Neurotoxicity

Eisai: FDA Grants Traditional Approval for LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Friday, July 7, 2023
Amyloid-related imaging abnormalities, Insurance, Disease, CMS, Clinical trial, PCNS, The New England Journal of Medicine, Deficit spending, Research, Today, MCI, Neurotoxicity, Committee, Medicare, Clarity, ARIA, HIV disease progression rates, Patient, Immunoglobulin G, Co-promotion, Diagnosis, Lecanemab, AD, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, ADCS, Conditional sentence, Pharmaceutical industry, Alzheimer's disease, Biogen, Eisai

Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.

Key Points: 
  • Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.
  • LEQEMBI treatment reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.
  • Importantly, following FDA's traditional approval of LEQEMBI, CMS confirmed that broader coverage of LEQEMBI is now available and released more details on the registry, including the easy-to-use data submission process.
  • "Today, the FDA approved LEQEMBI under the traditional approval pathway, making LEQEMBI the first and only approved anti-amyloid Alzheimer's disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease.

Eisai Files Marketing Authorization Application for Lecanemab as Treatment For Early Alzheimer's Disease in South Korea

Retrieved on: 
Thursday, June 8, 2023
Disease, Alzheimer's disease, Ministry of Food and Drug Safety, BIIB, Lecanemab, MFDS, Brain, The Different Forms of Flowers on Plants of the Same Species, Ministry, Clarity, Eisai, Co-promotion, AD, Neurotoxicity, Pharmaceutical industry, Biogen, Food

This application is the first application for lecanemab in Asia outside of Japan and China.

Key Points: 
  • This application is the first application for lecanemab in Asia outside of Japan and China.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
  • Lecanemab, Aducanumab, and Gantenerumab - Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer's Disease.

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Great Britain

Retrieved on: 
Saturday, May 20, 2023
Health care, Lecanemab, Brain, Marketing, Clarity, Eisai, Co-promotion, MAA, Innovation, AD, Neurotoxicity, Alzheimer's disease, Disease, MHRA, Pharmaceutical industry, Biogen

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
  • As such, lecanemab may have the potential to have an effect on disease pathology and the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Phyllodulcin Could be a Potential Candidate for Treating Alzheimer's Disease, Find Sahmyook University Researchers

Retrieved on: 
Friday, July 28, 2023
Rapunzel's Tangled Adventure (season 2), Male, Biomedicine, Pathology, Deficit spending, Traffic barrier, Brain, Research, Cell, Astrocyte, Assistant, Dementia, Polyphenol, Sahmyook University, Amnesia, Mouse, Microglia, Neurotoxicity, Alzheimer's disease, Hippocampus, Disease, Pharmaceutical industry, Vaccine

Brain lesions caused by the aggregation of amyloid β (Aβ) and neurofibrillary tangles are believed to be the main cause of AD.

Key Points: 
  • Brain lesions caused by the aggregation of amyloid β (Aβ) and neurofibrillary tangles are believed to be the main cause of AD.
  • While many drugs targeting Aβ have been developed, they have failed to demonstrate efficacy in clinical trial studies.
  • Moreover, the use of approved antibody drugs is associated with high costs of treatment and uncertain efficacy.
  • Therefore, developing a simple and efficient drug that targets Aβ for the treatment of AD is needed.

Continued Positive Performance of Novel Drug Development by Annovis Bio Presented at 2023 Alzheimer's Association International Conference

Retrieved on: 
Tuesday, July 18, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Cognition, Axonal transport, Neuron, Human, University, PD, Bio, Neurodegenerative disease, Trial of the century, Brain, Inflammation, Neurotoxicity, Movement, University of Washington School of Medicine, II, AAIC, Protein, Clinical trial, Patient, Nervous system, Mouse, APP, AD, III, Conference, NYSE, Mutation, ADCS, Kinetics, Pharmaceutical industry, Vaccine, Medical device, Buntanetap

Annovis’ drug acts through a novel mechanism of action that inhibits all the major neurotoxic proteins responsible for AD and PD even before they are produced.

