Health
Children with autism may see speech improvements with off-label prescription drug
An off-label prescription drug has been shown to help some non-verbal children with autism discover the ability to speak.
The drug, leucovorin, is a prescription vitamin that functions similarly to folic acid, helping to restore folate levels in patients who may have difficulty absorbing or using it, according to Katy Dubinsky, a New York pharmacist and the CEO and co-founder of Vitalize, a private supplement company.
“Leucovorin is FDA-approved to reduce the toxic effects of high-dose methotrexate in cancer treatment and to prevent or treat certain types of anemia caused by folate deficiency,” Dubinsky told Fox News Digital.
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While leucovorin isn’t prescribed for the treatment of autism, some families have found that its off-label use has led to significant improvements in autistic children’s communication skills, experts say.
Richard E. Frye, M.D., PhD, a behavioral child neurologist in Arizona, has studied the drug in his research of experimental treatments for children with autism spectrum disorder.
An off-label prescription drug has been shown to help some non-verbal children with autism discover the ability to speak. (iStock)
“Leucovorin is a special form of vitamin B9 that is water-soluble and does not build up in your body,” he told Fox News Digital.
“Folates have been found to be safe long-term for many years and that is why we supplement our food with folate.”
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The main benefit of leucovorin for children with autism is improvement in language, Frye said, but other advantages may include enhanced social function, reduced repetitive behaviors and stronger attention skills.
“Our goal is to get leucovorin approved by the FDA for autism so it can be widely prescribed to children as one of the first treatments once they are diagnosed.”
“We do find that leucovorin helps a substantial number of children with autism,” he said. “Language is one of the most obvious things, so that is what we measured in our clinical trial.”
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News’ senior medical analyst, also spoke to Fox News Digital about why the drug may have this positive impact.
While leucovorin isn’t prescribed for autism treatment, some families have found that its off-label use has led to significant improvements in the communication skills of children with autism. (iStock)
“Central folate deficiency is a lack of folate in the brain, which can interfere with neurological function,” he said. “A high percentage of children with autism spectrum disorder have been found to have antibodies against folic receptor alpha in the brain.”
Leucovorin is converted to folate in the brain by a different pathway, Siegel said.
“Small studies are showing that it improves neurological function and communication skills in kids with ASD, but larger studies need to be done.”
Experts urge caution
The fact that leucovorin has already been used long-term helps to reduce the associated risk, according to doctors.
“One of the advantages of using leucovorin is that it has been used for decades to protect the body from the effects of chemotherapy, so we know what dose to use and any side effects it may produce,” Frye told Fox News Digital.
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However, some children do become “extremely hyperactive,” do not respond to leucovorin and end up needing alternative treatments, the doctor noted.
It’s important for families to work with a medical professional when exploring the use of leucovorin for autism, he advised.
The drug leucovorin is a prescription vitamin that functions similarly to folic acid, helping to restore folate levels in patients who may have difficulty absorbing or using it, according to a pharmacist. (iStock)
“Leucovorin is given at much higher doses than regular vitamins, so it’s very important to work with a doctor knowledgeable in how to prescribe it,” Frye said.
“It is important to test the patient for abnormalities in the folate pathway, such as the folate receptor autoantibody, so we know that they are a candidate for this medication.”
While leucovorin is available in the pharmacy, Frye noted that some children need a compounded form because they are sensitive to some of the additives in commercial products.
“Our goal is to get leucovorin approved by the FDA for autism so it can be widely prescribed to children as one of the first treatments once they are diagnosed,” he said.
Frye pointed out that there is “no magic bullet” for autism, with many children benefiting from a combination of multiple treatments. (iStock)
Dubinsky agreed that physicians may prescribe the “widely used and well-tolerated drug” for autism treatment based on their “clinical judgment and emerging evidence,” but she also stressed the importance of clinical trials.
“While doctors can prescribe leucovorin now, FDA approval would provide stronger medical backing, making it a recognized treatment rather than just an off-label option,” she told Fox News Digital.
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“This could lead to insurance coverage, standardized dosing guidelines and broader acceptance in the medical community.”
Siegel added that leucovorin is a “safe drug” and should be considered for large-scale use based on the findings of recent research.
‘No magic bullet’
Frye pointed out that there is “no magic bullet” for autism, with many children benefiting from a combination of multiple treatments.
“It is unlikely that leucovorin will be used alone — it must be used with behavioral and speech therapy,” he said. “We believe that leucovorin can improve outcomes for these therapies.”
