Neonatal encephalopathy

External heart rate monitoring, the most common method of monitoring the fetus, may leave signs of fetal hypoxia undetected if the maternal pulse rate is not simultaneously monitored. The risk is that the fetal heart rate is masked by the maternal pulse, with fetal distress going unnoticed. Cardiotocography (CTG) refers to the electronic recording of the fetal heart rate and uterine contractions. Fetal heart rate recorded through the mother's abdomen is the most commonly used fetal monitoring method during childbirth. Now, a research team from the University of Helsinki and Helsinki University Hospital (HUS) has found that external fetal heart rate monitoring without simultaneous maternal pulse recording is associated with both an increased risk of neonatal encephalopathy and acidemia in fetal umbilical artery blood, i.e., critically low pH and base excess concentrations. Acidemia increases the need for newborn resuscitation and the length of intensive care. The study, published in the esteemed American Journal of Obstetrics and Gynecology, analysed almost 214,000 spontaneous full-term births in HUS maternity hospitals between 2005 and 2023. The study included the largest CTG dataset ever published. The study demonstrated that a newborn monitored during labour with external fetal heart rate monitoring alone had a 1.6-fold risk of neonatal encephalopathy and a 2.3-fold risk of severe umbilical cord blood acidemia compared to those monitored with an internal electrode attached to the skin of the fetal head (internal monitoring) or by concurrent external fetal heart rate monitoring and maternal pulse recording. "Especially during the second stage of labour, when mothers tend to display increased heart rate while pushing, fetuses more commonly exhibit heart rate decelerations. Consequently, the fetal heart rate can be quite easily mixed with the maternal pulse, in which case abnormal fetal heart rate tracing, indicating fetal hypoxia, may go unnoticed by professionals," says Researcher Mikko Tarvonen, describing the challenges of external CTG monitoring. In the majority of the labours in the study (38%), solely external monitoring was used. Internal monitoring was the second most common method (33%), followed by external monitoring simultaneously with maternal pulse recording (29%). Years of safer practice at HUS The world's largest organisations of obstetricians and midwives recommend in their fetal monitoring guidelines that external fetal heart rate monitoring be used as the primary CTG registration method. However, the new study indicates that, without simultaneous maternal pulse recording, this method is a significant risk factor predisposing the fetus to labour-related hypoxia and its long-term neurological effects. "Based on our results, this tragedy can be effectively prevented by combining maternal pulse recording with fetal heart rate monitoring. This method allows professionals to be sure of whose heart rate they are monitoring," says Tarvonen. In 2019 HUS adopted a new protocol emphasising the necessity of recording maternal heart rate alongside fetal heart rate during childbirth. "Practices have long varied at Finnish maternity hospitals, but training and research evidence have resulted in a shift in attitudes and thus the increased use in recent years of maternal pulse monitoring," Tarvonen notes. The present study demonstrated that, based on the incidence of neonatal encephalopathy, external fetal heart rate monitoring combined with maternal heart rate recording is equally as safe as internal fetal monitoring. However, internal monitoring was the most accurate way of assessing fetal wellbeing. Its use was associated with the lowest incidence of hypoxia-related neonatal outcomes. The incidence of both neonatal encephalopathy and severe umbilical artery blood acidemia has decreased significantly in the HUS region during the study's 18-year follow-up period. "This trend is exceptional even by international standards," Tarvonen points out. Facts: Monitoring the wellbeing of the unborn child through cardiotocography (CTG)

