Health
Father created a drug to save his son from a rare disease, now other families are desperate to get it
When his infant son was diagnosed with a rare, fatal disease, a Canadian father was dismayed to discover there was no treatment or cure. So he set out to make one himself.
Terry Pirovolakis, an IT director in Toronto, Ontario, welcomed his third son in Dec. 2017. It was a “normal, healthy birth,” he told Fox News Digital — but within six months, he and his wife, Georgia Pirovolakis, noticed their baby, Michael, was not lifting his head.
“He just didn’t seem like he was meeting his milestones,” Pirovolakis said.
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After months of doctors’ appointments, physiotherapy and genetic testing — what Pirovolakis describes as an “18-month diagnostic odyssey” — a neurologist diagnosed baby Michael with spastic paraplegia 50 (SPG50), a neurological disorder that affects fewer than 100 people in the world.
“They told us to just go home and love him — and said he would be paralyzed from the waist down by age 10, and quadriplegic by age 20,” Pirovolakis said.
When Michael Pirovolakis, pictured. was diagnosed with a rare, fatal disease as an infant, his father, Terry Pirovolakis, was dismayed to discover there was no treatment or cure. That’s when he set out to make one himself. (Terry Pirovolakis)
“They said he’d never walk or talk, and would need support for the rest of his life.”
What is SPG50?
Spastic paraplegia 50 (SPG50) is a neurological disorder that affects a child’s development, gradually leading to cognitive impairment, muscle weakness, speech impairment and paralysis, according to the National Organization for Rare Disorders.
Most people with the disease will die by the time they reach their 20s.
“Children with SPG50 may experience early developmental delays, muscle weakness and spasticity, but they continue to strive and adapt,” Dr. Eve Elizabeth Penney, an epidemiologist at the Texas Department of State Health Services and medical contributor for Drugwatch, told Fox News Digital.
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“Over time, these symptoms can worsen, making it hard for affected individuals to walk and perform daily activities,” added Penney, who was not involved in Michael Pirovolakis’ care.
“The prognosis varies from person to person, but it’s generally a progressive condition, meaning symptoms can become more severe over time,” she also said.
Georgia Pirovolakis (left) is pictured with her two sons, including baby Michael, who was diagnosed with SPG50. (Terry Pirovolakis)
In the absence of a cure, most families can only manage symptoms through physical therapy, occupational therapy, speech therapy and medications to help control spasticity or seizures, Penney said.
“Managing SPG50 requires a comprehensive, multidisciplinary approach to address its various symptoms and challenges,” she added.
A father’s mission
There is no treatment currently approved by the U.S. Food and Drug Administration (FDA) for SPG50.
After the shock of the diagnosis, Pirovolakis immediately started researching, with a focus on finding a gene therapy that could help his son.
“They said he would be paralyzed from the waist down by age 10, and quadriplegic by age 20.”
A month after his baby’s diagnosis, Pirovolakis flew to Washington, D.C., for a gene therapy conference, where he met with several experts. He also visited Sheffield, England, and the National Institutes of Health at the University of Cambridge, where scientists had been studying the disease.
“We then liquidated our life savings, refinanced our home and paid a team at the University of Texas Southwestern Medical Center to create a proof of concept to start Michael’s gene therapy,” Pirovolakis said.
Terry Pirovolakis, pictured with his family, used his life savings to create a genetic therapy for his youngest son, center, who has SPG50. (Terry Pirovolakis)
After successful tests showed the gene therapy was effective at stopping the disease’s progression in mice and in human cells, Pirovolakis worked with a small drug company in Spain to manufacture the drug.
On Dec. 30, 2021, Health Canada granted approval to move forward with the gene therapy for Michael Pirovolakis.
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“On March 24, 2022, my son was the first person to ever get treated with gene therapy at SickKids in Toronto,” Pirovolakis said.
The procedure, which involves injecting cerebral spinal fluid through a lumbar puncture, does come with risks — but the potential benefits are life-saving.
‘I couldn’t let them die’
After Michael Pirovolakis received the one-time treatment, there were three more doses left.
“We decided that we had to help other kids,” Pirovolakis said.
“When I heard that no one was going to do anything about it, I had to — I couldn’t let them die.”
Pirovolakis’ two older children, pictured with their little brother, Michael, bottom left, do not have the disease. (Terry Pirovolakis)
Pirovolakis opened up a Phase 2 study in the U.S., which treated three children two years ago.
One of those was 6-month-old Jack Lockard, the youngest child to ever receive the treatment.
“Jack has thrived since then,” Rebekah Lockard, the boy’s mother, told Fox News Digital.
