Health
Experimental ALS drug could offer new hope for patients if approved, researchers say
New hope could be on the horizon for ALS patients in the form of a “breakthrough” drug, researchers say.
Neuvivo, a California biopharmaceutical company that develops therapies for neurodegenerative diseases, is seeking approval for a new medication for ALS (amyotrophic lateral sclerosis).
ALS is a progressive neurodegenerative disease that gradually impairs muscle function, eventually robbing the patient of the ability to walk, talk, eat and even breathe, per the ALS Association.
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This month, Neuvivo submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for NP001 (sodium chlorite infusion).
New hope could be on the horizon for ALS patients in the form of a “breakthrough” drug, researchers say. (iStock)
The drug has been granted orphan drug and fast track designations by the FDA and is eligible for Accelerated Approval and Priority Review, which could shorten the time to a potential approval, according to a press release.
“If approved, NP001 would be the first immunotherapy for ALS, and the first ALS treatment shown to preserve lung function,” Matthew W. Davis, MD, chief medical officer of Neuvivo, told Fox News Digital.
An urgent need
There are currently no FDA-approved treatments for ALS that preserve breathing function or extend life by more than two or three months, the company noted.
The leading cause of death in patients with ALS is loss of lung function (respiratory failure).
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Approximately 30,000 adults in the U.S. are currently living with ALS, and one in 300 people will be diagnosed in their lifetime.
The average life expectancy after a patient is diagnosed with ALS is 18 months.
While existing drugs combat ALS through the nervous system, NP001 would be the first therapy that works by controlling inflammation in the immune system. (iStock)
“Half of the people living with ALS today will unfortunately not likely be living in three years,” Davis said.
Dr. Earnest Lee Murray, a board-certified neurologist at Jackson-Madison County General Hospital in Jackson, Tennessee, confirmed that current ALS treatments are “very limited” in their effectiveness.
A different kind of drug
While existing drugs combat ALS through the nervous system, NP001 — if approved — would be the first therapy that works by controlling inflammation in the immune system.
“NP001 would be indicated for all patients with ALS, although our data supports that patients with inflammation are likely to have significantly greater benefit,” Davis said.
“Half of the people living with ALS today will unfortunately not likely be living in three years.”
Murray, who is not affiliated with Neuvivo, noted that excessive inflammation has been a known factor in the progression of muscle weakness in ALS.
While initial studies of NP001 did not show any “statistically significant” improvement, the neurologist said, “reanalysis of the previous data looked at certain subgroups of patients with particularly high inflammatory markers.”
ALS is a progressive neurodegenerative disease that gradually impairs muscle function, eventually robbing the patient of the ability to walk, talk, eat and even breathe, per the ALS Association. (iStock)
“This data suggests that NP001 can slow progressive loss of muscle function, especially when it comes to a patient’s ability to breathe, by targeting a specific immune system cell called a macrophage,” Murray told Fox News Digital.
“Halting the activation of macrophages oftentimes can have an effect on other immune cells, which will hopefully alter the progression of ALS.”
During the first month of treatment, NP001 is given as a 30-minute infusion each day for five consecutive days. (iStock)
During the first month of treatment, NP001 is given as a 30-minute infusion each day for five consecutive days, according to Davis.
Every month thereafter, the medication is given for three consecutive days in the same way.
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NP001 was “generally well-tolerated” in clinical trials, Davis said.
The most commonly reported side effect was pain, redness and swelling where the drug was infused, which were “generally transitory and mild.”
“This data suggests that NP001 can slow progressive loss of muscle function.”
Murray echoed that early studies have demonstrated that NP001 is safe and well-tolerated.
“I am cautiously optimistic that as NP001 moves though the FDA process of clinical trials, it will show true improvement in ALS patients and offer some hope to patients and families dealing with this devastating disease,” he said.
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As the drug undergoes FDA review, Neuvivo will continue to post updates for patients and caregivers on its website, according to Davis.
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Americans consume foods every day that are marketed as “healthy,” when they could be quietly destroying their health, one doctor warns.
Dr. Mark Hyman, physician and co-founder of Function Health in California, says that much of America’s daily diet is filled with unhealthy ingredients.
“The amount of refined starches and sugars that are everywhere is just staggering to me, given what we know about how harmful they are,” he shared in an interview with Fox News Digital. “I don’t think people really understand.”
Hyman, author of the new book “Food Fix Uncensored,” said he’s “astounded” by what people are eating, especially for breakfast.
“People just eat sugar for breakfast,” he said. “They have muffins, they have bagels, they have croissants, they have sugar-sweetened coffees and teas.”
Dr. Mark Hyman is the author of the new book “Food Fix Uncensored.” (Function Health; Little, Brown Spark)
In addition to the traditionally sweet options for breakfast, some cereal brands and breakfast staples have adopted new “protein-packed” menu items and products, following health trends that encourage eating more protein.
“Highly processed food is not food.”
