Histology

PreciseDx's "Analytical Validation of a Digital Breast Cancer Test Predicting Recurrence in Early-Stage Breast Cancer" Featured in Clinical Breast Cancer

Retrieved on: 
Tuesday, November 7, 2023
Standard of care, LDT, New York State Department of Health, Doctor of Philosophy, Health, Artificial intelligence, CLIA, Disease, Risk, Recurrence, Machine learning, IBC, Breast cancer, Histology, NYSDOH, Clinical Breast Cancer, Breast Cancer Research, Patient, Medical device, Medical imaging

NEW YORK, Nov. 7, 2023 /PRNewswire/ -- PreciseDx®, a leading innovator in oncology diagnostics, leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven, disease analysis, today announced that its analytical validation study for its PreciseBreast™ assessment has been published in the November 3, 2023 issue of Clinical Breast Cancer.

Key Points: 
  • Collectively, these studies demonstrated an analytical performance that accurately predicts early-stage breast cancer risk of recurrence within 6 years.
  • PreciseBreast™ is an in vitro prognostic test that predicts breast cancer recurrence for patients diagnosed with early-stage IBC.
  • This latest study builds upon PreciseDx's earlier clinical validation study published in Breast Cancer Research (cited 2022 Dec 21, 24:93.
  • "Our innovative digital assessment holds immense promise in enhancing early-stage breast cancer recurrence prediction, ultimately improving patient care and outcomes.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Tuesday, November 7, 2023
Science, Glomerulosclerosis, B-cell activating factor, DSM-IV codes, Ramipril, Biomarker, Rare, Budesonide, EGFR, Kidney, Person, CD23, Fibrosis, GALT, ACE, Protein, Society, American Society of Nephrology, BAFF, CD30, Urine, ASN, Record, Serum, CET, NOX, Immunoglobulin A, CALT, Histology, Patient, CD27, Alport syndrome, Pharmaceutical industry, Vaccine, IgA nephropathy, Publication, Alport

The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.

Key Points: 
  • The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.
  • The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug.
  • Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points.
  • Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Tuesday, November 7, 2023
Science, Glomerulosclerosis, B-cell activating factor, DSM-IV codes, Ramipril, Biomarker, Rare, Budesonide, EGFR, Kidney, Person, CD23, Fibrosis, GALT, ACE, Protein, Society, American Society of Nephrology, BAFF, CD30, Urine, ASN, Record, Serum, CET, NOX, Immunoglobulin A, CALT, Histology, Patient, CD27, Alport syndrome, Pharmaceutical industry, Vaccine, IgA nephropathy, Publication, Alport

The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.

Key Points: 
  • The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.
  • The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug.
  • Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points.
  • Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation.

Madrigal Pharmaceuticals Provides Corporate Updates and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 6, 2023
Coordinated Specialty Care, FDA, Non-alcoholic fatty liver disease, Research, Nine Months, Biomarker, Therapy, Cirrhosis, Agency, Treatment, Histology, Priority review, Disease, Hepatology, NASH, Fibrosis, Employee compensation in the United States, Incremental cost-effectiveness ratio, New Drug Application, Intelligence, Diabetes, NAFLD, Atherosclerosis, Fatty liver disease, Electronic health record, Pharmaceutical industry, Cryptocurrency, Medical imaging, Rare-earth element, Risk, Patient, Sanofi, Nature Medicine, Dupilumab, Madrigal

At the AASLD Liver Meeting next week, we will present a comprehensive analysis of noninvasive tests and imaging from the MAESTRO-NASH trial.

Key Points: 
  • At the AASLD Liver Meeting next week, we will present a comprehensive analysis of noninvasive tests and imaging from the MAESTRO-NASH trial.
  • The Agency noted that it is not currently planning to hold an advisory committee meeting to discuss the application.
  • In October 2023, we completed a public offering and received an additional $472.0 million in net cash proceeds.
  • These increases in interest income were due primarily to higher average interest rates in 2023.

