Hepatic encephalopathy

Axcella Therapeutics Promotes Margaret Koziel, M.D., to Chief Medical Officer

Retrieved on: 
Monday, December 6, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Patient, Private Securities Litigation Reform Act, New England, Hepatic encephalopathy, EMM, The New England Journal of Medicine, Novartis Institute for Tropical Diseases, Fatty liver disease, Recurrence, IND, Beth Israel Deaconess Medical Center, SEC, Leadership, University, COVID-19, Massachusetts General Hospital, Journal of Clinical Investigation, Physician, Clinical research, Risk, Drug, NASH, Hospital, FDA, Associate, Compte rendu, Journal, Biomedical sciences, Vertex Pharmaceuticals, Therapy, Assistant, Long, Multimedia, Emms, OHE, Harvard Medical School, University of Massachusetts Medical School, Pharmaceutical industry

Dr. Koziel, who previously served as Vice President, Clinical Development, joined Axcella in 2019, bringing a wealth of leadership experience within both biopharma and academia.

Key Points: 
  • Dr. Koziel, who previously served as Vice President, Clinical Development, joined Axcella in 2019, bringing a wealth of leadership experience within both biopharma and academia.
  • View the full release here: https://www.businesswire.com/news/home/20211206005091/en/
    Margaret Koziel, M.D., Axcella Therapeutics Chief Medical Officer (Photo: Business Wire)
    Margaret joined Axcella at a pivotal stage in the companys evolution and has been a key contributor and leader since Day 1, helping to bring multiple clinical studies to a successful conclusion, contributing to our multi-national regulatory engagements and rapidly advancing our lead candidates into later-stage development, said Bill Hinshaw, President and Chief Executive Officer of Axcella.
  • As Chief Medical Officer, Dr. Koziel will lead Axcellas clinical development and regulatory affairs efforts.
  • from Dartmouth and her postgraduate medical training at New England Deaconess Hospital and Massachusetts General Hospital, affiliates of Harvard Medical School.

Sigyn Therapeutics Reports the Successful Completion of a Study to Address Gram-Positive Bacterial Toxins Associated with Sepsis

Retrieved on: 
Wednesday, December 1, 2021
CRRT, IDE, Hepatic encephalopathy, CEO, Blood, Septic shock, MRSA, Industry, Sepsis, Death, Company, Hospital, OTC Markets Group, Private Securities Litigation Reform Act, Virus, IL-6, Inflammation, Ammonia, COVID-19, Bioterrorism, Cytokine, United States v. 50 Acres of Land, Peptidoglycan, LTA, Community-acquired pneumonia, Risk, GLOBE, Adult, FDA, In vitro, PG, Infection, CA, Therapy, Failure, TNF, Hemofiltration, Vaccine, Pharmaceutical industry

SAN DIEGO, CA, Dec. 01, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire – Sigyn Therapeutics, Inc. (OTC Markets: SIGY), a medical technology company focused on the treatment of pathogen-associated indications that precipitate sepsis, today announced that preclinical invitro studies have validated the ability of Sigyn Therapy to deplete the presence of gram-positive bacterial toxins from human blood plasma.

Key Points: 
  • The invitro clearance of both targets was rapid, with an ~50% reduction of PG at one hour and a ~70% reduction of LTA at two hours.
  • In addition to being potent activators of sepsis, there is a heightened interest in gram-positive pathogens based on the continuing emergence of drug resistant species, including antibiotic-resistant Staphylococcus aureus (MRSA).
  • Sigyn Therapeutics is a medical technology company focused on the treatment of pathogen-associated indications that precipitate sepsis, the #1 cause of hospital deaths worldwide.
  • This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (Sigyn) that involve substantial risks and uncertainties.

Versantis to Present Positive Phase 1b Data at AASLD for VS-01 in Patients with Decompensated Cirrhosis

Retrieved on: 
Monday, November 15, 2021
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, American Association, Hepatic encephalopathy, Industry, American Association for the Study of Liver Diseases, Ascites, Cirrhosis, Safety, Institute of Liver and Biliary Sciences, Mark (given name), Goethe University Frankfurt, Non-alcoholic fatty liver disease, Prevalence, Urea, Mortality, PK, Section, Trial of the century, Standard of care, Research, Association, Internal, FDA, Brain, Ammonia, Public, PD, Health, CEO, ETH Zurich, Department, Liver, AASLD, Peritoneum, Drainage, Abstract, Pharmacokinetics, Obesity, Liposome, Peritoneal cavity, ODD, Part, U.S. FDA, EMA, Coma, Paracentesis, Board, Incidence, ACLF, Death, Diabetes, Chronic liver disease, Pharmaceutical industry, Medical imaging, Acute-on-Chronic Liver Failure (ACLF), Versantis, ACUTE-ON-CHRONIC LIVER FAILURE (ACLF), VERSANTIS

The data show that VS-01 was safe and well tolerated in these patients, and demonstrated promising early indications of efficacy in this clinical study.