“There is little evidence to suggest that the benefits observed in this individual case can be generalized to the broader autistic community.”
Andy Shih, PhD, chief science officer of Autism Speaks in New York, noted that every child’s experience with autism is unique.
“There is little evidence to suggest that the benefits observed in this individual case can be generalized to the broader autistic community,” he told Fox News Digital.
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“While some small studies have explored leucovorin as a potential treatment for people with autism, larger controlled clinical trials are needed to determine its efficacy and safety. We urge families to consult with their doctors before considering off-label treatments.”
Dubinsky added that if larger studies confirm leucovorin’s effectiveness, it could become a more accessible treatment for children with autism who may benefit from it.
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A new injectable therapy is showing positive results in reducing melanoma throughout a five-year period.
The personalized mRNA cancer therapy, called intismeran autogene, combined with the cancer immunotherapy drug KEYTRUDA (pembrolizumab), is a collaboration between Merck and Moderna.
The results from the phase 2b KEYNOTE-942 study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on May 27.
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After about a five-year follow-up, the combo drug was found to reduce the risk of melanoma recurrence or death by 49% compared to pembrolizumab alone.
The researchers analyzed data from 157 patients with high-risk stage 3 and 4 melanoma whose cancer had been removed via surgery. The participants were split into two groups — one received the combo therapy and the other only received pembrolizumab, according to a press release.
The therapy was found to reduce the risk of melanoma recurrence or death by 49% compared to pembrolizumab alone after a five-year follow-up. (iStock)
The findings revealed that the combination group saw benefits that were “sustained and durable over time.”
Intismeran autogene is designed using mutations identified in a patient’s own tumor, with the intention of teaching the immune system what the cancer looks like so that it can recognize and attack it.
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According to the researchers, intismeran is “well-tolerated” with a “manageable” safety profile.
The most commonly cited side effects of the personalized mRNA vaccine plus KEYTRUDA were fatigue, injection-site pain, chills, fever and headache. The researchers reported no new long-term safety concerns and no severe vaccine-related adverse events.
The combination therapy is currently being evaluated in a phase 3 study — the final confirmation stage.
Patients with late-stage melanoma have a “significant risk” of cancer recurrence, according to an expert. (iStock)
In a Merck press release from January, Kyle Holen, MD, Moderna’s senior vice president and head of development, oncology and therapeutics, noted that this data highlights the “potential of a prolonged benefit … in patients with resected high-risk melanoma.”
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“We continue to invest in our platform in oncology because of encouraging outcomes like these, which illustrate mRNA’s potential in cancer care,” he said.
Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, also commented that for many patients with stage 3 or 4 melanoma, there is a “significant risk of recurrence following surgery.”
Researchers confirmed that the combination therapy is currently being evaluated in a phase 3 study. (iStock)
“As such, demonstrating the longer-term potential of intismeran autogene and KEYTRUDA to reduce the risk of recurrence for certain patients with melanoma is a meaningful milestone,” she said.
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The company cited encouraging five-year follow-up data and pointed to upcoming late-stage INTerpath trial results with Moderna in several hard-to-treat cancers.
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An accidental lab discovery has opened the door to entirely new ways of preventing the flu.
While investigating how influenza replicates, researchers discovered that different flu strains use completely different strategies to infiltrate human cells, SWNS reported.
By targeting the specific molecules the viruses rely on, scientists found that they could block them from entering new cells and halt their replication altogether.
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Researchers say these “fundamental insights” into seasonal influenza highlight a clear path toward developing better preventive medications.
“The hope is that fundamental, curiosity-based research like this helps to pave the way for novel strategies to treat and prevent influenza infections,” principal investigator Dr. Emily Bruce, from the University of Vermont’s Larner College of Medicine, said in the SWNS report.
While investigating how influenza replicates, researchers discovered that different flu strains use completely different strategies to infiltrate human cells. (iStock)
While several flu strains cause illness, H1N1 and H3N2 influenza A viruses are the most common. However, current flu tests cannot differentiate between them, and clinical treatments are identical for both.
Although vaccines and antivirals are available, Bruce noted a “dire” need for better medications to stop the virus from spreading cell to xxcell.
“You don’t get sick when a virus is in one cell,” he noted. “You get sick because a virus replicates itself and goes into many more cells.”
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The study, which was published in The Journal of Virology, originally aimed to map how viral RNA segments are transported within cells to create new viral particles.
