Researchers may have hit “gold” when it comes to the treatment of multiple sclerosis.

An experimental medication called CNM-Au8 — a drinkable liquid with gold nanocrystals — has shown promising results in clinical trials in terms of improvements in MS symptoms.

The “catalytically active” liquid, developed by Clene Nanomedicine in North East, Maryland, can cross the blood-brain barrier to help improve cellular energy and restore neurological function, according to researchers.

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Doctors at the University of Sydney presented the Phase 2 clinical trial findings at the American Academy of Neurology’s annual meeting earlier in April 2024.

The clinical trials included 78 patients who had relapsing multiple sclerosis. 

The gold liquid suspension was found to have a “profound clinical benefit,” with the patients experiencing physical improvements not achieved in prior trials.

A need for new MS drugs

Multiple sclerosis is an autoimmune disease of the central nervous system, brain, spinal cord and optic nerve.

In people with MS, white cells called lymphocytes infiltrate the central nervous system and trigger inflammation.

That often causes them to feel off balance or lose their vision, according to Dr. Robert C. Sergott, chief of the neuro-ophthalmology service at Wills Eye Hospital and professor of ophthalmology, neurology and neurosurgery at Sidney Kimmel Medical College in Philadelphia.

The MS medications that are currently available work by addressing inflammation — but there is a subset of patients that continue to experience symptoms even without inflammation, he said. This is a condition called progression independent of relapse activity (PIRA).

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“This is a non-inflammatory component of the disease, where patients would worsen in vision and cognitive abilities,” Sergott, who was involved in the clinical trial for CNM-Au8, told Fox News Digital.

Researchers suspected that something to do with mitochondria — parts of cells that are responsible for supplying those cells with energy — was causing these patients’ symptoms.

“The theory was that if we could give the mitochondria an extra boost, the neurons, axons and other cells in the central nervous system may work better,” said Sergott.

The “catalytically active” liquid can cross the blood-brain barrier to help improve cellular energy and restore neurological function, according to researchers. (Clene Nanomedicine)

“In other words, maybe these cells aren’t dead, but they’re hibernating.”

Gold nanoparticles were originally used to treat rheumatoid arthritis many years ago, according to Sergott.

“Clene innovated a novel electrochemical method to make gold particles and [got] them to a very highly purified nanoparticle state — into very small particles, so they can get through the blood-brain barrier to the cells that need it to work better.”

‘Significant result’

Among the 78 participants in the randomized clinical trial performed in Australia, two-thirds of them received the gold treatment and the other third received a placebo over a three-year period.

“We had hoped to enroll more patients, but COVID intervened,” Sergott said.

Neither the patients nor the neurologist overseeing the trial knew who was receiving the actual medicine.

“We’re very encouraged and ready to take the next step. It’s going to help a lot of people.”

“Patients saw a clinical improvement in the function of their vision and their cognitive ability,” Sergott reported.

Doctors also noted an improvement in the electrophysiology, he said — “the patients’ MRIs looked better, which is a special measure.”

“The theory was that if we could give the mitochondria an extra boost, the neurons, axons and other cells in the central nervous system may work better,” a doctor said. (iStock)

The patients who received the medicine had no decline in retinal thickness, but those on the placebo did see a decline, he said.

“This was a very significant result, and gives us a lot of hope that we may be able to help patients who have deficits from MS and have had progression independent of relapse activity — or maybe they had an attack and didn’t get complete recovery from it,” Sergott said.

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None of the trial participants reported any adverse side effects, he said.

“The safety profile is excellent,” Sergott told Fox News Digital. “I can’t say this doesn’t have any side effects — but no patients discontinued the trial because of a side effect that was significant.”

None of the trial participants reported any adverse side effects from the gold treatment, the researchers said. (iStock)

With the successful Phase 2 trials complete, researchers are now looking ahead to Phase 3 trials.

“We’re very encouraged and we’re ready to take the next step,” said Sergott. “It’s really going to help a lot of people.”

Patients taking CNM-Au8 would still need to continue with the standard regimen of anti-inflammatory medications, the doctor noted.

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Looking ahead, there is the potential for the “liquid gold” medication to help treat symptoms of other neurological disorders, including amyotrophic lateral sclerosis (ALS), Alzheimer’s and Parkinson’s, according to Sergott — but the focus is on MS for now.

“We don’t want to get too far ahead of ourselves, but there is plenty of information to support trying this in other diseases.”

Patient shares his experience 

Damian Kunko of Arlington, Virginia, was one of the MS patients who participated in the trial. He had previously taken disease-modifying therapies that included Zeposia and Tecfidera. 

