antibody Archives - Amazing Health Advances

Antibody Shows Promise for Preventing Organ Rejection After Transplantation

The AHA! Team — Wed, 12 Jun 2024 04:30:14 +0000

Duke Health – DURHAM, N.C. – A man-made antibody successfully prevented organ rejection when tested in primates that had undergone a kidney transplant, Duke Health researchers report. The finding clears the way for the new monoclonal antibody to move forward in human clinical trials. Results of the study appear online Aug. 30 in the journal Science Translational Medicine. “Current medications to prevent organ rejection are good overall, but they have a lot of side effects,” said lead author Imran J. Anwar, M.D., a surgical research fellow in Duke’s Department of Surgery. “These therapies suppress the immune system, putting patients at risk of infections and organ damage, and many cause non-immune complications such as diabetes and high blood pressure. “The push over the last decades has been to develop new, less toxic drugs,” Anwar said. “We are hopeful this antibody moves us closer to that goal.” Anwar and colleagues, including co-senior author Allan Kirk, M.D., Ph.D., chair of the Department of Surgery, focused on a monoclonal antibody identified as AT-1501. It was engineered to minimize the risk of blood clots, which had become problematic for an earlier version of this therapy. In studies using primates that had undergone kidney transplantation, AT-1501 prevented rejection without the need for additional immunosuppressive drugs or promoting blood clots, confirming its immunosuppressive potential. In animals that had undergone islet transplantation, AT-1501 alone did not lead to uniform rejection control, but it was effective in combination with existing immunosuppressive agents. The combination therapies in islet transplantation led to uniform islet graft survival without weight loss or infections that can typically arise. The islet transplants were performed by Norma Kenyon, Ph.D., co-senior author and professor at the University of Miami. “These data support AT-1501 as a safe and effective agent to promote both islet and kidney transplant survival and function and allow us to advance into clinical trials right away,” Kirk said. “This less toxic approach has been pursued for over 20 years, and I think we are finally at a turning point. This could be a great advance for people in need of organ transplants.” In addition to Kirk and Anwar, study authors include Dora M. Berman, Isabel DeLaura, Qimeng Gao, Melissa A. Willman, Allison Miller, Alan Gill, Cindy Gill, Steve Perrin, Camillo Ricordi, Philip Ruiz, Mingqing Song, Joseph M Ladowski, and Norma S. Kenyon. The study received funding support from the National Institutes of Health (U19-AI051731), the Diabetes Research Institute Foundation, and Anelixis Therapeutics, now Eledon Pharmaceuticals, which is developing AT-1501 for kidney and islet cell transplant. To read the original article click here.

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New Alzheimer’s Prevention Trial in Young People

