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New drug for stiff person syndrome granted designation to speed up development: ‘Thrilled for the community’

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New drug for stiff person syndrome granted designation to speed up development: ‘Thrilled for the community’

Patients with stiff person syndrome are one step closer to having access to a new treatment.

Kyverna Therapeutics’ new drug, KYV-101, has been designated by the U.S. Food and Drug Administration (FDA) a Regenerative Medicine Advanced Therapy (RMAT), the company announced on Monday.

A drug is eligible for RMAT designation if it is “intended to treat, modify, reverse or cure a serious or life-threatening disease or condition” and if “preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition,” according to the FDA’s website.

STIFF PERSON SYNDROME PATIENTS SHARE WHAT IT’S LIKE TO LIVE WITH THE RARE DISEASE

One of the benefits of RMAT is that Kyverna will be able to work closely with the FDA to help support accelerated development, review and approval, according to the company.

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The FDA’s decision was based on positive results from clinical trials with patients, a company press release stated.

Carrie Robinette, left, was diagnosed with stiff person syndrome in 2023. The FDA named KYV-101 a Regenerative Medicine Advanced Therapy (RMAT) on Monday. (Carrie Robinette; iStock)

A rare neurological disorder, stiff person syndrome affects only one or two people for every million — including singer Celine Dion.

The disease can have a devastating impact, causing muscle rigidity, pain, spasms and loss of mobility.

LIKE CELINE DION, PENNSYLVANIA MAN IS FIGHTING STIFF PERSON SYNDROME WITH ‘EVERYTHING I HAVE’

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Kyverna Therapeutics, based in Emeryville, California, developed the new CAR-T cell therapy, KYV-101, with the goal of “resetting” the immune systems of patients with autoimmune diseases, according to the company.

“As a physician dedicated to optimizing diagnosis and treatments for patients with autoimmune neurological disorders, I am grateful to be able to witness and contribute to the advancement of treatments and patient outcomes in stiff person syndrome via collaborative research efforts with leading players in the field and the support of the FDA oversight,” Amanda Piquet, M.D., director of the Autoimmune Neurology Program at CU Anschutz Medical Campus in Aurora, Colorado, told Fox News Digital via email.

Céline Dion shared her stiff person syndrome diagnosis with the world in Dec. 2022. (Edward Berthelot/GC Images/Getty Images)

Piquet was not involved in the development of KYV-101, but did take part in one of the medical advisory boards.

Peter Maag, PhD, CEO of Kyverna, also commented on the announcement.

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“This RMAT designation means science agrees that fast-tracking this treatment could save lives.”

“Kyverna is focused on supporting patients and their clinical unmet needs, building patient-centric clinical trials to allow access to the latest medical advances in the CAR-T space for autoimmune disease,” Maag told Fox News Digital in a written statement. 

“We are proud to be able to investigate the potential of safe and effective long-lasting treatment that can lead to meaningful, durable remission for patients suffering from autoimmune diseases like SPS.”

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Patients also reacted to the news with a sense of excitement.

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“From the moment I learned what Kyverna’s treatment had done for the SPS patient in Germany, my dream was that it would get FDA-approved quickly so we could all benefit,” Carrie Robinette, 45, from San Diego, California, told Fox News Digital.

A drug is eligible for RMAT designation if it is “intended to treat, modify, reverse or cure a serious or life-threatening disease or condition” and if “preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition,” according to the FDA’s website. (REUTERS/Andrew Kelly/File photo)

Robinette, a Navy wife and mother, was diagnosed with stiff person syndrome in spring 2023.

“This RMAT designation means science agrees that fast-tracking this treatment could save lives,” she added. “I’m thrilled for the entire autoimmune disease community.”

                                            

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During clinical trials, 50 patients with oncological and autoimmune conditions have been treated with KYV-101 in more than 15 locations in Europe and the U.S., according to the company.

Kyverna will now continue collecting data from the drug’s Phase 2 trials for stiff person syndrome, multiple sclerosis and myasthenia gravis.

Carrie Robinette, 45, from San Diego, California, at left, and Corwyn Wilkey, 44, who lives in Anchorage, Alaska, right, are both living with stiff person syndrome. (Carrie Robinette; Corwyn Wilkey)

Phase 1 and 2 trials are also underway for systemic sclerosis and lupus.

“We are eager to begin generating data from our sponsored trial to advance the knowledge on a potential immunological reset of the patient’s immune system,” Maag said in the company’s release.

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Added Piquet, “Stiff-person syndrome has devastating and life-altering effects on patients suffering from this rare autoimmune disease … I look forward to the data that will emerge from the KYSA-8 trial, as this trial could drastically change the treatment landscape for SPS.”

Fox News Digital reached out to the FDA for additional comment.

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Brain Health Challenge: Test Your Knowledge of Healthy Habits

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Brain Health Challenge: Test Your Knowledge of Healthy Habits

Welcome to the Brain Health Challenge! I’m Dana Smith, a reporter at The New York Times, and I’ll be your guide.