“Now, we’re seeing this halo of protein in certain things,” Hyman said, mentioning that many protein smoothies are “full of sugar.”
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The doctor also noted that some popular cereals are now marketed as having protein in them. “My joke is, if it has a health claim on the label, it’s definitely bad for you,” he said.
Instead of starting the day with a “quick fix” or processed food, Hyman suggests choosing whole sources of protein and fat for breakfast, adding that “if there’s a little carbohydrate in there, it’s fine.”
More products marketed as “high protein” have cropped up on supermarket shelves. (iStock)
For his own breakfast, Hyman said he has a protein shake with whey protein, avocado and frozen berries. Eggs and avocados are also a great protein-and-fat combo option, he added.
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“It’s not that complicated — people need to just think about their breakfast not being dessert,” he said. “No wonder we’re in this cycle of obesity and diabetes. One in three teenage kids now has type 2 diabetes or pre-diabetes. That’s just criminal.”
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Instead of counting calories and being in a caloric deficit as a way to lose weight and stay healthy, Hyman instead suggests focusing on how certain foods make you feel and how they impact your health.
“When you look at the way in which different types of calories affect your biology, you can just choose what you’re eating, and then you don’t have to worry about how much,” he told Fox News Digital.
In addition to the traditionally sweet options for breakfast, some cereal brands and breakfast staples have adopted new “protein-packed” menu items and products. (iStock)
“For example, if you eat a diet that doesn’t cause your insulin to spike — which is low in starch and sugar, higher in protein and fat — you won’t develop those swings in blood sugar, you won’t develop the spikes in insulin, you won’t deposit hungry fat … You will break that cycle.”
People are more likely to “self-regulate when they eat real food” instead of processed foods, which “bypasses the normal mechanisms of satiety, fullness and brain chemistry,” according to Hyman.
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“Ultraprocessed food and junk food or highly processed food is not food,” he said. “It doesn’t support the health and well-being of an organism. It doesn’t do that. It does the opposite.”
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Small fragments of plastic were found in the tumors of most prostate cancer patients, according to a new study from NYU Langone Health.
In past studies, microplastics have been found in almost every human organ and in bodily fluids, but their impact on human health still isn’t fully understood.
The researchers analyzed tissue samples from 10 patients with prostate cancer who underwent surgery to remove the entire organ.
Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples, according to the study press release.
In past studies, microplastics were found in almost every single human organ along with bodily fluids, even the placenta. (iStock)
The cancerous tissue contained on average more than double the amount of plastic as healthy prostate tissue samples, the study found. This equates to about 40 micrograms of plastic per gram of tissue compared to 16 micrograms.
Researchers avoided contaminating the samples with other plastics by substituting standard tools with those made of aluminum, cotton and other non-plastic material, the release noted.
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The scientists say this is the first direct evidence linking microplastics to prostate cancer.
“By uncovering yet another potential health concern posed by plastic, our findings highlight the need for stricter regulatory measures to limit the public’s exposure to these substances, which are everywhere in the environment,” said senior study author Vittorio Albergamo, assistant professor in the department of pediatrics at NYU Grossman School of Medicine, in the release.
Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples. (iStock)
The study findings were presented during the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco on Feb. 26.
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“What is most striking is not that microplastics were detected, but that they were found embedded within tumor tissue itself,” Dr. David Sidransky, oncologist and medical advisor at SpotitEarly, a startup that offers an at-home breath-based test to detect early-stage cancer, told Fox News Digital.
“While complete avoidance is unrealistic, people can take practical steps to reduce exposure.”
“We already know microplastics are present in water, air, blood and even placental tissue. Their detection in prostate tumors suggests systemic distribution and long-term bioaccumulation,” added Maryland-based Sidransky, who was not involved in the study.
Study limitations
Albergamo cautioned that a larger sample is needed to confirm the findings. Additionally, Sidransky noted that the presence of microplastics alone does not prove they cause cancer.
“Tumors can act as ‘biologic sinks,’ meaning they may accumulate circulating particles simply because of altered vasculature and permeability,” he said.
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A key unanswered question, according to the doctor, is whether microplastics are biologically active in ways that “promote DNA damage, immune modulation or chronic inflammation within the prostate.”
About one in eight men in the U.S. will be diagnosed with prostate cancer at some point in their lifetime, according to the Centers for Disease Control and Prevention.
The most actionable step men can take is appropriate screening and early detection, according to doctors. (iStock)
For those concerned about microplastics, Sidransky offered some insights.
“I believe the appropriate response is curiosity, not panic, and a commitment to understand more,” he said.
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“While complete avoidance is unrealistic, people can take practical steps to reduce exposure, such as minimizing heating food in plastic containers, reducing bottled water consumption when possible, and favoring glass or stainless steel alternatives.”
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The most actionable step men can take, however, is getting appropriate screenings to help ensure early detection, according to the doctor. Screening discussions should be individualized based on age, family history and other risk factors.
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