Latest news with #neurogenesis
Associated Press
29-07-2025
- Business
- Associated Press
Pharmazz Inc. Announces Enrollment of First Patient in Phase 3 Clinical Trial of Sovateltide for Treating Patients with Cerebral Ischemic Stroke
The Phase 3 clinical trial of sovateltide, RESPECT-ETB, is expected to enroll over 500 patients with a primary endpoint of proportion of patients demonstrating functional independence at 90 days and is being conducted under a Special Protocol Assessment (SPA) with the FDA. Sovateltide, a potential first-in-class, highly selective endothelin-B (ETB) receptor agonist, has previously demonstrated significant improvement in stroke patients compared to standard of care in a Phase 3 trial that served as the basis for regulatory approval in India. Recent $25 million equity investment from Sun Pharmaceutical Industries Limited, provides sufficient capital to complete the Phase 3 trial. WILLOWBROOK, Ill., July 29, 2025 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ('Pharmazz' or the 'Company'), a late-stage biopharmaceutical company developing innovative therapies for unmet medical needs in critical care and neurology, today announced that the first patient has been enrolled and treated in the pivotal Phase 3 RESPECT-ETB clinical trial assessing the safety and efficacy of sovateltide for the treatment of acute cerebral ischemic stroke ( NCT05691244 ). Sovateltide represents a potential breakthrough as a first-in-class endothelin-B receptor agonist, uniquely promoting neurovascular remodeling—generating new neurons (neurogenesis), blood vessels (angiogenesis), and enhancing mitochondrial function. 'There has not been a new FDA approved non-thrombolytic therapy for stroke in over 30 years. We have already shown promising results in our previous Phase 3 study, which showed that sovateltide could be a meaningful advance over standard of care to promote a fast recovery and improve neurological outcomes in cerebral ischemic stroke patients,' said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. 'We have now treated the first patient in our US-based Phase 3 clinical trial and have sufficient capital to complete this study to further cement the potential for sovateltide to transform the treatment of cerebral ischemic stroke.' 'There is a massive and ongoing medical burden associated with ischemic stroke, which continues to be a leading cause of long-term disability, affecting hundreds of thousands of patients each year,' said Dr. Thomas Devlin, MD, PhD, FSVIN, physician executive of Neurosciences and medical director at CHI Memorial Stroke and Neuroscience Center, and principal investigator of the Phase 3 trial. 'Current treatment options remain limited, underscoring the critical need for novel therapies. Given the promising results already demonstrated with sovateltide, this rigorous Phase 3 study represents an important step toward addressing this urgent unmet medical need.' Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment Sovateltide is a first-in-class endothelin-B receptor (ETBR) agonist to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms. Pharmazz has received agreement from the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of sovateltide for the treatment of acute cerebral ischemic stroke patients. Pharmazz has now enrolled and treated the first patient in its Phase 3 trial, RESPECT-ETB ( ID: NCT05691244 ). The Phase 3 clinical trial is designed to enroll a total of 514 stroke patients at 65 sites in the US, Germany, Spain, and the UK. The primary endpoint is the proportion of patients demonstrating functional independence post-stroke, defined as a modified Rankin Scale (mRS) score of 0–2 at 90 days after stroke onset. About Sovateltide and Stroke Stroke is a leading cause of long-term disability in the United States, affecting more than 795,000 people each year, and reduces mobility in more than half of stroke survivors over the age of 651. Sovateltide is a first-in-class drug to treat acute cerebral ischemic stroke, a condition in which the loss of blood supply to the brain prevents brain tissue from receiving oxygen and nutrients, resulting in potential brain damage, neurological deficits, or death. Sovateltide is unique because its action site is the neural progenitor cells. Sovateltide promotes neurovascular remodeling by inducing the formation of new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. The Phase 3 trial that served as the basis for approval in India was published in 2024 and showed that the sovateltide group (n=80) had a significantly greater number of cerebral ischemic stroke patients with lower mRS and NIHSS scores at 90 days post-treatment than the control group (n=78).2 About Pharmazz, Inc. Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz, Inc. has obtained marketing authorization for two of its first-in-class drug molecules, centhaquine and sovateltide, for the treatment of hypovolemic shock and ischemic stroke, respectively, in India. In addition, the US Food and Drug Administration (FDA) has approved two phase III INDs for centhaquine as an agent for hypovolemic shock and sovateltide for cerebral ischemic stroke. Additional information may be found on the Company's website, Disclaimer: Statements in this 'Document' describing the Company's objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be 'forward-looking statements' within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: 1 Centers for Disease Control. 2 Drugs. 2024 Nov 15;84(12):1637–1650. doi: 10.1007/s40265-024-02121-5
Yahoo
07-07-2025
- Health
- Yahoo
Brain's Memory Center Never Stops Making Neurons, Study Confirms