AHA Publisher — Thu, 23 Dec 2021 08:00:56 +0000

Washington University in St. Louis via Newswise – Washington University School of Medicine in St. Louis is launching an international clinical trial aimed at preventing Alzheimer’s disease in people genetically destined to develop the illness at a young age. Unlike most other Alzheimer’s prevention trials, this one will enroll people before the disease has taken hold – up to 25 years before the expected onset of dementia. Called the Primary Prevention Trial, the new study will investigate whether gantenerumab — an investigational antibody under development for Alzheimer’s disease by Roche and Genentech, a member of the Roche Group — can clear a key Alzheimer’s protein called amyloid beta, and slow or stop the disease. Amyloid is the chief component of plaques that dot the brains of people with the disease. Many scientists suspect the disease originates from the buildup of amyloid plaques in the brain that start to develop up to two decades before symptoms of dementia begin. “Overwhelming evidence suggests that the most effective way to slow or stop amyloid beta is to prevent it from building up in the first place, but most of the drugs targeted to this protein have been tested in people who already have at least some early signs of the disease, such as memory loss – when the disease is far enough along that reducing amyloid alone isn’t likely to stop it,” said Eric McDade, DO, an associate professor of neurology and the trial’s principal investigator. “We’ll be recruiting participants as young as 18. In many ways, this trial will be a necessary test of the amyloid hypothesis, which has had a major influence on Alzheimer’s research and drug development over the past 30 years.” The new trial involves families with rare genetic mutations that cause Alzheimer’s at a young age – typically in a person’s 50s, 40s or even 30s. A parent with such a mutation has a 50% chance of passing the genetic mutation to a child, and any child who inherits the mutation is all but guaranteed to develop symptoms of dementia near the same age as his or her parent. This certainty gives researchers an opportunity to evaluate the effectiveness of drugs designed to prevent Alzheimer’s. Forestalling the earliest signs of disease could be game changing in the world of Alzheimer’s prevention, and the study has garnered support from all quarters: a U.S. governmental agency, nonprofit organizations, individual benefactors, and the health-care company Roche and Genentech. More than $130 million has been earmarked for the trial, including grants totaling an estimated $97.4 million from the National Institute on Aging (NIA) of the National Institutes of Health (NIH), $14 million from the Alzheimer’s Association and the GHR Foundation, and up to $11.5 million from longtime Washington University benefactor Joanne Knight of St. Louis and family, who have long supported Alzheimer’s research at Washington University. In addition, the university has pledged to raise an additional $6.5 million. The trial is being conducted in close partnership with Roche and Genentech, which also is providing significant funding. “We are thrilled to be part of this important clinical trial in one of the earliest stages of Alzheimer’s studied to date,” said Rachelle Doody, MD, PhD, global head of neurodegeneration at Roche and Genentech. “Our vision has always been to detect Alzheimer’s early, before damage in the brain is irreversible, offering tools and treatment all along the journey for people at risk of the disease. Close collaboration between industry, academia and patients is so critical to achieve this and tackle the complex challenge of this disease.” The trial will recruit people with rare, early-onset forms of the disease, but the results also will further our understanding of Alzheimer’s overall, which could benefit the millions of people living with the more common form, which affects people later in life. The processes that lead to memory loss and cognitive impairment in Alzheimer’s are thought to be similar, whether the disease is caused by an inherited mutation or by the complex combination of genetics and environment that causes most Alzheimer’s cases. McDade and colleagues are studying about 230 participants from families that carry genetic mutations that lead to early-onset Alzheimer’s disease. The participants come from sites on five continents and have no or very few amyloid deposits. The trial will test gantenerumab over four years, with a goal of determining whether early treatment will prevent the buildup of the toxic protein. “This trial is the first of its kind in that it aims to intervene before the onset of significant neuropathology in those young adults who are at a very high risk of developing the debilitating symptoms of Alzheimer’s dementia,” said Laurie Ryan, PhD, chief of the Clinical Interventions and Diagnostics Branch in NIA’s Division of Neuroscience. “We now know that changes in the brain can begin a decade or more before symptoms appear, so this trial is designed to provide another piece in the Alzheimer’s prevention puzzle.” The new trial is the second international Alzheimer’s prevention trial led by Washington University School of Medicine. The first trial, known as the Dominantly Inherited Alzheimer Network-Trials Unit-001 (DIAN-TU-001), began in 2012 and is ongoing. That trial was testing the effectiveness of drug treatments, including gantenerumab, in people who were likely to develop the disease during the trial because nearly all had some amyloid plaques at the time they entered it. Earlier this year, trial leaders reported from the DIAN-TU-001 study that, while the effects on clinical outcomes such as cognitive function were not clear, gantenerumab improved biomarkers of the disease. As a consequence, trial leaders have offered the drug to participants as part of an exploratory open-label extension and continue to monitor changes in measures of Alzheimer’s disease in those participants who are receiving the investigational drug. “Multiple drugs are being tested in the ongoing Knight Family DIAN-TU prevention trial, which involves people who are expected to develop symptoms within 10 years,” said Randall J. Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor of Neurology and the principal investigator and program director of the Knight Family DIAN-TU. “Initiating a new prevention trial alongside the DIAN-TU-001 trial gives family members an opportunity to attempt to stop the disease even earlier – 10 years or more before symptoms are likely to arise, which is before or just as the first brain changes begin. It’s the ultimate approach for prevention.” This new trial will draw from this same group of families and is aimed at determining whether targeting amyloid can prevent familial Alzheimer’s disease. Success would give researchers additional reasons to continue pursuing amyloid-based therapies at the earliest stages of the disease. “It’s exciting to think of the valuable insights this groundbreaking trial will provide in the prevention of Alzheimer’s dementia,” said Fred Miller, GHR Foundation’s chief operating officer and Alzheimer’s program lead. “We’re pleased to partner boldly on the multiple DIAN-TU trials, all made possible by the strong collaboration between academic researchers, government, industry, philanthropy and the DIAN families themselves.” Both trials are being conducted in association with the Dominantly Inherited Alzheimer Network (DIAN) – an NIH-funded international research network led by Washington University and involving nearly 40 research institutes in North America, Australia, Europe, Asia and South America. The National Institute on Aging has been a major supporter of DIAN and its clinical trials unit since the network was established in 2008. “The Alzheimer’s Association has been a long-term partner with DIAN, and we’re particularly proud of providing the initial funding for the establishment and launch of the Trials Unit in March 2012,” said Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer. “DIAN-TU is a landmark project and has dramatically accelerated the pace of discovery of treatment and prevention strategies for Alzheimer’s disease, and this innovative new prevention study is no exception.” This international effort to find ways to prevent Alzheimer’s disease would not be possible without the support of many partners, as well as the active involvement of DIAN families. “The stakes are high, and studies like this one are expensive to carry out,” McDade said. “We’re thankful for the support from many sources to make this trial possible. We’re also grateful to the families, for their encouragement and willingness to take part in trials like this one.” To read the original article click here.

