's model, and if your risk is more than 1.66% in five years, that would qualify some patients to receive medication to prevent breast cancer. In other words, the hormone blockers that are used to treat patients who already have breast cancer also can prevent breast cancer from happening in high-risk patients. These medications can cut down the risk up to almost 70%.

Being proactive and doing a monthly breast self-exam is a great first step for maintaining overall health. Regardless of COVID-19, I would encourage you to reach out to your primary health care provider to set up a screening appointment and get an answer about the lump you found.

Dr. Saranya Chumsri, Medical Oncology, Mayo Clinic, Jacksonville

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Breast cancer screening and COVID-19 | Feeling Fit - yoursun.com

By Dr. Mary Jane Minkin, Clinical Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine

In so many of my daily conversations with patients, colleagues, and friends, there is almost always a moment when someone exclaims I wish men knew how to support their female partners better when it comes to menopause. From those conversations, Ive discovered a constant theme: women living through menopause just want to know they are not alone, that they can speak about their experiences openly with their partners, and that they will be supported and loved. Normalizing menopause is the most important way a man (or anyone, really) can support a partner or the women in their life going through it, and there are myriad ways to treat many of the infamous symptoms caused by menopause that have unnecessarily and unjustly shrouded mid-life women in silence and shame.

For too long, the word menopause was whispered or quietly referred to as the change or the m worda phase of life when women were said to be irrational, irritable, cold, and sexless, some of the worst of the false stereotypes. Archie Bunker famously referred to menopause on national TV as Ediths Problem. It was certainly groundbreaking material for the 70s, but attitudes havent changed enough with the times. Recent studies show that despite plenty of progress, only 30% of women report talking about their menopausal symptoms with their healthcare provider, and 50% of women feel that the topic is taboo. It often takes women and their partners a while to acknowledge that changes to their mental health, sex drive, and body as they reach mid-life may be due in large part to the menopausal transition and not necessarily the relationship.

Little research has been done around mens attitudes or understanding of female menopause but studies are emerging. A 2019 survey, published in the Menopause: the Journal of the American Menopause Society, found that 63% of survey respondents reported that their partners menopausal symptoms had affected them personally, including emotional strain (34%), reduced frequency of sex/intimacy (33%), and trouble sleeping (10%). This proves male partners are aware of their female partners menopausal transition, but they are less aware of how to be supportive. In the same survey, less than half of the respondents knew there were treatments available for menopausal symptoms.

Destigmatizing menopause starts with knowing the facts. According to the Mayo Clinic, menopause is a natural biological process that a woman officially reaches when she has gone 12 months without her period, signaling the end of her reproductive years. In the years leading up to menopause, called perimenopause, the ovaries produce less and less estrogen, the hormone that regulates the female reproductive system, until the ovaries are no longer active. As a result of declining estrogen and other biological changes, women in perimenopause may experience a range of uncomfortable symptoms like hot flashes, difficulty sleeping, brain fog and other cognitive challenges, depression, and loss of sex drive. Women also often experience vaginal dryness, pain with sex, and other changes to their pelvic health. They will also be at higher risk for osteoporosis, heart disease, and other health problems.

The good news is that there are many safe hormonal and non-hormonal treatments and lifestyle changes that can mitigate menopausal symptoms and help women and their partners maintain a healthy relationship. The biggest barrier to these treatments is STIGMA. For a start, men can tell their partners that they love them unconditionally and will support them as they speak with their doctor or medical providers about treating their symptoms. They can also offer to join their partner for an appointment or telehealth conversation or help them develop a list of questions to ask. Regular exercise; holistic practices like yoga and meditation; eating a healthy and balanced diet; and taking calcium and vitamin D can also help to ease menopausal symptoms and create mutually beneficial opportunities for partners to spend time together and reconnect.

And yes, aging will change sex for both partnersregardless of gender!but there are many ways to keep things vibrant. Most importantly, men should let their partners know how much they love them and keep the lines of communication open. Be aware that intercourse may become painful or uncomfortable for a perimenopausal or menopausal woman through no fault of her own. Reassuring your partner that its okay is crucial to her self-confidence. A womans medical provider can recommend hormonal and non-hormonal treatments, medications, and devices to help with arousal and desire, and potentially refer her to a pelvic floor specialist if the pain is severe. There are many over-the-counter lubricants and vaginal moisturizers available as well.

Most importantly, find ways to have amazing sex that honor your partners body where it is. Most womenage notwithstandinghave their best orgasms without intercourse. And remember, it does take two to tangomen will endure changes to their sex drive as they age too. There is increasing evidence that men go through their own menopause of sorts. Both partners need to be open with their doctors for guidance on how they can address aging-related issues like erectile dysfunction and decreased energy and desire.

Menopause is not a time to check out and be afraid to broach the topic or become resentful. Ideally, a man who is involved and supportive can make a big difference for his partner going through the menopausal experience and in the relationship. Reducing the stigma about menopause and normalizing the conversation and the experience will go a long way.

Dr. Mary Jane Minkin is a practicing gynecologist, with a special interest in menopause. She is a North American Menopause Society Certified Menopause Clinician. Dr. Minkin is also the co-director of the Sexuality, Intimacy and Menopause for cancer survivors program at the Smilow Cancer Center. She has taught at Yale University School of Medicine for over 41 years, and is a clinical professor of obstetrics, gynecology and reproductive sciences.

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A Time to Man-Up: Supporting the Menopausal Women in Your Life - The Good Men Project

Ever feel like you have an endless craving for all the junk food salty, sweet or both that you can get your hands on?

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You just cant seem to give it up and keep eating, especially during times of heavy stress. And theres certainly been plenty of stress to keep us hitting the bags of chocolate the last several months.

Especially when were stressed, junk food often soothes us with the least amount of fuss and effort. We look for sugary and fatty foods to make us feel good, says registered dietitian Beth Czerwony, RD. But there are ways to get control of your food cravings, instead of them controlling you.

Junk food is food that is unhealthy for you, just as the word junk implies. It runs the gamut from sickly sweet (think: cookies, candy and cake) to heavy on saturated fats (think: fried and processed foods). Eating too much junk food can have short- and long-term consequences for your body thanks to these ingredients.

Eating foods rich in saturated fats can increase your cholesterol levels and the amount of plaque in your blood vessels. If you have blood vessels that are stiffening and not moving blood effectively, you have a higher risk for heart disease, including heart attacks and strokes, says Czerwony.

Too much sugar in your diet can lead to weight gain, a risk factor for diabetes. Some animal studies also suggest that artificial sweeteners make our bodies resist insulin. This may also increase the likelihood of developing prediabetes, diabetes and heart disease.

Most Americans are walking around with prediabetes, putting them at risk for developing Type 2 diabetes, Czerwony adds. Once you have diabetes, doctors treat you as if youve already had a heart attack because the rate of heart disease is so much higher. All of these health issues affect all the organs, so its important to get a handle on them.

Czerwony lists four reasons you may be craving sweets and other junk food.

Unfortunately, our bodies are hard-wired to crave junk food. When you eat foods you enjoy, you stimulate the feel-good centers in your brain, triggering you to eat even more.

Especially in patients with excess weight and obesity, the brains reward processing system for food is like its mechanisms related to substance abuse. Sugar makes us want to eat more sugar. Fat makes us want to eat more fat, notes Czerwony. Our brains are chasing that pleasurable state of food euphoria.

Studies suggest that sleep deprivation is associated with increased hunger (especially snack and sweet cravings). And you can blame it on your hormones. Lack of sleep causes hormone shifts:

If its normal for you to eat junk food, it can be hard to break that cycle, explains Czerwony. Youre used to not cooking, preparing or planning. You eat whatevers on hand because thats what youve always done.

Stress, or emotional, eating really is a thing and its the result of both nature and nurture.Some people find food helps distract them from negative thoughts and feelings. Others learned as children to use food to cope.

Hormones are also responsible. Like lack of sleep, ongoing stress causes the body to increase levels of cortisol and other hormones connected to hunger. Studies show this hormone tsunami increases appetite along with your desire for sugary and fatty foods.

Czerwony says these strategies can help you master your food cravings:

Czerwony also emphasizes that its OK to ask for help when youre feeling stuck. Talk with your primary care physician or a registered dietitian. Thats what were here for: to educate and empower you to make better decisions. We can help you choose healthier options and modifications rather than focusing on things you have to cut.

When you make an effort to understand what flavors you do and dont like, its easier to find healthier alternatives. Czerwony offers a few ideas to get you started:

Try changing up the style of food instead of the food itself.

Figure out a great switch to keep you going.

Resisting food cravings is important if youre trying to lose weight or reduce blood pressure or cholesterol. But there is such a thing as being too restrictive. If youre relatively healthy, at a healthy weight, and your blood pressure and blood sugar are on point, feel free to indulge if you plan for it, Czerwony says.

Many of my patients eat around their craving. When they want something chocolatey, they eat a piece of fruit that doesnt hit the spot. Then they go for an ice pop with the same result and it goes on, Czerwony says.

Just eat what youre craving, really enjoy it and be done with it, she suggests. That way, youll be satisfied and wont need to go back for more.

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Heres the Deal With Your Junk Food Cravings - Health Essentials from Cleveland Clinic

Photo: Fotolia/aquarious83men

Michelle Janas (PhD) trained as an immunologist and worked in research and experimental medicine for 20 years. She recently embarked on a career change into social work.

On 1 December, a landmark judgment was delivered in the case of Bell & Anor v The Tavistock And Portman NHS Foundation Trust [2020] EWHC 3274. The High Court was asked to determine whether children experiencing gender dysphoria could give informed consent to receive puberty-suppressing drugs, by achieving Gillick competence.

The court found that competence to consent to such treatment is was highly unlikely for 13-year-olds and very doubtful for those aged 14 or 15. While consent can be presumed for young people aged 16 and 17, medical professionals may want to seek court approval before treatment if there are doubts as to whether it would be in the young persons long-term best interests.

The judgment will be implemented on 22 December. If the Tavistock or the two NHS trusts who administer the treatment appeal by then, and this is granted by the Court of Appeal, implementation will be deferred until the appeal is decided.

However, on the day of the judgment, NHS England, which commissions the Tavistocks Gender Identity Development Service (GIDS), ordered it to cease referring patients under 16 to paediatric endocrinology clinics for puberty blockers unless a best interests order for the child in favour of the treatment has been made.

It also ordered GIDS to review all current patients under 16 it had referred for puberty blockers, with lead clinicians either making a best interests application to the courts to determine what should happen or safely withdrawing treatment.

Although NHS England has commissioned a full review of services for children and young people experiencing issues with their gender identity, for the foreseeable future such medical treatment via the GIDS clinic will not be an option for children under 16 without a court order.

This is an important judgment for social work. GIDS provides social work support and also liaises with social workers already working with the children referred to it, while many practitioners work with children with gender identity issues.

There were two factors that combined to play key roles in this decision: that the treatment is experimental in nature and, because of this, there are unknown and potentially profound lifelong consequences that a child will struggle to comprehend for their adult self.

In this article I will refer directly to the judgment throughout and attempt to outline why the treatment was determined to be experimental, and how the experimental classification impacted on the ruling of competence. I draw upon my 20 years of experience in working in research medicine and early-stage clinical trials, as well as my interest in the ethics of social science research, which I have written about previously.

Puberty blockers (PBs) are formally known as gonadotropin-releasing hormone agonists (GnRHas). This is important as this medication was originally developed for a different use to how it was being prescribed at GIDS. These drugs act by supressing the release of the sex hormones and are typically used to treat prostate cancer and breast cancer, and to assist in fertility treatments in women. Controversially, GnRHas are sometimes used to chemically castrate male sex offenders in other countries.

In children, these drugs are used to treat a very rare condition called precocious puberty, in which puberty occurs early at around the age of six. GnRHas halt this premature puberty until the child has reached the appropriate developmental age of around 12 hence the name puberty blockers.

The diagnosis of gender dysphoria in itself is somewhat contested, but one which the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) defines as a difference between ones experienced gender and assigned gender, and significant distress or problems functioning.

GnRHas were being prescribed by GIDS as an off-label treatment meaning the medication is not being used for its licensed purpose to treat gender dysphoria in adolescent children after the commencement of normally timed puberty. Off-label use of medication is relatively common, particularly for paediatric populations. The caveat, however, is that there should be justifiable scientific evidence that the treatment is safe and beneficial for the patient. The safety data here is paramount, as it helps prevent catastrophic unintended consequences of untested medications, as seen in the thalidomide scandal of the 1950s.

The court found that for PBs, the evidence for safety and efficacy was lacking. Indeed, the judges found the absence of data on the age distribution of patients (until 2019-20), the proportion of children referred to it for the treatment with an ASD diagnosis and the percentage who move on to take cross-sex hormones surprising.

Also, an interim report from a GIDS Early Intervention Study (which commenced in 2011) concluded that for 44 young people who received pubertal suppression, there was no overall improvement in mood or psychological wellbeing using standardized psychological measures (para 73).

The judges also noted an incongruence between the GIDS claim that puberty blockers were fully reversible and other evidence, including the NHS websites section on the treatment of gender dysphoria, which states, little is known about the long-term side effects of hormone or puberty blockers in children with gender dysphoria (para 67).

Therefore, due to the lack of both safety and efficacy data on the use on GnHRas for gender dysphoria, the court has considered the treatment to be experimental in nature.

For experimental medicines to become licensed, they need to progress through a strictly defined series of clinical trials, starting from small-scale safety studies and then increasing in size and complexity as the efficacy of the treatment is tested. The design of the studies is agreed in advance, including all the data to be collected, and the patients are carefully monitored. It is an issue which is currently writ large in the public imagination, as we watch the Covid vaccine make its way through these hurdles. To date, GIDS has been unable to produce data from the types of clinical trials that would set puberty blockers along the road to licensing for gender dysphoria. But it has also not produced sufficient scientific evidence to justify their use as off-label medication.