Though it's now clear humans continue to grow new brain cells throughout their entire lives, debate persists over whether this applies to specific areas involved with memory. Previous studies have made the case for and against the existence of neurogenesis in hippocampus beyond childhood. A new study now offers some of the clearest evidence yet that this crucial memory-forming region does form fresh neurons well into adulthood. The study is the work of researchers from the Karolinska Institute and the Chalmers University of Technology in Sweden, and looks specifically at the dentate gyrus section of the hippocampus, the part of the brain that acts as a key control center for emotions, learning, and storing episodic memories. Related: "This gives us an important piece of the puzzle in understanding how the human brain works and changes during life," says molecular biologist Jonas Frisén. Confirmation that humans can form new neurons in the hippocampus through life (as several other animals can) would inform a whole host of other scientific investigations, from how adults learn new skills to what happens to the brain as it deteriorates in old age. The team used RNA analysis to identify functions of brain cells in samples collected from people up to age 78, finding that some neurons were geared to function as neural progenitor cells (NPCs), which generate new nerve cells. The researchers also found similarities between human NPCs and those in mice, pigs, and monkeys. Through a process of machine learning, the researchers could also group cells according to their development, from their initial 'blank slate' stem cell characterization to being an immature neuron in the process of dividing. The results address questions raised by earlier studies (including one from some of the same researchers), which determined that new neurons were present in the human brain without being able to confirm exactly how they'd got there. "We have now been able to identify these cells of origin, which confirms that there is an ongoing formation of neurons in the hippocampus of the adult brain," says Frisén. By studying such a wide range of ages, the researchers confirmed neurogenesis keeps happening in the hippocampus throughout our adult lives – albeit at a slower rate, generally speaking, as we get older. It's also important to note that the analysis revealed different rates of neurogenesis in different people. That might point to differences in brain plasticity that affect learning, personality, and disease risk, but that's something that future studies will need to look at. One hypothesis is that certain brain conditions might be affected by how quickly fresh new neurons can be produced – some of the subjects in this study had a history of psychiatric or neurological diseases – but again this wasn't something that the researchers looked at directly, so follow-up studies will be needed. "Our research may also have implications for the development of regenerative treatments that stimulate neurogenesis in neurodegenerative and psychiatric disorders," says Frisén. The research has been published in Science. Pomegranates Could Limit Risks From Controversial Sports Supplement OCD's Origins Might Not Lie in The Brain Like We Thought The News Cycle Is a Stress Monster. But There's a Healthy Way to Stay Informed.
Yahoo
04-07-2025
- Health
- Yahoo
Human brains keep growing neurons even in old age, study finds for first time
For decades, scientists believed the human brain stopped producing new neurons after childhood. This long-held view painted the adult brain as a fixed organ, incapable of generating fresh cells in the very region responsible for memory and learning. But a landmark new study turns that dogma on its head, offering the clearest evidence yet that adult humans continue to form new neurons well into the old age. A team of researchers from Karolinska Institutet in Sweden has identified and tracked the formation of new neurons in the hippocampus, a region critical for memory, learning, and emotional regulation. In 2013, a team of researchers led by Professor Jonas Frisén made headlines with a study showing that new neurons can form in the hippocampus of adult humans. They used carbon-14 dating in DNA extracted from brain tissue to pinpoint when individual cells were created, providing rare evidence of adult neurogenesis. But while the study proved that new neurons could exist, it did not answer where these neurons come from. Until now, scientists lacked direct proof that the neural progenitor cells were present and actively dividing in the adult human brain. 'We have now been able to identify these cells of origin, which confirms that there is an ongoing formation of neurons in the hippocampus of the adult brain,' said Frisén. In the new study, the team analyzed post-mortem brain tissue from individuals ranging in age from infancy to 78 years to discover that neural progenitor cells—precursors to fully developed neurons—not only exist in the adult brain but are also actively dividing. The study used advanced techniques like single-nucleus RNA sequencing to map gene activity in individual brain cell nuclei. Combined with flow cytometry and machine learning, the approach allowed researchers to identify various stages of neuronal development, ranging from stem-like cells to immature, still-dividing neurons. To visualize where these new neurons were forming, the scientists employed RNAscope and Xenium, two powerful spatial transcriptomics tools. These confirmed that the cell formation was happening in the dentate gyrus, a part of the hippocampus linked to learning, cognitive flexibility, and the encoding of new memories. The findings reveal that adult human neural progenitor cells closely resemble those seen in mice, pigs, and monkeys, though some gene activity patterns differ between species. What's especially intriguing is the variability between individuals. While some adults had abundant neural progenitor cells, others had very few, raising new questions about what factors might influence adult neurogenesis. 'This gives us an important piece of the puzzle in understanding how the human brain works and changes during life,' Frisén explained. 'Our research may also have implications for the development of regenerative treatments that stimulate neurogenesis in neurodegenerative and psychiatric disorders.' The findings could also pave the way for new regenerative therapies for neurodegenerative and psychiatric conditions, potentially helping to restore or enhance brain function by stimulating neuron formation in targeted ways. The groundbreaking study has been published in the journal Science.