Inventiva announces a late breaker abstract and two additional abstracts on its lead compound, lanifibranor, at the AASLD The Liver Meeting® 2023  

Retrieved on: 
Monday, November 6, 2023
Adiponectin, Arm, University, American Association for the Study of Liver Diseases, Hepatology, Diabetes, II, Liver, C-reactive protein, CAP, Genotype, Lipid metabolism, Fibrosis, Metabolic syndrome, PNPLA3, Inflammation, Type 2 diabetes, HOMA-IR, Euronext Paris, Scan (company), Steatosis, NASH, Risk, Insulin, T2D, Abstract, Histology, Serum, MM, Insulin resistance, Adipose tissue, Patient, Fatty liver disease, Metabolism, Glucose, Medical device, Medical imaging, Pharmaceutical industry

The phase II study led by Dr. Kenneth Cusi evaluating lanifibranor in patients with T2D and MASLD was selected as late breaker.

Key Points: 
  • The phase II study led by Dr. Kenneth Cusi evaluating lanifibranor in patients with T2D and MASLD was selected as late breaker.
  • Two additional scientific abstracts from the NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH have been selected  for presentation.
  • The two abstracts show:
    the correlation between the increase of adiponectin under lanifibranor and the improvement of histological and serum markers of NASH severity both in terms of activity and fibrosis.
  • the improvement of liver histology and markers of cardiometabolic health in patients with NASH treated with lanifibranor, independent of PNPLA3 genotype.

Natera’s Landmark RenaCARE Study Demonstrates Significant Diagnostic and Clinical Utility of Renasight™ in Chronic Kidney Disease

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, Medical Devices, Health, Genetics, Oncology, Genetic testing, Patient, Journal of the American Society of Nephrology, Kidney disease, Columbia University Irving Medical Center, Hematuria, Therapy, Medicare, Physician, AUC, Diabetes, NTRA, Journal, Society, Chronic kidney disease, Disease, Division, Medicine, Hypertension, Histology, Biopsy, Nephrology, CKD, Diagnosis, DNA, Pharmaceutical industry, Medical imaging, Dietary supplement

Genetic testing can address many of these limitations by identifying the underlying origin of disease, enabling physicians to properly diagnose and stratify CKD patients.

Key Points: 
  • Genetic testing can address many of these limitations by identifying the underlying origin of disease, enabling physicians to properly diagnose and stratify CKD patients.
  • In the RenaCARE study, 20.8% of CKD patients had a positive genetic finding.
  • Of those, 48.8% of patients received a new or reclassified diagnosis and 34% received information on disease subtype.
  • In the study, 35.5% of patients with positive results received a diagnosis that could make them eligible for available therapeutics.

Aurinia Presents Breadth of Data at ASN 2023 Demonstrating Clinical Importance of LUPKYNISⓇ for Managing Lupus Nephritis

Retrieved on: 
Thursday, November 2, 2023
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Patient, Lupus nephritis, National Institutes of Health, CNI, EGFR, Kidney failure, AURORA, Safety, Lupus, Kidney, ALMS, Society, Acute kidney injury, Clinical trial, ASN, MMF, NIH, Histology, Glucocorticoid, UPCR, Conditional sentence, Bangladesh Technical Education Board, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Ohio State University Wexner Medical Center, Proteinuria, Toxic leukoencephalopathy, Pharmaceutical industry, Black, Aurinia, LN

Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.

Key Points: 
  • Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.
  • Activity scores for both arms improved to a similar degree, while the chronicity scores remained stable in both arms.
  • “The results presented at ASN this week demonstrate important clinical and mechanistic findings associated with LUPKYNISⓇ treatment.
  • Following is the complete guide to Aurinia’s presentations at ASN 2023:
    Title: Comparison of dual-immunosuppressive therapy and a voclosporin-based, triple-immunosuppressive regimen for lupus nephritis: a propensity analysis of ALMS and AURORA 1 studies

Cytrellis Announces Six Abstracts to be Presented on Ellacor Micro-Coring at the American Society for Dermatologic Surgery's Annual Meeting (ASDS)

Retrieved on: 
Thursday, November 2, 2023
Biomarker, ASDS, Face, Skin, Cyber Safety Review Board, Research, Inflammation, Society, MCT, Abstract, Histology, Scar, Overalls, Patient, Gene expression, Petroleum jelly, Medical device, Vaccine

"We are excited about the breadth and depth of the groundbreaking ellacor data that will be presented at the ASDS meeting," said Jason Richey, President and CEO of Cytrellis.