To live a healthy life, it’s crucial to have a healthy brain. In the short term, it keeps you sharp and firing on all cylinders. In the long term, it can reduce your risk of cognitive decline, dementia and stroke.

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Practicing basic healthy behaviors, like eating nutritious food and getting regular exercise, is the best way to enhance your brain power and protect the longevity of your neurons. These types of lifestyle habits can benefit the brain at any age. And while they won’t guarantee that you’ll never develop dementia or another brain disease, several clinical trials have shown that they can improve cognition or slow decline.

Every day this week, you’ll do an activity that’s good for your brain, and we’ll dig into the science behind why it works. Some of these activities can provide a small immediate cognitive benefit, but the bigger reward comes from engaging in them consistently over time. So along with the neuroscience lessons, we’ll include a few tips to help you turn these actions into lasting habits.

To keep you accountable, we’re encouraging you to complete this challenge with a friend. If you don’t have a challenge buddy, no problem: We’re also turning the comments section into one big support group.

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There are so many fascinating ways your daily behaviors affect your brain. Take sleep, for example.

Lots of studies have shown that getting a good night’s rest (seven to eight hours) is associated with better memory and other cognitive abilities. That’s because sleep, especially REM sleep, is when your brain transfers short-term memories — things you learned or experienced during the day — into long-term storage.

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Sleep is also when your brain does its daily housekeeping. While you rest, the brain’s glymphatic system kicks into high gear, clearing out abnormal proteins and other molecular garbage, including the protein amyloid, which is a major contributor to Alzheimer’s disease. A buildup of amyloid is one reason experts think that people who routinely get less sleep have a higher risk of dementia.

What other behaviors play a big role in brain health? For today’s activity, we’re going to test your knowledge with a quiz. Share your score with your accountability partner and in the comments below — I’ll be in there too, cheering you on.

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What your butt shape could reveal about your health, according to scientists

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What your butt shape could reveal about your health, according to scientists

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An often-overlooked part of the body may reveal important clues about overall health.

Researchers from the University of Westminster in the U.K. discovered that the shape of the gluteus maximus muscle in the buttocks changes with age, gender, lifestyle and frailty, as well as certain conditions like osteoporosis and type 2 diabetes.

Using advanced MRI scans that create 3D images, researchers revealed “distinct” patterns in the gluteus maximus associated with type 2 diabetes.

HOW TO AVOID GETTING ‘OFFICE CHAIR BUTT’ FROM PROLONGED SITTING AT WORK

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This suggested that the shape of the muscle, rather than the size, may “reflect underlying metabolic differences,” a press release stated.

The findings were presented in December at the annual meeting of the Radiological Society of North America (RSNA) in Chicago.

Butt shape may indicate underlying health conditions, according to new research. (iStock)

Unlike previous studies looking at muscle size or fat, the 3D imaging identified exactly where the muscle changes occur, according to the researchers.

As one of the largest muscles in the human body, the gluteus maximus “plays a key role” in metabolic health, according to lead study author E. Louise Thomas, Ph.D., professor of metabolic imaging at the University of Westminster’s School of Life Sciences.

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The researchers analyzed more than 61,000 MRI scans from a large UK health database to better understand the muscle’s structure.

The data also included the participants’ physical measurements, demographics, disease biomarkers, medical history and lifestyle habits. The researchers studied how these variables were linked to muscle shape over time.

An infographic from the Radiological Society of North America presentation displays research findings on the shape of the gluteus maximus. (RSNA)

“People with higher fitness, as measured by vigorous physical activity and hand grip strength, had a greater gluteus maximus shape, while aging, frailty and long sitting times were linked to muscle thinning,” study co-author Marjola Thanaj, Ph.D., a senior research fellow at the University of Westminster’s Research Centre for Optimal Health, said in the release.

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The researchers concluded that butt shape changes may indicate an “early functional decline” and “metabolic compromise” in type 2 diabetes patients.

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Men with type 2 diabetes showed muscle shrinkage, while women displayed enlarged muscle, likely due to “infiltration of fat” within it, according to the researchers.

These results suggest that men and women have “very different biological responses to the same disease,” Thanaj suggested.

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Butt shape changes may indicate an “early functional decline” and “metabolic compromise” in type 2 diabetes patients.  (iStock)

Men who were categorized as “frail” were recognized as having more “general shrinkage” across the gluteus maximus, but women experienced a “limited” frailty effect.

Building strong glutes for better health

Strengthening the glutes is an “investment in long-term health,” according to Tanya Becker, co-founder of Physique 57 in New York City.

“While full-body strength training is essential, focusing on your glutes — the largest muscle group in your body — deserves special attention,” she told Fox News Digital.

“While full-body strength training is essential, focusing on your glutes — the largest muscle group in your body — deserves special attention.” (iStock)

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Becker refers to the glutes as the body’s “shock absorbers,” because they protect the lower back, knees and hips from taking on stress they weren’t designed to handle. 

Larger muscle groups also burn more calories and help regulate blood sugar, the expert added, noting that muscles are often referred to as the “organ of longevity.”

