Health
Ovarian cancer treatment on fast track for FDA approval as chemo alternatives emerge: 'We're making progress'
A new wave of cancer treatments is looking promising for the future of oncologic care.
The ovarian cancer drug RC88, which is made by the Chinese biopharmaceutical company RemeGen, received FDA approval for Phase 2 clinical trials earlier this month.
The drug received fast-track designation (FTD) for the treatment of “platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers,” the company confirmed to Fox News Digital.
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RC88 is an anti-drug conjugate (ADC) designed to treat aggressive ovarian cancers in patients with “poor prognosis,” according to the company.
An ADC is “a class of drugs designed as a targeted therapy for treating disease,” per the National Institutes of Health.
RC88 aims to treat aggressive ovarian cancers in patients with a poor prognosis, according to RemeGen, the China-based company that makes the drug. (iStock)
The drug targets mesothelin, a protein found in tumors.
“This development is not just a scientific advancement, but a beacon of hope for countless women battling this formidable disease,” a RemeGen spokesperson said in an email to Fox News Digital.
RemeGen intends to launch international and multicenter clinical studies in the U.S., China, the European Union and other regions, according to a press release.
The new drug received fast-track designation (FTD) for the treatment of “platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers,” RemeGen confirmed to Fox News Digital. (iStock)
The clinical trials will study participants in multiple countries to determine optimal dosage, effectiveness and safety of the treatment.
RC88’s clinical data findings are slated to be released at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in May 2024 in Chicago.
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Dr. Brian Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida, is familiar with RemeGen’s treatment, noting that anti-drug conjugates have surfaced as a “relatively new class of drug.”
He told Fox News Digital in an interview, “[It] definitely has a lot of promise,” noting also that there have been many more failures than successes.
Brian Slomovitz, M.D., is director of Gynecologic Oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida. He noted the “promise” of the ovarian cancer drug RC88. (Mount Sinai Medical Center)
Among those successes is an ADC drug called Elahere (mirvetuximab soravtansine-gynx), which is indicated for FRa positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer.
The FDA granted accelerated approval for Elahere in Nov. 2022, according to an agency press release.
Other ADCs in development include a drug called TIVDAK for cervical cancer as well as anti-HER2 treatments for breast cancer, according to Slomovitz.
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“It’s going to be much more effective than [chemo drug] Herceptin,” he predicted. “So, it’s really a novel class [of drugs] that go into the cells in a unique way.”
Phase 3 clinical trials of TIVDAK (tisotumab vedotin) were linked to a 30% overall reduction in the risk of death compared to chemotherapy.
A cancer doctor described ADC approaches to treating cancer as a “novel class [of drugs] that go into the cells in a unique way.” (iStock)
In a previous interview with Fox News Digital, Dr. Kathleen Moore, associate director of clinical research at Stephenson Cancer Center in Oklahoma City, shared that the TIVDAK therapy has been effective in shrinking her own patients’ tumors.
“In the past, we just did not have active medications and our patients really were left with ineffective therapies, and they just died,” she said. “They’re feeling better because their disease is shrinking.”
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During the 2023 European Society of Medical Oncology Congress in Madrid, Spain, Moore presented another ADC treatment called raludotatug deruxtecan (R-DXd), which was confirmed as “efficacious” by the National Library of Medicine in treating ovarian and kidney cancers.
As ovarian cancer develops, the level of mesothelia increases — which gives RC88 its “unique” target.
“R-DXd is the first ADC targeting CDH6, [which has been] tested in ovarian cancer and demonstrates very strong signals of efficacy,” Moore said in her data presentation, according to OncLive, the Oncology Specialty Group’s website.
Seventy percent of women who were diagnosed with epithelial ovarian cancer (EOC) have already reached an advanced stage, according to RemeGen.
Phase 3 clinical trials of TIVDAK (tisotumab vedotin) were linked to a 30% overall reduction in the risk of death compared to chemotherapy. (iStock)
EOC remains a “significant cause of cancer deaths among women,” as there are “no effective screening methods” and most patients experience a relapse within two years, the company added.
As ovarian cancer develops, the level of mesothelia increases — which gives RC88 its “unique” target, the RemeGen press release stated.
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The FDA’s approval of RC88 as an investigational new drug “marks a pivotal moment in our commitment to address the challenges of platinum-resistant recurrent ovarian cancer,” RemeGen CEO Dr. Jianmin Fang wrote in a statement to Fox News Digital.