The team used H1N1 and H3N2 viruses isolated from the nasal passages of positive patients in 2022.
Clinical treatments remain identical for both primary strains of the flu virus. (iStock)
During the investigation, the team unexpectedly stumbled upon a cellular pathway that blocked the virus from entering lung cells, SWNS reported.
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The data revealed that when a specific human protein called Rab11B was depleted, H3N2 viruses failed to enter human lung cells. H1N1 viruses were completely unaffected.
Using reverse genetics, the team mapped this defect and uncovered a brand-new, H3N2-specific role for Rab11B during viral entry.
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This discovery challenged the scientific assumption that all flu viruses enter cells the same way.
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“Viruses are like pirates from different countries hijacking someone’s ship,” Bruce said. “Different viruses, like different types of pirates, use different methods to get onboard.”
This discovery challenged the scientific assumption that all flu viruses enter cells the same way. (iStock)
“We had previously thought that all flu viruses used the same way to get into a cell, but we discovered that this is not true,” she went on. “H1N1 and H3N2 need different proteins to get in, and if you get rid of the right protein, a specific virus can’t get in.”
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While these findings identify a critical cellular pathway for viral entry, the study was conducted using isolated cells, the researchers acknowledged.
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Further research is needed to determine whether blocking the protein is safe and effective within a live, complex human respiratory system.
Bruce and the team hope to conduct further research to determine whether this Rab11B-dependency is a fundamental property of H3N2, or if it’s a trait unique to currently circulating flu strains.
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Eating processed meat like ham, sausage and bacon may be linked to a higher risk of certain types of cancer, according to new research.
While health organizations have already confirmed that processed meat can contribute to colon cancer, this study looked closer at cancers in the upper digestive tract, where the link has historically been less clear.
To understand these connections, researchers from the European Prospective Investigation into Cancer and Nutrition (EPIC), one of the world’s largest long-term nutrition and cancer cohorts, tracked the health and diets of 450,112 people across Europe for an average of 14 years.
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The study group included 131,426 men and 318,686 women, according to the study’s press release.
During the follow-up period, 876 people developed stomach cancer and 215 people developed esophageal adenocarcinoma, which is cancer of the tube connecting the mouth to the stomach.
For female participants, eating both processed meat and white meat was linked to an increased risk of developing the disease. (iStock)
Researchers tracked where the stomach cancers grew, separating them into the upper part of the stomach near the throat and the lower part of the stomach.
The researchers also sorted the tumors into two categories based on how the cancer cells appeared under a microscope: intestinal, which forms more organized structures, and diffuse, in which the cells are more scattered throughout the tissue.
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After adjusting for other lifestyle factors, the researchers found that for every extra 30 grams of processed meat a person ate per day, their overall risk of stomach cancer went up by 9%. Eating that same extra 30 grams a day was also linked to a 13% higher risk of esophageal adenocarcinoma.
A standard single slice of regular deli-sliced ham or lunch meat averages around 28 grams, according to USDA data and nutritional tracking databases.
An extra 20 grams of white meat, such as chicken and turkey, was linked to a 12% higher risk of cancer in the main body of the stomach. (iStock)
An extra 20 grams of white meat, such as chicken or turkey, was linked to a 12% higher risk of cancer in the main body of the stomach, the researchers noted.
The study also revealed differences between men and women. For male participants, only processed meat showed a clear, statistically significant link to a higher risk of stomach cancer. For female participants, however, eating both processed meat and white meat was linked to an increased risk.
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These findings align with global health benchmarks, particularly those established by the World Health Organization’s International Agency for Research on Cancer.
The agency has long classified processed meat as a known human carcinogen, primarily due to its strong, well-documented links to colorectal cancer.
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However, health organizations have also consistently pointed to a potential, yet less definitive, relationship between these meats and cancers of the stomach.
Eating 30 grams of processed meat a day, or the equivalent to one slice of ham, was linked to a 13% higher risk of esophageal adenocarcinoma. (iStock)
Further scientific investigation is needed to confirm the findings and to account for other underlying risk factors, such as certain stomach infections, which could interact with dietary habits.
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A key limitation of the study is its reliance on self-reported diets, which can sometimes lead to inaccuracies in how participants recall their meat consumption over time, the researchers noted.
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The findings were published in the International Journal of Cancer.
Fox News Digital reached out to the researchers requesting comment.
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