Sepsis

Enlivex Announces Topline Results of Its Phase II Trial Evaluating Allocetra™ In Patients With Sepsis

Retrieved on: 
Jeudi, avril 11, 2024
Doctor of Philosophy, UTI, Mortality, Randomized controlled trial, Urinary tract infection, Safety, High Risk, Sepsis, Immunotherapy, Septic shock, Ventilation, Community-acquired pneumonia, System, Patient, Therapy, Overalls, Infection, Pharmaceutical industry

Enlivex intends to consider a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population.

Key Points: 
  • Enlivex intends to consider a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population.
  • The study was designed for patients to be randomized with equal degree of SOFA scores across treatment and placebo groups.
  • Both of these patient attributes are associated with a significantly higher degree of difficulty of treatment and higher mortality rates.
  • Nes-Ziona, Israel, April 11, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive indication of effect and safety results from its Phase II study of Allocetra™ in patients with sepsis, in which 120 patients enrolled.

AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock

Retrieved on: 
Mercredi, avril 10, 2024
Septic, Infection, Mortality, FDA, Public, CMO, Fast Track, Organ dysfunction, Priority review, Food, Adrenomedullin, Septic shock, Communication, Collection, DPP3, Intensive care medicine, Accelerated approval (FDA), Patient, Death, Biomarker, RCI, Medicine, Sepsis, Pharmaceutical industry

AdrenoMed is now preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach.

Key Points: 
  • AdrenoMed is now preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach.
  • AdrenoMed’s CEO Dr. Richard Jones commented: “We are very pleased that enibarcimab has received Fast Track designation from the FDA, recognizing its potential as an innovative biomarker-guided treatment against septic shock to fill the unmet medical need in this very serious condition with a high death toll.
  • With a mortality rate of 20-30% for sepsis1 and 30%-50% for septic shock in developed countries,2 sepsis represents an enormous public health burden and is responsible for almost 20% of all deaths worldwide.
  • Dr. Stephan Witte, CMO of AdrenoMed, said: “We are very confident that the use of enibarcimab in combination with two biomarkers, Adrenomedullin (bio-ADM) and circulating dipeptidyl peptidase 3 (cDPP3), holds the promise to become the first effective targeted treatment against septic shock.

Spectral Medical Provides Tigris Trial Update

Retrieved on: 
Mercredi, avril 10, 2024
Baxter, Randomized controlled trial, Septic shock, TSX, Patient, Sepsis, Lipopolysaccharide, Pharmaceutical industry

TORONTO, April 10, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Key Points: 
  • TORONTO, April 10, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
  • Robust enrollment activity continues throughout 2024:
    With 49 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial
    In-person meeting well attended with multiple stakeholders present, including: principal investigators and clinical research coordinators from existing and new trial sites; CRO, Beaufort; and representatives from the Company’s strategic partner Baxter
    Currently 22 Tigris trial sites, with continued progress opening an additional two new, high quality clinical sites

Recce Pharmaceuticals Provides Business Update

Retrieved on: 
Mercredi, avril 10, 2024
Urine, FDA, Congress, Multi, WHO, Ecosystem, Safety, World Health Organization, Blood, Food, Burn, Poster, Infection, AMR, Partnership, Recce, Escherichia coli, Fungal infection, Research, Sputum, BIO, Development, IND, Pharmacology, Defense, Science, Society, MDR, Clinical trial, Annual general meeting, Antimalarial medication, Government, Therapy, Biotechnology, Investigational New Drug, Sepsis, Pharmaceutical industry

These achievements collectively position Recce on track with its upcoming IND application, underscoring the company's dedication to bringing novel therapies to market swiftly and responsibly.

Key Points: 
  • These achievements collectively position Recce on track with its upcoming IND application, underscoring the company's dedication to bringing novel therapies to market swiftly and responsibly.
  • Recce has been actively pursuing various grant applications and submissions, particularly in government antimicrobial resistance (AMR) initiatives and military and health security.
  • Recce delivered a company presentation at the request of the U.S. Biomedical Advanced Research and Development Authority (BARDA), further strengthening its relationship and collaboration with U.S. governmental organizations.
  • This acknowledgment highlights the potential of RECCE® compounds to address critical global health challenges posed by antibiotic-resistant bacteria.

