Amyloid

NKGen Biotech Presents Additional Phase 1 Clinical Trial Data in Alzheimer’s Disease at the Tau2024 Global Conference

Retrieved on: 
Monday, March 25, 2024
Plasma, Conference, Tau, Cell, Disease, CSF, Patient, Biomarker, Research, Median, Asian literature, ADAS-Cog, Tau protein, Safety, NK, Amyloid, Pharmaceutical industry

SANTA ANA, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (“NK”) cell therapeutics, today presented additional Phase 1 clinical trial data on the use of its investigational autologous NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (“AD”) at the Tau2024 Global Conference in Washington, D.C.

Key Points: 
  • The additional Phase 1 SNK01 trial data suggest clinical activity regarding cognitive function in patients with advanced Alzheimer’s disease in addition to previously disclosed positive effects on amyloid protein and neuroinflammation biomarkers.
  • Cognitive assessments and CSF/plasma pTau217 and pTau181 analyses were performed at baseline and at 1 and 12 weeks after the final dose.
  • “The data presented today demonstrate additional beneficial effects of SNK01 for the treatment of Alzheimer’s disease,” commented Paul Y.
  • While the results were positive, the Phase 1 trial was a dose-escalation trial that only administered four total doses over 11 weeks.

Arctic Therapeutics and Nacuity Pharmaceuticals Announce European Medicines Agency Approval to Initiate First Clinical Trial of AT-001 (NPI-001) for the Treatment of HCCAA

Retrieved on: 
Tuesday, March 12, 2024
Retinitis pigmentosa, Disease, Partnership, Tablet, SVP, Stroke, Deficit spending, EMA, Cystinosis, GMP, European Medicines Agency, Clinical trial, Intraparenchymal hemorrhage, NACA, Safety, CSO, Cataract, Usher syndrome, Dementia, Oxidative stress, Amyloid, Service provider, Pharmaceutical industry

Current treatment options are severely limited, focusing primarily on symptom management rather than addressing the underlying cause of the disease.

Key Points: 
  • Current treatment options are severely limited, focusing primarily on symptom management rather than addressing the underlying cause of the disease.
  • “EMA's approval paves the way for a comprehensive investigation into the safety and efficacy of a novel therapeutic approach designed to halt or reverse the progression of HCCAA.
  • Nacuity is also currently evaluating NPI-001 in Phase 1/2 clinical trials in Australia for retinitis pigmentosa associated with Usher syndrome and cystinosis.
  • “Our proprietary NPI-001 has potential to address the myriad diseases and conditions where oxidative stress plays a role.

AltPep Study Published in Nature Journal, Scientific Reports, Further Affirms Potential of Blood Test to Detect Alzheimer's Disease

Retrieved on: 
Friday, April 5, 2024
Research, Neurology, Publishing, Communications, Clinical Trials, Biotechnology, Managed Care, Health, Science, Plasma, Scientific Reports, Patient, University, Amyloid, Neuropathology, MCI, Pharmaceutical industry

The data, consistent with an earlier study , further support the potential value of the SOBA-AD test as a promising blood-based tool for the selective detection and confirmation of AD.

Key Points: 
  • The data, consistent with an earlier study , further support the potential value of the SOBA-AD test as a promising blood-based tool for the selective detection and confirmation of AD.
  • The SOBA-AD blood test targets toxic soluble oligomers, an early molecular trigger of amyloid diseases, with the ultimate goal of identifying patients with the disease years before symptoms manifest.
  • The SOBA-AD blood test identified AD patients from cognitively unimpaired (CU) subjects with 100% sensitivity, >95% specificity, and >98% area under the curve (95% CI 0.95-1.00).
  • These results for our simple SOBA-AD blood test support the goal of earlier, pre-symptomatic detection of patients with AD.

Peer-Reviewed Scientific Publication Proposes Unifying Single Toxin Theory of Brain Neurodegeneration that Identifies New Drug Targets and Treatments for Alzheimer’s Disease and Other Neurodegenerative Disorders

Retrieved on: 
Tuesday, March 26, 2024
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Toxicity, Brain, DSM-IV codes, APOE4, Patient, Biomarker, NDA, Standard of care, Prion, Doctor of Philosophy, MD, Protein, Neurotoxicity, Genotype, Treatment, Safety, ALS, Canadian International Council, Amyloid

In addition, our single toxin theory of brain neurodegeneration identifies new targets and approaches for the development of disease-modifying treatments,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.