The court stated explicitly that it was not addressing whether the use of PBs for gender dysphoria was effective, but whether a child could consent to such experimental treatment. Two key issues were defined by the court: whether Gillick competence could be achieved and whether the information being given was adequate (to enable Gillick competence).

Gillick competence is the legal test, in which a minor can consent to surgical, medical or dental treatment in the absence of a parent or guardian. The child needs to show sufficient maturity to understand what is involved (Lord Scarman, 1986). Whilst case law has made clear that the child does not need to comprehend all the peripheral detail, they do need to be able to demonstrate sufficient understanding of the salient facts (Cobb J, 2019).

It is important to note that the demonstration of Gillick competence is crucial for these children, as GIDS guidelines state that although the parents or guardian must also be in agreement, they cannot give consent on behalf of the child.

The judges considered both evidence presented and case law, and as it is not within my expertise to cover them all, (Marina Wheeler QC gives a neat summary). I will instead restrict myself to medical aspects. One of the pertinent pieces of medical information given in evidence was that practically all children (although, as stated above, GIDS could not give exact data) who started on puberty blockers progress to cross-sex hormone (CSH) treatment (testosterone for females and estrogen for males). Therefore, it was considered relevant by the court that a child was able to understand both the consequences of PBs and CSHs for Gillick competence.

The issues of lifelong and life-changing implications were raised throughout the judgment. These included the possibilities presented in evidence by GIDS regarding uncertainty of apparent long-term physical consequences of puberty blocking on bone density, fertility, brain development and surgical options (para 62).

The judgment cites several pieces of evidence regarding the courts concerns on a childs ability to understand the impact on future fertility and sexual relationships. This includes the GIDS testimony that for children these implications will always involve some act of imagination (para 122) and a witness statement from a 13-year-old trans boy who wrote, I havent really thought about parenthoodI just have no idea what me in the future is going to think. Also, Kiera Bell, who brought the legal challenge, stated in evidence, It is only until recently that I have started to think about having children and if that is ever a possibility.

In determining competence, the judgment states that a child must not only have sufficient understanding of the factors relevant to the present, but also be able to objectively weigh information relevant to the future (para 124). Thus, although a child might understand the concept of fertility loss, it is not the same as understanding how this might affect their adult life (para 139).

Induced sterility is a principal ethical dilemma in paediatric cancer medicine, as the treatments given for advanced or complex tumours can render a child infertile. However, as the treatment is usually a final life-saving option, sterility, although distressing, is perhaps considered acceptable. The court also refers to this to emphasise the gravity of these types of decisions by stating that apart from life-saving treatment, there will be no more profound medical decisions for children than whether to start on this treatment pathway (para 149), a statement which gives context to the courts justification for the high bar it has set.

Therefore, although the court acknowledges that a lack of evidence in experimental medicine is not a barrier to competence per se, it is the combination of this with the potentially profound lifelong consequences that a child will struggle to comprehend that has led it to conclude that Gillick competence for a child under 16 is highly unlikely to be reached, no matter how much information and support is given.

This judgment also gives social work pause for thought. Social workers, by virtue of the profession, are interested in issues of social justice and welcome diversity and difference. However, just as for the medical profession, we do need to ensure that foremost, we do no harm.

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Puberty blockers and consent to treatment: an analysis of the High Court's ruling - Communitycare.co.uk

Robust pooled analysis demonstrating how CTC count may help to optimize treatment choices

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Dec. 9, 2020 /PRNewswire/ -- Menarini Silicon Biosystems, a pioneer of liquid biopsy technology, today announced the results of a pooled analysis of 14 clinical trials on the relevance of circulating tumor cell (CTC) count to predict both disease prognosis and treatment efficacy in metastatic breast cancer (MBC). This global study, based on 4079 cases across all advanced breast cancer subtypes, is the largest pooled analysis to-date on the role of serial CTC count in the MBC setting. It included individual patient data and was selected for an oral presentation at the 2020 San Antonio Breast Cancer Symposium.

The analysis was led by Minetta C. Liu, MD, Professor and Research Chair for the Department of Oncology and Consultant in the Department of Laboratory Medicine & Pathology at Mayo Clinic in Rochester, Minnesota, USA and Prof. Prof, Dr med Wolfgang Janni, Professor of Obstetrics, Adult and Pediatric Gynecology of the University Hospital Ulm, Germany. According to Dr. Liu, "This pooled analysis represents an international collaboration including an unprecedented number of multi-institutional clinical trials conducted across Asia, Europe, and North America. Colleagues kindly provided de-identified, individual patient level data from prospective clinical studies published in the peer-reviewed literature to generate a dataset of over 4000 participants. This statistical power allowed us to achieve our main objective namely, to further define and validate the role of CTC enumeration for early monitoring of disease status in patients with metastatic breast cancer, irrespective of subtypes defined by hormone receptor and HER2 status."

Data from this pooled analysis were gathered at baseline and then at a median of 29 days after treatment initiation.Detection, capture, isolation and phenotyping of tumor cells circulating in the blood in all patients was carried out with Menarini Silicon Biosystems' CELLSEARCH CTC System. Results were determined by commonly used log rank and Cox regressions tests. The focus of these statistical analyses was on the association between serial CTC enumeration results and overall survival (OS) in the full patient cohort and defined subgroups. Subgroups included patients with hormone receptor positive, HER2 type and triple negative MBC as well patients whose breast cancer type was not specified. The conclusion across all groups is that patients whose CTC status is negative, both at baseline and follow-up, namely the reference group, have a median OS rate of 47.05 months compared to 17.87 months for those with a positive CTC status at both check points (p-value <0.0001). The importance of conducting follow-up analyses of patient CTCs is underlined by the data from all subgroups because they indicate that patients, whose CTC status went from positive to negative, had an OS of 32.2 months (HR 0.49, p-value <0.0001) an almost two-fold increase in the OS of patients whose CTC status remained positive.

"With the efficacy of novel therapies increasingly linked to the biological characteristics of a given tumor and the urgent need to continue to improve clinical interventions in the metastatic setting, this study strongly supports the potential of early CTC monitoring in all subtypes of MBC to optimize individual patient management along the treatment pathway and thereby improve patient outcomes," further commented Prof. Dr med Wolfgang Janni.

For Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems: "The results of this large and robust pooled analysis represent not only a major contribution to the expanding body of evidence aimed at validating the role of repeat CTC counts to optimize clinical interventions for the more difficult to treat MBC, they are also a testimony to the importance of developing more sophisticated prognostic/predictive approaches alongside new targeted therapies to reach the ultimate goal of improving both patient outcome and quality of life." As the pioneer in liquid biopsies, Menarini Silicon Biosystems is committed to developing its technology to help physicians identify appropriate treatment strategies in the challenging environment of heterogenous advanced breast cancers and growing number of therapeutic options from which to choose.

About CELLSEARCH

CELLSEARCH is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs to aid physicians in managing patients with metastatic breast, prostate, and colorectal cancers when used in conjunction with other clinical methods of monitoring. The test is also approved by the China National Medical Products Administration (NMPA) for use in monitoring patients with Metastatic Breast Cancer. The CELLSEARCH Systemis the most extensively studied CTC technology, with research published in more than 650 peer-reviewed publications.

For more information on the full intended use and limitations of the CELLSEARCH system, please refer to the Instructions for Use athttp://documents.cellsearchctc.com/.

About Menarini Silicon Biosystems

Menarini Silicon Biosystems offers unique rare cell technologies and solutions that provide clinical researchers with access to unparalleled resolution in the study of cells and their molecular characterization.

Menarini Silicon Biosystems, based in Bologna,Italy, andHuntingdon Valley, Pa., U.S., is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics company headquartered inFlorence, Italy, with more than 17,000 employees in 140 countries.

Contact: Linda Pavy - [emailprotected]

Logo - https://mma.prnewswire.com/media/1362208/Menarini_Logo.jpg

SOURCE Menarini Silicon Biosystems

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New Global Pooled Analysis Supports Clinical Utility of Circulating Tumor Cell Count for Early Monitoring of Metastatic Breast Cancer - PRNewswire

Want to know the easiest one thing you can do to predict your risk of disease later in life? Take the jiggle test. This easy test can help you differentiate the type of fat on your body, and if your body is holding any of the fat that causes the risk of disease.

Biologically, there's an enormous difference between subcutaneous fatthe stuff that's right below your skin, the stuff that makes up love handles and the likeand visceral fat, which is inside your abdominal wall, wrapped around your internal organs. The easiest way to tell the differences might be this: subcutaneous fat jiggles, but visceral fat doesn't. Subcutaneous fat is fat you can pinch; visceral fat is the solid stuff that makes your gut stick out. And unlike subcutaneous fat, visceral fat isn't just hanging out, keeping us warm. It's a lot more dangerous to our bodies than you think.

Here's why, and for more helpful tips, be sure to check out our list of 15 Underrated Weight Loss Tips That Actually Work.

Visceral fat secretes more than 100 biochemicals, which are collectively known as adipokines. But they ought to be known as adipo-unkinds, because they include such nasty substances as:

Resistin, a hormone that undermines your body's ability to metabolize glucose ad leads to high blood sugar

Angiotensinogen, a compound that raises blood pressure

Interleukin-6, a chemical associated with arterial inflammation

Tumor necrosis factorwhich is as bad as it soundscauses inflammatory issues such as Crohn's disease and various forms of arthritis.

Now, this is a bit different for those that have "pear-shaped" bodies. Studies suggest that subcutaneous fat in your hips and thighs is associated with reduced insulin levels and increased insulin sensitivity (meaning that it actually protects against diabetes). People who are "pear-shaped" and store fat in their hips and thighs also tend to have higher HDL cholesterol (the good kind) and lower triglycerides.

According to the National Institutes of Health, people who carry excess fat around their waists are at a greater risk of dying early from cancer and heart disease. So, the jiggle or pinch test can clue you into the need to reduce your visceral belly fat. An even better test involves a tape measure. Just wrap it around your waist at your belly button so the tape is parallel with the floor. Read it and consider the findings of an analysis of waist circumference and mortality in 650,000 adults published in the Mayo Clinic Proceedings. The data determined that men with a waist circumference of 43 inches had more than a 50% greater risk of death than did men with a 37-inch waist. And women with a 37-inch waist had an 80% higher risk of death than women with a 27.5-inch waist.

For more information on the dangers of visceral fat and a practical guide to getting rid of it, check out my book Zero Belly Diet: Lose Up to 16 lbs. in 14 Days!.

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This One Thing Can Predict Your Risk of Disease, Says Science - Yahoo Lifestyle

Period poops are totally normal, but there are a few things you can do about them.

Image Credit: LuckyBusiness/iStock/GettyImages

Mood swings, cramps and food cravings are just a few surefire symptoms you can expect during your menstrual cycle. But that time of the month often also comes with unpleasant GI side effects like period poops.

Indeed, a January 2014 study in BMC Women's Health found that nearly three-quarters of people with uteruses experienced at least one tummy-related issue during their period, with abdominal pain and diarrhea being most frequent.

We spoke to experts to learn how your period can mess with your poop habits, plus ways you can get your bowels back on track.

Loose poops may predominate when you have your period.

"Diarrhea has been associated with periods due to the increase in prostaglandins [hormone-like compounds] during the uterine shedding," Shweta Desai, MD, a urogynecologist and chief wellness advisor at Love Wellness, tells LIVESTRONG.com.

"While the prostaglandins cause your uterus to contract [and to shed its lining], they also cause the intestines to contract as well, thus leading to increased cramping and diarrhea in some cases," Dr. Desai explains.

2. But You Could Be Constipated

Conversely, your period may back up your bowel movements. Period-related hormones can cause constipation, but the exact mechanism is still unknown, Dr. Desai says.

"There are far more studies in pre-clinical models (i.e. mice, rats) than in humans, but studies have shown that estrogen can decrease gastrointestinal motility," says Lea Ann Chen, MD, a gastroenterologist and assistant professor at Rutgers Robert Wood Johnson School of Medicine.

Here's the thing: High estrogen levels appear to reduce colon transit time i.e., they slow down your poop's travel through your GI tract which can lead to being clogged up, Dr. Desai explains.

"Other studies have suggested that [the hormone] progesterone may play a bigger role in causing constipation," Dr. Desai says. "Regardless of which hormone is the culprit, constipation has been related to the menstrual cycle due to fluctuations in hormonal levels."

3. Food Cravings Dont Help

If you're jonesing for junk food during your period, shifts in your hormones are likely to blame. For example, the neurotransmitter serotonin fluctuates throughout your cycle, and when levels are low, you might experience food cravings, according to the Mayo Clinic.

The problem is, eating lots of sugary and fatty foods may affect your bowel movements.

"If you're experiencing period-related bowel changes, it's important to avoid foods that trigger diarrhea and continue to eat a high-fiber diet in order to avoid constipation," Dr. Desai says.

4. Certain Health Conditions Can Make Things Worse

Certain health conditions can exacerbate period-related bowel changes, Dr. Desai says.

Case in point: uterine fibroids, which are benign pelvic tumors that arise from the smooth muscle cells of the uterus.

"If the fibroid is located close to the rectum, there is a possibility that it can place pressure on the rectum, leading to constipation," Dr. Desai says.

"Also, if you suffer from irritable bowel disease or irritable bowel syndrome, symptoms can fluctuate during your cycle," she adds.

5. Stress and Anxiety Play a Role

The same BMC Women's Health study also found a link between period-related emotional symptoms and stomach complaints. People who had feelings of anxiety or depression during menstruation were more likely to report two or more GI issues. The researchers thought this had something to do with the gut-brain link.

Dr. Desai agrees that emotional factors like stress can affect bowel habits.

"Stress can cause the bowels to slow down, thus leading to increased time for the stool to pass through the digestive tract, which can lead to constipation," she explains.

How to Combat Period Poops

Daily exercise can help reduce stress and keep you regular.