Bruker Further Enhances Clinical Microbiology & Infection Diagnostics Portfolio at ESCMID Global 2024 Conference

Retrieved on: 
Vendredi, avril 26, 2024
Biotechnology, Health, Genetics, Science, Research, MALDI, RUO, Yeast, Infection, Gastroenteritis, Piperacillin/tazobactam, HAI, Hospital, Antimalarial medication, Certification, Mycobacterium tuberculosis, Fungal infection, Bacteria, ESCMID, Daptomycin, Patient, Microbiology, Acquisition, Multimedia, Gram-negative bacteria, Diagnosis, Colistin, IVDR, TB, IVD, Sepsis, MBT, Sirius, Vaccine

At the ESCMID Global 2024 conference, Bruker is enhancing its innovative diagnostic solutions in microbial identification, antimicrobial susceptibility testing (AST), early sepsis diagnostics, and other infectious disease assays.

Key Points: 
  • At the ESCMID Global 2024 conference, Bruker is enhancing its innovative diagnostic solutions in microbial identification, antimicrobial susceptibility testing (AST), early sepsis diagnostics, and other infectious disease assays.
  • Simplifying microbiology and infectious disease diagnostics and workflows in the clinical laboratory is a key goal for Bruker in support of earlier and improved patient treatment decisions.
  • Bruker offers additional clinical workflows for rapid functional antibiotic resistance testing, like the MBT STAR®-Carba IVD assay for the detection of carbapenemase activity.
  • Dr. Wolfgang Pusch, President of the Bruker Microbiology & Infection Diagnostics division, commented: “Bruker is committed to innovation in routine microbiology and infectious disease testing.

Global Sepsis Therapeutics Strategic Research Report 2023-2024 and 2030: New Nanoparticles - A Revolution in the Development of Clinical Sepsis Therapy - ResearchAndMarkets.com

Retrieved on: 
Mercredi, avril 24, 2024
Pharmaceutical, Health, Other Health, FDA, Common, Cephalosporin, Antimicrobial spectrum, Sepsis, Growth, Research, Therapy

The "Sepsis Therapeutics - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Sepsis Therapeutics - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.
  • Common treatments for sepsis include antibiotics and vasopressors, with cephalosporins holding a significant share of the treatment market.
  • Despite the global economic update, the competitive landscape of the sepsis therapeutics market remains strong, with players worldwide categorized by their market presence.
  • The current standard of care involves antibiotics and vasopressors, with GIAPREZA being the only FDA-approved branded drug for sepsis treatment.

American Thoracic Society Selects Vasomune Therapeutics, Inc., to Present the AV-001 Development Update at the 2024 Respiratory Innovation Summit

Retrieved on: 
Lundi, avril 15, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, TEK tyrosine kinase, H3N2, Pneumonia, Safety, Sepsis, Survival, HVR, Conference, Stroke, PEGylation, Disease, Acute kidney injury, Therapy, Patient, RIS, Death, American Thoracic Society, Vascular dementia, Infection

Activation of this receptor plays a critical role in vascular stability, barrier integrity and endothelial quiescence, particularly within the pulmonary space.

Key Points: 
  • Activation of this receptor plays a critical role in vascular stability, barrier integrity and endothelial quiescence, particularly within the pulmonary space.
  • Vasomune’s Scientific co-founder, Dr. Harold Kim, will speak on May 18th, at 11:30 AM PT, at the Manchester Grand Hyatt, San Diego, CA.
  • “We are extremely excited to be invited to present our work at the Respiratory Innovation Summit during the American Thoracic Society 2024 Conference.
  • Join Dr. Kim at the Respiratory Innovation Summit to learn how Vasomune Therapeutics has brought together decades of research to create AV-001, a clinical-stage candidate for the treatment of diseases associated with vascular dysfunction.

MEI Pharma Reports Initial Data from Clinical Study Evaluating ME-344 in Combination with Bevacizumab (Avastin®) in Relapsed Metastatic Colorectal Cancer Patients

Retrieved on: 
Jeudi, avril 11, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, PFS, Patient, Safety, Sepsis, Progression-free survival, Survival, Bevacizumab, Glycolysis, Cohort, OXPHOS, Week, Fatigue, Neoplasm, Trial of the century, Overalls, Abdominal pain, Pharmaceutical industry

This landmark analysis exceeded the 20% threshold set in the Clinical Study Protocol to add an additional 20 patients to the study via the initiation of Cohort 2.

