Cerebrospinal fluid

Development of Prediction Model for Brain Amyloid-Beta Accumulation Using Wristband Sensor

Retrieved on: 
fredag, december 29, 2023
CSF, Alzheimer's Research & Therapy, Alzheimer's disease, Dementia, Learning, Cerebrospinal fluid, Woman, Elastic net regularization, Heart rate, Sleep, Support vector machine, Hypertension, PET, Disease, Diabetes, Thyroid disease, Brain, Ageing, Risk, Stroke, Oita University, Faculty, Speech, Associate professor, Amyloid beta, Biomarker, Machine learning, Future Development, Manuscript, Transport, Patient, Medical school, Cardiovascular disease, MCI, AUC, Social isolation, Eisai, Area, Exercise, Medical imaging

TOKYO, Dec 29, 2023 - (JCN Newswire) - Oita University and Eisai Co., Ltd. (Eisai) hereby announce the development of the world's first machine learning model to predict amyloid beta*1 (Aβ) accumulation in the brain using a wristband sensor.

Key Points: 
  • TOKYO, Dec 29, 2023 - (JCN Newswire) - Oita University and Eisai Co., Ltd. (Eisai) hereby announce the development of the world's first machine learning model to predict amyloid beta*1 (Aβ) accumulation in the brain using a wristband sensor.
  • This model is expected to enable screening for brain Aβ accumulation, which is an important pathological factor of Alzheimer's disease*2 (AD), simply by collecting biological and lifestyle data from daily life.
  • The key to maximizing treatment effects of the medicine is detecting Abeta accumulation in the brain of patients with mild cognitive impairment before the onset of symptoms.
  • This machine learning model is able to predict brain Aβ accumulation using readily available non-invasive variables.

ResMed Notifies Customers About Updated Instructions and Labeling for Masks with Magnets Due to Potential Interference with Certain Medical Devices

Retrieved on: 
onsdag, december 20, 2023
Magnet, CSF, Neurostimulation, Patient, Mask, ASX, Contraindication, Cerebrospinal fluid, Death, FDA, ICD, Field line, SAN, RMD, Eye, Metallic, Stent, Letter, Use, ResMed, Electrode, Hearing, Medical device

This voluntary field correction does not require a return of a mask with magnets unless the patient is contraindicated.

Key Points: 
  • This voluntary field correction does not require a return of a mask with magnets unless the patient is contraindicated.
  • All ResMed masks containing magnets are safe when used in accordance with the Field Safety Notice and updated Instructions for Use in the guides of affected masks.
  • Refer to the ResMed Magnet Update website for more information about the updates issued to contraindications and warning labels.
  • ResMed voluntarily updated its contraindications and warning labels in response to new information obtained through post-market surveillance and industry practices.

Plus Therapeutics Partners With K2bio for Development of Novel Tests for Cerebrospinal Fluid (CSF) Tumor Cell and Molecular Biomarker Analyses

Retrieved on: 
tisdag, december 12, 2023
CSF, Patient, Ecosystem, Partnership, Neoplasm, Cerebrospinal fluid, Learning, PSTV, Cancer prevention, Caregiver, Research, FDA, Doctor of Philosophy, Cancer, Therapy, CNS, Texas Medical Center, LM, Plus Therapeutics, Central nervous system, Diagnosis, Rhenium, Fast Track, Research institute

This trial is currently receiving grant funding through The Cancer Prevention and Research Institute of Texas (CPRIT).

Key Points: 
  • This trial is currently receiving grant funding through The Cancer Prevention and Research Institute of Texas (CPRIT).
  • K2bio is based in Houston and is part of the Texas Medical Center life sciences ecosystem specializing in all aspects of translational cancer diagnostic and therapeutic research and development.
  • “K2bio is a leader in enabling rapid diagnostic and therapeutic progress for innovative companies such as Plus,” said Colby Suire, PhD, acting President and CEO of K2bio.
  • Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov ( NCT05034497 ).