Image Credit: fizkes/iStock/GettyImages

While you might not be able to fully prevent period poops, Dr. Desai offers strategies to help mitigate tummy problems during your menstrual cycle:

The best way to manage period-related bowel issues is to maintain a healthy diet (think: fruits, veggies and whole grains).

Avoid triggers for diarrhea, such as:

2. Add Certain Supplements

Follow a bowel-friendly regimen of probiotics and fiber supplementation to help keep you regular and your stool a good consistency.

If you're not sure where to start with these supplements, ask your doctor or pharmacist to point you in the right direction.

Reducing stress and staying active are also great ways to keep your bowels moving and healthy. Combine the two with stress-reducing exercises like yoga and stretching.

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Period Poops: Why They Happen and What You Can Do About Them - LIVESTRONG.COM

Following the harassment of Christian Cooper in Central Park in May 2020, Black birders created #BlackBirdersWeek to celebrate Black nature enthusiasts and highlight their belonging in outdoor spaces. Since then, dozens of campaigns have emerged to amplify and appreciate Black academics, scientists, and naturalists.

Next up is #BlackInMarineScienceWeek, running from November 29th to December 5th.Led by founder Dr. Tiara Moore and organizers Amani Webber-Schultz, Dr. Camille Gaynus, Carlee Jackson, Al Troutman, Jasmin Graham, Jeanette Davis, Kris Howard, Leslie Townsell, Kaylee Arnold, and Jaida Elcock, this week represents an opportunity for community building and improved representation.

There are few Black folks in ecology and even fewer in marine ecology, says Arnold, a science communicator and disease ecologist. The network that Ive gained through organizing this week is phenomenal. Meeting other Black marine scientists and showing that to the world, especially young Black folks, is a way to say we exist, were here. We have a full day dedicated to young kids, which is unique and exciting.

The organizers hope that the week will help normalize Black folks doing marine research, inspire younger generations, and remind everyone to check their preconceived notions.

"When I say I study sharks people seem concerned about my swimming or my hair, [and] sometimes respond with 'Oh, thats super interesting'... I dont know if that's because it's unusual for people to study sharks or because Im Black and I study sharks, recalls Elcock, an elasmobranch movement ecologist, science communicator, and co-founder of Minorities in Shark Science. Science is for everybody. People say there isn't diversity because [Black] people arent interested... thats clearly not true theres a whole week dedicated [to it]."

Discussion this week will address the fact that exclusion, not lack of interest, led to todays lack of representation. Centuries of segregation and underinvestment in Black neighborhood pools led to, and are perpetuated by, these incorrect and harmful ideas.

My grandparents and my mom said there were just no pools for her to go to... I had a very different experience. Despite people trying to push us out of the water and science, we persevered, and now we get to break down those stereotypes, notes Arnold.

Black in Marine Science Week is here to do just that, showcasing organizers and participants from every imaginable marine science niche, all shaping how society views the oceans and its inhabitants.

There's more Black folks than even we know and are showcasing. I hope that if the media picks up on the number of us as well, and has better representation. Seminar series are extremely white, and now you have a resource of people you can invite instead, emphasizes Arnold, pointing to the necessity of non-Black marine scientists to step up and ensure representation continues beyond this joyous and educational week.

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Dozens of bird and mammal species have been saved from extinction since 1993 - Massive Science

AACHEN, HENNIGSDORF and BERLIN, GERMANY / ACCESSWIRE / December 10, 2020 / The Uniklinik RWTH Aachen ("Uniklinik RWTH Aachen") has successfully translated the collaboration for research and biomarker validation with SphingoTec GmbH ("SphingoTec") into clinical routine. The routine measurements of the innovative biomarkers are providing organ-specific information for monitoring critical care conditions such as sepsis and acute kidney injury and support clinical decisions to improve patient outcomes.

Uniklinik RWTH Aachen is one of Germany's most modern hospitals due to the way it integrates diagnostics and therapy, research and teaching under the same roof. Following a patient-centric approach, Uniklinik RWTH Aachen has adopted innovative pathways in intensive medicine by introducing these new diagnostic tools for monitoring organ function of critically ill patients. The routine measurements of penKid(R) and bio-ADM(R) provide clinicians with more insights on the disease pathology and etiology of clinical symptoms and facilitate more efficient, timely, and adequate treatment.

Prof. Dr. Gernot Marx, the Director of the Clinic for Operative Intensive Care and Intermediate Care at Uniklinik RWTH Aachen explained: "Critically ill patients are highly dynamic with many complications interfering in the diagnostics process, thus a very challenging environment for introducing innovations. We have been looking for a long time for the right diagnostic tools to allow us a faster and better diagnosis, risk stratification, and monitoring of the disease progression so that we can provide the best available treatment immediately for acute cases. The first routine measurements do confirm the utility and value of these novel diagnostic biomarkers in clinical decision-making and ultimately in maximizing the patient's benefit. "

In intensive care units, 1 in 3 patients is developing acute kidney injury [1]. The existing diagnostic parameters for the determination of renal function or kidney damage, which are routinely used as standard procedure, have a considerable time delay or are influenced by inflammation or other diseases. These limitations are underlining the need for more precise tools to support clinical decisions. The biomarker penKid(R) offers real-time information about the kidney function with the first measurement and without being influenced by co-morbidities or the frequently occurring inflammation in critically ill patients [2,3,4]. Moreover, penKid(R) shows the best representation of the current kidney function, measured by the glomerular filtration rate (true GFR). [5]

World-wide, sepsis is accountable for 1 in 5 deaths [6]. Reduced organ perfusion in shock, which can be determined by existing laboratory values, is the culprit for the fatal course, but it can be induced by various factors. The loss of endothelial function is often a main cause for shock in sepsis, but it could not be detected by blood-based tests so far. The measurement of the bio-ADM(R) biomarker now allows for the first time the direct assessment of endothelial function in real time [7,8,9] independent of co-morbidities and inflammation, thus supporting precise and rapid treatment decisions.Dr. Andreas Bergmann, founder and CEO of SphingoTec added: "We are excited that the initial clinical evaluation ended in a successful translation of the biomarkers into clinical routine. The comprehensive amount of routine data on our biomarkers collected by Prof. Gernot Marx and his team will allow us to deepen our knowledge of the biomarkers and to explore further application areas. Encouraged by this implementation of our novel diagnostic tools at the frontlines of medical care, we intend to offer them in a near future on a larger scale in other European countries."

References [1] Ponce et. al. (2016), Acute kidney injury: risk factors and management challenges in developing countries Int. J. Nephrol. Renovasc. Dis., DOI: 10.2147/IJNRD.S104209[2] Hollinger et. al. (2018) Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study, Kidney Int Rep, DOI: 10.1016/j.ekir.2018.08.006[3] Siong Chan (2018) Proenkephalin in heart failure[4] Beunders et. al. (2017) Proenkephalin (PENK) as a novel biomarker for kidney function.[5] Beunders, R. et al. (2019), Proenkephalin compared to conventional methods to assess kidney function in critically ill sepsis patients, Shock,, doi:10.1097/SHK.0000000000001510(6) Rudd et al (2020), Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study, The Lancet, DOI: https://doi.org/10.1016/S0140-6736(19)32989-7(7) Geven (2018): Vascular Effects of Adrenomedullin and the anti-Adrenomedullin Antibody Adrecizumab in Sepsis. Shock. doi: 1097/SHK.0000000000001103(8) Mebazaa (2018): Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock (AdrenOSS-1) study. doi:10.1186/s13054-018-2243-2(9) Caironi (2017): Circulating biologically active adrenomedullin (bio-ADM) predicts hemodynamic support requirement and mortality During Sepsis. Chest. doi: 10.1016/j.chest.2017.03.035.

Uniklinik RWTH AachenThe Uniklinik RWTH Aachen is a supramaximal care provider that combines patient-oriented medicine and nursing, teaching and research at an international level. With 36 specialist clinics, 28 institutes and five interdisciplinary units, the University Hospital covers the entire medical spectrum. Excellently qualified teams of doctors, nurses and scientists are competently committed to the health of the patients. The bundling of patient care, research and teaching in one central building offers the best conditions for intensive interdisciplinary exchange and close clinical and scientific networking. Around 8.000 employees provide patient-oriented medicine and care according to recognised quality standards. With 1.400 beds, the University Hospital treats around 50.000 inpatient and 200.000 outpatient cases per year.

About SphingoTec SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM(R)), a biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid(R)), a biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression. IVD tests for SphingoTec's proprietary biomarkers are made available as sphingotest(R) microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec's subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

About penKid(R)sphingotest(R) penKid(R) measures Proenkephalin (penKid(R)), a stable fragment of the kidney stimulating hormone Enkephalin. penKid(R) has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate, the gold standard to assess renal function. Measuring penKid(R) blood concentrations allows for timely information on kidney function in critically ill patients. Early assessment of worsening and improving of renal function on intensive care units and in emergency departments allows adjustment of nephrotoxic drug administration and the initiation of kidney-protective strategies to prevent acute kidney injury and thereby improve outcomes. Learn more about penKid(R) at https://www.youtube.com/watch?v=6SYhs7it4R4About bio-ADM(R)sphingotest(R) bio-ADM(R) measures bioactive Adrenomedullin (bio-ADM(R)), a hormone maintaining endothelial function. The endothelium contributes to blood pressure and separates blood from the surrounding tissue. Elevated blood levels of bio-ADM(R) predict blood pressure break down and leaky vessels resulting in oedema. Imbalanced endothelial function is the major cause of shock ultimately resulting in organ dysfunction and death. Early identification of an imbalance in endothelial function allows guidance of vasopressor and diuretic therapy in critically ill patients to improve outcomes. Learn more about bio-ADM(R) at https://www.youtube.com/watch?v=52lrrRNb0k4

Press contact Dr. Mathias BrandstdterLeitung UnternehmenskommunikationUniklinik RWTH AachenPauwelsstrae 3052074 AachenTelefon: 0241 80-89893mbrandstaedter@ukaachen.dewww.ukaachen.de

Ruxandra LenzSr. Manager Marketing and CommunicationsSphingoTec GmbHNeuendorfstr. 15 A16761 HennigsdorfTel. +49-3302-20565-0press@sphingotec.dewww.sphingotec.com

SOURCE: SphingoTec GmbH via EQS Newswire

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Uniklinik RWTH Aachen is the First Hospital to Implement Sphingotec's Innovative Biomarkers in Clinical Routine with the Aim of Making Intensive Care...

Winter is here, and this year feels different for a variety of reasons. The ongoing pandemic has many of us reconsidering the usual plans to travel home for the holidays, amplifying the feelings felt during the most stressful time of year. And thats on top of the dread of watching the sun peace out at around 4:30pm every day. While theres not much we can do about the darkness, there are a number of actions we can take to ease Seasonal Affective Disorder, also known as SAD. Here are the best foods for fighting the winter blues naturally.

In most cases, SAD emerges around late fall and early winter every year. According to the Mayo Clinic, symptoms include oversleeping, fatigue, change in appetite (especially cravings for food that are high in carbohydrates), and weight gain. Symptoms may start out mild and get worse as the season progresses.

The exact causes of SAD are unknown, but doctors have an idea of what might trigger it.

In the winter, theres a decrease in sunlight. And its thought that this could cause a drop in serotonin, a brain chemical that affects your mood, Amy Gorin, MS, RDN, a plant-based registered dietitian and owner of Plant-Based Eats in Stamford, CT, tells LIVEKINDLY.

This in turn can trigger depression. Shorter days may also disrupt your circadian rhythm (your bodys internal clock) as well as the bodys level of melatonin, which affects your sleep patterns and mood.

| iStock.

Everyone has days where they feel down, but its important to monitor your symptoms. The Mayo Clinic notes that you should see a doctor when you feel unmotivated to partake in activities that you normally enjoy, especially if youre experiencing the above symptoms or thinking about suicide or self-harm.

Gorin notes that some foods can help lift your mood. but again, seeking professional help is best as the first course of action. Left untreated, symptoms of SAD may worsen.

A reduction in serotonin caused by the winter blues could lead to cravings for carbs, as consuming carbohydrates can increase your bodys release of serotonin, says Gorin. When reaching for carbs, choose fiber-rich options such as oats, quinoa, fruits, and vegetables.

Whole grain rice, pasta, and bread are also choice options. Oh, and potatoes just keep the skin on, as thats where approximately half of the dietary fiber and the majority of nutrients (like potassium and vitamin C) are found. Choosing carb-rich, high-fiber foods has an extra boon: dietary fiber helps maintain bowel health, lowers cholesterol levels, and helps reduce the risk of cardiovascular disease.

Eating protein-rich foods releases dopamine, a neurotransmitter associated with feelings of pleasure as part of the reward system and feelings of motivation. Eating low-fat, protein-rich foods can also give you more energy a huge plus for anyone who struggles with sluggishness in winter. Choose foods that are rich in plant protein and low in fat (i.e., tofu, tempeh, beans, and legumes) and combine them with whole grain carbs like brown rice, whole wheat pasta, and wheat berries, for a filling, energizing meal. (See here for the top vegan sources of protein.)

Blueberries, strawberries, cranberries, and raspberries are rich in vitamin C and antioxidants. That helps control cortisol, your bodys primary stress hormone that puts a stopper on functions that are not essential to the fight-or-flight response to stressful situations. With the exception of cranberries, fresh berries can get pricey in winter, but frozen is just as good (and much less expensive). Add berries to your morning oatmeal and sprinkle it with omega-rich nuts or seeds for a hearty, filling, and mood-balancing meal.

| Natalia Khimich / iStock.

The field of nutritional psychiatry is uncovering the connection not only between what you eat and your overall mental well-being, but also what kind of bacteria lives in your gut, according to Harvard Health. About 95 percent of your serotonin is produced in the gastrointestinal tract. This means that your gut does much more than just digest your meals; it also plays a significant role in how you feel. Studies have shown that following a traditional diet, such as the Mediterranean or Japanese diets, is associated with a 25 to 30 percent lower risk of depression. This is partly because these diets tend to be high in vegetables, fruits, and whole grains and low in meat, dairy, and processed and refined foods.