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Strengthening the glutes also helps to protect the lower back, hips and knees, and also improves posture and balance, reducing the risk of falls and improving mobility.

“People with higher fitness, as measured by vigorous physical activity and hand grip strength, had a greater gluteus maximus shape.”

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Becker recommends traditional weighted exercises like squats, lunges and bridges, although they are not suited for everyone, especially older adults with injuries and joint pain.

“Pilates and barre classes offer bodyweight exercises that are ideal for beginners or individuals with physical limitations,” she suggested. “They can be done anytime, anywhere, making them accessible for beginners before progressing to weighted versions.”

Glute bridges (demonstrated above) are a recommended exercise for strengthening those muscles. (iStock)

Becker shared the following three glute exercises that improve hip mobility, stability and overall strength.

No. 1: Quadruped leg lifts (strengthens entire core and glutes) 

Start on the hands and knees, engage your core, and lift one leg off the floor (bent or straight). Pulse up and down a few inches for 30 to 60 seconds, then repeat on the other leg.

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No. 2: Clamshells (strengthens gluteus medius)

Lie on your side with knees bent at 90 degrees in front of you. Lift your top knee away from your bottom knee, then lower slowly. 

For an increased challenge, lift both feet off the ground while keeping the heels together. Repeat for 30 to 60 seconds per side.

Strong muscles are responsible for maintaining metabolic health, according to Becker. (iStock)

No. 3: Glute bridges (strengthens lower back and glutes) 

Lie on your back with knees bent and feet parallel, a few inches from your hips. Engage your abs, and squeeze your glutes to lift your hips toward knee height, then lower. 

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If you feel pressure in your neck, you’ve lifted too high. Perform for 30 to 60 seconds. Complete three sets with 30-second rests between them.

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Those looking to start a new fitness routine should first consult with a doctor.

Fox News Digital reached out to the study authors for comment.

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Viral New Year reset routine is helping people adopt healthier habits

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Viral New Year reset routine is helping people adopt healthier habits

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What if your New Year’s resolution could fit inside a tote bag? Social media users are trying the “analog bag” trend, replacing phones with offline activities.

The trend is widely credited to TikTok creator Sierra Campbell, who posted about her own analog bag — containing a crossword book, portable watercolor set, Polaroid camera, planner and knitting supplies — and encouraged followers to make their own. 

Her video prompted many others to share their own versions, with items like magazines, decks of cards, paints, needlepoint and puzzle books.

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“I made a bag of non-digital activities to occupy my hands instead of the phone,” said Campbell, adding that the practice has significantly cut her screen time and filled her life with “creative and communal pursuits that don’t include doom-scrolling.”

“I created the analog bag after learning the only way to change a habit is to replace it with another,” she told Fox News Digital.

Social media users are trying the “analog bag” trend, replacing phones with offline activities like cameras, notebooks and magazines. (Fox News Digital)

The science of healthier habits

Research on habit formation supports the idea of the analog bag, according to Dr. Daniel Amen, a California-based psychiatrist and founder of Amen Clinics. 

“Your brain is a creature of habit,” Amen said during an interview with Fox News Digital. “Neurons that fire together wire together, meaning that every time you repeat a behavior, whether it’s good or bad, you strengthen the neural pathways that make it easier to do it again.”

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Studies show that habits are automatic responses to specific cues — such as boredom, stress or idle time — that typically deliver some kind of reward, according to the doctor. When no alternative behavior is available, people tend to fall back on the same routine, often without realizing it.

Research suggests that replacing an old habit with a new one tied to the same cue is more effective than trying to suppress the behavior altogether.

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“[When] cutting out coffee — you need to have another drink to grab for, not just quit cold turkey. It’s how the pathways in our brains work,” Campbell said.

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By substituting a different routine that still provides stimulation and engagement, people can gradually weaken the original habit and build a new automatic response.

Substituting another activity instead of scrolling on your phone can help quell the impulse to reach for it. (iStock)

“Simply stopping a behavior is very challenging,” Amen said. “Replacing one habit with something that is better for your brain is much easier. That’s how lasting change happens, one step at a time.”

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If alternatives are within arm’s reach, people will be more likely to use them, the doctor said. “Your brain does much better with small, simple actions than big, vague intentions.”

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Instead of saying, “I’ll stop scrolling today,” the doctor recommends choosing a small habit you can do in a few moments in specific situations, like knitting 10 rows of a scarf on your commute or reading a few pages of a book while waiting at the doctor’s office.

“If alternatives are within arm’s reach, you’re more likely to use them,” a brain doctor said. “Your brain does much better with small, simple actions than big, vague intentions.” (iStock)

Campbell shared her own examples of how to use an analog bag. At a coffee shop with friends, she said, she might pull out a crossword puzzle and ask others to help with answers when the conversation lulls.

Instead of taking dozens of photos on her phone, she uses an instant camera, which limits shots and encourages more intentional moments.

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In casual outdoor settings, such as a park or winery, she brings a small watercolor set for a quick creative outlet.

“It’s brought so much joy,” Campbell said of the analog bag trend, “seeing how it resonates with so many.”

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