Voyager Therapeutics Announces Selection of Development Candidate for SOD1 Amyotrophic Lateral Sclerosis Gene Therapy Program

Retrieved on: 
onsdag, december 6, 2023
Motor cortex, Food, ALS, Survival, Cerebrospinal fluid, IND, Plasma, Small RNA, Astrocyte, Spinal cord, Therapy, Animal, SOD1, Biomarker, Neurology, Neuron, Pharmaceutical industry

LEXINGTON, Mass., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to breaking through barriers in gene therapy and neurology, today announced that it has selected a lead development candidate for its superoxide dismutase 1 (SOD1)-mutated amyotrophic lateral sclerosis (ALS) gene therapy program.

Key Points: 
  • LEXINGTON, Mass., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to breaking through barriers in gene therapy and neurology, today announced that it has selected a lead development candidate for its superoxide dismutase 1 (SOD1)-mutated amyotrophic lateral sclerosis (ALS) gene therapy program.
  • The Company anticipates filing an investigational new drug (IND) application with the Food and Drug Administration for the candidate in mid-2025.
  • Voyager’s SOD1-ALS lead candidate combines a highly potent siRNA construct to decrease the expression of SOD1 with an IV-delivered, blood-brain barrier-penetrant TRACER™ capsid.
  • The candidate demonstrated robust knockdown of SOD1 across all levels of the spinal cord and motor cortex.

ProMIS Neurosciences Doses First Subjects in Phase 1a Clinical Trial of PMN310 to Treat Alzheimer’s Disease

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måndag, november 20, 2023
CSF, ALS, MSA, Medicine, Cerebrospinal fluid, Neuroscience, Multiple system atrophy, Plasma, PMN, Biomarker, Patient, Safety, MCI, Plaque, Therapy, Pharmaceutical industry

“Initiation of this milestone study of PMN310 marks our transition to a clinical stage company.

Key Points: 
  • “Initiation of this milestone study of PMN310 marks our transition to a clinical stage company.
  • We are excited to bring our precision medicine approach into the clinic in hopes of developing better therapeutics for neurodegenerative diseases,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences.
  • “Results from the Phase 1a study will facilitate dose selection for subsequent Phase 1b study in patients with Mild Cognitive Impairment (MCI) due to AD and patients with mild AD.
  • In addition, our Phase 1b study will provide important insights into the safety profile of PMN310, which we anticipate may differentiate PMN310 from other available and potentially disease-modifying treatments.”

NKGen Biotech, Inc. Reports Third Quarter 2023 Financial Results and Business Highlights

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tisdag, november 14, 2023
Alzheimer's disease, Business analyst, Microsoft PowerPoint, IND, Clinical trial, CSF, Patient, GFAP, Intellectual property, Research, Week, FDA, Glial fibrillary acidic protein, G&A, Conference, Cerebrospinal fluid, R, Loss, NK, Traffic barrier, Medical device, Pharmaceutical industry, Security (finance), Graf

SANTA ANA, Calif., Nov. 14, 2023 (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 announced its financial results for the third quarter ended September 30, 2023, and provided business highlights.

Key Points: 
  • 90% of patients demonstrated improvement or maintained stable cognitive function as per Alzheimer’s disease composite score (ADCOMS) following 11 weeks.
  • Research and development (R&D) expenses: R&D expenses for the third quarter of 2023 were $3.9 million compared to $4.1 million in the same period in 2022.
  • General and administrative (G&A) expenses: G&A expenses for the third quarter of 2023 were $3.0 million compared to $1.9 million in the same period in 2022.
  • The increase was primarily due to stock option grants made during the first quarter of 2023.

ProMIS Neurosciences Announces Third Quarter 2023 Financial Results and Recent Highlights

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tisdag, november 14, 2023
Acumen, Neurogranin, Research, Safety, Food, AAIC, Incidence, ALS, Immunoglobulin G, Translational neuroscience, PROMIS, CSF, Patient, MSA, Pharmacokinetics, ITN, Immunization, Therapy, Blood, Neuroscience, ARIA, PMN, Biomarker, Cerebrospinal fluid, Multiple system atrophy, Initiative, Lecanemab, Pharmaceutical industry, Cryptocurrency, Boston

CAMBRIDGE, Massachusetts, Nov. 14, 2023 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • “The third quarter was marked by significant progress across both our clinical and corporate initiatives,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences.
  • These results replicated biomarker findings from the CLARITY-AD trial of lecanemab, which also predominantly targets soluble amyloid beta oligomers.
  • In July 2023, the Company presented preclinical data from mouse vaccination studies at AAIC 2023.
  • Net loss was $2.4 million for the quarter ended September 30, 2023, compared to a net loss of $6.0 million for the same period in 2022.