In addition, many of the foods in those diets are fermented, which helps promote gut health. A healthy gut is home to billions of good bacteria, which protect the intestinal lining from bad bacteria, reduce inflammation, improve your bodys ability to absorb nutrients, and activate neural pathways between your gut and your brain.

Add fermented foods to your diet like sauerkraut (make your own with this jar), kimchi, tempeh, and miso. For tips on making fermented foods at home, see here.

Some research suggests that eating dark chocolate may lower symptoms of depression. Theres also that old anecdote that people with periods crave chocolate during that-time-of-the-month because of its mood-boosting abilities. According to Harvard Health, you should choose 70 percent dark chocolate or higher in order to obtain the most flavanols, an antioxidant found in cocoa, red wine, and blueberries.

Dark chocolate also has anti-inflammatory benefits and may help improve mood and lower stress levels, says Gorin.

Although theres no definitive proof, a big mug of dairy-free hot chocolate certainly cant hurt on a dreary, chilly day.

On a final note: In addition to food, Gorin notes to get moving. Exercise does wonders for lifting your mood. Find what kind of movement brings you joy whether thats yoga, running, or bike riding.

More:
How to Reduce the Winter Blues With Plant-Based Food - LIVEKINDLY

Gambling addiction is a clinically recognized problem that requires special therapy and medical intervention in most cases to achieve full recovery. The premise of gambling is simple you risk something you have in the hopes of adding to the value of your original stake.

However, by repeatedly engaging with products recognized as gambling, many people are prone to developing gambling addiction or showing symptoms of compulsive gambling without realizing it. If you find yourself addicted to gambling, this article is your path to recovery and understanding pathological gambling better.

The official gambling addiction definitionstates that an individual must experience an uncontrollable urge to gamblewith increasing amounts despite the high risk involvedand possibly serious consequences for ones own well-being or the well-being of family members, friends, and loved ones. Gambling can be addictive because it targets the brains reward system and leads to the release of dopamine, the hormone connected with happiness.

However, not all people are at risk of developing compulsive or pathological gambling. In fact, most people are able to resist, but a good number of people are experiencing problem gamblingor are at risk of becoming compulsive gamblers themselves.

Today, gambling addiction or compulsive gambling is a mental health issue, and the addiction at its core is equated to abuseof substancessuch as alcoholand drugs. Gambling affects more men than women, but it is a genderless disorder with a high incidence across the human population. Different countries around the world recognize gambling addiction as a serious mental problem that needs specialist intervention.

The term compulsion used to describe an independent aberration but today compulsive gambling is equated to or synonymous with gambling addiction.

Problem gambling begins discreetly and privately. In most cases, an individual is unaware that they are developing an addiction to compulsive gambling right to the point where the condition starts interfering with day-to-day chores and responsibilities. Anxietyor depressionis another concomitant symptom of burgeoning or pathological gambling addiction. Similar to other addictions, as in the case of substance addicts who overuse drugs or alcohol, problem gambling is driven on by a chemical component in the brain.

Compulsive gamblers feel rewarded for pursuing an activity that feels good, but this feeling of elation or high, is connected to a chemical response from the brain which floods the frontal cortex with dopamine. Addictive substances may trick the brain into releasing these hormones that are ten levels above normal levels.

Studies have established that gambling products can elicit the same chemical response from peoples brains, leading to high-dopamine production and spiraling into problem gambling without the knowledge of the individual.

Impulsivity and reward-seeking behavior become norms without explanation and perfectly ordinary individuals begin to behave as problem gamblers, showing symptoms and signs of gambling addiction that appear almost without a warning. Today gambling addiction is also referred to as gambling disorderand it encompasses an effort by the scientific community, including the American Psychiatric Association, to establish the reasons behind addictive behavior, in gambling and beyond.

By now, research has shown that addicts, regardless of their chosen form of addiction, whether that is substance abuse problems or gambling products, have a genetic predisposition that gives insight into how these problems develop, evolve, and how they can be eventually treated to the benefit of problem gamblers. Gambling is officially recognized as an impulse control disorderand this is good news because treatment professionals are tasked with making feel better. But first, they need to know how to read the symptoms.

Gambling addiction in patients tends to be approached differently. To start helping, though, experts must first identify gambling addictionsignsand symptoms, which is essential to getting an early start in treatment. These symptoms will vary between individuals in terms of intensity and some may remain hidden until very late in the addiction.

From the standpoint of most problem gamblers, gambling addiction is described as a complete loss of controlover the individuals ability to control spending habits, even though the potentially ruinous consequences are well-understood by the majority of pathological gamblers.

Therefore, problem gambling will always pivot around core behavioral aberrations that can be predicted, studied, and counterweightedin therapy or by the individual themselves depending on how advanced the compulsion is.

To spot a symptom, you may use our manual, which will help you help determine if you are currently showing compulsive gambling symptoms to a point where they need professional help.

Even if you are not a problem gambler, it is always important to monitor your condition, especially if you have a history of substance abuse in your family or recognize addictive patterns in your own behavior. Here are several points that constitute symptoms and signs of gambling addiction.

Thanks to clinical experience and government-funded research, we understand the downsides of gambling a little better. Moreover, studying gambling has allowed health expertsto come with a very detailed breakdown and create accessible help materials that will assist you in identifying a problem if there is one. More importantly, remember to answer truthfully to the following questions for accurate results:

The National Healthcare System (NHS) in the United Kingdom recommends using a four-answer system where you will score differently based on your answers. Your answers should be never, sometimes, most of the time, almost always and you should score 0, 1, 2, and 3 for each respectively. If your score is higher than 8, the NHS suggests that you may be a problem gambler or you may have a gambling addiction.

Pathological gamblingis not an easy thing to deal with, and this is why governments continue to spend money on research and to fund specialist clinic centers. While some individuals may find it easier to distance themselves from compulsive gambling, for others fighting addiction is a life-long struggle.

Compulsion has a powerful pull and most health experts try to find a way that individuals can stay away from temptation, and resist your craving to gamble. With this said, stopping gambling is easy, but replacing it with a positive, constructive emotion can take time, effort, and grit.

The good news is that despite the difficulties, maintaining recovery is very possible, although it may require lifestyle changes and constant effort of will on your part. Certain pathologies, such as mental disorders, can be channeled into something positive. Start small and remember that exerting control over behavior is essential to long-lasting effects. Self-help is a good place to start, but you may seek professional help over time.

When you are a diagnosed gambling addict, the best thing you can do is to stop gambling. To do so, you must put some distance between gambling products and yourself. However, this is difficult at a time when the Internet makes it very easy for gambling firms to have targeted outreach through data use. Because of this, gambling companies know exactly who wishes to gamble based on social media and browser history.

Thankfully, there is a solution. You can put considerable distance between yourself and temptations. Avoid searching for gambling, and channel addiction elsewhere. Flag every ad you get on social media or Google that targets you, explaining that you are a recovering gambling addict and such content must not be displayed to you.

Avoid visiting casinos, whether in person or online and ask your friends and family members to respect your wishes in not bringing topics that are associative with your gambling addiction or that may trigger a strong urge to gamble.

Gambling addiction can be controlled by a system of checks and balances whereby you create a social circle that will help you keep yourself in check. Networking and joining groups with other people experiencing the same issues as you are, or better yet, who have recovered completely, is a good way to begin your recovery.

In addiction vernacular, individuals who take care of struggling addicts are known as mentors. Peer groups can have a strong and positive influence on your life, creating a sort of achievement system which you want to unlock, and that influences your life for the better.

When the desire to gamble becomes too strong, make sure to reach out to family, friends, or your designated mentor. Relapses are common, so do not beat yourself up if you do happen to give in on occasion, but know that your recovery depends on unwavering determination.

Because addiction takes time to tackle, and then effort and consistency to maintain recovery, many people create if-scenarios where they agree to complete a certain part of their treatment if they are allowed to experience the subject of their addiction.

Such if-statements are dangerous and they do not address the issue at hand, but rather postpone the urge to gamble and lead to pent-up desire to play. The best way to deal with any compulsive or pathological gambling is to be aware of your situation and not predicate your recovery on future rewards.

In todays world, avoiding exposure to gambling productscan be difficult. Clever algorithms target you to the point where you almost cannot avoid running into a piece of advertisement, regardless of the medium that is used to deliver the message. However, this is where smart and powerful self-help tools come in handy.

Online gambling may seem all-pervasive, but advanced gambling markets have rolled out solutions that will literally block your access from every licensed operator in the country that is part of the exclusion program. Such programs exist in all European regulated markets, the United Kingdom, the United States, and Australia.

They are admittedly developed better in some regions than others, but ultimately they are used to treat pathological gambling. Governments still have to put more effort into helping gambling addicts, but the good news is that considerable efforts have already been made.

Gambling addicts have many ways out of this difficult position. The main challenge addicts face has to do with the fact that they are reluctant to admit they have a problem. Forcing therapy or treatment options on individuals rarely work, as an addict much more likely to resist help unless they have opted into it.

To this end, all recovery and treatment processes are predicated on the willingness of participants. An individual who acknowledges that they have a gambling problem can start experimenting with ways that allow him or her to control their failings.

Cognitive-behavioral therapy is a good approach to mental health. The therapy is predicated on finding the underlying reason for your behavior and why certain things trigger you. Most commonly, the conclusion is that certain experiences elicit a stronger response in your brain that sends a dopamine rush.

By teaching yourself to study, analyze, and understand these individual bursts of hormones, you can master and model your behavior in a way that is positive and healthy. There are many private and government treatment centers that offer this type of therapy.

Sometimes, an individual may experience a range of mental health problems that relate to and tie into gambling addiction. In fact, conditions such as OCDand ADHDmay be the originator of negative emotions that make you seek validation or quick thrill by engaging in reckless gambling behavior. Therefore some mood stabilizers and anti-depressants can go a long way in helping you deal with your gambling problem. Remember to not resort to medication on your own and seek professional help.

Self-help for gambling addiction is becoming very popular. Some people prefer to try and deal with the issue on their own. This is a perfectly valid approach and individuals who are strong-willed and in the habit of addressing their behavior analytically stand to benefit. Joining peer groups is a way to have a natural self-check and

Relapses are a problem gamblers bigger fear. Unfortunately, they also happen quite often, which is not in itself something to be worried about. Mental health and achieving a healthy mindset towards your gambling problem are important, and a relapse is not an end of your road to recovery.

Just the opposite, you need to develop the right attitude towards this momentary setback. Instead of hiding it, fearing stigma the same way you probably first hid your gambling addiction, its best to open up to a loved one, your support group, or a health specialist.

Dont let the cravings simmer and fester. Talk out your issue or urge to gamble with someone whom you trust and who has proven a moral bulwark for your recovery. The support of people whom you have come to trust and appreciate is essential to genuinely pushing past your addiction.

If you do relapse, dont spend too much time agonizing over this. It happens, and the fact you feel guilty means that you are advancing in your recovery. Talk out what you have achieved by relapsing and whether it was worth it.

Compare how you felt during recovery with how you felt when you satisfied your urge. More often than not, you will establish that your addiction is now physically and mentally unpleasant and your desire to gamble is much lesser than before you started treatment.

Relapses arent too bad when they happen, and if anything, they are a quick reality-check if your treatment is working.

Addiction simply means that you have enough energy and determination, notwithstanding the chemical factor involved. You can channel your determination to pursue an activity into something that has a far more beneficial effect on you.

Of course, moderation will be essential, as the goal is to master addictive behavior, not encourage it in one form or another. You can take up any hobby that has to do with sports, music, art, books or anything you wish, really.

Even 15 minutes of exercise a day can help you achieve much better mental health. Exercise releases dopamine and boosts your cognitive and mental abilities, leading to a healthier lifestyle free of cravings to achieve momentary satisfaction.

Remind yourself that your pursuit of the almighty dollar is illusionary and that gambling is rigged and statistically stacked against you. You cannot realistically expect the win simply because the odds are against you, and this is always the case.

Who is at a risk to develop a gambling addiction? Gambling problems come in many forms, but understanding the type of personality that it would take to go over the tipping point is important to understand impulse control disorders in the first place.

Common risk factors are now identified, but they are by no means final or a blueprint. However, gambling studies have proven with a fair degree of accuracy that there are several ways to understand who is the most at risk from pathological gambling.

Maybe you have been told that you ought to hide your gambling problems for the sake of decency. Perhaps that used to be right, but support and reaching out to others is the best way to tackle gambling addictions.

Today, treatment professionals encourage their patients to share stories so that people who are only beginning to deal with their issues may know they are not alone. While your suffering may seem personal and exclusive, your emotions are universal and human, and by sharing, you can cope and move on with your life.

No problem gambling story should be buried or covered up. By opening up, you will be helping others to see a way out as well as assist researchers and professionals who are genuinely concerned to study and understand problem gambling and a gamblers mind closer. All this health information can be put to good use.

To convince you that you are not in this alone, we have put together the stories of people whom you may know, but to whom you will feel a unique connection after hearing about their own experience with gambling. Read the personal gambling stories of people who have been through the crucible of problem gambling:

Pathological gamblers need help to address a gambling problem. This can be a loved one or trained medical professionals, a helpline, or a peer group. Whatever your choice and approach to tackling gambling addictions, you can rest assured that help is readily available.

Pathological gambling is a condition that should be taken seriously and deserves the attention of health experts. Thankfully, attitudes towards problem gamblers have evolved and your struggle is recognized as a valid medical concern.

With the help of your family, friends, peer groups, a helpline, or treatment facility, you can make sure that you deal with your impulses and control your cravings.

By following your healthcare professional advice and building a safe environment for yourself, you can not only learn to live with gambling addiction but outlive it. You can do better, and your friends, family, and people you love believe in you.

Problem gambling, also known as compulsive gambling, pathological gambling, or gambling addiction in laymens terms, is a mental health issue that affects close to 0.5% of the population. Its characterized by the compulsive need to spend money on gambling and gambling without a stop.