Key Points: 
  • This landmark analysis exceeded the 20% threshold set in the Clinical Study Protocol to add an additional 20 patients to the study via the initiation of Cohort 2.
  • The study was designed to evaluate ME-344 plus bevacizumab in up to two cohorts of approximately 20 patients each.
  • ME-344 in combination with bevacizumab at the dose and schedule evaluated was generally well tolerated with no overlapping toxicities observed.
  • Two patients (9%) discontinued therapy due to an adverse event: fatigue considered related to study drugs and sepsis considered unrelated.

Nu.Q® Vet Cancer Test launched in-clinic in U.S. and Europe through Antech

Retrieved on: 
Mardi, avril 23, 2024
Cancer, BMC, Pet, Sepsis, Veterinarian, Death, Volition, Neutrophil extracellular traps, Analyser, Dog, Plasma, Element, Vaccine

HENDERSON, Nev., April 23, 2024 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, has announced that its Nu.Q® Vet Cancer Test is now available in-clinic to veterinarians across the U.S and Europe through Antech , a leading veterinary diagnostics company.

Key Points: 
  • HENDERSON, Nev., April 23, 2024 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, has announced that its Nu.Q® Vet Cancer Test is now available in-clinic to veterinarians across the U.S and Europe through Antech , a leading veterinary diagnostics company.
  • By incorporating the Nu.Q® Canine Cancer Test into annual checkups or regular senior wellness exams, veterinarians can detect cancer¹ earlier and help pet owners make timely, informed decisions about cancer care."
  • Volition's original license and supply agreement was between Belgian Volition SRL and Heska, an Antech company, part of Mars Science & Diagnostics.
  • https://doi.org/10.1186/s12917-022-03429-8
    According to The Veterinary Cancer Society,  one in four dogs will be diagnosed with cancer, and it's the leading cause of death in pets who are beyond middle age.

Sepsis Alliance Applauds Reintroduction of Lulu's Law in Advance of Pediatric Sepsis Week

Retrieved on: 
Jeudi, avril 18, 2024
Congress, Patient, Personality, Stroke, System, Sepsis Alliance, United, Amputation, Sepsis, Convulsion, Hope, Hospital, Skin, Death, House, Legislation, Eye, Representative, Cost, Lethargy, Rash, Memory, Diagnosis, Pelvic floor dysfunction, Infection

WASHINGTON, April 18, 2024 /PRNewswire-PRWeb/ -- A bill named in memory of four-year-old Ana Lucía "Lulu" Haynes, who passed away from sepsis in 2014, has been reintroduced in the House of Representatives. It arrives ahead of next week's Pediatric Sepsis Week observance, which provides an annual opportunity to raise awareness of the symptoms of sepsis in children and honor the 75,000 children who, like Lulu, develop sepsis in the U.S. each year. The Sepsis Harm and Cost Reduction Act, or Lulu's Law, develops a U.S. strategy for responding to sepsis and launches a program of state-based information repositories to improve sepsis diagnosis, treatment, and outcomes. This will help to answer the many unanswered questions about this condition, improve our ability to diagnose and treat it, and organize the country's strategy for solving sepsis. The legislation is championed by Sepsis Alliance, the nation's first and leading sepsis organization, and jointly sponsored by Representative Mikie Sherrill (D-NJ-11), who represents Lulu's district, and Representative Larry Bucshon, M.D. (R-IN-08).

Key Points: 
  • The Sepsis Harm and Cost Reduction Act, or Lulu's Law, develops a U.S. strategy for responding to sepsis and launches a program of state-based information repositories to improve sepsis diagnosis, treatment, and outcomes.
  • According to Sepsis Alliance, children, particularly those under five, can be especially susceptible to developing sepsis.
  • "That's why, this Pediatric Sepsis Week, it is so heartening to see the reintroduction of Lulu's Law, a serious effort to tackle the enormous national burden of sepsis.
  • Sepsis Alliance applauds and sincerely thanks Representative Sherrill and Representative Bucshon for their leadership on this vital bill."