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“He is sitting independently, banging toys together, drinking from a straw cup and working really hard on crawling.”
She added, “Doctors and therapists share the same sentiment: The treatment works!”
Other children who participated in the trial have experienced similar results, Lockard said.
The Lockard family, shown here, is fighting to raise funds to obtain treatment for their daughter Naomi, at right, who has SPG50. (Rebekah Lockard)
“They’ve all shown that their disease has stopped progressing and their cognition has improved.”
There are more children who still need the treatment — including Lockard’s first child, 3-year-old Naomi, who also has SPG50 — but are unable to access it because the clinical trial has now run out of money, as Fox News Digital previously reported.
‘Time is of the essence’
It costs about $1 million to make the drug for each child, Pirovolakis said, and another $300,000 or so to treat the patient in the U.S. at the hospital.
Pirovolakis has approached pharmaceutical companies, but all of them have declined to manufacture the drug.
“We want to make sure the trial moves on and these kids get treated.”
“No investor is going to give you money to treat a disease that is not going to make money,” he said. “That’s the dilemma we’re in.”
While Pirovolakis and his team are actively working to secure grants and investors, it’s largely up to the parents to raise funds for the next phase of the clinical trial.
So far, Lockard has raised more than $90,000 via GoFundMe (called “Naomi and Jack Battle SPG50”) to get her daughter’s treatment, but that is only a fraction of what is needed. (Rebekah Lockard)
So far, Lockard has raised more than $90,000 via GoFundMe (called “Naomi and Jack Battle SPG50”) to get her daughter’s treatment, but that is only a fraction of what is needed.
Penney noted that treatment for SPG50 is challenging and expensive to develop — “mainly because it’s a sporadic disease.”
The doctor told Fox News Digital, “Pharmaceutical companies often prioritize conditions that affect larger populations, with a more significant potential for recouping research and development costs.”
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“The market is much smaller for rare diseases like SPG50, making it financially less viable for companies to invest in creating a treatment.”
To devote himself to the cause, Pirovolakis quit his job and started a nonprofit in California, which now has five employees and 20 consultants.
The company — called Elpida Therapeutics, after the Greek word for “hope” — will run a Phase 3 study for SPG50 at the NIH in November.
Terry Pirovolakis, second from left, is pictured with members of his team at his nonprofit, Elpida Therapeutics. Elpida Therapeutics has partnered with the Columbus Children’s Foundation (Fundación Columbus in Spain) and CureSPG50 to help save children with the disease. (Pirovolakis)
Without the backing of major drug companies, however, there isn’t funding available to get the therapies to the children who need them.
Eight doses of the drug for SPG50 were produced in Spain and have been flown to the U.S.
“The treatment is here, just literally sitting in a refrigerator, ready to go,” Lockard said. “Doctors are ready. There just isn’t enough money to make it happen.”
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There are currently four families in the U.S. who are trying to raise the money that’s needed, according to Pirovolakis.
“Time is of the essence,” he said. “We want to make sure the trial moves on and these kids get treated.”
The end goal
Looking ahead to the Phase 3 clinical trial at the NIH, Pirovolakis’ goal is to treat eight children with SPG50.
“If we can show that it works in all eight children — and we can prove to the FDA that it is making a difference — then the drug will get approved and every child can get it,” he said.
Michael Pirovolakis is pictured walking with the aid of a walker. Spastic paraplegia 50 (SPG50) is a neurological disorder that affects a child’s development, gradually leading to cognitive impairment, muscle weakness, speech impairment and paralysis. (Terry Pirovolakis)
Ideally, after the drug is approved — which could take three to five years, Pirovolakis estimates — SPG50 will be added to hospitals’ newborn screening programs and every child with the disease will be able to get the therapy.
Elpida Therapeutics has partnered with the Columbus Children’s Foundation (Fundación Columbus in Spain) and CureSPG50 to help save children with the disease.
“Our partnership with Elpida is driven by an unwavering commitment to leaving no child behind,” Sheila Mikhail, co-founder of the CCF, said in a statement to Fox News Digital.
“At the Columbus Children’s Foundation and Fundacion Columbus, as a global organization, we believe that every child deserves a chance for a healthy future. Together, we’re making groundbreaking strides in treating ultra-rare genetic disorders, ensuring that no child is left to face these challenges alone.”
“The biggest challenge in providing treatment for children with rare diseases often comes down to a lack of funding and vision.”
Pirovolakis said he gets several calls each week from families around the world, asking for help saving their children.
“Unfortunately, the biggest challenge in providing treatment for children with rare diseases often comes down to a lack of funding and vision,” he told Fox News Digital.