Yes, gambling addiction is a type of impulse control disorder and is a recognized mental health problem. Sufferers cannot control themselves from making potentially perilous decisions that impact their livelihoods, mental, and physical well-being.

Find a therapist, use self-exclusion tools, and join a support group. Fighting gambling addiction and avoiding relapsing is a lifetime battle. With proper nurturing and guidance, you can avoid returning to pathological gambling, though.

Healthcare facilities, free clinics, non-for-profit organizations all offer help in dealing with problem gambling. Pathological gamblers can find numerous organizations willing to help, including GamblersAnonymous, GamCare, GamStop, and more.

Cognitive-behavioral therapy, peer groups, gambling addiction treatment programs are among the most popular choices. Self-help is another viable option with free clinics offering pro-bono help to problem gamblers.

Gambling addiction begins with anxiety, overspending, and constant preoccupation about gambling games. Individuals experiencing gambling addiction may lie to, borrow, or steal money from friends, family, and employers to fuel their habit.

Go here to read the rest:
What Is Gambling Addiction and Problem Gambling? - GamblingNews.com

Good afternoon, and welcome health colleagues to the first European Alliance for Personalised Medicine (EAPM) update of the week, as we move delightedly towards Christmas. EAPM has just released a leading paper on gene therapy more of this below, along with the customary updates, writes EAPM Executive Director Denis Horgan.

ATMPs push forward prospects for tackling severe disease

EAPM has released a paper on gene therapy, based on its recent policy discussion, Propelling Healthcare with Advanced Therapy Medicinal Products.Challenges confront the sector, complicating the translation from research into patient access. Scientific, clinical development and regulatory issues are compounded by limited experience with clinical and commercial use, limited manufacturing know-how, high costs, and difficulties in accessing development funding and investment.

Pricing and reimbursement and market access issues are an additional challenge, particularly in Europe, where unfamiliarity with the technology and uncer- tainty over the use of real-world evidence induce caution among clinicians, health technology assessment bodies and payers. There is a need for a review of the suitability of the regula- tory and market access framework for these products, focused development of data, public/ private partnerships, and fuller collaboration governments, doctors, insurers, patients, and pharmaceutical companies.

This paper makes specific recommendations for allstakeholders, ranging from early dialogue on potential products, linking of clinical data, and patient registries or standardization of control frameworks, to a comprehensive approach to evidencegeneration, assessment, pricing, and payment for ATMPs.The paper isavailable here.

5.1 billion secured for EU Health Programme

On 14 December, the biggest ever EU Health Programme and the rules to distribute its 5.1 billion funds were agreed. Negotiators of the European Parliament and EU member states struck a deal on the law setting up the European Unions so called 'EU4Health' Programme from 2021 onwards.

"The COVID-19 pandemic has revealed that Europe was not equipped to deal with a serious health crisis. During the first peak of the pandemic, we not only lacked doctors, nurses and medical staff, but also medicines and medical equipment. It must never happen again that a doctor must choose who lives or dies because the hospital does not have resources to help all," said the EPP Group's Cristian Silviu Buoi MEP, the lead negotiator for the European Parliament and a stronger support of EAPM.

"Therefore, the programme will allocate funds for the establishment of a reserve for essential crisis-relevant products, medical and healthcare staff, in synergy and complementarity with other EU instruments," he added. Requisite to the health programme that Buoi negotiated is an increase in health funding in the new EU long-term budget.

The EPP Group also wanted the programme to support the training of health staff, reduce health inequalities, support digitalization in the health-care sector, finance a masterplan against cancer and bring back the production of medicines to Europe.

WHO does not envisage COVID-19 vaccines being made mandatory

The World Health Organization (WHO) does not foresee countries making it mandatory for citizens to take the new COVID-19 vaccines which have been developed, an official said. I dont think we envisage any countries creating a mandate for vaccinations, Kate OBrien, the WHOs director of immunization vaccines and biologicals, told a news conference.

Pressure mounts on EU drug regulator to approve COVID-19 vaccine

Europes drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine developed by Germanys BioNTech, officials said, as inoculations get started in Britain and the United States. The push underscores the frictions between regulators and governments wishing to curb the pandemic that has killed more than 1.6 million people worldwide. Four EU sources said that the European Medicines Agency (EMA) has been under pressure from the European Commission and EU governments to approve vaccines more quickly. One EMA official said on 14December that pressure had increased on the agency from EU governments through usual channels of communications after 2 December, when the British regulator granted an emergency authorization to the Pfizer/BioNTech vaccine.

UK health secretary announces discovery of new coronavirus variant

UK Health SecretaryMatt Hancock appeared in the House of Commons on Monday (14 December) to give an urgent statement to MPs on the coronavirus pandemic in the UK. He said experts haveidentified a new variant of COVID-19 which may be responsible for the "faster spread" in south-east England.

Hancock said: "Over the last few days, thanks to our world-class genomic capability in the UK, we have identified a new variant of coronavirus which may be associated with the faster spread in the south of England."

He added: "Initial analysis suggests that this variant is growing faster than the existing variants. We've currently identified over 1,000 cases with this variant predominantly in the South of England although cases have been identified in nearly 60 different local authority areas."

When asked if the new variant will impact the effectiveness of the vaccine, Hancock said: "The medical advice that we have is that it is highly unlikely that this new variant will impinge the vaccine and the impact of the vaccine. But we will know that in the coming days and weeks as the new strand is cultured at Porton Down and then the tests conducted upon it.

WHO a touch more circumspect

The World Health Organization is aware of the new variant of COVID-19 that has emerged in Britain, but there is no evidence the strain behaves differently to existing types of the virus, it said onMonday (14 December).We are aware of this genetic variant reported in 1,000 individuals in England, the WHOs top emergencies expert Mike Ryan told a news briefing in Geneva. Authorities are looking at its significance. We have seen many variants, this virus evolves and changes over time.

FDA authorizes vaccine following extreme Trump pressure

The US Food and Drug Administration (FDA) on Friday (11 December) gave emergency use authorization to the nations first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed more than 290,000 Americans, shredded the nations social and political fabric and devastated the economy.

The historic authorization of thevaccine from Pfizer and BioNTech for people age 16 and older, just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists, sets in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States to curb the pandemic.

US President Donald Trump had put the FDA under extreme pressure to approve thevaccine, describing the organization as a slow, old turtle in a tweet. The FDA action came after White House Chief of Staff Mark Meadows on Friday told FDA commissioner Stephen Hahn to be prepared to submit his resignation if the agency did not clear the vaccine by days end, according to people familiar with the situation who spoke on the condition of anonymity because they were notauthorized to discuss what happened.

And that is everything for the start of the week from EAPM dont forget to check our gene therapy paperhere,have an excellent week.

See original here:
EAPM Advancing gene therapy with Advanced Therapy Medicinal Products - EU Reporter

Locanabio, a San Diego gene therapy company focused on treatments for severe neurodegenerative diseases such as Huntingtons and Lou Gehrigs disease, has raised $100 million in a second round of venture capital funding.

The Torrey Pines Mesa company will use the money for further pre-clinical and clinical development of its proprietary RNA-targeting system to fight degenerative diseases including myotonic dystrophy type 1 and retinal disease, along with Huntingtons and genetic ALS.

Locanabios approach is to combine two methods for treating diseases gene therapy and RNA modification. The platform consists of several RNA-targeting systems that are combined with gene therapy delivery to modify dysfunctional RNA.

The capabilities of the platform could allow Locanabio to develop treatments for a wide range of genetic diseases beyond those on its current roadmap.

This financing positions us to accelerate our efforts to advance multiple promising programs into (new drug) studies in 2021 and to further develop our novel RNA-targeting platform, which has the potential to be a major new advance in medicine that can bring hope to patients with many devastating genetic diseases, said Chief Executive Jim Burns in a statement.

Burns joined Locanabio in December 2019 from Casebia, where he served as the chief executive and led the team in developing CRISPR-based therapeutics to treat blood disorders, blindness and heart disease. Before that, he spent the bulk of his career at Sanofi-Genzyme, where he held several leadership roles.

This latest financing was led by Vida Ventures. Other new investors participating include RA Capital Management, Invus, Acuta Capital Partners and an investment fund associated with SVB Leerink.

Prior investors ARCH Venture Partners, Temasek, Lightstone Ventures, UCB Ventures and Google Ventures also participated. Lonanabio previously raised $55 million in May 2019.

As part of the funding round, Rajul Jain, a medical doctor and director of Vida Ventures, will join Locanabios board of directors.

The unique approach in RNA targeting using gene therapy to deliver RNA binding proteins developed by Locanabio represents the next frontier of genetic medicine with the ability to target the root cause of a range of genetic diseases, said Jain in a statement. They have built a strong management team to execute this bold vision, and we are proud to support them.

See the article here:
San Diego's Locanabio raises $100 million for treatments aimed at degenerative diseases - The San Diego Union-Tribune

Good afternoon, and welcome health colleagues to the first European Alliance for Personalised Medicine (EAPM) update of the week, as we move delightedly towards Christmas. EAPM has just released a leading paper on gene therapy more of this below, along with the customary updates, writes EAPM Executive Director Denis Horgan.

ATMPs push forward prospects for tackling severe disease

EAPM has released a paper on gene therapy, based on its recent policy discussion, Propelling Healthcare with Advanced Therapy Medicinal Products.Challenges confront the sector, complicating the translation from research into patient access. Scientific, clinical development and regulatory issues are compounded by limited experience with clinical and commercial use, limited manufacturing know-how, high costs, and difficulties in accessing development funding and investment.

Pricing and reimbursement and market access issues are an additional challenge, particularly in Europe, where unfamiliarity with the technology and uncer- tainty over the use of real-world evidence induce caution among clinicians, health technology assessment bodies and payers. There is a need for a review of the suitability of the regula- tory and market access framework for these products, focused development of data, public/ private partnerships, and fuller collaboration governments, doctors, insurers, patients, and pharmaceutical companies.

This paper makes specific recommendations for allstakeholders, ranging from early dialogue on potential products, linking of clinical data, and patient registries or standardization of control frameworks, to a comprehensive approach to evidencegeneration, assessment, pricing, and payment for ATMPs.The paper isavailable here.

5.1 billion secured for EU Health Programme

On 14 December, the biggest ever EU Health Programme and the rules to distribute its 5.1 billion funds were agreed. Negotiators of the European Parliament and EU member states struck a deal on the law setting up the European Unions so called 'EU4Health' Programme from 2021 onwards.

"The COVID-19 pandemic has revealed that Europe was not equipped to deal with a serious health crisis. During the first peak of the pandemic, we not only lacked doctors, nurses and medical staff, but also medicines and medical equipment. It must never happen again that a doctor must choose who lives or dies because the hospital does not have resources to help all," said the EPP Group's Cristian Silviu Buoi MEP, the lead negotiator for the European Parliament and a stronger support of EAPM.

"Therefore, the programme will allocate funds for the establishment of a reserve for essential crisis-relevant products, medical and healthcare staff, in synergy and complementarity with other EU instruments," he added. Requisite to the health programme that Buoi negotiated is an increase in health funding in the new EU long-term budget.

The EPP Group also wanted the programme to support the training of health staff, reduce health inequalities, support digitalization in the health-care sector, finance a masterplan against cancer and bring back the production of medicines to Europe.

WHO does not envisage COVID-19 vaccines being made mandatory

The World Health Organization (WHO) does not foresee countries making it mandatory for citizens to take the new COVID-19 vaccines which have been developed, an official said. I dont think we envisage any countries creating a mandate for vaccinations, Kate OBrien, the WHOs director of immunization vaccines and biologicals, told a news conference.

Pressure mounts on EU drug regulator to approve COVID-19 vaccine

Europes drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine developed by Germanys BioNTech, officials said, as inoculations get started in Britain and the United States. The push underscores the frictions between regulators and governments wishing to curb the pandemic that has killed more than 1.6 million people worldwide. Four EU sources said that the European Medicines Agency (EMA) has been under pressure from the European Commission and EU governments to approve vaccines more quickly. One EMA official said on 14December that pressure had increased on the agency from EU governments through usual channels of communications after 2 December, when the British regulator granted an emergency authorization to the Pfizer/BioNTech vaccine.

UK health secretary announces discovery of new coronavirus variant

UK Health SecretaryMatt Hancock appeared in the House of Commons on Monday (14 December) to give an urgent statement to MPs on the coronavirus pandemic in the UK. He said experts haveidentified a new variant of COVID-19 which may be responsible for the "faster spread" in south-east England.

Hancock said: "Over the last few days, thanks to our world-class genomic capability in the UK, we have identified a new variant of coronavirus which may be associated with the faster spread in the south of England."

He added: "Initial analysis suggests that this variant is growing faster than the existing variants. We've currently identified over 1,000 cases with this variant predominantly in the South of England although cases have been identified in nearly 60 different local authority areas."

When asked if the new variant will impact the effectiveness of the vaccine, Hancock said: "The medical advice that we have is that it is highly unlikely that this new variant will impinge the vaccine and the impact of the vaccine. But we will know that in the coming days and weeks as the new strand is cultured at Porton Down and then the tests conducted upon it.

WHO a touch more circumspect

The World Health Organization is aware of the new variant of COVID-19 that has emerged in Britain, but there is no evidence the strain behaves differently to existing types of the virus, it said onMonday (14 December).We are aware of this genetic variant reported in 1,000 individuals in England, the WHOs top emergencies expert Mike Ryan told a news briefing in Geneva. Authorities are looking at its significance. We have seen many variants, this virus evolves and changes over time.

FDA authorizes vaccine following extreme Trump pressure

The US Food and Drug Administration (FDA) on Friday (11 December) gave emergency use authorization to the nations first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed more than 290,000 Americans, shredded the nations social and political fabric and devastated the economy.

The historic authorization of thevaccine from Pfizer and BioNTech for people age 16 and older, just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists, sets in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States to curb the pandemic.