Key Points: 
  • In addition, our single toxin theory of brain neurodegeneration identifies new targets and approaches for the development of disease-modifying treatments,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.
  • The application of biomarkers, in particular p-tau, synaptic markers, and brain volumetrics for the evaluation of disease course and therapeutic efficacy in AD trials.
  • Other neurodegenerative disorders follow the same pattern of protein dysregulation, impaired clearance, and increased aggregation, leading to neurotoxicity and loss of function.
  • In these diseases, a normal essential protein starts accumulating in the brain, misfolding and aggregating into soluble oligomers.

New Research Shows the PrecivityAD2™ Blood Test Has High Accuracy Compared to Amyloid PET Scans in Individuals with Cognitive Impairment

Retrieved on: 
Monday, March 18, 2024
Mental Health, Managed Care, Medical Devices, Hospitals, Neurology, Science, Medical Supplies, Clinical Trials, Biotechnology, Health, Health Technology, Health Insurance, Other Science, Research, Radiology, Pharmaceutical, Seniors, Radiation, APS2, Certification, Brain, Alzheimer's disease, Deficit spending, Disease, Memory, AUC, Patient, Ageing, PET, Journal, Apolipoprotein, City, CLIA, Pathology, Medicare, Amyloid, Medical imaging

The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2 (APS2), was 0.94, yielding 88% agreement with brain amyloid status based on a single cut-off value.

Key Points: 
  • The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2 (APS2), was 0.94, yielding 88% agreement with brain amyloid status based on a single cut-off value.
  • The APS2 result was the most robust method among the individual plasma amyloid and tau analytes measured to identify disease.
  • In the published study, the PrecivityAD2 blood test was clinically validated in 583 individuals with cognitive impairment across two independent cohorts.
  • C₂N is working toward obtaining the requisite certification that will permit the PrecivityAD2 test to be available in New York in the near future.

Public Comment Period Opens for the “Workup of Amyloidosis” Guideline

Retrieved on: 
Wednesday, March 13, 2024
Education, Managed Care, Health, General Health, Pharmaceutical, Oncology, Other Science, Training, Science, Other Education, Clinical Trials, Amyloid, College, Quality of life, Laboratory, Marie Cassidy, Diagnosis, Patient, Cardiology, Nursing, Disease, CAP, Amyloidosis

—The draft statements are available for public comment through April 3, 2024 on cap.org .

Key Points: 
  • —The draft statements are available for public comment through April 3, 2024 on cap.org .
  • “This process ensures tailored care, early detection, and ongoing optimization of treatment strategies for individuals with amyloidosis,” adds co-chair Billie S. Fyfe-Kirschner, MD, FCAP.
  • Following the open comment period, the guideline authors will consider all feedback to finalize the statements.
  • The final statements will appear in the guideline manuscript and will be available at no cost.

Beckman Coulter and Fujirebio Expand Partnership to Develop Patient-friendly, Blood-based Neurodegenerative Disease Diagnostics

Retrieved on: 
Tuesday, March 12, 2024
Research, Clinical Trials, Health Technology, Biotechnology, Biometrics, Other Health, Health, Other Science, Science, Neurodegenerative disease, Fujirebio, DirectX, Partnership, Patient, Biomarker, RUO, IVD, Beckman Coulter, Apolipoprotein E, Therapy, Physician, AFL, Amyloid, Medical imaging

Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced an expansion of their partnership focused on development, manufacturing and clinical adoption of neurodegenerative disease assays.

Key Points: 
  • Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced an expansion of their partnership focused on development, manufacturing and clinical adoption of neurodegenerative disease assays.
  • In 2023, Beckman Coulter and Fujirebio entered into a collaboration agreement focused on new biomarkers aligned with recently approved monoclonal antibody-based Alzheimer’s disease therapeutics.
  • These new assays are being developed for use on the recently introduced Beckman Coulter DxI 9000 Immunoassay Analyzer.
  • Kevin O’Reilly, President, Beckman Coulter Diagnostics, commented, “We are very excited by our expanded partnership with Fujirebio designed to overcome challenges of developing highly sensitive assays, measuring ultra-low concentrations of neurodegenerative disease biomarkers circulating in the blood stream.”
    “Our expanded partnership with Beckman Coulter will enable increased laboratory, clinician and patient access to more neurodegenerative biomarkers around the world,” stated Monte Wiltse, President & CEO, Fujirebio Diagnostics, Inc. “We look forward to continued collaboration with Beckman Coulter bringing these critical assays to physicians and patients worldwide.”