RemeGen calls RC88 — given its “unique targeting mechanism” — a “beacon of hope for countless women battling this formidable disease.” (iStock)
“Our focus remains on developing innovative treatments that can significantly improve patient outcomes in areas with critical unmet needs,” he said.
“RC88, with its unique targeting mechanism, exemplifies our dedication to pioneering advancements in cancer therapy.”
It’s important that ADCs are continuously studied, Slomovitz noted, as the bar for approval is “getting higher and higher.”
He added, “The good news is, we’re making progress.”
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Eat More To Lose Weight? She Dropped 55 Pounds by Having 5 Meals a Day
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Health
Intermittent fasting’s real benefit may come after you start eating again
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Research continues to uncover new details on how fasting may help extend life.
A new study published in the journal Nature Communications investigated how intermittent fasting can boost longevity in small worms often used in aging research.
Researchers from the University of Texas Southwestern Medical Center in Dallas compared worms that were fed normally to those that underwent a 24-hour fast in early adulthood and were then fed again, according to a press release.
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The scientists measured a variety of factors, including stored fat, gene activity related to fat metabolism and lifespan.
The results showed that the life-boosting benefit did not depend on the fasting itself but on the body’s behavior after eating again.
Experts say sustainability is key when choosing a long-term weight-loss strategy. (iStock)
Study lead Peter Douglas, associate professor of molecular biology and a member of the Hamon Center for Regenerative Science and Medicine at UT Southwestern, suggested that these discoveries “shift the focus toward a neglected side of the metabolic coin – the re-feeding phase.”
“Our data suggest that the health-promoting effects of intermittent fasting are not merely a product of the fast itself, but are dependent on how the metabolic machinery recalibrates during the subsequent transition back to a fed state,” he said.
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“Our findings bridge a gap between lipid metabolism and aging research,” he added. “By targeting aging, the single greatest risk factor for human disease, we move beyond treating isolated conditions toward a preventive model of medicine that enhances quality of life for all individuals.”
Lauri Wright, director of nutrition programs at the University of South Florida’s College of Public Health, called this a “high-quality” study that adds an “important nuance to how we think about fasting and longevity.”
Intermittent fasting typically involves limiting meals to an eight-hour daily window or fasting every other day. (iStock)
The benefits of the refeeding phase after fasting were “especially interesting,” Wright, who was not involved in the study, told Fox News Digital.
“The researchers showed that longevity was linked to the body’s ability to turn off fat breakdown after fasting, allowing cells to restore energy balance,” she reiterated.
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“From a scientific standpoint, that’s a meaningful shift because it suggests fasting is not just about burning fat, but about metabolic flexibility.”
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Fasting may support longevity through triggering metabolic switching, enhancing cellular repair and stress resistance and improving markers like insulin sensitivity, research shows.
Limitations and cautions
Although this study provides “important insight” on the power of refeeding, Wright noted that the findings should be approached with caution, as the study was done on worms and cannot always be translated to humans.
“Additionally, it explains how a process might work in a controlled lab condition rather than real-world eating behaviors,” she added as a limitation. “Finally, the study is short-term and doesn’t give us the long-term translation on lifespan outcomes.”
The review found intermittent fasting was barely more effective than doing nothing, according to the study authors. (iStock)
Wright cautioned that fasting is “not a magic solution for longevity, and how you eat overall matters more than when you eat.”
“I advise, first and foremost, to focus on diet quality, including a variety of fruits and vegetables, healthy fats and minimally processed foods,” she said.
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For those who are considering fasting, it’s better to stick with a moderate plan — like a 12- to 14-hour overnight fast — rather than going to extremes, Wright said. After fasting, she recommends focusing on well-balanced meals.
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Several groups of people should be cautioned against fasting, according to Wright, including those with diabetes who are on insulin or hypoglycemic medications, those who are pregnant or breastfeeding, anyone with a history of eating disorders and older adults at risk of malnutrition.
Anyone considering intermittent fasting should consult with a doctor before starting.
Health
Cheap surgery overseas may come with devastating complications, doctors warn
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More than three million people travel to undergo cosmetic surgery each year, statistics show — but the potential savings come at a cost.
Most people opting to pursue this so-called “medical tourism” are chasing budget-friendly price tags.