Key Points: 
  • Annovis’ drug acts through a novel mechanism of action that inhibits all the major neurotoxic proteins responsible for AD and PD even before they are produced.
  • This contrasts with other companies’ AD and PD drugs which remove only one of the toxic proteins after it is produced.
  • The combined findings from the posters tell the story of an exceptionally promising treatment for neurodegenerative disease such as AD and PD.
  • Cheng Fang , Ph.D., senior vice president of research and development at Annovis Bio, presented two posters at AAIC.

IGC Reports Financial Results for Fiscal Year Ended March 31, 2023

Retrieved on: 
Wednesday, July 12, 2023
Biotechnology, Alternative Medicine, FDA, Health, Cannabis, Pharmaceutical, Mental Health, Natural Resources, Research, Science, Clinical Trials, Epilepsy, Seizure, Commissioner, Human, University, USF, Marketing, Neurotoxicity, Fiscal, Calendar, European Patent Office, Cannabinoid, Amnesia, Composition, Nursing, Dementia, Amyloid, Patent, Patient, Animal, Dog, European Patent Convention, IGC, Medicine, Mouse, Growth, P&O Bank, Health Canada, Death, THC, NYSE, Agitation, Cat, Pharmaceutical industry, CBD

IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC), a clinical-stage pharmaceutical company, today announced its financial results for the fiscal year ended March 31, 2023 (“Fiscal 2023”).

Key Points: 
  • IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC), a clinical-stage pharmaceutical company, today announced its financial results for the fiscal year ended March 31, 2023 (“Fiscal 2023”).
  • On March 8, 2023, the Company filed a provisional patent application with the USPTO titled “Composition, Synthesis, and Medical Use of Hybrid Cannabinoid”.
  • Ram Mukunda, CEO of IGC, commented, “Fiscal 2023 was characterized by remarkable growth and progress as we continue to advance our drug formulations through FDA trials.
  • Net loss for Fiscal 2023 was approximately $11.5 million or $0.22 per share, compared to approximately $15 million or $0.30 per share for Fiscal 2022.

Alzheon to Present Baseline Imaging Characteristics from Ongoing APOLLOE4 Phase 3 Trial of Oral Tablet ALZ-801 (Valiltramiprosate) and Positive Biomarker/Clinical Correlations from Phase 2 Biomarker Study at AAIC in Amsterdam

Retrieved on: 
Tuesday, July 11, 2023
Research, Other Health, General Health, Pharmaceutical, Biometrics, Mental Health, Clinical Trials, Science, Neurology, Biotechnology, FDA, Health, Other Science, Genotype, Atrophy, MH, Cerebral amyloid angiopathy, CAA, Prevalence, Pathology, NDA, Black box, COVID, Siderosis, Biomarker, MCI, Doctor of Philosophy, Female, Mild, Common, Blood, Plasma, MRI, Alzheimer's disease, ARIA, Occipital bone, Magnetic resonance imaging, Cortex, MD, Patient, Risk, Horseshoe kidney, CEST, Lateral ventricles, Composite, Medicine, Drug development, Oral, AD, Cerebral edema, MMSE, Conference, Neurotoxicity, Safety, Disease, Pharmaceutical industry, Medical imaging, APOE4, Alzheon, Early

ALZ-801 (valiltramiprosate) is an investigational oral disease-modifying therapy in Phase 3 development for the treatment of Early AD.

Key Points: 
  • ALZ-801 (valiltramiprosate) is an investigational oral disease-modifying therapy in Phase 3 development for the treatment of Early AD.
  • In mechanism-of-action studies, ALZ-801 fully blocked the formation of neurotoxic soluble beta amyloid (Aβ) oligomers at the Phase 3 clinical dose.
  • This population is the focus of Alzheon’s pivotal Phase 3 APOLLOE4 trial , which is now fully enrolled and will be completed in the third quarter of 2024.
  • We look forward to communicating the final 24-month data from our Phase 2 study later in 2023.”