Key Points: 
  • The data show that VS-01 was safe and well tolerated in these patients, and demonstrated promising early indications of efficacy in this clinical study.
  • The data show that VS-01 is safe and well tolerated in cirrhotic patients with ascites and covert (mild) hepatic encephalopathy, so very promising.
  • VS-01 represents a promising new therapeutic for the potential treatment of patients with ascites and acute complications of cirrhosis.
  • We are now preparing to initiate a multi-center Phase 2a study in patients with ACLF, a seriously underserved and under-resourced indication.

Data Presentation Today at The Liver Meeting® 2021 Shows Increasing Hospital Admissions for Alcohol-Associated Hepatitis (AH) in the U.S.

Retrieved on: 
Friday, November 12, 2021
American Association, Hepatic encephalopathy, Ascites, Clinical trial, Necrosis, SABER, Food, Cell death, COVID-19, Coagulopathy, ICD-10, Chronic liver disease, Kidney failure, Review, Prevalence, Risk, American Association for the Study of Liver Diseases, AH, NIS, Mortality, Safety, Fast track (FDA), Technology, HIV disease progression rates, Sepsis, Association, Liver, Nationwide, NASH, Multiple organ dysfunction syndrome, Hospital, Liver transplantation, Poster, Patient, FDA, Cirrhosis, Boxed warning, Fatty liver disease, Division, Survivor, Disease, Department, Indiana University, ALD, Inflammation, AASLD, Publication, Contraindication, Alcoholic liver disease, DNA, Liver failure, Hepatitis, ICD-9, Institute of Liver and Biliary Sciences, Company, Hepatology, Death, Pharmaceutical industry

Effective therapy for severe and hospitalized AH patients is currently lacking, and is a significant unmet medical need."

Key Points: 
  • Effective therapy for severe and hospitalized AH patients is currently lacking, and is a significant unmet medical need."
  • The study analyzed more than seven million hospital stays annually from approximately 1,000 U.S. hospitals using the Nationwide Inpatient Sample (NIS) database.
  • Patients hospitalized with a primary or secondary diagnosis of AH were identified using ICD-9 (Q1-Q3 2015) and ICD-10 (Q4 2015, 2016-2018) codes.
  • The poster is available to attendees of The Liver Meeting 2021 today and throughout the meeting ending November 15, 2021 after which, it will be available on the DURECT website under "DUR-928 Publications" here: DURECT | DUR-928 Publications .

Galmed Pharmaceuticals Provides Additional Positive Data from the Open Label Part of ARMOR Study and Reports Third Quarter 2021 Financial Results

Retrieved on: 
Monday, November 8, 2021
F1, Mortality, Safety, Hepatic encephalopathy, Ascites, Cirrhosis, Clinical trial, Eleazar Sukenik, Terminology, EMA, Liver, COVID-19, Overweight, Medication, Annual report, Forward-looking statement, Perception, Risk, Hebrew University of Jerusalem, Kinetics, ARMOR, Patient, NASH, SEC, Inflammation, Pharmacokinetics, Physician, Fibrosis, Time, MELD, FDA, Biopsy, Drug development, Pharmaceutical industry

Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases.

Key Points: 
  • Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases.
  • Our lead compound, Aramchol, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study.
  • We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide.
  • Patients are randomized (1:1:1) into three groups with post-baseline liver biopsy being performed at 24 weeks, 48 weeks, or 72 weeks, respectively.

Galmed Announces New Positive Data from Ongoing ARMOR Study Open Label Part Showing Clinically Significant Effect on Fibrosis Improvement

Retrieved on: 
Monday, November 8, 2021
F1, Mortality, Safety, Hepatic encephalopathy, Ascites, Cirrhosis, Clinical trial, Eleazar Sukenik, Terminology, EMA, Liver, COVID-19, Multimedia, Overweight, Medication, Annual report, Forward-looking statement, Perception, Risk, Hebrew University of Jerusalem, Kinetics, ARMOR, Patient, NASH, SEC, Inflammation, Pharmacokinetics, Physician, Fibrosis, Time, MELD, FDA, Biopsy, Drug development, Pharmaceutical industry

-- Results are an early indication that higher dose of Aramchol could provide statistically and clinically meaningful effect on fibrosis in the double-blind placebo controlled regulatory part for submission of an NDA under Sub-part H--

Key Points: 
  • Our lead compound, Aramchol, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study.
  • We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide.
  • Patients are randomized (1:1:1) into three groups with post-baseline liver biopsy being performed at 24 weeks, 48 weeks, or 72 weeks, respectively.
  • The primary histology-based endpoint is NASH resolution without worsening of fibrosis or fibrosis improvement without NASH worsening.

