GFAP

NKGen Biotech Announces Upcoming Presentation on Autologous NK Cell Therapy at the 5th International Cell & Gene Therapy China Summit & Exhibition

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木曜日, 5月 16, 2024
GFAP, Patient, NK, CMC, AFL, Neurodegenerative disease, Frontotemporal dementia, Biomarker

Dr. Song’s presentation will cover a variety of important topics, including industry challenges in manufacturing autologous NK cells at scale, which has been successfully overcome by NKGen’s next-gen CMC manufacturing process in its production of its autologous NK cell therapy product, SNK01.

Key Points: 
  • Dr. Song’s presentation will cover a variety of important topics, including industry challenges in manufacturing autologous NK cells at scale, which has been successfully overcome by NKGen’s next-gen CMC manufacturing process in its production of its autologous NK cell therapy product, SNK01.
  • In addition, Dr. Song will discuss the results from SNK01 treatment in combination with either immune checkpoint inhibitors in patients with advanced solid tumors, or, in combination with Erbitux in tyrosine kinase inhibitor-resistant non-small cell lung cancer.
  • The presentation will also include the scientific rationale and supporting data behind the use of SNK01 in neurodegenerative disease specifically emphasizing the ability of SNK01 to improve levels of amyloid beta, tau, and alpha-synuclein proteins as well as GFAP, NfL, and YKL-40, which are elevated in numerous neurodegenerative diseases including Alzheimer’s, Parkinson’s, Lewy Body Dementia, Frontotemporal Dementia, Multisystem Atrophy, and Progressive Supranuclear Palsy alluding to the potential use of SNK01 to treat these diseases or as a possible prevention in high risk asymptomatic patients with elevated biomarkers.

Vaccinex Reports First Quarter 2024 Financial Results and Provides Corporate Update

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水曜日, 5月 15, 2024
Cash, Security (finance), Classification, Patient, SIGNAL, Plasma, Gene expression, Semaphorin, Quarter, Prevalence, Investment, Letter, Neurodegenerative disease, Listing, Bank statement, Health, 8-K, GFAP, Research, Cancer, Neuron, Biomarker, Dementia, Security, ARIA, Brain, Observation, Glial fibrillary acidic protein, Astrocyte, Neurotoxicity, Amyloid-related imaging abnormalities, Pharmaceutical industry

ROCHESTER, N.Y., May 15, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update on its key program for Alzheimer’s disease.

Key Points: 
  • Financial Results for the Quarter Ended March 31, 2024:
    Cash and Cash Equivalents and Marketable Securities.
  • Research and development expenses for the quarter ended March 31, 2024, were $3.4 million as compared to $3.8 million for the comparable period in 2023.
  • General and administrative expenses for the quarter ended March 31, 2024, were $1.8 million as compared to $1.7 million for the comparable period in 2023.
  • Stockholders’ Equity as of March 31, 2024, was $2.7 million on March 31, 2024, as compared to a deficit of $(2.3) million on December 31, 2023.

NKGen Biotech Presents Updated NK Cell Therapy Data for Neurodegenerative Disease at the 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit

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木曜日, 4月 25, 2024
Amyloid, Pure autonomic failure, Protein, GDF15, Cell, Safety, AFL, Median, Neuroinflammation, Fluid mechanics, Corticobasal degeneration, Cytokine, Plasma, MD, Dementia, Latency, GFAP, IND, Frontotemporal dementia, Patient, Multiple system atrophy, UK Biobank, CSF, ADAS-Cog, Biomarker, Clinical trial, PD, NK, LTBP2, Pharmaceutical industry

90% of patients enrolled in the proof-of-concept Phase 1 Alzheimer’s trial had improved or stable cognitive function at week 11 using the composite ADCOMS score.

Key Points: 
  • 90% of patients enrolled in the proof-of-concept Phase 1 Alzheimer’s trial had improved or stable cognitive function at week 11 using the composite ADCOMS score.
  • NKGen submitted an IND for SNK01 in Parkinson’s disease (“PD”) in Q1 2024 and anticipates to begin enrollment for its Phase 2 trial in advanced Alzheimer’s disease (“AD”) in Q2 2024.
  • Cognitive assessments and extensive CSF/plasma biomarker analyses were performed at baseline and at 1 and 12 weeks after the final dose.
  • A larger Phase 2 placebo-controlled AD trial with a higher dosing and longer duration will begin to enroll in Q2 2024.

Acumen Pharmaceuticals Presents First Comprehensive Clinical and Biomarker Data for Sabirnetug (ACU193) at American Academy of Neurology 2024 Annual Meeting

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火曜日, 4月 16, 2024
Science, APOE, American Academy, Brain, ABOS, Safety, Hope, Neurogranin, Poster, Plasma, Colorado Convention Center, ES2, GFAP, Patient, Incidence, AAN, CSF, Biomarker, Annual general meeting, Plaque, Cerebrospinal fluid

Acumen is developing sabirnetug as a potential best-in-class antibody treatment for early AD.