RevBio Receives FDA Approval to Conduct a First-in-Human Clinical Trial for its Regenerative Bone Adhesive for Cranial Flap Fixation

Retrieved on: 
fredag, december 8, 2023
Research, Surgery, Medical Devices, Medical Supplies, FDA, Clinical Trials, Biotechnology, Health, Science, Subdural empyema, Safety, Food, Crystal skull, Risk, Aneurysm, CSF, Clinical trial, Multimedia, Skull, Infection, Osteoblast, MPH, Pain, Intracranial pressure, Cerebrospinal fluid, Meningitis, Architecture, Boston, MD, Brigham, Doctor of Philosophy

This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.

Key Points: 
  • This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.
  • As part of the surgical closure process, the cranial flap is secured back into place with plates and screws.
  • The kerf line, however, is typically not sealed, which compromises the ability of the flap to integrate with the surrounding bone.
  • “We are truly excited to move this project into the clinical phase of testing,” said Brian Hess, CEO and Founder of RevBio.

Amylyx Pharmaceuticals Announces Publication of Data Showing the Effect of AMX0035 on Plasma Neuroinflammatory Biomarkers in ALS

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måndag, december 4, 2023
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Amylyx Pharmaceuticals, Barrow Neurological Institute, CRP, Chitinase, ALS, Plasma, Disease, Journal, Week, Psychiatry, Survival, Journal of Neurology, AMX0035, Doctor of Philosophy, Biomarker, C-reactive protein, Cerebrospinal fluid, Medication, Neurosurgery, HIV disease progression rates, ITT, Medical imaging, Neurology, PHOENIX

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of analyses performed on neuroinflammatory biomarkers using plasma samples from participants with amyotrophic lateral sclerosis (ALS) from the Phase 2 CENTAUR trial.

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of analyses performed on neuroinflammatory biomarkers using plasma samples from participants with amyotrophic lateral sclerosis (ALS) from the Phase 2 CENTAUR trial.
  • During the CENTAUR trial, plasma samples were prospectively collected from trial participants for future biomarker analyses.
  • “Neuroinflammatory biomarkers are important for assessing disease progression and therapeutic response in ALS with chitinases and CRP emerging as potential treatment response biomarkers.
  • Further analyses of neuroinflammatory biomarkers are planned in the ongoing Phase 3 PHOENIX trial to confirm these results.

AriBio Co., Ltd. Announces Global Expansion of POLARIS-AD, A Phase 3 Early Alzheimer’s Disease Registration Trial

Retrieved on: 
tisdag, november 14, 2023
FDA, Seniors, Neurology, Clinical Trials, Biotechnology, Managed Care, Health, Consumer, Pharmaceutical, Ministry, Safety, Research, European Medicines Agency, MFDS, MMSE, Plasma, MHRA, NMPA, Collection, CSF, EMA, Patient, Cerebrospinal fluid, European, POLARIS, CHMP, Committee, Investigational New Drug, IND, GDS, Biomarker, CTA, Pharmaceutical industry, Food

AriBio Co., Ltd. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China.

Key Points: 
  • AriBio Co., Ltd. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China.
  • The phase 3 study is a double-blind, randomized, placebo-controlled, multi-center registration trial to evaluate the efficacy and safety of AR1001 (mirodenafil dihydrochloride) over 52 weeks of treatment in patients with early Alzheimer’s disease.
  • This global trial by AriBio highlights the regulatory appetite for further research for Alzheimer’s disease and the need for alternative safe and oral therapies compared to the recently FDA approved monoclonal antibodies.
  • AriBio is well positioned and adequately financed to execute on this global expansion”, stated Matthew Choung, Chairman and Chief Executive Officer (CEO) of AriBio.