Grant of Its Newest U.S. Patent Expands Anavex’s Intellectual Property Portfolio in Neurologic IndicationsNEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was granted new U.S. Patent No. 11,839,600 entitled “NEURODEVELOPMENTAL DISORDER THERAPY” from the United States Patent and Trademark Office (USPTO) for its patent application number 17/890,083. Anavex’s newest patent expands coverage of ANAVEX®2-73 (blarcamesine) therapy to ameliorate various conditions associated with loss-of-function mutations of the gene encoding methyl-CpG binding protein (MeCP2). The patent claims protect use of ANAVEX®2-73 (blarcamesine) to address a range of symptoms exhibited by patients suffering from neurodevelopmental and neurological conditions related to McCP2, such as abnormal breathing, abnormal cardiac function, abnormal feeding, abnormal choking, weight gain failure, abnormal sleep, seizures, abnormal gadolinium-enhancing lesions. Such conditions are frequently associated with diseases such as Rett syndrome, autism spectrum disorder, multiple sclerosis, cerebral palsy, Angelman syndrome, Williams syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), childhood disintegrative disorder, Smith-Magenis syndrome, non-syndromic mental retardation, idiopathic neonatal encephalopathy, and idiopathic cerebral palsy. This newest patent is expected to remain in force at least until January 2037, not including any patent term extension. “This new patent on use of ANAVEX®2-73 (blarcamesine) in ameliorating difficult symptoms associated with loss-of-function gene mutations of MeCP2 will be important for Anavex, further reinforcing our already strong position providing novel and effective therapies for debilitating neurodevelopmental and neurological diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We are pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine). The grant of this new patent to Anavex further demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our product portfolio.” About Neurodevelopmental Disorders Neurodevelopmental disorders refer to a group of conditions that affect the way the brain and nervous system develop. These disorders can cause changes to thinking, feeling, language, and physical abilities like movement and coordination. Neurodevelopmental conditions typically start before adulthood and may continue into adulthood. They are often associated with social impairments and difficulties in communication.1 The number of people globally with developmental intellectual disability was estimated at 107.62 million according to IHME, Global Burden of Disease (2019).2 About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information:Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: info@anavex.com Investors:Andrew J. BarwickiInvestor Relations Tel: 516-662-9461Email: andrew@barwicki.com 1 https://www.empowerbh.com/blog/what-are-neurodevelopmental-disorders/2 https://ourworldindata.org/neurodevelopmental-disorders

NEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was granted new U.S. Patent No. 11,839,600 entitled “NEURODEVELOPMENTAL DISORDER THERAPY” from the United States Patent and Trademark Office (USPTO) for its patent application number 17/890,083. Anavex’s newest patent expands coverage of ANAVEX®2-73 (blarcamesine) therapy to ameliorate various conditions associated with loss-of-function mutations of the gene encoding methyl-CpG binding protein (MeCP2). The patent claims protect use of ANAVEX®2-73 (blarcamesine) to address a range of symptoms exhibited by patients suffering from neurodevelopmental and neurological conditions related to McCP2, such as abnormal breathing, abnormal cardiac function, abnormal feeding, abnormal choking, weight gain failure, abnormal sleep, seizures, abnormal gadolinium-enhancing lesions. Such conditions are frequently associated with diseases such as Rett syndrome, autism spectrum disorder, multiple sclerosis, cerebral palsy, Angelman syndrome, Williams syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), childhood disintegrative disorder, Smith-Magenis syndrome, non-syndromic mental retardation, idiopathic neonatal encephalopathy, and idiopathic cerebral palsy. This newest patent is expected to remain in force at least until January 2037, not including any patent term extension. “This new patent on use of ANAVEX®2-73 (blarcamesine) in ameliorating difficult symptoms associated with loss-of-function gene mutations of MeCP2 will be important for Anavex, further reinforcing our already strong position providing novel and effective therapies for debilitating neurodevelopmental and neurological diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We are pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine). The grant of this new patent to Anavex further demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our product portfolio.” About Neurodevelopmental Disorders Neurodevelopmental disorders refer to a group of conditions that affect the way the brain and nervous system develop. These disorders can cause changes to thinking, feeling, language, and physical abilities like movement and coordination. Neurodevelopmental conditions typically start before adulthood and may continue into adulthood. They are often associated with social impairments and difficulties in communication.1 The number of people globally with developmental intellectual disability was estimated at 107.62 million according to IHME, Global Burden of Disease (2019).2 About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at . You can also connect with the Company on Twitter,Facebook, Instagram, and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information: Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: info@anavex.com Investors: Andrew J. Barwicki Investor Relations Tel: 516-662-9461 Email: andrew@barwicki.com 1 2