US President Donald Trump had put the FDA under extreme pressure to approve thevaccine, describing the organization as a slow, old turtle in a tweet. The FDA action came after White House Chief of Staff Mark Meadows on Friday told FDA commissioner Stephen Hahn to be prepared to submit his resignation if the agency did not clear the vaccine by days end, according to people familiar with the situation who spoke on the condition of anonymity because they were notauthorized to discuss what happened.

And that is everything for the start of the week from EAPM dont forget to check our gene therapy paperhere,have an excellent week.

Continue reading here:
Italy needs new restrictions to avoid third, devastating COVID-19 wave - PM to paper - EU Reporter

PHOENIX, Dec. 16, 2020 /PRNewswire/ --Creative Medical Technology Holdings Inc., (OTC CELZ) announced today positive preclinical data supporting the utilization of its ImmCelz cell based immunotherapy for treatment of stroke. In an animal model of ischemia stroke, the middle cerebral artery ligation model, administration of ImmCelz resulted in 34% reduction in infarct volume, whereas control bone marrow mesenchymal stem cells reduced infarct volume by 21%. Additionally, improvements in functional recovery where observed using the Rotarod test. At 28 days after induction of stroke the animals receiving ImmCelz had superior running time (92% of non-stroke controls) compared to animals which received bone marrow mesenchymal stem cells (73% of non-stroke control). Animals that received saline had a running time that was 50% of non-stroke controls.

"The regenerative potential of immune cells that have been programmed by stem cells is a fascinating and novel area of research." Said Dr. Amit Patel, coinventor of ImmCelz, and board member of the Company. "Conceptual advantages of using reprogrammed T cells include higher migratory ability due to smaller size, as well as ability to replicate and potentially form "regenerative memory cells."

"This data, which is covered by our previous filed patents, such as no. 15/987739, Generation of autologous immune modulatory cells for treatment of neurological conditions, demonstrate that immune modulation via this stem cell based method may be a novel and superior way of addressing the $30 billion dollar market for stroke therapeutics1." Said Dr. Thomas Ichim, coinventor of the patent and Chief Scientific Officer of the Company. "The fact that this technology, which has priority back to 2017, is demonstrating such stunning results, motivates us to consider filing an Investigational New Drug Application for use in stroke."

Creative Medical Technology Holdings possesses numerous issued patents in the area of cellular therapy including patent no. 10,842,815 covering use of T regulatory cells for spinal disc regeneration, patent no. 9,598,673 covering stem cell therapy for disc regeneration, patent no. 10,792,310 covering regeneration of ovaries using endothelial progenitor cells and mesenchymal stem cells, patent no. 8,372,797 covering use of stem cells for erectile dysfunction, and patent no. 7,569,385 licensed from the University of California covering a novel stem cell type.

"While stroke historically has been a major area of unmet medical need, the rise in stroke cases , as well as the fact that younger people are increasingly falling victim to stroke, strongly motivates us to accelerate our developmental programs and to continue to explore participation of Big Pharma in this space." Said Timothy Warbington, President and CEO of the Company. "We are eager to replicate the existing experiments start compiling the dossier needed to take ImmCelz into humans using the Investigational New Drug Application (IND) route through the FDA."

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of urology, neurology and orthopedics and trades on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website atwww.sec.gov.

Timothy Warbington, CEOCEO@ CreativeMedicalHealth.com

Creativemedicaltechnology.comwww.StemSpine.comwww.Caverstem.comwww.Femcelz.com

1 Stroke Management Market Size Forecasts 2026 | Statistics Report (gminsights.com)

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Creative Medical Technology Holdings Announces Successful Application of ImmCelz Immunotherapy for Treatment of Stroke - KPVI News 6

Cancer researchers have created a new class of drugs to selectively target and destroy myeloid leukaemia cells with TET gene mutations.

Photomicrograph of bone marrow biopsy showing myeloblasts of acute myeloid leukemia (AML), a cancer of white blood cells.

Researchers have developed a novel class of targeted cancer drug that may be highly effective for the treatment of myeloid leukaemias. According to the team, their synthetic molecule, called TETi76, was able to selectively kill cells with TET2 gene mutations, one of the most common driver mutations in myeloid leukaemias.

Myeloid leukaemias are cancers derived from stem and progenitor cells in the bone marrow that give rise to all normal blood cells. These malignancies are normally treated with chemotherapy, either alone or in combination with targeted drugs; however, the significant side-effects associated with this treatment mean a more selective/targeted treatment is desirable.

In a new study published inBlood Cancer Discovery, researchers from the Cleveland Clinics Taussig Cancer Institute and Lerner Research Institute, both US, describe a new pharmacological strategy to preferentially target and eliminate leukaemia cells with TET2 mutations.

In preclinical models, we found that a synthetic molecule called TETi76 was able to target and kill the mutant cancer cells both in the early phases of disease what we call clonal haematopoiesis of indeterminate potential, or CHIP and in fully developed TET2 mutant myeloid leukaemia, said Dr Jaroslaw Maciejewski, a practicing haematologist and chair of the Cleveland Clinic Department of Translational Hematology & Oncology Research, who has been investigating the TET2 gene for the last decade.

TET genes encode DNA dioxygenase enzymes, which remove chemical groups from DNA molecules. Their activity ultimately changes what genes are expressed and can contribute to the development and spread of disease.

TET genes act as tumour suppressors, so loss-of-function mutations are common in haematological cancers, like leukaemias. While all members of the TET family are dioxygenases, TET2 is the most powerful. Genetic TET2 deficiency has been shown to skew differentiation of blood cells and clonal expansion of progenitor and stem cells. However, its related genes TET1 and TET3 provide residual enzymatic activity, sufficient to facilitate the survival of these progenitor cells harbouring cancerous mutations, thereby promoting the spread of the cancer, even when TET2 is inactive.

In their study, the research team designed TETi76 to replicate and amplify the effects of a natural molecule called 2-hydroxyglutarate (2HG), which inhibits the enzymatic activity of TET genes. They hoped to selectively eliminate TET2 mutant leukaemia cells centres by targeting their reliance on this residual DNA dioxygenase activity.

We took lessons from the natural biological capabilities of 2HG, explained Dr Babal Kant Jha, Maciejewskis collaborator from the Department of Translational Hematology & Oncology Research. We studied the molecule and rationally designed a novel small molecule, synthesised by our chemistry group headed by Dr James Phillips. Together, we generated TETi76 a similar, but more potent version capable of inhibiting not just TET2, but also the remaining disease-driving enzymatic activity of TET1 and TET3.

The researchers studied TETi76s effects in both preclinical disease and xenograft models (where human cancer cells are implanted into preclinical models). In both models, treatment with the novel TET inhibitor suppressed the clonal evolution of TET2 mutant cells.

While the team cautioned that additional studies would be critical to investigate the small molecules cancer-fighting capabilities in patients, Dr Jha said we are optimistic about our results, which show not just that TETi76 preferentially restricts the growth and spread of cells with TET2 mutations, but also gives survival advantage to normal stem and progenitor cells.

Read more here:
Novel class of targeted cancer therapies could treat myeloid leukaemias - Drug Target Review

Victoria Gray (second from left) with children Jamarius Wash, Jadasia Wash and Jaden Wash. Now that the gene-editing treatment has eased Gray's pain, she has been able be more active in her kids' lives and looks forward to the future. "This is really a life-changer for me," she says. Victoria Gray hide caption

Victoria Gray (second from left) with children Jamarius Wash, Jadasia Wash and Jaden Wash. Now that the gene-editing treatment has eased Gray's pain, she has been able be more active in her kids' lives and looks forward to the future. "This is really a life-changer for me," she says.

The last thing a lot of people want to do these days is get on a plane. But even a pandemic would not stop Victoria Gray. She jumped at the chance to head to the airport this summer.

"It was one of those things I was waiting to get a chance to do," says Gray.

She had never flown before because she was born with sickle cell disease. She feared the altitude change might trigger one of the worst complications of the devastating genetic disease a sudden attack of excruciating pain.

But Gray is the first person in the United States to be successfully treated for a genetic disorder with the help of CRISPR, a revolutionary gene-editing technique that makes it much easier to make very precise changes in DNA.

About a year after getting the treatment, it was working so well that Gray felt comfortable flying for the first time. She went to Washington, D.C., to visit her husband, who has been away for months on deployment with the National Guard.

"It was exciting. I had a window. And I got to look out the window and see the clouds and everything," says Gray, 35, of Forest, Miss.

Gray wore a mask the whole time to protect herself against the coronavirus, kept her distance from other people at the airport, and arrived happily in Washington, D.C., even though she's afraid of heights.

"I didn't hyperventilate like I thought I would," Gray says, laughing as she recounts the adventure in an interview with NPR.

NPR has had exclusive access to follow Gray through her experience since she underwent the landmark treatment on July 2, 2019. Since the last time NPR checked in with Gray in June, she has continued to improve. Researchers have become increasingly confident that the approach is safe, working for her and will continue to work. Moreover, they are becoming far more encouraged that her case is far from a fluke.

At a recent meeting of the American Society for Hematology, researchers reported the latest results from the first 10 patients treated via the technique in a research study, including Gray, two other sickle cell patients and seven patients with a related blood disorder, beta thalassemia. The patients now have been followed for between three and 18 months.

All the patients appear to have responded well. The only side effects have been from the intense chemotherapy they've had to undergo before getting the billions of edited cells infused into their bodies.

The New England Journal of Medicine published online this month the first peer-reviewed research paper from the study, focusing on Gray and the first beta thalassemia patient who was treated.

"I'm very excited to see these results," says Jennifer Doudna of the University of California, Berkeley, who shared the Nobel Prize this year for her role in the development of CRISPR. "Patients appear to be cured of their disease, which is simply remarkable."

Another nine patients have also been treated, according to CRISPR Therapeutics in Cambridge, Mass., and Vertex Pharmaceuticals in Boston, two companies sponsoring the research. Those individuals haven't been followed long enough to report any results, officials say.

But the results from the first 10 patients "represent an important scientific and medical milestone," says Dr. David Altshuler, Vertex's chief scientific officer.

The treatment boosted levels of a protein in the study subjects' blood known as fetal hemoglobin. The scientists believe that protein is compensating for defective adult hemoglobin that their bodies produce because of a genetic defect they were born with. Hemoglobin is necessary for red blood cells to carry oxygen.

Analyses of samples of bone marrow cells from Gray six months after getting the treatment, then again six months later, showed the gene-edited cells had persisted the full year a promising indication that the approach has permanently altered her DNA and could last a lifetime.

"This gives us great confidence that this can be a one-time therapy that can be a cure for life," says Samarth Kulkarni, the CEO of CRISPR Therapeutics.

Gray and the two other sickle cell patients haven't had any complications from their disease since getting the treatment, including any pain attacks or hospitalizations. Gray has also been able to wean off the powerful pain medications she'd needed most of her life.

Prior to the treatment, Gray experienced an average of seven such episodes every year. Similarly, the beta thalassemia patients haven't needed the regular blood transfusions that had been required to keep them alive.

"It is a big deal because we we able to prove that we can edit human cells and we can infuse them safely into patients and it totally changed their life," says Dr. Haydar Frangoul at the Sarah Cannon Research Institute in Nashville. Frangoul is Gray's doctor and is helping run the study.

For the treatment, doctors remove stem cells from the patients' bone marrow and use CRISPR to edit a gene in the cells, activating the production of fetal hemoglobin. That protein is produced by fetuses in the womb but usually shuts off shortly after birth.

The patients then undergo a grueling round of chemotherapy to destroy most of their bone marrow to make room for the gene-edited cells, billions of which are then infused into their bodies.

"It is opening the door for us to show that this therapy can not only be used in sickle cell and thalassemia but potentially can be used in other disorders," Frangoul says.

Doctors have already started trying to use CRISPR to treat cancer and to restore vision to people blinded by a genetic disease. They hope to try it for many other diseases as well, including heart disease and AIDS.

The researchers stress that they will have to follow Gray and many other patients for a lot longer to be sure the treatment is safe and that it keeps working. But they are optimistic it will.

Gray hopes so too.

"It's amazing," she says. "It's better than I could have imagined. I feel like I can do what I want now."

The last year hasn't always been easy for Gray, though. Like millions of other Americans, she has been sheltering at home with three of her children, worrying about keeping them safe and helping them learn from home much of the time.

"I'm trying to do the things I need to do while watch them at the same time to make sure they're doing the things they need to do," Gray says. "It's been a tough task."

But she has been able do other things she never got to do before, such as watch her oldest son's football games and see her daughter cheerleading.

"This is really a life-changer for me," she says. "It's magnificent."

She's now looking forward to going back to school herself, learning to swim, traveling more when the pandemic finally ends, and watching her children grow up without them worrying about their mother dying.

"I want to see them graduate high school and be able to take them to move into dorms in college. And I want to be there for their weddings just everything that the normal people get to do in life. I want to be able to do those things with my kids," she says. "I can look forward now to having grandkids one day being a grandmama."

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1st Patients To Get CRISPR Gene-Editing Treatment Continue To Thrive - NPR

Bone Regeneration Material Market: Introduction

Bone-regeneration techniques, either with autografts or allografts, represent a challenge for reconstructive surgery. Biomaterials are temporary matrices for bone growth and provide a specific environment and architecture for tissue development. Depending on the specific intended application of the matrix, whether for structural support, drug-delivery capability, or both, certain material categories may be more or less well suited to the final structure.

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Key Drivers and Restraints of Global Bone Regeneration Material Market

Increase in prevalence of degenerative joint diseases boost the market. Worldwide estimates of degenerative joint diseases indicate that 9.6% men and 18.0% women above 60 years have symptomatic osteoarthritis. According to expert opinions presented in the EULAR committee report, radiographic evidence of knee osteoarthritis in men and women over 65 years of age is found in 30% of the population.

