Glial fibrillary acidic protein

Vaccinex Reports Completion of Last Patient Visit in Randomized, SIGNAL-AD Phase 1b/2 Study of Pepinemab Treatment for Alzheimer’s Disease

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星期四, 六月 6, 2024
Donanemab, Semaphorin, Astrocyte, Blood, Gene expression, Patient, Neurotoxicity, Prevalence, Dementia, Safety, Brain, Biomarker, GFAP, Glial fibrillary acidic protein, Health, Eli Lilly, Investment, FDG-PET, Neurodegenerative disease, Neuron, Plasma, SIGNAL, Cancer

ROCHESTER, N.Y., June 06, 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 that the last patient completed their last visit in its randomized, placebo-controlled double-blind study of pepinemab treatment for Alzheimer’s disease.

Key Points: 
  • Pepinemab targets astrocyte reactivity and neuroinflammation,
    believed to be key drivers of neurodegeneration.
  • ROCHESTER, N.Y., June 06, 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 that the last patient completed their last visit in its randomized, placebo-controlled double-blind study of pepinemab treatment for Alzheimer’s disease.
  • What can we expect to learn from this study?
  • Pepinemab has, to date, been well-tolerated in clinical trials that enrolled a total of more than 600 patients.

Vaccinex Reports First Quarter 2024 Financial Results and Provides Corporate Update

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星期三, 五月 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.

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

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星期一, 四月 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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星期一, 四月 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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星期一, 四月 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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星期二, 三月 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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星期一, 十二月 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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星期三, 十一月 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.

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

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星期二, 十一月 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.

Vaccinex Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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星期一, 十一月 13, 2023
Encephalitis, Nature, HD, Eurosport 1, Patient, Research, Neuron, Dementia, Conference, Cash, ORR, Cognition, Drug discovery, Cancer, Doctor of Philosophy, Form 10-Q, Glial fibrillary acidic protein, FCMI, Prevalence, Astrocyte, GFAP, Microglia, Blood, Head and neck cancer, Three Months, Completeness, Risk, PFS, Merck, L.L.C, SEMA4D, Clinical trial, Security, Drug, Drug development, Patent, SIGNAL, Biomarker, Brain, CCR8, Plasma, Disease, Private placement, Neurodegenerative disease, Private, Neoplasm, G protein-coupled receptor, Cryptocurrency, Pharmaceutical industry, Medical imaging, Vaccine, HNSCC

ROCHESTER, N.Y., Nov. 13, 2023 (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 SEMA4D, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update on progress in key programs.

Key Points: 
  • ROCHESTER, N.Y., Nov. 13, 2023 (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 SEMA4D, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update on progress in key programs.
  • The potential impact of the AD program on Vaccinex valuation and financial resources make this Vaccinex’s most important near-term catalyst.
  • On August 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.20 million shares1 of common stock for aggregate proceeds of $0.7 million.
  • Similarly, on September 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.25 million shares of common stock for aggregate proceeds of $0.6 million.