“These drugs reduced the risk of relapse, but had no effect on progressive symptom worsening,” Kunko told Fox News Digital.

Damian Kunko of Arlington, Virginia, was one of the MS patients who participated in the trial. (Clene Nanomedicine)

Kunko’s primary symptoms included heat intolerance, foot drop/limping, numbness, balance issues, double vision and minor decline of cognitive function and energy.

After four months of taking CNM-Au8, Kunko found that his walking speed was 14% faster.  

“I was also able to do short 5-10-yard jogs without falling, which was impossible prior to taking [the drug],” he said.

“The best ‘side effect’ was knowing that this drug will fix my MS issues.”

“I also experienced improved visual acuity, less severe double vision, zero cognitive fog issues and increased energy levels.”

Later in the trial, Kunko was able to withstand high heat and humidity for several hours and did not experience any double vision, foot drop, excessive numbness or fatigue issues. 

“It was nice to be able to go up and down stairs without having to hold the railing,” he said. 

Clinical improvements were seen in both the visual system and on patients’ MRI scans, according to doctors. (iStock)

The patient said he did not experience any negative side effects or adverse reactions.  

“The best ‘side effect’ was knowing that this drug will fix my MS issues,” Kunko said.

“I am very disappointed that this therapy is not yet commercially available for those who need to restore function and alleviate MS symptoms,” he added. 

Doctors weigh in

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, was not involved in the drug’s development but commented on the potential of gold therapies.

“Gold-containing analogies have long been treatments for rheumatoid arthritis — what is known as disease-modifying anti-rheumatic drugs,” he told Fox News Digital.

“And now gold-containing agents are being studied in MS and ALS.”

While the latest study is small, Siegel said, it “looks promising in terms of modifying disease and improving thinking and vision, which can be affected in the early stages of MS.”

He added, “More research with larger numbers needs to be done to be conclusive.” 

“Gold-containing analogies have long been treatments for rheumatoid arthritis — what is known as disease-modifying anti-rheumatic drugs,” one doctor told Fox News Digital. (Clene Nanomedicine)

Dr. James Kuo, vice president of R&D at Silo Pharma in New Jersey, was also not involved in the drug’s development but said the trial results are “encouraging.”

“These new long-term results from the Phase 2 clinical trial support the therapeutic hypothesis that CNM-Au8 is remyelinating nerve cells in MS patients,” Kuo told Fox News Digital. 

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“What is further encouraging is that both the primary and secondary endpoints showed continued improvement,” he added. “There was physiological enhancement in the visual neural pathway, a biomarker of nerve health. Further MRI measurements support remyelination occurring.”

“If further clinical data supports these initial findings, MS patients could well have a new, well-tolerated oral therapy that is not based upon immune system modulation.”

Ensuring proper dosing, monitoring patients for potential side effects and following proper follow-up protocols are “essential aspects” of bringing this therapy into clinical practice, a doctor said. (iStock)

Dr. Sameea Husain Wilson, director of movement disorder neurology at Marcus Neuroscience Institute, at Boca Raton Regional Hospital in Florida, said that CNM-Au8 offers hope for patients and their families.

“It shows promise in the possibility of slowing disease progression, improving symptoms and enhancing quality of life,” he told Fox News Digital in a statement.

Wilson noted, however, that it is important to “approach the drug development cautiously and be aware of potential risks.”

“The complexity of neurodegenerative diseases necessitates a comprehensive understanding of individual patient profiles,” he said. 

“It’s essential to recognize that not all patients may respond uniformly to treatment, and factors such as disease stage, comorbidities and genetic predispositions may influence outcomes.”

Ensuring proper dosing, monitoring patients for potential side effects and following proper follow-up protocols are “essential aspects” of bringing this therapy into clinical practice, Wilson added.

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It is the biggest change to abortion access since the period immediately after the reversal of Roe v. Wade in 2022.

“This is a seismic event for everyone in the ecosystem,” said Jenny Black, the chief executive of Planned Parenthood South Atlantic, which operates in North Carolina, South Carolina, Virginia and West Virginia. “It is impossible to overstate the impact of this ban on abortion access in the whole Southeast, probably all up the Eastern Seaboard.”

Florida, unlike much of the South, has long had many abortion clinics — more than 50, spread throughout the state. The average Florida woman lives less than 20 miles from one. Last year, clinics in Florida provided around 86,000 abortions, behind only California, New York and Illinois, according to estimates from the Guttmacher Institute.