In the absence of disease modifying therapy, a large number of patients with osteoarthritis progress to advance joint destruction. Surgery with bone grafts and substitutes play a major role in the management of osteoarthritis to avoid advanced joint destruction. According to the American College of Rheumatology, advances in biomaterial and tissue engineering are expected to create new opportunities to integrate surgical approaches in osteoarthritis.

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Increase in the number of orthopedic surgeries also fuels the market. According to the American Academy of Orthopaedic Surgeons (AAOS), approximately 129,000 total knee arthroplasty (TKA) surgeries were performed in the U.S. in 1990, and the number has increased to over 600,000 in 2010. The AAOS has projected that 3 million TKA procedures would be performed by 2030 in the U.S. alone. Moreover, spinal surgeries are becoming increasingly popular, and approximately 432,000 spinal fusions are performed in the U.S. each year. Bone grafts and substitutes are extensively used for the surgeries mentioned above. This is likely to fuel the bone regeneration material market.

Bone graft and substitutes are a long-term solution to bone problem treatment; however, these are expensive. No two patients or their customized bone grafts and substitutes treatments are exactly alike. Hence, the number of appointments, procedures, and costs vary accordingly. Surgeons charge US$ 35,000 to US$ 40,000 for a complex posterolateral lumbar spine fusion bone graft surgery. Most surgeons refer patients to specialty surgeons, neurologists, or orthopedic physicians, which increases the cost of procedure. Asia is price-sensitive and displays inhibitions with respect to investing in bone graft and substitutes, which are often only affordable to the elite population; therefore offering a comparatively smaller market.

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Cell-based Segment to Expand Significantly

Based on product type, the global bone regeneration material market can be divided into ceramic-based, polymer-based, growth factor-based, cell-based and others

The ceramic-based segment dominated the global market in 2019. It is projected to sustain its position during the forecast period. Ceramic-based bone grafts are widely used to reduce the need for iliac crest bone grafting. Rise in geriatric population with oral health issues across the world has augmented the number of bone graft surgeries performed in the last few years.

However, the cell based segment is projected to expand at a notable CAGR during the forecast period. Bone tissue engineering (BTE) using bone marrow stem cells has been suggested as a promising technique for reconstructing bone defect in order to overcome the drawbacks of bone graft materials.

Orthopedic surgery segment to dominate global bone regeneration material market

Based on application, the global bone regeneration material market can be segregated into orthopedic surgery, bone trauma, dental surgery and others.

In terms of revenue, the orthopedic surgery segment accounted for a prominent share of the market in 2019 owing to a rise in the geriatric population and increase in cases of orthopedic diseases. According to WHO, between 2015 and 2050, the proportion of the world's population over 60 years would nearly double from 12% to 22%. The number of people aged 60 years and older is estimated to outnumber children younger than 5 years by 2020. As per MVZ Gelenk-Klinik data, more than 2400 orthopedic surgical procedures are performed per year at the Gelenk Klinik Orthopaedic Hospital.

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North America to dominate global bone regeneration material market

In terms of region, the global bone regeneration material market can be divided into: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa

North America accounted for a significant share of the bone regeneration material market in 2019, followed by Europe. Usage of new and innovative products in both premium and value segments among various bone grafts substitutes is projected to boost the bone regeneration material market in several countries in Europe and North America in the next few years. According to the Centers for Disease Control and Prevention (CDC), the total number of inpatient surgeries carried out in the U.S. were 51.4 million in 2014; of these 719,000 were total knee replacements and 332,000 were total hip replacement.

The market in developing countries in Asia Pacific is estimated to expand at a significant CAGR during the forecast period. The market in Asia Pacific is driven by an increase in population and time taken to accept new technologies. Increase in the number of patients and geriatric population are major factors that are expected to propel the market in Japan during the forecast period. According to the Gerontological Society of America, Japan has the highest proportion of geriatric population in the world. Hence, demand for orthopedic surgeries is estimated to be higher in Japan than that in other countries in Asia Pacific.

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Key Manufacturers Operating in Market

The global bone regeneration material market was highly fragmented in 2019. Key manufacturers operating in the global market are:

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Bone Regeneration Material Market: Cell-based Segment to Expand Significantly - BioSpace

If youre like 95% of American adults, you had chickenpox as a kid. Before the United States started its widespread vaccination program in 1995, there were roughly four million cases of chickenpox every year. So, most people suffered through an infection with this highly contagious virus and its itchy, whole-body rash.

But unlike many childhood viruses, the varicella-zoster virus that causes chickenpox doesnt clear from the body when the illness ends. Instead it hangs around, taking up residence and lying dormant in the nerves, sometimes for decades, with the immune system holding it in check. In some people, it lives there harmlessly for the rest of their life. But in others, the virus can suddenly emerge and strike again, this time appearing as a different condition known as shingles.

Like chickenpox, shingles also causes a blistering rash, but this time it generally appears as a painful band around one side of your ribcage or on one side of your face. The first symptom for many people is pain or a burning sensation in the affected area. You may also have fever, a headache, and fatigue. Along with the rash and other temporary symptoms, shingles can also bring unpleasant, long-lasting, and sometimes permanent complications, such as skin infections, nerve pain in the area where the rash appeared, or even vision loss.

Experts dont fully understand this. One theory is that shingles occurs when your immune system loses its ability to keep the virus in check.

After you get chickenpox, your immune system is able to recognize the varicella-zoster virus thanks to specialized immune system cells, called B and T cells, that are able to remember the virus and quickly marshal an attack on it. Factors that weaken the immune system increase your risk of developing shingles. These include

While you may not be able to control certain factors that might trigger shingles, there are strategies you can use to prevent shingles. The most important is vaccination. Research shows that the shingles vaccine Shingrix is 90% effective in preventing an outbreak of shingles. Even if you do get shingles after being vaccinated, Shingrix greatly reduces your risk of developing persistent pain in the affected area, known as post-herpetic neuralgia.

In addition to getting vaccinated, its always a good idea to take steps to keep your body healthy, such as choosing healthy foods, staying active, and getting sufficient sleep. Its not clear if healthy lifestyle habits like these can prevent shingles, but even if they dont, theyre worthwhile because they will benefit your body in many other ways.

Link:
Shingles: What triggers this painful, burning rash? - Harvard Health Blog - Harvard Health

Global Orthopedic Regenerative Medicine Market Growth To Increase Manifold By 2027 A fundamental overview of the Orthopedic Regenerative Medicine Market niche is provided in the Orthopedic Regenerative Medicine Market report accompanying definitions, classifications, applications along with industry chain framework. The Orthopedic Regenerative Medicine market report provides a broad assessment of the required market dynamics and the latest trends. It also highlights regional markets, prominent market players, multiple market segments [products, applications, end users, and key regions] and subsectors that broadly consider numerous departments along with applications.

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Top Key Players Global Orthopedic Regenerative Medicine Market Competition: Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.

The market can be segmented into:By Procedure Cell TherapyTissue EngineeringBy Cell TypeInduced Pluripotent Stem Cells (iPSCs)Adult Stem CellsTissue Specific Progenitor Stem Cells (TSPSCs),Mesenchymal Stem Cells (MSCs)Umbilical Cord Stem Cells (UCSCs)Bone Marrow Stem Cells (BMSCs)By SourceBone MarrowUmbilical Cord BloodAdipose TissueAllograftsAmniotic FluidBy ApplicationsTendons RepairCartilage RepairBone RepairLigament RepairSpine RepairOthers

Furthermore, the report acknowledges that in this growing and immediately intensifying market situation, the most recent advertising and marketing details are critical to determining the performance of the forecast period and making an essential choice for the profitability and growth of the Orthopedic Regenerative Medicine market. Do it. Additionally, the report covers various factors influencing the growth of the Orthopedic Regenerative Medicine market during the forecast period. Additionally, this particular analysis will also determine its impact on individual segments of the market.

To identify the growth opportunities in the Orthopedic Regenerative Medicine market, the report has been segmented into regions that are growing faster than the overall market. This region was focused on regions with slower growth rates than the global market. Each geographic segment of the Orthopedic Regenerative Medicine market has been independently investigated, with price, distribution and demand data specifically for North America (US, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), and Asia-region markets. . Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Colombia, etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa).

Research purpose:

Provides strategic profiling of key players in the market, comprehensively analyzes core competencies, and derives the competitive landscape of the market.

Provides insight into factors influencing market growth. Orthopedic Regenerative Medicine market analysis based on various factors such as price analysis, supply chain analysis, Porter Five Force analysis, etc.

It provides detailed analysis of the market structure with forecasts for various segments and sub-segments of the global Orthopedic Regenerative Medicine market.

Provides a country level analysis of the market in relation to its current market size and future outlook.

Provides country-level analysis of the market by application, product type and sub-segment.

Provides historical and forecast revenue for the market segment and sub-segments in relation to the four major regions and countries in North America, Europe, Asia and other countries.

Track and analyze competitive developments such as joint ventures, strategic alliances, new product development and research and development in the global Orthopedic Regenerative Medicine Market.

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The chapters covered in the research report are as follows:

Chapter 1, 2: Targets of the Global Orthopedic Regenerative Medicine Market, encompassing market introduction, product images, market summary, and development scope.

Chapter 3, Chapter 4: Global Market Competition, Sales Volume, and Market Profit by Manufacturer.

Chapters 5, 6, 7: Global Supply (Production), Consumption, Exports, Imports by Regions such as USA, Asia Pacific, China, India, Japan. From 2015 to 2024, we conduct regional market research based on regional sales rate and market share.

Chapters 8, 9, 10: Global Market Analysis by Application, Cost Analysis, Marketing Strategy Analysis, Distributor/Trader

Chapters 11, 12: Market Information and Research Conclusions, Appendix and Data Sources.

The market report also primarily identifies additional useful and useful information about the industry, including the Orthopedic Regenerative Medicine market development trends analysis, return on investment, and feasibility analysis. Additionally, SWOT analysis is distributed in the report to analyze the growth of key global market players in the Orthopedic Regenerative Medicine market industry.

In addition, the research report investigates:

Competitors and manufacturers in the global market

By product type, application and growth factor

Industry status and outlook for major applications / end users / usage areas

Thanks for reading this article. You can also get individual chapter sections, such as North America, Europe, or Asia, or regional versions of the report.

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Impact of Covid-19 On Orthopedic Regenerative Medicine Market Business Overview and Forecast to 2027 | Curasan, Inc., Carmell Therapeutics...

The allogeneic off-the-shelf CD22-directed T-cell product, UCART22, showed early signs of activity and no evidence of unexpected toxicities at 2 dose levels for adult patients with relapsed/refractory CD22-positive B-cell acute lymphoblastic leukemia, according to the results of a study presented during the 2020 ASH Annual Meeting.1

In the phase 1 BALLI-01 (NCT04150497) dose-escalation and dose-expansion study, 2 patients at the 1 x 105 cells/kg dose achieved a complete remission (CR) with incomplete hematologic recovery on day 28. One of these patients attained a minimal residual disease (MRD)positive CR at day 42 followed by subsequent inotuzumab ozogamicin (Besponsa) and then transplant.

One patient at dose level 2, 1 x 106 cells/kg, experienced a significant bone marrow blast reduction at day 28, followed by disease progression.

No patients experienced dose-limiting toxicities (DLTs), immune effector cellassociated neurotoxicity syndrome (ICANS), graft-versus-host disease (GVHD), adverse effects (AE) of special interest (AESI), a UCART22-related AE that was grade 3 or higher, or a serious AE (SAE).

UCART22 showed no unexpected toxicities at the doses of 1 x 105 cells/kg and 1 x 106 cells/kg with fludarabine and cyclophosphamide lymphodepletion, lead study author Nitin Jain, MD, an assistant professor in the Department of Leukemia, The University of Texas MD Anderson Cancer Center, said in a virtual presentation during the meeting. Host immune recovery was observed early, and the addition of alemtuzumab [Lemtrada] to fludarabine and cyclophosphamide lymphodepletion is currently being explored with the goal to achieve deeper and more sustained T-cell depletion and to promote expansion and persistence of UCART22.

Standard treatment for adult patients with B-cell ALL includes multiagent chemotherapy with or without allogeneic stem cell transplant. However, 30% to 60% of patients with newly diagnosed B-cell ALL who achieve a CR will relapse, and the expected 5-year survival rate for those with relapsed/refractory disease is approximately 10%.

Previously, UCART19, when paired with lymphodepletion using fludarabine, cyclophosphamide, and alemtuzumab, was found to show efficacy in this patient population.2

CD22 is an FDA-approved therapeutic target in B-cell ALL. UCART22 is an immediately available, standardized, manufactured agent with the ability to re-dose, and its CAR expression redirects T cells to tumor antigens, Jain explained.

Moreover, through its mechanism of action, TRAC becomes disrupted using Transcription activator-like effector nucleases (Talen) technology to eliminate TCR from cell surface and reduce the risk of GVHD. CD52 is also disrupted with the use of Talen to eliminate sensitivity to lymphodepletion with alemtuzumab. Finally, there is a CD20 mimotope for rituximab (Rituxan) as a safety switch, Jain added.

UCART22 has also demonstrated in vivo antitumor activity in immune-compromised mice that were engrafted with CD22-positive Burkitt lymphoma cells in a dose-dependent manner.

In the dose-escalation/dose-expansion BALLI-01 study, investigators are enrolling up to 30 patients in a modified Toxicity Probability Interval design. There are 3 cohorts, which have 2 to 4 patients on each cohort: 1 x 105 cells/kg (dose level 1), 1 x 106 cells/kg (dose level 2), and 5 x 106 cells/kg. The focus of the dose-escalation phase of the trial was to determine the maximum-tolerated dose (MTD) and the recommended phase 2 dose (RP2D) before heading into the dose-expansion portion of the trial.

To be eligible for enrollment, patients must have been between 18 and 70 years old, have acceptable organ function, an ECOG performance status of 0 or 1, at least 90% of B-cell ALL blast CD22 expression, and had previously received at least 1 standard chemotherapy regimen and at least 1 salvage regimen.