After Jack Lockard, pictured, received the gene therapy at 6 months old, the family soon noticed improvements in his cognitive and physical milestones. (Rebekah Lockard)
“The technology to cure our children is already here. I hope that someone with immense wealth — and more importantly, the vision and influence — will step in,” he said.
“Their support could not only impact a handful of diseases and children, but extend hope to thousands of rare diseases and millions of children, both this generation and the next.”
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Currently, 40 million Americans are living with a rare disease, and one in 10 will be afflicted by a potentially treatable rare condition.
Pirovolakis added, “Someone you know or love will likely be affected by a rare disease.”
U.S. Surgeon General Vivek Murthy issued a public health advisory on Wednesday addressing the mental health and well-being of parents.
The advisory, which is reserved for “significant public health challenges that require the nation’s immediate awareness and action,” discussed various factors that cause stress for parents and noted an urgent need for support.
“Parents have a profound impact on the health of our children and the health of society,” Murthy wrote in a statement posted by the U.S. Department of Health and Human Services (HHS).
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“Yet parents and caregivers today face tremendous pressures, from familiar stressors such as worrying about their kids’ health and safety and financial concerns, to new challenges like navigating technology and social media, a youth mental health crisis, and an epidemic of loneliness that has hit young people the hardest,” he went on.
“As a father of two kids, I feel these pressures, too.”
Dr. Vivek H. Murthy speaks onstage at The Archewell Foundation Parents’ Summit: Mental Wellness in the Digital Age at Hudson Yards on Oct. 10, 2023, in New York City. (Bryan Bedder/Getty Images for Project Healthy Minds)
In the 30-page advisory, Murthy called for a “fundamental shift” in prioritizing the mental health and well-being of parents.
“I am also outlining policies, programs and individual actions we can all take to support parents and caregivers,” he said.
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Thirty percent of parents reported high levels of stress in the past month, compared to 20% of other adults, according to the advisory.
Severe stress can have “a deleterious effect,” Murthy wrote — as 41% of parents reported that most days, they experience so much stress that they cannot function, while 48% said their stress is “completely overwhelming” on most days.
What’s causing this stress?
The COVID-19 pandemic was cited as a contributor to stressors among parents and caregivers, as well as financial stability, concerns for health and safety, management of tech and social media, parental loneliness, cultural pressures and their children’s future.
School safety concerns among parents are particularly high, as firearm-related injury has become the leading cause of death among children and adolescents in the U.S.
Financial stability, concerns for health and safety, management of tech and social media, and uncertainty about children’s futures are among the stressors experienced by parents. (iStock)
Many parents also face circumstances such as family or community violence, poverty, and racism and discrimination, all of which can impact mental health.
“Both maternal and paternal mental health conditions are shown to impact the well-being of children,” the advisory noted.
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“Maternal mental health conditions have been found to significantly impact a child’s well-being and environment, and can serve as a critical determinant of child outcomes.”
What can be done?
The surgeon general intends to “take steps to mitigate stress at every stage” for parents and caregivers, he said.
Murthy’s advisory encouraged governments and employers to establish programs to ensure that parents have access to affordable mental health care, paid family and medical leave, and other family services.
“Both maternal and paternal mental health conditions are shown to impact the well-being of children,” according to the advisory. (iStock)
The surgeon general also encouraged schools and communities to provide support services and groups to help parents manage stress.
Robin Hilmantel, senior director of editorial strategy and growth at What to Expect, part of Everyday Health, told Fox News Digital that this advisory “feels like a long-overdue acknowledgment of what has been obvious for a while now: Parents are struggling.”
Thirty percent of U.S. parents reported high levels of stress in the past month.
A What to Expect survey of more than 3,000 women found that more than two-thirds of moms (68%) experience anxiety, while 79% of Gen Z moms reported the same.
“There are a lot of reasons why being a parent today is so challenging — parenthood is isolating, as 76% of moms say they don’t have enough support in the form of a ‘village,’” said Hilmantel, who is based in North Carolina.
School safety concerns are high among parents, the advisory said. (iStock)
“There’s also a culture of comparison for today’s parents — 83% of Gen Z moms say they feel pressure to be a perfect parent,” she added.
Some other top parental stressors, according to the survey, include safety, lack of time for themselves, finances and children’s development.
Eighty-three percent of Gen Z moms say they feel pressure to be a perfect parent.
“Remember that you’re not alone if you feel overwhelming stress; other parents are dealing with their own stressors,” Hilmantel said.