Yahoo
04-07-2025
- Health
- Yahoo
Proof That Adult Brains Make New Neurons Settles Scientific Controversy
For at least six decades, neuroscientists have been arguing over a big, foundational question: Do adult brains make new neurons? This process of 'neurogenesis' had been shown in other adult animals, but its evidence in humans was circumstantial—until now. Using a new technique, scientists have found newly formed neurons in the brains of adults as old as age 78—and, for the first time, have identified the other brain cells that birthed them. The results, published on Thursday in Science, are the first signs that cells with the capacity to turn into neurons, called neural precursor cells, exist in adult human brains. 'Now we have very strong evidence that the whole process is there in humans, from the precursor cells to the immature neurons,' says Gerd Kempermann, a neurobiologist at the Dresden University of Technology, who was not involved in the study. Throughout gestation, our brain churns out new neurons until it reaches the 100 billion we start life with, and that count declines as we age. As early as 1962, studies in rats had shown that neurogenesis continued throughout the animals' life. Others found that young neurons existed in adult human brains. But it was unclear whether these 'immature' neurons were truly new—or whether humans just start life with a collection of them, after which they slowly develop during adulthood. [Sign up for Today in Science, a free daily newsletter] One thing was clear from these studies: if adult neurogenesis happened anywhere, it was in the hippocampus, a deep-brain structure known for its role in memory processing and storage. But even in the human hippocampus, neuroscientists had not yet found the precursor cells that divide and develop to turn into new neurons. Researchers at the Karolinska Institute in Sweden had previously found immature neurons in the human brain. Marta Paterlini, a neuroscientist at the institute, and her colleagues, set out to pin down how those neurons came to be. Paterlini and her team took advantage of a new combination of techniques to examine immature neurons and neural precursor cells in the hippocampi of six young children, whose brain had been donated to science upon their death. From more than 100,000 cells, the researchers sequenced RNA—bits of genetic information used to carry out actions within each cell. These markers come together to form a sort of molecular fingerprint that can be used to predict a cell's stage of life. 'It's not a matter of one marker defining active neurogenesis; it's the combination of many markers,' says Paterlini, who is co-lead author of the new study. After identifying these markers in young brains, the team then searched for those same signatures in 19 postmortem brains ranging from 13 to 78 years old. All of the brains contained immature neurons except one. The researchers also found neural precursor cells in each of the child brains and in 12 of the 19 adolescent and adult brains. Two adults stood out for having many more neural precursor cells and immature neurons than the rest. The younger of these two people had lived with epilepsy, which could potentially connect to the apparent abundance of neurogenesis. In mice, higher levels of neurogenesis can cause seizures, though the connection to epilepsy in humans is still unclear. The team suspects that neurogenesis happens in other parts of the adult brain, too. In mice, new neurons are regularly made in the olfactory bulb (a structure that processes smells) as well—but the same hasn't been shown in humans. Paterlini plans to investigate whether adult neurogenesis might happen there or elsewhere in the brain. Some research in mice suggests that disrupted neurogenesis is linked to Alzheimer's disease and depression. Learning more about how neurogenesis happens—and whether the process can be altered—could prove helpful for understanding a range of disorders and diseases, says the study's co-lead author Ionut Dumitru, a neuroscientist at the Karolinska Institute. With the question of adult neurogenesis resolved, scientists can begin learning more about what neurogenesis does in the brain and how it affects various disorders. 'This is an important paper because it should finally put this all to rest,' Kempermann says. 'And we can now concentrate on the question: How do these cells in the human contribute to brain function?'