International surgeries, such as hair transplants in Turkey, can cost as little as $4,000 to $5,000 compared to $20,000 to $30,000 in the U.S., but often come with extreme risks, according to board-certified plastic surgeon Dr. Sheila Nazarian of California.
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The doctor recently joined Lisa Brady on the “The FOX News Rundown” podcast to discuss the rising trend of medical tourism. One of the biggest risks, she said, is the lack of safety regulations in popular destinations like Mexico and Turkey.
As demand spikes in these medical tourism “mills,” there have been reports of non-medically trained staff performing procedures like hair transplants.
Most people opting to pursue “medical tourism” are chasing budget-friendly price tags. (iStock)
“I’ve heard that they [international clinics] are even recruiting people who maybe were taxi drivers and then putting them through their own training program … to become hair transplant technicians,” Nazarian said. “That’s how high the demand has become.”
In the U.S., medical school graduates are granted a “physician and surgeon” license, which means doctors — including pediatricians or OB-GYNs — can legally perform cosmetic surgeries, even if they didn’t receive specialized training for those procedures during residency, Nazarian noted.
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Instead of pinching pennies, the doctor recommended paying whatever amount is necessary to ensure quality treatment.
“People think of it as, you know, going to the mall. … It’s surgery, and surgery has risks,” she said. “You need to be with someone who not only can perform a beautiful surgery, but who can handle possible complications well.”
“You need to ask them: ‘What was your residency training in? And if you wanted to, would you be allowed to do this procedure in a hospital?’”
Aftercare is another critical factor in the success and safety of a cosmetic procedure, as the doctor emphasized that 20% of a surgical result depends on post-operative care.
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This can be difficult or even impossible to manage when a doctor is in a different time zone, she cautioned, or if the clinic disappears shortly after the procedure.
Nazarian also noted the importance of addressing the psychological component of plastic surgery, noting that no procedure will fix underlying unhappiness. The doctor said she uses screening questionnaires to ensure that patients are truly seeking self-improvement rather than a “cure” for deeper issues.
International surgeries, such as hair transplants in Turkey, can cost as little as $4,000 to $5,000 compared to $20,000 to $30,000 in the U.S., but often come with extreme risks. (iStock)
“If you’re not already generally very content with your life, a knife in my hand is not going to bring you there,” Nazarian said.
“The analogy I always give is you don’t want a paisley couch — you want a neutral couch and you can put paisley pillows on it,” she said, noting that a procedure should “make you look normal, God-given, athletic. And then you can change your clothes when the trends come and go.”
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Samuel Golpanian, M.D., a double board-certified plastic surgeon in Beverly Hills, said he has also seen an increasing number of patients undergoing cosmetic procedures abroad, sometimes with “devastating consequences.”
“The key is being extremely careful before embarking on this journey.”
“I’ve seen a wide range of complications, including infections, poor wound healing, significant scarring and tissue necrosis (skin death),” he told Fox News Digital. “These complications often lead to prolonged pain, ongoing medical problems, and significant additional costs to repair the damage.”
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Golpanian said he’s treated patients who received unsafe or non-medical-grade injectable materials, which can lead to serious long-term health issues.
One surgeon said he’s treated patients who received unsafe or non-medical-grade injectable materials, which can lead to serious long-term health issues. (iStock)
“I’ve also seen damage to underlying structures, asymmetry and results that are extremely difficult — sometimes impossible — to correct.”
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“That said, I’ve also seen some good outcomes, so it’s not all bad,” he noted. “The key is being extremely careful before embarking on this journey.”
Quick tips for safe ‘medical tourism’
Fully vet the surgeon. “Most surgeons will provide information about their education and training, but it’s important not to accept these claims at face value,” Golpanian said. “Verify them directly by contacting the institutions where they trained.”
Ask for references from prior patients. Ideally, it’s best to get references from U.S.-based patients who can speak candidly about both their experience and their results, the surgeonsaid.
Think beyond the cost. Golpanian emphasized the adage “you get what you pay for.” “Cost should take a back seat to experience, training, judgment and proven results,” he advised.
Be cautious about relying on before-and-after photos. These can be selective or even enhanced, Golpanian warned.
Keep aftercare in focus. “Make sure the practice emphasizes comprehensive follow-up care and has a clear, realistic post-operative plan in place.”
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