BioArctic: Professor Lars Lannfelt, awarded Fondation Recherche Alzheimer's European Grand Prix for his contributions to science and treatment of Alzheimer's disease

Retrieved on: 
Tuesday, March 19, 2024
Diagnosis, Amyloid, Brain, Disease, Eisai, Patient, Research, European Grand Prix

"Being able to give hope and contribute to the treatment of patients affected by Alzheimer's disease is what has driven me throughout my research life," said Professor Lars Lannfelt.

Key Points: 
  • "Being able to give hope and contribute to the treatment of patients affected by Alzheimer's disease is what has driven me throughout my research life," said Professor Lars Lannfelt.
  • Professor Lars Lannfelt founded BioArctic together with Pär Gellerfors in 2003 to develop an antibody treatment based on Lannfelt's groundbreaking discoveries of the role of amyloid-beta protein in Alzheimer's disease.
  • By binding to specific forms of amyloid-beta, which causes Alzheimer's disease, lecanemab helps to clear them from the brain, thereby altering the course of the disease.
  • La Fondation Recherche Alzheimer was founded in 2004 and aims to improve the diagnosis of Alzheimer's disease and pave the way for effective treatments.

BioArctic: Professor Lars Lannfelt, awarded Fondation Recherche Alzheimer's European Grand Prix for his contributions to science and treatment of Alzheimer's disease

Retrieved on: 
Tuesday, March 19, 2024
Diagnosis, Amyloid, Brain, Disease, Eisai, Patient, Research, European Grand Prix

"Being able to give hope and contribute to the treatment of patients affected by Alzheimer's disease is what has driven me throughout my research life," said Professor Lars Lannfelt.

Key Points: 
  • "Being able to give hope and contribute to the treatment of patients affected by Alzheimer's disease is what has driven me throughout my research life," said Professor Lars Lannfelt.
  • Professor Lars Lannfelt founded BioArctic together with Pär Gellerfors in 2003 to develop an antibody treatment based on Lannfelt's groundbreaking discoveries of the role of amyloid-beta protein in Alzheimer's disease.
  • By binding to specific forms of amyloid-beta, which causes Alzheimer's disease, lecanemab helps to clear them from the brain, thereby altering the course of the disease.
  • La Fondation Recherche Alzheimer was founded in 2004 and aims to improve the diagnosis of Alzheimer's disease and pave the way for effective treatments.

San Diego Alzheimer's Partners Come Together

Retrieved on: 
Monday, March 18, 2024
Research, Partner, Aisén, Brain, MRI, Disease, CSF, SHARP, Diabetes, SAN, PET, Cerebrospinal fluid, Molina Healthcare, ACTC, Blood, Collection, Dementia, Amyloid, CBS 8

SAN DIEGO, March 18, 2024 /PRNewswire/ -- The Alzheimer's Therapeutic Research Institute (ATRI) and over a half-dozen of San Diego's Alzheimer's partners invite the community to a free event on March 23, 2024. A Day of SCervice, in support of accelerating Alzheimer's disease (AD) research through blood testing. Though the entire San Diego community is invited to visit ATRI and learn about new advances in AD research, those attending who are over the age of 55 and interested in participating in AD clinical trials can consent and, if eligible, have their blood drawn that day.

Key Points: 
  • SAN DIEGO, March 18, 2024 /PRNewswire/ -- The Alzheimer's Therapeutic Research Institute (ATRI) and over a half-dozen of San Diego's Alzheimer's partners invite the community to a free event on March 23, 2024.
  • Local CBS 8 news anchor and Alzheimer's San Diego Board Chair, Carlo Cecchetto, will moderate the morning panel.
  • "March 23 is also Day of SCervice, and the San Diego Trojan Family will be making a difference," said Shelley Moore, President-Elect of the San Diego Trojan League of San Diego County.
  • These clinical trials are vital to the work we do," said Janet Hamada-Kelley, Executive Director of the Alzheimer's Association San Diego & Imperial County an one of the event partners.