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FDA Allows Emergency use of Antibody Drug President Trump Received

AHA Publisher — Mon, 23 Nov 2020 08:00:26 +0000

Associated Press via CBN News – U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month. The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms. The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions. Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said. Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program. Those patients will not be charged for the drug but may have to pay part of the cost of giving the IV. Initial supplies will likely be vastly outstripped by demand as the U.S. has surged past 12 million reported cases, with the country facing what health experts say will be a dark winter due to the uncontrolled spread of the virus. Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs. The drugs are concentrated versions of ones that proved best able to do this in lab and animal tests, and in theory, help the body start to fight the virus right away. The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied. There’s no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recover on their own. FDA regulators authorized the Regeneron drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises. In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies, the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks. The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Regeneron will have to submit additional research to fully define the drug’s safety and benefit for patients. The White House cast the decision as a victory for Trump’s efforts “to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans,” according to a statement from spokesman Michael Bars. To read the original article click here. For more articles from CBN News click here.

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New Therapy Provides Relief in Patients with Chronic Low Back Pain

AHA Publisher — Tue, 23 Jun 2020 07:00:27 +0000

University of Rochester Medical Center via News-Medical Net – A new study has found that tanezumab, a monoclonal antibody that inhibits nerve activity, provides relief in patients with chronic low back pain, one of the leading reasons why people seek medical care and the number one cause of disability worldwide. “This demonstration of efficacy is a major breakthrough in the global search to develop non-opioid treatments for chronic pain,” said John Markman, M.D., director of the Translational Pain Research Program in the University of Rochester Medical Center (URMC) Department of Neurosurgery and lead author of the study which appears in the journal Pain. “There were also improvements in function linked to the reduction in pain severity.” This is the first study that shows long-term relief for chronic low back pain with a single dose of tanezumab delivered under the skin once every two months. The study was conducted in 191 sites across eight countries in North America, Europe, and Asia. Researchers are increasingly finding that certain proteins circulating in the bloodstream heighten the sensitivity of cells in the nervous system to pain. One of these proteins, called nerve growth factor (NGF), may explain why some individuals experience more intense and chronic back pain. Tanezumab is an NGF inhibitor. The patients with chronic low back pain enrolled in this study did not previously have relief with at least three different types of pain medication, including opioids, and were considered “difficult-to-treat.” Patients with symptoms, signs, and x-ray evidence of moderate-to-severe osteoarthritis, a disorder commonly found in older patients with chronic low back pain, were excluded from the study. Tanezumab has not been associated with the often serious adverse side effects seen with opioids or nonsteroidal anti-inflammatory drugs (NSAIDs), which are often used to treat low back pain. However, this class of drugs has been linked to joint problems, which are sometimes serious enough to require joint replacement. Because of this concern, the researchers followed participants for an extended period and determined there was a low rate of serious joint problems requiring joint replacement. “In the future, clinicians may have to weigh the different risks of lumbar fusion surgery, chronic opioid use, or NSAIDs against the unique risks of a rare but rapidly progressive form of joint problem associated with blocking nerve growth factor. I expect that that the tradeoffs between benefit and risk will be different for osteoarthritis than for chronic low back pain.” John Markman, M.D., Director of the Translational Pain Research Program in the University of Rochester Medical Center (URMC) Department of Neurosurgery. To read the original article click here.