Of those, more than 9,000 were for patients who came from other states, part of an influx after many Southern states banned or severely restricted abortion following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.

With few exceptions, women across the South who are beyond six weeks of pregnancy — before many women know they’re pregnant — will now have to travel much farther to a clinic for an abortion. Also, for around a decade, Florida has required two appointments 24 hours apart to get an abortion, making it harder to receive one before the six-week mark. In other states, six-week bans have decreased abortions by about half.

“We’re hopeful that not only will the numbers in Florida for abortions take a deep nosedive, but also it does have national implications,” said Andrew Shirvell, the founder and executive director of Florida Voice for the Unborn, a group that lobbied the Legislature for the ban. Gov. Ron DeSantis, a Republican, has said he does not want the state to remain an “abortion tourism destination.”

Despite bans in 14 states, and restrictions in several others, the number of legal abortions nationwide is about the same as before Roe was overturned. Florida’s new ban could change that, researchers said — an illustration of how regional abortion access has become. Shutting down abortion access in one linchpin state, Florida, could reduce the number of abortions across the entire region, while in swaths of the rest of the country, abortion has remained accessible, and in some places has even become more so.

The maps above show how the distances to the nearest clinic have increased for women in the South who are more than six weeks pregnant, based on data from Caitlin Myers, a professor of economics at Middlebury College, who has been measuring the effects of abortion bans for years.

Women in Miami who are beyond six weeks will now need to travel more than 700 miles to reach the nearest clinics — in Charlotte, N.C., where state law requires two visits spread over three days. The current wait time there is a week or more to get an appointment, according to a recent survey of clinics led by Professor Myers. Otherwise, women would need to travel farther, to clinics in Virginia or Washington, D.C.

Driving distances would also increase by more than 100 miles for women in parts of Alabama, Georgia, Louisiana and Mississippi.

“This is going to be the biggest change to abortion access since Dobbs, and the impact is clear: More people are going to have to travel further distances if they have the financial resources to do so, and many people will be forced to remain pregnant,” said Stephanie Loraine Piñeiro, executive director of Florida Access Network, which helps women in Florida pay for abortions and travel to clinics.

Clinic operators in North Carolina and Virginia say they are trying to expand capacity, but are already struggling to meet demand. Several clinics in those states are already reporting waits of two weeks for appointments, according to Professor Myers’s survey and interviews with clinic staffers.

Decades of research show that, as driving distances to abortion clinics increase, fewer women obtain abortions. The typical seeker of an abortion is poor, and often struggles to arrange transportation, time off from work, housing and child care to travel long distances.

Yet there is uncertainty about the precise long-term effects of the ban. The same day the Florida Supreme Court allowed the six-week limit to go into effect, it also allowed a constitutional amendment on abortion to appear on the November ballot. If the amendment earns the support of 60 percent of voters, it will reverse the ban and protect abortion rights until about 24 weeks.

And in recent months, more women have been ordering abortion pills through telemedicine. This includes women in states with bans, who order from clinicians in states with laws that shield them from out-of-state prosecution.

Such abortions could become more common in the South. But some women are unaware of the option or uncomfortable managing an abortion without a nearby medical provider. Others are too far along in their pregnancies for the option — abortion pills are recommended by the Food and Drug Administration only during the first 10 weeks of pregnancy.

As a result, telemedicine is unlikely to replace all the abortions currently occurring in Florida. “I don’t think it means that everybody just perfectly substitutes it for traveling to a brick and mortar facility and seeing a provider in person,” Professor Myers said.

For members of the so-called “sandwich generation,” doing double-duty caregiving can take a toll.

Serving as a caregiver for a parent with dementia while also caring for kids and maintaining social and work relationships can come with physical, mental and emotional challenges, several experts expressed to Fox News Digital. 

It can be especially difficult dealing with the role reversal, experts say.

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“The role of a parent is someone to look up to, respect and listen to,” Dr. Nancy Frye, PhD, a professor of psychology at Long Island University Post Campus in Brookville, New York, told Fox News Digital.

When a parent is in cognitive decline, questions arise about how to step out of traditional parent-child roles, she said, with “no clear norms or guidelines.”

“People have lived their lives looking up to their parents, turning to them for advice, and respecting their privacy and autonomy,” Frye continued. 

“Now, they find themselves poking around in their parents’ affairs and wondering when to start making decisions for them.”

Stress of the ‘sandwich generation’

“Sandwich generation” caregivers — those who are tasked with taking care of multiple generations, such as parents and children, simultaneously — reported significantly higher levels of personal burnout compared to those who care solely for children, according to a 2023 study published in the International Journal of Aging & Human Development.