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“What you see on social media is often a highlight reel, so you definitely shouldn’t feel bad about your parenting based on anything you see online.”
The expert suggested that parents should try to “cultivate a network of friends, family and acquaintances.”
There is “no shame in directly asking family and friends for help,” one parenting expert said. (iStock)
“Parents can add people to their village by attending in-person meetups where they can connect with other new parents, and by joining online communities where parents can openly discuss anything they’re struggling with,” she said.
Hilmantel added that there is “no shame in directly asking family and friends for help.”
Health
Women’s heart disease risk could be predicted up to 30 years in advance with one blood test, study finds
Predicting a woman’s future heart disease risk could be as simple as administering a single blood test to screen for three risk factors.
That’s according to research published in The New England Journal of Medicine on Saturday — research that was also presented at the European Society of Cardiology (ESC) Congress this weekend.
The study, which included nearly 30,000 women averaging 55 years of age, measured two types of fat in the bloodstream along with a certain type of protein with a blood test in 1993, then monitored the participants’ health for a 30-year period, the researchers said.
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“The strongest predictor of risk was a simple blood measure of inflammation known as high sensitivity C-reactive protein, or hsCRP, followed by cholesterol and lipoprotein(a),” lead study author Dr. Paul Ridker, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, told Fox News Digital.
The study, which included nearly 30,000 women averaging 55 years of age, measured two types of fat in the bloodstream along with a certain type of protein. (iStock)
“Knowing all three predicted risks not just at five or 10 years, but at 20 and 30 years, gives us a road map for how to target specific therapies for the individual patient, rather than an overly simple ‘one-size-fits-all’ approach,” he said.
C-reactive protein (CRP) is a protein made by the liver that rises when inflammation occurs in the body, according to Mayo Clinic.
High levels of the protein indicate an elevated risk of heart disease.
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LDL cholesterol — also known as the “bad” cholesterol — can build up in the arteries and raise the chances of heart attack or stroke, Mayo Clinic noted.
Lipoprotein(a), or Lp(a), is a type of LDL cholesterol that can also cause plaque buildup in the arteries.
“This is a large, convincing study that puts together three predictive blood tests that haven’t been looked at in this way before.”
Women with the highest levels of LDL cholesterol were found to have a 36% increased associated risk for heart disease compared to those with the lowest levels, the researchers found.
Those with the highest levels of Lp(a) had a 33% greater risk.
The highest levels of CRP put women at a 70% increased associated risk.
LDL cholesterol, also known as the “bad” cholesterol, can build up in the arteries and raise the chances of heart attack or stroke. (iStock)
Women who had high levels of all three measures were 1½ times more likely to experience a stroke and more than three times as likely to have coronary heart disease, the researchers found.
While most doctors measure cholesterol, very few measure hsCRP and Lp(a), Ridker noted.
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“It is a truism of medicine that doctors will not treat what they do not measure.”
The fact that a single combination blood test predicted risk 30 years later is “astonishing,” the researcher said.
“It is a truism of medicine that doctors will not treat what they do not measure.”
“It tells us how much silent risk we simply are unaware of, and gives us an opportunity to start preventive efforts far earlier in life,” he added.
Dr. Marc Siegel, senior medical analyst for Fox News and clinical professor of medicine at NYU Langone Medical Center, was not involved in the study, but said it is a “big step forward” in using a combination of blood tests to determine a woman’s cardiac risk.
“This is a large, convincing study that puts together three predictive blood tests that haven’t been looked at in this way before,” Siegel told Fox News Digital.
Women who had high levels of all three measures were 1½ times more likely to experience a stroke and more than three times more likely to have coronary heart disease. (iStock)
“Since inflammation can cause heart attacks, it is confirmatory that an elevated inflammation marker (CRP) conveys a 70% increased risk for heart disease,” he went on.
“LDL and Lp(a) have both previously shown an increased risk of heart disease.”
Siegel predicts that in the future, blood markers like these will be used in combination with artificial intelligence to determine the risk of heart disease and stroke.
Based on these findings, Ridker recommends that patients ask their physicians to specifically measure hsCRP and Lp(a).
“The time has come for our guidelines to change.”
Some patients will benefit from drug therapies to reduce inflammation and lower cholesterol levels, the researcher said. (iStock)
In Ridker’s experience, women tend to be less concerned about heart disease than men.
“Unfortunately, our traditional screening guidelines rarely identify at-risk women until they are in their late 60s or 70s,” he said.
“Yet prevention must start in our 30s and 40s for it to be most effective.”
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While prevention efforts should initially focus on a heart-healthy diet, regular exercise, smoking cessation and stress management, some patients will benefit from drug therapies to reduce inflammation and lower cholesterol levels, according to Ridker.