Cartesian Therapeutics Announces Landmark Study in The Lancet Neurology of First Successful Clinical Trial of RNA Cell Therapy in Autoimmunity

Retrieved on: 
Thursday, June 22, 2023
Research, Neurology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, University, Therapy, Lancet Neurology, Phase II, Neurotoxicity, Efficacy, Immunoglobulin therapy, Clinical trial, Bone marrow, Oregon Health & Science University, NIH, Chapel Hill, DRS, University of South Florida, Myasthenia gravis, RNA, Autoimmunity, University of Miami, Bangladesh Technical Education Board, CAR, DSM-IV codes, National Institute of Neurological Disorders and Stroke, Cytokine release syndrome, MG, Patient, Physician, Northwestern Health Sciences University, Autotransplantation, NINDS, Paper, Toxic encephalopathy, American Neurological Association, Immunosuppression, Myasthenia, The Lancet, Lancet, Safety, Pharmaceutical industry, Vaccine, Stroke, Cartesian

Cartesian Therapeutics , a clinical-stage biotechnology company pioneering cell therapies for autoimmune diseases, announced today the publication of a landmark paper in The Lancet Neurology.

Key Points: 
  • Cartesian Therapeutics , a clinical-stage biotechnology company pioneering cell therapies for autoimmune diseases, announced today the publication of a landmark paper in The Lancet Neurology.
  • The study describes Descartes-08, a cutting-edge RNA CAR-T (rCAR-T) therapy administered to patients with generalized myasthenia gravis (MG), a debilitating autoimmune neurological disease.
  • This is the first clinical trial using rCAR-T to treat autoimmunity, and the first successful Phase 2 trial using an engineered cell therapy to treat autoimmunity.
  • Clinical benefit was sustained long-term for most patients, even months after completing the course of therapy.

Nkarta Presents NKX019 Clinical Data at the European Hematology Association 2023 Congress and 17th International Conference on Malignant Lymphoma

Retrieved on: 
Saturday, June 10, 2023
Graft-versus-host disease, Royal Melbourne Hospital, CD19, European Hematology Association, CRS, ICML, Lymphoma, NHL, Histology, NK, Toxicity, CAR, Asilomar International Conference on Climate Intervention Technologies, Patient, Mantle cell lymphoma, SAN, The Retreat, EHA, Biology, MCL, Conference, Neurotoxicity, Pharmaceutical industry, Lead

SOUTH SAN FRANCISCO, Calif., June 10, 2023 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced presentations highlighting preliminary data based on a November 2022 data cut-off from its Phase 1 dose escalation clinical trial of NKX019 at two scientific conferences: the European Hematology Association (EHA) 2023 Hybrid Congress and the 17th International Conference on Malignant Lymphoma (17-ICML).

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., June 10, 2023 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced presentations highlighting preliminary data based on a November 2022 data cut-off from its Phase 1 dose escalation clinical trial of NKX019 at two scientific conferences: the European Hematology Association (EHA) 2023 Hybrid Congress and the 17th International Conference on Malignant Lymphoma (17-ICML).
  • NKX019 is an allogeneic, off-the-shelf NK cell therapy candidate derived from healthy donors and engineered to target CD19.
  • The presentations will ensure that the broader clinical and academic community has the opportunity to assess the NKX019 clinical data in a peer-reviewed format.
  • Nkarta plans to provide an update from the NKX019 program, including data from dose expansion cohorts, in 2023.

Innovative Cellular Therapeutics (ICT) Presented Data at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting

Retrieved on: 
Wednesday, May 24, 2023
Gene, Diarrhea, CRS, RECIST, Clinical trial, Neurotoxicity, CAR, ICT, Hospital, Cytokine release syndrome, Patient, Cell, American Society of Gene and Cell Therapy, Society, ORR, Safety, Pharmaceutical industry

ROCKVILLE, Md., May 24, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual meeting in Los Angeles, California.

Key Points: 
  • ROCKVILLE, Md., May 24, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual meeting in Los Angeles, California.
  • ICT presented GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in an oral presentation.
  • Thirteen patients were enrolled in dose level 1 (1x106 cells/kg) and 8 patients were enrolled in dose level 2 (2x106 cells/kg).
  • GCC19CART is now in clinical development in the U.S. and is on track to complete Phase 1 dose escalation clinical trial this year.