Key Points: 
  • "We are excited about the breadth and depth of the groundbreaking ellacor data that will be presented at the ASDS meeting," said Jason Richey, President and CEO of Cytrellis.
  • "This is an example of our continued commitment to shaping the future of aesthetics through robust research and innovation."
  • Improvements in scar texture, color, and overall appearance were seen in scars treated with dermal micro-coring.
  • The study retrospectively evaluated this new minimally invasive device's safety issues and possible complications in 200 treated patients.

CDR-Life Presents Precise Tumor and Patient Selection for CDR404: First-of-its-Kind Dual MAGE-A4 T-cell Engager, at ESMO Congress 2023

Retrieved on: 
Monday, October 23, 2023
Bispecific monoclonal antibody, The Cancer Genome Atlas, Adenocarcinoma, TCGA, TCE, NSCLC, ESMO, IHC, HPV, Data, Head, Bladder cancer, Neck, Neoplasm, Histology, Messenger, Bivalent, Patient, HLA, Vaccine

ZÜRICH, Switzerland, Oct. 23, 2023 (GLOBE NEWSWIRE) -- CDR-Life Inc. presented findings on tumor target expression and precise patient selection for the upcoming Phase 1 trial of CDR404 (Abstract 200P), a first-of-its-kind bispecific and bivalent antibody fragment-based T-cell engager (TCE) targeting MAGE-A4, an intracellular protein which is presented on HLA-A*02:01 on the surface of cancer cells, at the ESMO Congress 2023, occurring October 20-24 in Madrid, Spain.

Key Points: 
  • The key objective of this study was for CDR-Life to explore MAGE-A4 expression levels in solid tumors using The Cancer Genome Atlas (TCGA) mRNA dataset.
  • In addition, subgroups of high MAGE-A4 expression were present across a wide range of solid cancers including lung adenocarcinoma, ovarian and gastric cancers.
  • “CDR404 is a novel, bispecific and bivalent T-cell engager differentiated from previous solid tumor T-cell engagers targeting MAGE-A4 in the clinic.
  • The MAGE-A4 mRNA distribution profiles across multiple tumor types indicate, that a tumor MAGE-A4 assay will be indispensable for trial screening.

Harpoon Therapeutics Announces Updated Interim Tolerability and Response Data from Phase 1/2 Clinical Trial of T Cell Engager HPN328 at ESMO Congress 2023

Retrieved on: 
Saturday, October 21, 2023
MTD, ESMO, Trae tha Truth, Publication, Carcinoma, CEST, Prostate cancer, Poster, Memorial Sloan Kettering Cancer Center, Index, DLT, Cytokine release syndrome, Webcast, Histology, European Society for Medical Oncology, CRS, DLL3, Therapy, Patient, Medical imaging, Pharmaceutical industry, SCLC

Treatment-related adverse events (TRAEs) occurred in 67 patients (94%), and Grade ≥ 3 TRAEs in 18 patients (25%).

Key Points: 
  • Treatment-related adverse events (TRAEs) occurred in 67 patients (94%), and Grade ≥ 3 TRAEs in 18 patients (25%).
  • The preliminary response data for evaluable patients treated in 1 mg priming dose cohorts showed confirmed response rate of 35% (11/31) across all tumor types.
  • In SCLC, the confirmed response rate was 32% (6/19) with one confirmed complete response.
  • A replay of the webcast will be available shortly after the live event and can be accessed at the same weblink.