Based on these findings, the researchers recommend that patients ask their physicians to specifically measure hsCRP and Lp(a). (iStock)
The main limitation of the study is that the women who participated were health professionals, the researchers acknowledged.
“Yet in other settings, we know this is also true for men — and, if anything, an even greater concern for minority individuals,” Ridker said.
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The research was funded by the National Institutes of Health (NIH), the National Heart, Lung, and Blood Institute (NHLBI), and the National Cancer Institute (NCI).
A disease transmitted by mosquitoes — the Oropouche virus, also known as sloth fever — has been detected in the United States.
Travelers returning to the U.S. from Cuba contracted the virus in recent months, as reported by The Associated Press. No fatalities have been reported.
The Oropouche virus is endemic in the Amazon basin and has also been reported in South America and the Caribbean.
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More than 8,000 cases were reported globally between Jan. 1 and Aug. 1, 2024, including two deaths and five cases of transmission from mother to fetus, the CDC noted in an Aug. 16 advisory.
Sloth fever has been reported in Brazil, Bolivia, Peru, Colombia and Cuba.
More than 8,000 cases were reported globally between Jan. 1 and Aug. 1, 2024, including two deaths and five cases of transmission from mother to fetus. (iStock)
So far, 11 cases have been identified in travelers returning from Cuba and Brazil, the CDC stated.
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“Although travel-associated cases have been identified in the United States, no evidence of local transmission currently exists within the United States or its territories,” the agency said.
“As testing and surveillance for Oropouche virus disease increase in the Americas, reports of cases from additional countries are expected.”
What is the Oropouche virus?
The Oropouche virus first emerged in Trinidad and Tobago in 1955.
Since then, it has had “limited circulation” in regions of South America, particularly in forested areas, according to the CDC.
The disease is typically spread through bites from mosquitoes and midges (small flies, particularly the Culicoides paraensis species).
Three-toed sloths and birds have been identified as “natural reservoirs” for the Oropouche virus, which means they act as hosts of the disease. (iStock)
Three-toed sloths and birds have been identified as “natural reservoirs” for Oropouche, which means they act as hosts of the disease.
“The virus doesn’t spread from person to person,” Dr. Marc Siegel, senior medical analyst for Fox News and clinical professor of medicine at NYU Langone Medical Center, confirmed to Fox News Digital.
“There is some risk to the fetus in terms of birth defects.”
Symptoms of Oropouche
Oropouche, classified as an arbovirus, is often mistaken for other similar viruses, like Zika, dengue, chikungunya and malaria, according to the CDC.
Symptoms of the virus include fever, headache, muscle aches, stiff joints and chills.
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Some may develop a rash that begins on the torso and spreads to other body parts.
Symptoms usually begin within four to eight days of being bitten, and last for three to six days.
Symptoms of the virus include fever, headache, muscle aches, stiff joints and chills. (iStock)
“Symptoms can abate and reoccur,” Siegel noted.
In severe cases, patients may develop meningitis, encephalitis or other “neuroinvasive” diseases, the CDC stated.
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For those patients, symptoms can include intense headaches, dizziness, confusion, nausea, vomiting, light sensitivity, lethargy, stiff neck and involuntary eye movements.
“Around 4% of patients develop [neurologic symptoms] after the first febrile illness,” Siegel said.
Treatment and prevention
Most people who contract Oropouche will recover on their own without any long-term effects, the CDC stated.
“There are no vaccines for prevention and no treatments,” Siegel said.
The best means of prevention is to avoid bites from midges and mosquitoes, according to experts.
“Patients who develop more severe symptoms should be hospitalized for close observation and supportive treatment,” the CDC stated. (iStock)
“People are advised to take preventive measures, including the use of repellents, clothing that covers legs and arms, and fine mesh mosquito nets, and to take extra precautions during outbreaks, particularly for vulnerable groups such as pregnant women,” the Pan American Health Organization advised in an alert.
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Supportive care can include rest, fluids and medication to reduce fever and alleviate pain.
“Patients who develop more severe symptoms should be hospitalized for close observation and supportive treatment,” the agency stated.
“As testing and surveillance for Oropouche virus disease increase in the Americas, reports of cases from additional countries are expected.”
Those who are experiencing symptoms and have risk factors can contact their local health department for testing.
“Clinicians in these areas where importation has occurred may not be familiar with this infection and need to be alert to its possibility,” Dr. Amesh Adalja, M.D., an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, told Fox News Digital.
Fox News Digital reached out to the CDC for comment.
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