Key Points: 
  • Acumen is developing sabirnetug as a potential best-in-class antibody treatment for early AD.
  • Acumen remains on track to initiate the ALTITUDE-AD placebo-controlled Phase 2 trial of sabirnetug in the first half of 2024.
  • Based on safety, target engagement and biomarker data from the INTERCEPT-AD trial, Acumen has determined sabirnetug doses of 35 mg/kg Q4W and 50 mg/kg Q4W in ALTITUDE-AD.
  • Acumen also plans to initiate a Phase 1 bioavailability study to support a subcutaneous dosing option of sabirnetug in mid-2024, as announced in November 2023 .

Labcorp Announces First-of-Its-Kind Test for Early Indication of Neurodegenerative Diseases and Brain Injuries Using a Blood Draw

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月曜日, 4月 15, 2024
Neurodegenerative disease, Nerve, Hospital, Blood, AFL, Brain, LH, Glioblastoma, GFAP, TBI, Alzheimer's disease, Disease, Injury, Astrocyte, Physician, Multiple sclerosis, Health, Traumatic brain injury, Biomarker, Glial fibrillary acidic protein, Medical imaging

BURLINGTON, N.C., April 15, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the availability of the nation's first test for glial fibrillary acidic protein (GFAP), a critical blood-based biomarker for the early detection of neurodegenerative diseases and neurological injuries.

Key Points: 
  • The new GFAP test – a first-of-its-kind test to be offered commercially nationwide – offers physicians a more efficient pathway to assess the presence and progression of neurodegenerative diseases such as Alzheimer's disease, multiple sclerosis, glioblastoma and injuries like traumatic brain injury (TBI).
  • The biomarker test also expands on Labcorp's comprehensive neurology portfolio, which includes biomarker tests for neurofilament light chain (NfL), pTau181, pTau217 and beta amyloid 42/40.
  • "The introduction of the GFAP biomarker test marks a significant milestone for Labcorp, extending our leadership in the rapidly accelerating field of blood-based biomarkers for neurodegenerative diseases," said Dr. Brian Caveney, Labcorp's chief medical and scientific officer.
  • In the context of neurodegenerative disease or injury, astrocytes release GFAP into the blood, allowing brain injury and disease to be assessed through a simple blood draw.

CervoMed Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates

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月曜日, 4月 1, 2024
Lewy body, Research, GBA, Administration, Plasma, Conference, MRI, DLB, GFAP, Basal forebrain, Patient, Journal, Chairperson, Sale, TID, Manuscript, Public expenditure, Biomarker, Glial fibrillary acidic protein, MD, University College London, Atrophy, Publication, Frontotemporal dementia, Alpha-synuclein, NIA, Research and development, Vertex Pharmaceuticals, Axonal transport, Dementia, CRVO

BOSTON, April 01, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today reported its financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Moreover, the neflamapimod treatment effects on GFAP were correlated to clinical outcomes, assessed by the CDR-SB.
  • Cash Position: As of December 31, 2023, CervoMed had $7.8 million in cash and cash equivalents as compared to $4.1 million as of December 31, 2022.
  • This increase was attributed to the RewinD-LB Phase 2b clinical study in DLB which began in the first quarter of 2023.
  • Net Loss: Net Loss was $2.2 million for the year ended December 31, 2023, compared to a net loss of $5.8 million for year ended December 31, 2022.

Abbott Receives FDA Clearance for Whole Blood Rapid Test to Help with Assessment of Concussion at the Patient's Bedside

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月曜日, 4月 1, 2024
Brain, Plasma, Head, L1, Concussion, Serum, GFAP, Patient, Biomarker, Research, TBI, Triage, University, Neurosurgery, Doctor of Philosophy, Glial fibrillary acidic protein, Head Injuries, Pediatrics, Traumatic brain injury, Hospital, San Francisco General Hospital, Glasgow Coma Scale, FDA, Health, Food, Medical imaging

The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury or mTBI, commonly known as concussion.

Key Points: 
  • The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury or mTBI, commonly known as concussion.
  • Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care.
  • The i-STAT TBI cartridge with the i-STAT Alinity System requires a small venous blood sample, which is applied to the test cartridge.
  • Now, we have a whole blood test that can help assess the brain right at the patient's bedside – expanding access to more health providers and therefore patients."