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Scientists Discover an Antibody That Neutralizes the Coronavirus

AHA Publisher — Thu, 07 May 2020 07:00:21 +0000

Angela Betsaida B. Laguipo, BSN via News-Medical Net – The breakthrough is a significant step in the fight against COVID-19 because the scientists developed it from a single recovered cell, hence, the term monoclonal antibody. This means that the antibody is more potent in developing an effective treatment. To compare, the antibodies that have been extracted across the globe are all polyclonal. …Israel has been one of the most active countries in battling COVID-19, and has been successful in “flattening the curve.” The country has announced dozens of medical studies and technologies they are developing to contain the spread of the virus and treat those who are critically ill. Now, in a significant medical breakthrough, Israel’s Institute for Biological Research Institute (IIBRI) has wrapped up the development of a potential treatment for the coronavirus disease. The scientists say they have identified an antibody that neutralizes SARS-CoV-2 in vitro or outside of a living organism. Identifying an Antibody Against SARS-CoV-2 Israel’s Defense Minister Naftali Bennett said he witnessed a significant breakthrough accomplished by the IIBR in moving towards an antibody against the dreaded virus. The team had already completed the developmental phase and is now preparing for the mass-production of the potential treatment after obtaining a patent for the discovery. Bennett visited the laboratories of the IIBR, a secretive unit that works under the auspices of the office of the Prime Minister. The team shows how the antibody can attack the virus in a monoclonal way and can neutralize it. Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance, or mimic the immune system’s attack on cancer cells. They are designed to bind to antigens that are generally more numerous on the surface of cancer cells than healthy cells. Statement from the Israel Ministry of Defense 3 key parameters: The antibody is monoclonal, new and refined, and contains an exceptionally low proportion of harmful proteins The antibody is able to neutralize the coronavirus The antibody was specifically tested on the aggressive coronavirus “Based on comprehensive scientific publications from around the globe, it appears that the IIBR is the first institution to achieve a scientific breakthrough that meets all three aforementioned parameters simultaneously,” Bennett said in a statement. The IIBR has been leading Israel’s efforts to develop a vaccine and treatment for the novel coronavirus, including testing of blood from those who have already recovered. Antibodies in the samples taken from recovered patients are now being studied for their potential as a possible cure for COVID-19. Antibodies are immune system proteins that are residues of the body’s successful fight against a pathogen. The breakthrough is a significant step in the fight against COVID-19 because the scientists developed it from a single recovered cell, hence, the term monoclonal antibody. This means that the antibody is more potent in developing an effective treatment. To compare, the antibodies that have been extracted across the globe are all polyclonal. Promising Milestone IIBR is now working to patent its antibody discovery, possibly landing a contract for its commercial development. If the antibody continues to show promise as a cure for the coronavirus disease, it will make a significant impact across the affected countries, particularly the hardest-hit countries in Europe. “This is an important milestone, which will be followed by a series of complex tests and a process of regulatory approvals. That said, the scientists at the institute believe that the nature of this breakthrough could lead to a shortening of the process, which could span over several months,” Bennett added. The IIBR has not only developed the antibody against the novel coronavirus, but it was also involved in collecting plasma from recovered patients in an attempt to aid in research. It has also taken part in the progress of developing a vaccine, along with MigVax, an affiliate of the MIGAL Galilee Research Institute. The scientists have reported being close to completing the first phase of developing a potent coronavirus vaccine. The institute is working tirelessly to find a cure for the novel coronavirus, which has infected more than 16,000 in the country and has killed at least 238. The IIBR and the town of Yeoham plan to open the country’s first vaccine production facility. They will team up with two international pharmaceutical companies and present the plan for the quick establishment of the facility if the Israeli government provides approval. The coronavirus global pandemic has now affected more than 187 countries and territories. North American and Europe reported the highest number of infections. The high infection rate of the pathogen is driving scientists to race in developing effective vaccines and treatments for the infection. Now, the United States has the highest number of infections… This article has been modified. To read the original article click here.

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