Fetal Alcohol Spectrum Disorders

SUNDAY, Aug. 4, 2024 -- It's a question many women may ask themselves during pregnancy: Will an occasional glass of wine harm the baby? While the latest research shows the answer is definitely yes for large quantities of alcohol or binge drinking, the answer is less clear for small amounts, although any alcohol consumption carries some risk, said Vidya Rajagopalan , a principal investigator at The Saban Research Institute of Children’s Hospital Los Angeles. Her research includes studying the development of a baby’s brain in utero using advanced MRI scans. Rajagopalan is also participating in the National Institutes of Health's HEALthy Brain and Child Development (HBCD) Study , which looks at the use of alcohol and other substances in pregnancies, she noted. What have they found so far? Studies clearly show that drinking large quantities of alcohol while pregnant does affect a baby’s health. “When pregnant women drink a lot of alcohol, they are at higher risk of having children with neuro-developmental problems,” Rajagopalan said. “The science shows that fetal alcohol spectrum disorders occur with heavy or binge drinking.” Such disorders involve a range of symptoms, including: Children with these disorders are more likely to have cognitive and behavioral issues, and they may also be at higher risk of developing alcohol or substance abuse problems later in their lives. But what about much smaller amounts of drinking during pregnancy ? “The general guideline of national organizations like the CDC and the American College of Obstetrics and Gynecology is that there is no safe limit,” Rajagopalan said. “There is no accepted scientific evidence showing that low levels of drinking are safe.” One reason for that is the fact that studies requiring pregnant women to drink alcohol wouldn't be feasible or ethical. “We can’t run tests that could potentially harm a baby or mother,” she noted. Another reason is that alcohol is only one of many factors that drive a baby’s development, Rajagopalan said. Genetic factors, the mother’s physical and mental health and environmental concerns also have to be taken into account. What should pregnant women do? Before deciding whether to have a drink or not, they should understand all of the risks, Rajagopalan said. “We don’t have a scientific way of proving that one glass of wine is OK,” she said. “I encourage women to discuss the risks with their provider and hold their provider responsible for giving them reliable information.” SOURCE: Children's Hospital Los Angeles, news release, July 25, 2024 Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (“IGC Pharma,” “IGC,” or the “Company”) (NYSE American: IGC) today announced that it has appointed Terry Lierman as an independent director to its board of directors. Mr. Lierman is currently Co-Chair of the Board of Advisors at the Institute of Human Virology (IHV), a center in the U.S. focused on accelerating the discovery of diagnostics and therapeutics for deadly viral and immune disorders and a member of the Board of Visitors at the La Follette School of Public Affairs at the University of Wisconsin, his alma mater. Terry founded the Children’s Research Institute, one of America's top children’s research programs, the Pancreatic Cancer Action Network (PanCAN), and the National Organization on Fetal Alcohol Syndrome (NOFAS). In addition, from 1987 to 1999, he served as a director/trustee of the NY Life-Mainstay Funds. His distinguished career includes serving at the National Institutes of Health (NIH), as the chief administrator for drug research and development at the National Cancer Institute (NCI), and as the Staff Director for the Committee on Appropriations at the U.S. Senate and the Chief of Staff and White House liaison to the U.S. House of Representative’s Majority Leader. Ram Mukunda, CEO of IGC Pharma, commented, “With his track record of execution and extensive experience in health care, Mr. Lierman will undoubtedly bring invaluable insights and strategic guidance to IGC Pharma. His appointment is pivotal for our Company as we advance our Phase 2 trial investigating IGC- AD1 as a treatment for agitation in dementia in Alzheimer’s and prepare our second AD candidate, TGR-63, for a Phase 1 clinical trial. We are eager to leverage Mr. Lierman’s expertise as we continue our mission to develop innovative therapeutics to address critical unmet medical needs.” Terry Lierman stated, “I am honored to be part of a company developing non-invasive solutions to address the challenges of Alzheimer’s disease and related central nervous system disorders. I am deeply impressed by IGC Pharma’s commitment to advancing research and development efforts, as evidenced by the ongoing Phase 2 trial of IGC-AD1 for agitation in Alzheimer’s disease, the preclinical analysis of TGR-63, and the Company’s artificial intelligence (AI) initiatives. The Company's dedication to improving the quality of life for millions affected by Alzheimer’s aligns perfectly with my lifelong passion for advancing healthcare initiatives. I look forward to collaborating with the talented team at IGC Pharma to drive forward the mission of bringing transformative therapies to patients in need.” About IGC Pharma Inc. (IGC): IGC Pharma Inc. (IGC) is at the forefront of the fight against Alzheimer's disease, developing innovative solutions to address this devastating illness. The company's mission is to transform the landscape of Alzheimer's treatment with a robust pipeline of five promising drug candidates. IGC-AD1 and LMP target the hallmarks of Alzheimer's disease, including neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently undergoing a Phase 2b clinical trial for agitation in dementia associated with Alzheimer's (clinicaltrials.gov, CT05543681). TGR-63 disrupts the progression of Alzheimer's by targeting Aβ plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer's. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer's therapy. In addition to its drug development pipeline, IGC Pharma is actively leveraging Artificial Intelligence (AI) for Alzheimer's research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer's. Forward-Looking Statements: This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma’s U.S. Securities and Exchange Commission ("SEC") filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, and Quarterly Report on Form 10-Q filed with the SEC on February 14, 2024, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. View source version on businesswire.com: Contacts Investors IMS Investor Relations Rosalyn Christian igc@imsinvestorrelations.com (203) 972-9200 Media JVPRNY Janet Vasquez jvasquez@jvprny.com (212) 645-5498 Source: IGC Pharma, Inc. View this news release online at:

New research has now demonstrated that it takes much longer than previously believed, longer than a month, for the effects of alcohol consumption to leave the father's sperm. Because of this, it's crucial that couples planning on getting pregnant know how far in advance to stop drinking in order to prevent birth defects. Researchers at Texas A&M University have already shown that paternal drinking habits prior to conception can have a negative effect on fetal development -- with semen from men who regularly consume alcohol impacting placenta development, fetal alcohol syndrome (FAS)-associated brain and facial defects, and even IVF outcomes. In an article published this month in Andrology, the lab of Dr. Michael Golding has now demonstrated that it takes much longer than previously believed, longer than a month, for the effects of alcohol consumption to leave the father's sperm. "When someone is consuming alcohol on a regular basis and then stops, their body goes through withdrawal, where it has to learn how to operate without the chemical present," said Golding, a professor in the School of Veterinary Medicine & Biomedical Sciences' Department of Veterinary Physiology & Pharmacology. "What we discovered is that a father's sperm are still negatively impacted by drinking even during the withdrawal process, meaning it takes much longer than we previously thought for the sperm to return to normal." The Dangers Of Paternal Drinking One of the major risks associated with alcohol consumption before and during pregnancy is FAS, which causes abnormal facial features, low birth weight and/or height, attention and hyperactivity issues, and poor coordination. Currently, doctors are required to confirm only that the mother has consumed alcohol -- not the father -- to diagnose a child with FAS. "For years, there's really been no consideration of male alcohol use whatsoever," Golding said. "Within the last five to eight years, we've started to notice that there are certain conditions where there's a very strong paternal influence when it comes to alcohol exposure and fetal development. "With this project, we wanted to see how long it would take for the effects of alcohol on sperm to wear off," he said. "We thought it would be a relatively quick change back to normal, but it wasn't. The withdrawal process took over a month." When drinking alcohol, an individual's liver experiences oxidative stress, leading the body to overproduce certain chemicals, which then interrupts normal cellular activity. Golding's team discovered that withdrawal causes the same kind of oxidative stress, effectively lengthening the duration of alcohol's effects on the body beyond what was previously thought. "During withdrawal, the liver experiences perpetual oxidative stress and sends a signal throughout the male body," Golding said. "The reproductive system interprets that signal and says, 'Oh, we are living in an environment that has a really strong oxidative stressor in it. I need to program the offspring to be able to adapt to that kind of environment.' But Golding suspects that the adaptations to the sperm aren't beneficial -- they lead to problems like FAS." He also noted that it doesn't take excessive alcohol use for a person to experience withdrawal. "In the models we're using, even drinking three to four beers after work several days a week can induce withdrawal when the behavior ceases," Golding said. "You may not feel inebriated, but your body is going through chemical changes." Changing The Narrative Golding's work is vital to improving pregnancy outcomes by changing the conversation about who is responsible for alcohol-related birth defects, since society has historically placed all blame on mothers, even when they do not consume alcohol during their pregnancy. "There's psychological trauma associated with the question, 'Did you drink while you were pregnant?' It's also difficult for physicians to have that conversation," he said. "But if they don't, then FAS doesn't get diagnosed right away and the child may not get the support that they need until later in life." Because of this, it's crucial that couples planning on getting pregnant know how far in advance to stop drinking in order to prevent birth defects. While Golding and his lab will continue to research the effects of paternal drinking to help doctors advise couples, he suggests that fathers abstain from alcohol at least three months prior to conceiving, given this groundbreaking discovery. "There's still a lot of work to be done to get a hard answer, but we know that sperm are made over the course of 60 days, and the withdrawal process takes at least one month," he said. "So, my estimate would be to wait at least three months."