
Celldex says barzolvolimab study meets primary endpoint, will not advance in EoE
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Business Insider
2 days ago
- Business Insider
Celldex says barzolvolimab study meets primary endpoint, will not advance in EoE
Celldex (CLDX) reported topline results from the company's ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis, a chronic inflammatory disease of the esophagus. The primary endpoint of the study, absolute change from baseline to Week 12 in peak esophageal intraepithelial mast cell count was met, but the profound mast cell depletion observed did not result in improvement in EoE symptoms or endoscopic assessment of disease activity compared to placebo. Consistent with previously reported studies, barzolvolimab demonstrated a favorable safety and tolerability profile. Based on these results, Celldex will not advance development in EoE. The results do support future development with KIT- or SCF-targeted therapies in other GI indications where mucosal mast cells are believed to play an important role. Profound reduction in CD117+ and tryptase+ intraepithelial mast cells. Primary endpoint met with high statistical significance. Peak mast cell counts per high power field at baseline were 50.3 in the placebo arm and 55.4 in the barzolvolimab 300mg Q4W arm. At Week 12 the absolute change from baseline was -2.7 for placebo compared to -36.0 for barzolvolimab. Mast cells defined by tryptase staining also showed profound decreases at week 12 in barzolvolimab treated patients with sustained and deepening decreases observed at Week 28. Despite profound mast cell depletion, no definitive evidence of clinical improvement in EoE symptoms, as measured by the Dysphagia Symptom Questionnaire, or endoscopic scoring of EoE-related inflammation & fibrosis were observed compared to placebo. There was also no difference observed in histological reduction in esophageal intraepithelial infiltration of eosinophils. Barzolvolimab demonstrated a favorable safety profile at the 300 mg Q4 weekly dosing regimen, consistent with prior studies where barzolvolimab was dosed less frequently. An unblinded review of all available data through the full treatment period and full study was conducted and clinical and safety outcomes were consistent at these timepoints. Elevate Your Investing Strategy:


Fox News
6 days ago
- Fox News
Specific symptoms could warn of MS more than a decade before diagnosis, study finds
People with multiple sclerosis (MS) may show warning signs long before classic symptoms appear — and mental health concerns could be among the first red flags, according to new research. A University of British Columbia (UBC) study, published last week in JAMA Network Open, examined the medical records of 2,038 patients with the autoimmune disease and compared them to 10,182 patients without it. The researchers found that future MS patients had elevated rates of mental health-related issues, psychiatrist and general practice visits, and complaints of vague symptoms such as fatigue and pain — all as early as 15 years before the onset of clear symptoms. "These findings suggest that MS may begin much earlier than previously recognized, with mental health–related issues as early indicators," the researchers wrote. MS, which attacks the protective myelin coating around nerve cells in the brain and spinal cord, affects about one million adults in the U.S., according to Cleveland Clinic. While there is no known cause or cure, treatment can help manage symptoms and slow the progression of the disease, which can cause muscle weakness, vision changes, numbness and memory issues. Previous research has shown that in the five to 10 years leading up to an MS diagnosis, people typically seek medical attention more frequently for headaches, fatigue, sleep disorders, pain, gastrointestinal issues and psychiatric concerns, the researchers wrote. The UBC study, however, tracked physician visits in the 25 years leading up to the onset of symptoms in MS patients in British Columbia. They found a steady uptick in general practice visits starting 15 years out, followed by more frequent trips to psychiatrists beginning 12 years before symptoms. Neurology and ophthalmology visits increased eight to nine years prior, likely due to blurred vision or eye pain, two common early symptoms of MS. Three to five years before onset, emergency room and radiology visits rose sharply. Across nearly every specialty, physician visits peaked in the year before symptoms began. Psychiatrist consultations, in particular, skyrocketed 159% before MS onset, and mental health visits increased 76%, according to the research. The increase in psychiatric visits may correlate to the earliest stages of MS-related immune dysregulation, as higher levels of certain inflammation-related chemicals and problems with the blood-brain barrier can affect mood, the researchers noted. While most people who experience