End points of the trial included safety and tolerability, MTD/R2PD, investigator-assessed response, immune reconstitution, and UCART22 expansion and persistence.

The lymphodepletion regimens were comprised of fludarabine (at 30 mg/m2 x 4 days) plus cyclophosphamide (1 g/m2 x 3 days); the study has since been amended to include the regimen of fludarabine (at 30 mg/m2 x 3 days), cyclophosphamide (500 g/m2 x 3 days), and alemtuzumab (20 mg/day x 3 days) and is currently enrolling patients.

Following screening, lymphodepletion, and UCART22 infusion, patients underwent an observation period for DLTs with a primary disease evaluation at 28 days; additional efficacy evaluations occurred at 56 days and 84 days. Patients were followed for 2 years and continued to be assessed for long-term follow-up.

As of July 1, 2020, 7 patients were screened, of which 1 patient failed and 6 were therefore enrolled on the study. One patient discontinued therapy before receiving UCART22 due to hypoxia from pneumonitis that was linked with lymphodepletion. Five patients were treated with UCART22 at dose level 1 (n = 3) and dose level 2 (n = 2).

The median age of participants was 24 years (range, 22-52), 3 of the 5 patients were male, and 3 had an ECOG performance status of 0. The median number of prior therapies was 3 (range, 2-6), and there were a median 35% bone marrow blasts (range, 10%-78%) prior to lymphodepletion.

Three patients had complex karyotype and 2 had diploid cytogenetics. One patient each had the following molecular abnormalities: CRLF2, CRLF2 and JAK2, CDKN2A loss, KRAS and PTPN11, and IKZF1. Only 1 patient had undergone haploidentical transplant. Four patients previously received prior CD19- or CD22-directed therapy, including blinatumomab (Blincyto), inotuzumab ozogamicin (Besponsa), and CD19-directed CAR T-cell therapy. At study entry, 3 patients had refractory disease and 2 patients had relapsed disease.

Grade 3 or higher treatment-emergent AEs (TEAEs), which were unrelated to study treatment, included hypokalemia, anemia, increased bilirubin, and acute hypoxic respiratory failure. Also not related to UCART22, 3 patients experienced 4 treatment-emergent SAEs: porta-hepatis hematoma, sepsis, bleeding, and sepsis in the context of disease progression. No treatment discontinuations due to a treatment-related TEAE were reported.

The patient who achieved a CR followed by transplant was a 22-year-old male who had undergone 2 prior treatments for B-cell ALL and received UCART22 at a dose of 1 x 105 cells/kg. He did not experience CRS, ICANS, GVHD, nor a SAE, and all TEAEs were grade 1.

Jain also noted that host T-cell constitution was observed in all patients within the DLT observation period. UCART22 was also not detectable through flow cytometry or molecular analysis, the latter of which was at dose level 1 only.

References:

1. Jain N, Roboz GJ, Konopleva M, et al. Preliminary results of BALLI-O1: a phase I study of UCART22 (allogeneic engineered T cells expressing anti-CD22 chimeric antigen receptor) in adult patients with relapsed/refractory anti-CD22+ B-cell acute lymphoblastic leukemia (NCT04150497). Presented at: 2020 ASH Annual Meeting and Exposition; December 4-8, 2020; Virtual. Abstract 163.

2. Benjamin R, Graham C, Yallop D, et al. Preliminary data on safety, cellular kinetics and anti-leukemic activity of UCART19, an allogeneic anti-CD19 CAR T-cell product, in a pool of adult and pediatric patients with high-risk CD19+ relapsed/refractory b-cell acute lymphoblastic leukemia. Blood. 2018;132(suppl 1):896. doi:10.1182/blood-2018-99-111356.

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Early Signs of Activity and Tolerability Found in Allogeneic Product UCART22 for Patients with Relapsed/Refractory CD22+ B-Cell ALL - Cancer Network

As interest in chimeric antigen receptor (CAR) T-cell therapy continues to grow with more promising data coming out and approvals from the FDA in various hematologic malignancies, the role of this cellular therapy has yet to be defined in multiple myeloma, but recent data have inspired hope for this therapy in the relapsed/refractory population.

The B-cell maturation antigen (BCMA)directed CAR T-cell therapy idecabtagene vicleucel (ide-cel; bb2121) has generated excitement in this population following the submission of a Biologics License Application (BLA) in March 2020, seeking approval of ide-cel in patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody, and a Priority Review designation granted in September 2020. Following delays in the review due to coronavirus disease 2019, the Prescription Drug User Fee Act action date has been set as March 27, 2021.

Deep and durable responses were observed with ide-cel as treatment of heavily pretreated patients with relapsed/refractory multiple myeloma, according to updated results from the CRB-401 study presented by Yi Lin, MD, PhD, assistant professor of oncology and associate professor of medicine at Mayo Clinic, during the 2020 American Society of Hematology (ASH) Annual Meeting. The efficacy and safety findings were consistent with prior findings and supported a favorable clinical risk-benefit profile at target dose levels 150 x 106.1

The median overall survival with ide-cel was 34.2 months (95% CI, 19.2-not evaluable) among all patients in this triple-classexposed population, and half of the patients who had ongoing responses achieved a duration of response >2 years. The median progression-free survival (PFS) was 8.8 months (95% CI, 5.9-11.9). The objective response rate (ORR) overall was 75.8%, which included complete responses (CRs) in 38.7%.

These results from CRB-401 are comparable to the findings from the pivotal phase 2 KarMMa study (NCT03361748), which were presented earlier this year during the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program and support the Biologics License Application. The median OS for this study was 19.4 months, and the median PFS was 8.8 months. The ORR was 73%, which included a CR rate of 33%, and the median duration of response was 10.7 months.2

Ide-cel is being explored in several ongoing studies as well, including the phase 2 KarMMa-2 (NCT-3601078), phase 3 KarMMa-3 (NCT03651128), and phase 1 KarMMa-4 (NCT04196491) clinical trials. These phase 2 and 3 studies are evaluating ide-cel in patients with triple-classexposed disease, and the phase 1 study will explore the use of this CAR T-cell therapy in patients with high-risk newly diagnosed multiple myeloma.

These data have also set the stage for other BCMA-directed CAR T-cell therapies in development for the treatment of patients with multiple myeloma.

In an interview with Targeted Oncology, Lin discussed the updated findings from the CRB-401 study of ide-cel as treatment of patients with relapsed/refractory multiple myeloma.

TARGETED ONCOLOGY: What historical data have we seen with BCMA-directed CAR T-cell therapy in patients with relapsed/refractory multiple myeloma?

Lin: With the CAR T approach in multiple myeloma, the very first case report was actually with CD19-targeted CAR T because there was already experience with that particular antigen in leukemia and lymphomas. There's some ongoing effort in terms of dual targeting with CD19 and BCMA, but BCMA very quickly emerged as an ideal candidate for the myeloma space. This is an antigen that is more uniformly expressed on plasma cells, including myeloma cells, and maybe a small subset of mature B cells, but otherwise BCMA is not expressed on healthy tissues.

There have been some single-center clinical trials with the BCMA-targeted CAR T approach prior to the CRB-401 study, both with National Cancer Institute and the University of Pennsylvania with slightly different constructs. With those early phase 1 studies, there was a little bit more toxicity seen, although there was certainly some response, but the response wasn't particularly durable. CRB-401 is the first in a series of now industry-sponsored multicenter studies, in which we are now seeing a much more encouraging durable response rate and also a more favorable side effect profile as well. At ASH this year, I presented the longer follow-up on the phase 1 CRB-401 study. There is a pivotal phase 2 KarMMa study using the same CAR T construct that had been presented at ASCO earlier this year.

TARGETED ONCOLOGY: Please describe the design of the trial and what was different about the study.

Lin: The CRB-401 study has 2 parts. The first part is the dose-escalation part, and the second part is the dose expansion. The dose escalation is basically testing the range of a fixed dose of 50 million all the way up to 800 million of ide-cel CAR T cells in a relatively small number of patients, basically looking for signs of severe side effects to identify a safe dose. The dose expansion cohort is where we take the more promising doses in terms of response, and also safety profile, and test them in more patients to get a better safety signal, which is then moved forward for phase 2 testing in the KarMMa study.

In the dose-expansion portion of CRB-401, we required that each patient must have had exposure to an anti-CD38 antibody. That was allowed in a dose escalation but not required for everybody. [To be included in the study,] the patient must have had become refractory to the most recent line of treatment before they came on the study. The other thing that was different was that in the dose-escalation cohort, all patients had their myeloma cells in the bone marrow reviewed centrally by immunohistochemistry staining, and they were required to have at least 50% of these cells having BCMA expression in a dose-expansion cohort, to better understand the clinical efficacy and safety profiles of this treatment. We also included some patients that had BCMA expression below that to even levels that were not detectable by immunohistochemistry.

TARGETED ONCOLOGY: What were the results from this study?

Lin: The study [included] a total of 62 patients. The results from the first 33 patients were already published in the New England Journal of Medicine last year, and this year at ASH, data were presented for outcomes of the entire 62-patient cohort, with a median follow-up of now 18.1 months. What we have seen so far is in this entire treated patient cohort these are patients with very high-risk features of myeloma, and close to a third of these patients had high-risk cytogenetics, 37% of these patients had extra modularity plasma effect, and almost half of these patients needed some type of systemic therapy while their CAR T cells are being made. These patients, on average, had 6 lines of prior therapy, and in close to 70% or higher, these patients are either triple-refractory or were refractory to the most recent line of therapy.

For this group of patients that was treated overall, the safety signal was very tolerable, which is not surprising with CAR T therapy because these patients also do get lymphodepletion chemotherapy as part of the treatment with CAR T. We do see that low blood count is the most common side effect, including the more severe low blood counts, but on average, the recovery of these blood counts can be seen well under the first 3 months after CAR T infusion. The other most common side effects that we need to watch for with CAR T are cytokine release syndrome (CRS) and neurotoxicity. What we have seen in this study is that, on average, about 76% of these patients had some type of CRS. However, those that had grade 3 or higher, that is only [seen] in 6.5% of the patients, so much lower, and that's also reflected in the relative lower use of tocilizumab and steroids, as well, to manage the side effects. About 35% of these patients had some type of neurologic side effect, but again, only 1 patient had a more severe form of neurotoxicity. Compared to what we have seen with the CAR T experience in the lymphoma/leukemia space, this is a very, very encouraging safety profile.

We have also now seen that the ORR is quite high. It's 75.8% with a CR and stringent CR rate of about 38.7%. Many of these patients that had bone marrow that were evaluable for minimal residual disease (MRD) response were MRD-negative. We are seeing, since we tested many doses, that there is a dose-related increase in response with increasing [the] dose, and we have also seen that the duration of response is 10.3 months. When we look at the dose that was tested as well in those expansions [in] the 150 to 450 range, what we have seen is that the duration of response is comparable, so not significantly decreased, for patients with high-risk features like those with extramedullary disease for older patients, as well as patients who needed to get bridging therapy during treatment. The median PFS is 8.8 months, and the median OS is 34.2 months.

So far, the response rate, duration of response, and PFS seem to be comparable to what we also now see in the KarMMa study, which has less follow-up, but we are seeing a very nice median OS for a treatment in which we're just giving a 1 dose infusion and no follow-up maintenance therapy.

TARGETED ONCOLOGY: In terms of CAR T-cell therapy, how do you see this strategy impacting this patient population in the future?

Lin: I think there's definitely a role for this in the practice. The BLA for ide-cel has been submitted to the FDA, so we're anticipating review sometime in early 2021. This is very exciting because this could very well be the first CAR T for multiple myeloma. I think this would definitely be a treatment option for these patients. Based on how KarMMa is designed, we anticipate that the FDA approval will be in the space of patients who [have] had at least 3 lines of prior therapy and have been exposed to the currently approved 3 main backbones of treatmenta PI, IMiD, and the CD38 antibody. The full detail is pending final FDA review and the label. However, in that space, certainly looking at the demographic of the patient that's been treated so far as CRB-401 and KarMMa, that's a wider group of patients. Based on the fact that this is a treatment that is a basically living active cells, I perceive that the earlier that patient could get this therapy in the earliest possible approved indication, there would likely be potentially more benefit for the patients.

TARGETED ONCOLOGY: Do you think there is hope for this treatment in other hematologic malignancies outside of lymphomas and leukemias as well?

Lin: That is actually a very interesting question because what we're seeing in terms of the severity of CRS and neurotoxicity is a reflection of our evolving learning about how to manage the toxicity, as well. There is a component to the CAR design, the disease, the nature of the disease, the kinetics of the CAR T actions, in the manifestation of these symptoms. What we are seeing now, with even the prior CAR and next-generation CAR coming on, we will likely see an ongoing improvement in terms of a reduction of severity of these symptoms and also in the ways that we could manage these symptoms.

The fact that myeloma would be the next disease that has an FDA-approved CAR T also relates to the fact that the BCMA antigen is more restricted on the cell type where the malignancy is involved, similar to CD19 for lymphoid malignancy. We are seeing that there are some challenges, for example with acute myeloid leukemia or myeloid neoplasms where a number of antigens could overlap with stem cells, which we wouldn't want to try to hurt. There are some novel CAR approaches to try to overcome that, and those are in very early phase testing, so we'll need to see how those results evolve.

References

1. Lin Y, Raje NS, Berdeja JG, et al. Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T cell therapy, in patients with relapsed and refractory multiple myeloma: updated results from phase 1 CRB-401 study. Presented at: 2020 ASH Annual Meeting & Exposition; December 5-8, 2020; Virtual. Abstract 131.

2. Munshi NC, Anderson Jr LD, Jagannath S, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T-cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): Initial KarMMa results.J Clin Oncol. 2020;38(suppl):8503. doi:10.1200/JCO.2020.38.15_suppl.8503

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Updated Findings Show Continued Efficacy for CAR T-Cell Therapy in Heavily Pretreated Myeloma - Targeted Oncology