Yahoo
04-07-2025
- Health
- Yahoo
Can adults make new brain cells? New study may finally settle one of neuroscience's greatest debates
When you buy through links on our articles, Future and its syndication partners may earn a commission. Researchers say they have found clear evidence that the human brain can keep making new neurons well into adulthood, potentially settling decades of controversy. This new neuron growth, or "neurogenesis," takes place in the hippocampus, a critical part of the brain involved in learning, memory and emotions. "In short, our work puts to rest the long-standing debate about whether adult human brains can grow new neurons," co-lead study author Marta Paterlini, a researcher at the Karolinska Institute in Stockholm, told Live Science in an email. Other experts agree that the work makes a strong case for adult neurogenesis. While a single study does not constitute absolute proof, "this is strong evidence in support of the idea" that stem cells and precursors to new neurons exist and are proliferating in the adult human brain, said Dr. Rajiv Ratan, CEO of the Burke Neurological Institute at Weill Cornell Medicine, who was not involved in the study. "This is a perfect example of great science teeing up the ball for the clinical neuroscience community," he told Live Science. Related: Babies' brain activity changes dramatically before and after birth, groundbreaking study finds The researchers combined advanced techniques, including single-nucleus RNA sequencing and machine learning, to sort and examine brain tissue samples from international biobanks, they reported in a paper published July 3 in the journal Science. RNA, a cousin of DNA, reflects genes that are "switched on" inside cells, while machine learning is a type of artificial intelligence often used to crunch huge datasets. Since the 1960s, researchers have known that mice, rats and some nonhuman primates make new brain cells in the dentate gyrus, part of the hippocampus, throughout life. But getting quality brain tissue samples from adult humans is extremely challenging. "Human tissue comes from autopsies or surgeries, so how it's handled — how long before it's fixed in preservative, which chemicals are used, how thin the slices are — can hide those newborn cells," Paterlini said. Employing new technologies enabled the team to overcome this challenge. They analyzed more than 400,000 individual nuclei of hippocampus cells from 24 people, and in addition, looked at 10 other brains using other techniques. The brains came from people ages 0 to 78, including six children and four teens. Using two cutting-edge imaging methods, the team mapped where new cells sat in the tissue. They saw groups of dividing precursor cells sitting right next to the fully formed neurons, in the same spots where animal studies have shown that adult stem cells reside. "We didn't just see these dividing precursor cells in babies and young kids — we also found them in teenagers and adults," Paterlini said. "These include stem cells that can renew themselves and give rise to other brain cells." The newer technologies enabled the researchers to detect the new brain cells at various stages of development and conduct research that wouldn't have been possible a few years ago, Ratan added. The team also used fluorescent tags to mark the proliferating cells. This enabled them to build a machine learning algorithm that identified the cells that they knew would turn into neurogenic stem cells, based on past rodent studies. This was a "clever approach" for tackling the challenges of studying brain-cell formation in adolescents and adults, Ratan said. As expected, the brains of children produced more new brain cells than the brains of adolescents or adults did. Meanwhile, nine out of 14 adult brains analyzed with one technique showed signs of neurogenesis, while 10 out of 10 adult brains analyzed with a second technique bore new cells. Regarding the few brains with no new cells, Paterlini said it's too soon to draw conclusions about the disparity between adult brains with evidence of new cells and those without. RELATED STORIES —How much of your brain do you need to survive? —You're born with most of your neurons — but the brain makes some mysterious new ones in adulthood —Brain aging accelerates dramatically around age 44 — could ketone supplements help? Next, the researchers could explore whether the adults who produced new brain cells did so in response to a neurological disease, such as Alzheimer's, or whether adult neurogenesis is a sign of good brain health, said Dr. W. Taylor Kimberly, chief of neurocritical care at Massachusetts General Brigham, who was not involved in the study. "They were able to find these needles in a haystack," Kimberly told Live Science. "Once you detect them and learn about them and understand their regulation," scientists can research how to track the precursor cells through time and see how their presence relates to disease, he said. He envisioned comparing patients who have dementia to "super agers" who are cognitively resilient in old age. If the link between neurogenesis and disease can be uncovered, perhaps that could open the door to treatments. "Although the precise therapeutic strategies in humans are still under active research," Paterlini said, "the very fact that our adult brains can sprout new neurons transforms how we think about lifelong learning, recovery from injury and the untapped potential of neural plasticity."