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One middle-aged caregiver from Long Island, New York, who asked to withhold her name, told Fox News Digital she can barely find time to take a shower when taking care of her mother with dementia. 

“How can I find time to go for a walk or coffee with friends when I am afraid she will wander or fall?” she asked.

Those who are tasked with caring for members of multiple generations reported significantly higher levels of personal burnout compared to those who care solely for children. (iStock)

To avoid caregiver burnout when taking care of a parent who is dealing with an illness such as dementia, health experts said it is important to carve out time for yourself.

“Caring for a person with dementia can be very stressful,” Frye said. “In order to take care of somebody else, you need to take care of yourself. It is OK to take a break.”

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Dr. Marc L. Gordon, chief of neurology at Zucker Hillside Hospital Northwell Health on Long Island, New York, said caregivers should not hesitate to rely on others.

“It is important to find time for respite, and to ask for help rather than trying to do it all by yourself.”

He added, “Just like they tell you on an airplane, in case of an emergency, you should put on your own oxygen mask before attempting to assist others.”

“How can I find time to go for a walk or coffee with friends when I am afraid she will wander or fall?”

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Darci Henry, a certified dementia practitioner and licensed nursing home administrator with Trualta — a Canadian company that provides online support and education for caregivers — said caregivers experience a range of emotions, all which are valid.

Henry emphasized to Fox News Digital the importance of delegating responsibilities to other family members and outsourcing tasks. 

There are approximately 53 million caregivers in the U.S. as of 2020, a jump from 43.5 million in 2015, according to the Centers for Disease Control and Prevention (CDC). (iStock)

This may mean using community resources, such as meal prep, grocery delivery and laundry services.

“Reaching out and getting that extra layer of support is really important for your own preservation,” Henry said. 

“Taking time for self-care is not selfish. It’s necessary.”

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Even for those who cannot leave the house, Henry suggested taking “micro moments.” 

“It can be something as small as taking a few deep breaths, doing some stretching, standing outside on your porch or just enjoying a cup of coffee,” she said.

When it comes to speaking with children about their grandparent’s condition, an expert said knowledge is power.  (iStock)

It is also important to carve out time for family relationships and daily check-ins with spouses or partners, according to Henry. 

That could include going for a walk after dinner, having regular family meetings and discussing the division of responsibilities. 

Navigating difficult discussions

“If there are underlying issues in the family, you’re definitely going to see them come up once the caregiving role starts,” Henry said. 

People should seek professional help if the strain of caregiving is affecting the relationship, she advised.

“Many families have someone from the outside come in and mediate the meetings.”

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Having an outside perspective can help “provide a different lens” for the conversation and make sure everyone is heard, Henry noted. 

While communicating, she said it’s key to be respectful and understand limitations and expectations.

“Try to take things as they come, moment by moment,” said one expert. “Focus on a parent having a good or a bad hour or day, as opposed to the parent improving or declining quickly.” (iStock)

When it comes to speaking with children about their grandparent’s condition, Henry said knowledge is power. 

“The more you can educate the teenager or young adult about what is happening, the more empathy they may have about the situation.”

“If there are underlying issues in the family, you’re definitely going to see them come up once the caregiving role starts.”

To help deal with the mood swings often associated with dementia, Henry suggested adhering to a stable routine as much as possible and developing strategies to identify and prevent triggers for certain behaviors.

“Educating yourself on what is happening in that person’s brain is really important, because that will help you understand that they are not giving you a hard time, they’re having a hard time,” Henry said.

‘One day at a time’

It’s best to embrace a “one-day-at a time” mindset, Frye suggested.  

“It’s tempting to take a parent’s state and behavior — whether it’s good or bad — as an indication of what’s to come,” she said.

To help deal with the mood swings that are often associated with dementia, an expert suggested adhering to a stable routine as much as possible and developing strategies to identify and prevent triggers. (iStock)

“Try to take things as they come, moment by moment. Focus on a parent having a good or a bad hour or day, as opposed to the parent improving or declining quickly,” Frye suggested.

Continuing to give a parent as much say and autonomy as possible can be helpful, she added — as long as it’s safe.

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“Decades ago, Ellen Langer did a study in which people in a nursing home were given a plant and told either that they needed to care for it, or that the staff would care for it,” Frye said.

“Those who were tasked with caring for their own plants lived longer.”

There are approximately 53 million caregivers in the U.S. as of 2020.

That’s a jump from 43.5 million in 2015, according to the Centers for Disease Control and Prevention.

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