CervoMed Announces Presentation of Biomarker Data from the AscenD-LB Phase 2a Trial and Preclinical Data Supporting Potential of Neflamapimod in Tau-Mediated Disease at AD/PD ™ 2024

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火曜日, 3月 5, 2024
Axonal transport, Tauopathy, Neuron, CRVO, Cell biology, DLB, Plasma, Medical laboratory, MB, Phosphorylation, Overalls, FTD, GS, Vrije Universiteit Amsterdam, Publication, MAPK, Glial fibrillary acidic protein, GFAP, Axon, Brain, CNR, IW, EM, SDL, UCL, RAF kinase, Alpha-synuclein, Conference, Biomarker, AG, Lewy body, GBA, MD, Neurochemistry, PDF, JC, CP, Patient, Dementia, Basal forebrain, JA, Medical imaging

BOSTON, March 05, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for degenerative diseases of the brain, today announced the presentation of biomarker data from the AscenD-LB Phase 2a trial of neflamapimod in patients with dementia with Lewy bodies (DLB), demonstrating that neflamapimod reduces plasma levels of glial fibrillary acidic protein (GFAP) compared placebo, and that the effects of neflamapimod on GFAP were inversely correlated to change in CDR-SB (reduction in GFAP associated with improvement in CDR-SB, and increase in GFAP associated with worsening in CDR-SB). These data will be featured in a poster presentation at the 18th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024, being held both virtually and in Lisbon, Portugal from March 5–9, 2024. In addition, academic researchers from UCL will be presenting data in a separate poster at the meeting demonstrating that p38MAPK inhibition, including with neflamapimod specifically, improves tau-induced axonal transport defects both in vitro and in a tauopathy mouse model.

Key Points: 
  • These data will be featured in a poster presentation at the 18th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024, being held both virtually and in Lisbon, Portugal from March 5–9, 2024.
  • “The effects on GFAP, particularly the association between GFAP response and clinical outcomes, further support that neflamapimod is clinically efficacious in patients with DLB,” said John Alam, MD, Chief Executive Officer of CervoMed.
  • A PDF copy of the GFAP poster presentation will be available on the “ Presentations and Publications ” section of the CervoMed website.
  • Title: NEW INSIGHTS IN THE DEVELOPMENT OF BIOMARKERS, IMAGING, AND THERAPY OF ALPHA-SYNUCLEIN, LRKK2, AND GBA PATHOLOGIES

Nasdaq Grants Vaccinex Extension Until March 4, 2024 to Regain Compliance with Listing Rule

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月曜日, 12月 4, 2023
GFAP, Cognition, Dementia, Risk, Astrogliosis, Plasma, Encephalitis, Disease, Glial fibrillary acidic protein, Brain, Blood, HD, Cancer, Biomarker, FDG-PET, Patient, Neuron, Medical imaging

ROCHESTER, N.Y., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease and cancer, previously reported that on October 10, 2023 it was advised by Nasdaq that the Company was no longer in compliance with Nasdaq’s minimum bid price requirement and that Nasdaq could move to suspend trading of the common stock and to delist the Company’s securities unless the company appealed Nasdaq’s determination. The Company appealed that decision and has been granted an exception until March 4, 2024 to address this issue. Subject to fulfilling its commitments to Nasdaq, it is expected that Vaccinex shares will continue to be listed on the Nasdaq Capital Market throughout this time and subsequently if compliance is restored.

Key Points: 
  • The Company appealed that decision and has been granted an exception until March 4, 2024 to address this issue.
  • Subject to fulfilling its commitments to Nasdaq, it is expected that Vaccinex shares will continue to be listed on the Nasdaq Capital Market throughout this time and subsequently if compliance is restored.
  • The last patient in this trial is expected to complete the planned 12-months of treatment by early June 2024.
  • We believe that these findings portend a potentially favorable clinical outcome for pepinemab treatment in AD.

BioVie Announces Efficacy Data from Phase 3 Trial of NE3107 in Patients with Mild to Moderate Alzheimer’s Disease

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水曜日, 11月 29, 2023
Patient, DNA methylation, MITT, GFAP, Food, Activator (genetics), Glial fibrillary acidic protein, FDA, Disease, Biostatistics, DNA, OSI, GCP, Neurofilament, Natural history, Good clinical practice, Horváth, COVID-19, Dementia, Ageing, Biomarker, Pathology, Safety, Therapy, Significance, Pharmaceutical industry

CARSON CITY, Nev., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced positive analysis of unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate Alzheimer’s Disease (AD).

Key Points: 
  • Data from evaluable patients show NE3107’s treatment advantage compared to placebo may be equal to or greater than the benefit from approved AD monoclonal antibodies.
  • NE3107-treated patients also experienced a 4.66-year advantage in age deceleration vs. placebo as measured by epigenetics/DNA methylation Skin Blood Clock.
  • The trial started during the COVID-19 pandemic when access to clinical sites was limited and enrolled a total of 439 patients through 39 sites.
  • Patients treated with NE3107 saw an average of -5.66 years of age deceleration of the DNA methylation advantage compared to those on placebo.