Galmed Announces Positive Results from First 16 Patients in Open-Label Part of ARMOR Study

Retrieved on: 
Monday, November 1, 2021
Safety, Fibrosis, Medication, Hebrew University of Jerusalem, Inflammation, Drug development, F1, Hepatic encephalopathy, MELD, Cirrhosis, Kinetics, EMA, Perception, Eleazar Sukenik, Patient, ARMOR, FDA, Terminology, Biopsy, SEC, Time, Annual report, Forward-looking statement, Risk, Clinical trial, Ascites, COVID-19, Overweight, Pharmacokinetics, Mortality, NASH, Liver, Physician, Pharmaceutical industry

Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases.

Key Points: 
  • Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases.
  • Our lead compound, Aramchol, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study.
  • We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide.
  • Patients are randomized (1:1:1) into three groups with post-baseline liver biopsy being performed at 24 weeks, 48 weeks, or 72 weeks, respectively.

Sigyn Therapeutics Featured on National Public Radio: “Addressing the Cytokine Storm”

Retrieved on: 
Monday, August 30, 2021
Storm, Industry, Company, Sepsis, Internet, Program, Hemofiltration, Sirius XM, Technology, GLOBE, Infection, Science, CRRT, Interview, NPR, Private Securities Litigation Reform Act, Cytokine, Death, CA, Inflammation, Hospital, Cytokine storm, Radio, Risk, Failure, Tech Nation, Hepatic encephalopathy, SAN, CEO, OTC Markets Group, Toxin (comics), COVID-19, Global health, Pharmaceutical industry

Founded in 1993, Tech Nation is a weekly National Public Radio program hosted by Dr. Moira Gunn.

Key Points: 
  • Founded in 1993, Tech Nation is a weekly National Public Radio program hosted by Dr. Moira Gunn.
  • During the current pandemic, the cytokine storm has been a leading cause of death in severe COVID-19 infections.
  • Sigyn Therapeutics is focused on significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome.
  • This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (Sigyn) that involve substantial risks and uncertainties.

Sigyn Therapeutics CEO Note: A Treatment Candidate to Address Bloodstream Pathogens, Deadly Toxins and Inflammatory Disease Targets

Retrieved on: 
Tuesday, August 10, 2021
Storm, CRRT, Bilirubin, IDE, FDA, Private Securities Litigation Reform Act, COVID-19, Adult, Sepsis, Cytokine storm, IL-6, Global health, Hemofiltration, TNF, Safety, Hospital, Hepatic encephalopathy, Cytokine, OTC Markets Group, Toxin (comics), Industry, GLOBE, Technology, SAN, Ammonia, Risk, Inflammation, Company, CA, Failure, CEO, Therapy, Medical device, Pharmaceutical industry, Vaccine

Sigyn Therapeutics was founded on the belief that a properly designed medical device could address sepsis and other life-threatening inflammatory conditions that remain beyond the reach of drug therapies.

Key Points: 
  • Sigyn Therapeutics was founded on the belief that a properly designed medical device could address sepsis and other life-threatening inflammatory conditions that remain beyond the reach of drug therapies.
  • Since December 2020, we reported results from a series of studies that have demonstrated first-in-industry capabilities of Sigyn Therapy to address pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators.
  • Our adsorbent formulation provides more than 170,000 square meters of surface area on which to adsorb and remove bloodstream targets.
  • Sigyn Therapy has been demonstrated to address inflammatory targets as well as pathogen sources of inflammation whose molecular size can exceed 100 nanometers in size.

Optime Care Offers Patient-First Humatin Total Care Program, Maximizes Therapeutic Benefits of Humatin™ for Hepatic Encephalopathy

Retrieved on: 
Tuesday, August 3, 2021
Practice Management, Pharmaceutical, Managed care, Health, Data management, Infectious diseases, Hospitals, Technology, Brain disorders, Medical specialties, Anatomy, Branches of biology, Hepatology, Coma, Hepatic encephalopathy, Encephalopathy, Orphan drugs, Paromomycin, Liver

Optime Care , a nationally recognized pharmacy, distribution and patient management organization maximizing therapeutic opportunities for the treatment of orphan and rare disorders, announces the availability of Humatin (paromomycin sulfate) exclusively through Humatin Total Care .

Key Points: 
  • Optime Care , a nationally recognized pharmacy, distribution and patient management organization maximizing therapeutic opportunities for the treatment of orphan and rare disorders, announces the availability of Humatin (paromomycin sulfate) exclusively through Humatin Total Care .
  • Humatin Total Care enables physicians to maximize the therapeutic opportunity for treating hepatic encephalopathy.
  • In the most severe form of hepatic encephalopathy, affected individuals may develop marked confusion or disorientation, amnesia, stupor or coma.
  • Quill concludes, As part of our patient-first focus, Humatin Total Care helps every stakeholder group impacted by this disease.