mental health issues, fatigue and headaches do not develop MS, the researchers said that recognizing and characterizing the "prodromal phase" — the early period marked by subtle symptoms — could speed up diagnosis and improve outcomes. "Mental health and psychiatric-related issues may be among the earliest features of the prodromal phase of MS, preceding nervous system-related symptoms and neurologist visits by several years," senior author Dr. Helen Tremlett, professor of neurology at UBC, told Fox News Digital. "This suggests that in the future, there may be an opportunity to recognize and manage MS early, maximizing mental health and brain reserve," she said. The findings also open "new avenues for research into early biomarkers, lifestyle factors and other potential triggers that may be at play during this previously overlooked phase of the disease," the researcher added. Monitoring for early warning signs could also potentially help to detect other brain diseases, like Alzheimer's or ALS, and ensure early intervention, Tremlett noted. For more Health articles, visit Between 2016 and 2021, MS cases increased globally from about 2.2 million to as many as 2.9 million, according to research published in July in the journal Frontiers in Neurology. The disease has gained public attention in recent years as celebrities like Selma Blair, Christina Applegate and Montel Williams have shared their experiences of living with MS.
Yahoo
7 days ago
- Yahoo
Alarming new study reveals overlooked factor that can lead to brain tumors: 'These findings point to a possible link'
Alarming new study reveals overlooked factor that can lead to brain tumors: 'These findings point to a possible link' Harmful gases can pose even more serious health concerns than respiratory problems. Researchers have found a link between exposure to ultrafine particles and aggressive brain tumors. What's happening? According to Euronews, a study by researchers from the Danish Cancer Institute indicates that long-term exposure to fine particulate matter, elemental carbon, nitrogen dioxide, and ultrafine particles contributes to the development of a common brain tumor. "While research on the health effects of ultrafine particles is still in its early stages, these findings point to a possible link between traffic-related ultrafine particle exposure and the development of meningioma," said Ulla Hvidtfeldt, one of the authors of the study. Though meningiomas are not typically cancerous, they cause neurological symptoms that impair brain function. The findings echo earlier reports, such as one linking PM2.5 exposures to brain damage, cancer, and premature death, and another tying toxic airborne substances to higher dementia risk. Why is this discovery important? This research shows how polluting particles affect more than just our lungs — they can harm the brain too. What makes this especially concerning is that these pollutants come from common sources such as traffic exhaust, smoke, and even ordinary household products, meaning regular, long-term exposure is more common than we realize. Children, older adults, and low-income communities face the greatest risks because of long-term exposure and limited access to clean-air infrastructure. Left unaddressed, this could translate into more cases of brain disease, rising health care costs, and irreversible neurological damage — all driven by an invisible yet largely preventable threat in the air we breathe. What's being done about the issue? While there are no findings that suggest cleaner air reduces the risk of brain tumors, improving air quality could still have public health benefits. That's why efforts to clean up the air, including advocacy within workplaces, are increasingly urgent. Do you worry about the quality of the air inside your home? Yes — often Yes — but only sometimes Only when it's bad outside No — I never do Click your choice to see results and speak your mind. Governments around the world are taking steps to reduce air pollution. Europe is pursuing an action plan to reach a 55% decrease in premature deaths caused by air pollution, per the European Environment Agency. In Asia, countries are implementing air quality monitoring solutions, as the Asia-Pacific Economic Cooperation reported. Individuals can take local action and support community initiatives to improve air quality. People can also help reduce harmful gases in the air by choosing electric vehicles, using public transit, and installing solar panels at home. As scientists continue to investigate the connection between air quality and brain health, this study serves as a crucial reminder: A cleaner environment isn't just better for the planet — it may also help protect our brains. Join our free newsletter for weekly updates on the latest innovations improving our lives and shaping our future, and don't miss this cool list of easy ways to help yourself while helping the planet. Solve the daily Crossword