Acute respiratory distress syndrome

Orphan designation: Plerixafor Treatment of acute respiratory distress syndrome (ARDS), 19/02/2024 Positive

Retrieved on: 
Thursday, April 18, 2024
Patient, Committee, Acute respiratory distress syndrome, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of acute respiratory distress syndrome on 19 February 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Arch Biopartners Clinical Team Publishes Data from Phase II Trial for LSALT Peptide Targeting Organ Inflammation in Hospitalized Patients Infected with SARS-CoV-2

Retrieved on: 
Monday, March 18, 2024
CCL7, COVID, Major, BMJ Open, IL-6, AKI, Inflammation, Lung, Biomarker, Hospital, Acute respiratory distress syndrome, TMX Group, CXCL10, Acute kidney injury, SARS-CoV-2, Human, TSX, Chemokine, Arch, Cytokine, Periodic breathing, Phase, OTCQB, CXCL8, Liver, Somayaji, BMJ, Randomness, Pharmaceutical industry

New biomarker data from the pandemic Phase II trial, provides further scientific rationale for Arch to bring LSALT peptide into larger trials to inhibit DPEP-1 mediated organ inflammation.

Key Points: 
  • New biomarker data from the pandemic Phase II trial, provides further scientific rationale for Arch to bring LSALT peptide into larger trials to inhibit DPEP-1 mediated organ inflammation.
  • Arch is currently performing a Phase II human trial to support LSALT peptide as a first ever treatment for preventing cardiac surgery-associated acute kidney injury.
  • The results of the Phase II trial provided first-ever evidence validating DPEP-1 as a mediator of organ inflammation and therapeutic target in humans.
  • The new data provides more scientific rationale for Arch to advance LSALT peptide to prevent leukocyte recruitment and organ inflammation for other indications, including a larger Phase II trial targeting cardiac surgery-associated AKI, which recently began recruiting patients.

SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients

Retrieved on: 
Tuesday, March 12, 2024
CKRT, Randomness, Sepsis, Survival rate, Neutrophil, Monocyte, AKI, Humanitarian Device Exemption, Patient, Hospital, Acute respiratory distress syndrome, Mortality, Acute kidney injury, Standard of care, MD, HDE, KRT, Safety, Dialysis, Chronic kidney disease, SCD, FDA, Food, Pharmaceutical industry

DENVER, March 12, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI.

Key Points: 
  • “We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients.
  • Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We expect the pace of enrollment will accelerate as more medical centers come onboard.
  • With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.

Global Ventilators Market Focused Insights and Outlook 2024-2029 - KoninKlijke Philips, Hamilton Medical, Resmed, Medtronic & GE Healthcare Lead the Market - ResearchAndMarkets.com

Retrieved on: 
Monday, March 18, 2024
Managed Care, General Health, Oncology, Medical Devices, Infectious Diseases, Hospitals, Health Technology, Surgery, Biotechnology, Nursing, Medical Supplies, Practice Management, Health, Growth, Prevalence, Application, Molecular Modeling Database, Incidence, Patient, Ventilation, Hospital, Acute respiratory distress syndrome, GE HealthCare, Asthma, Medtronic, COPD, Nursing care plan, ICU, USD, Ageing, Medical device

The global ventilators market, valued at USD 1.75 billion in 2023, is expected to grow at a CAGR of 6.50% from 2023 to 2029.

Key Points: 
  • The global ventilators market, valued at USD 1.75 billion in 2023, is expected to grow at a CAGR of 6.50% from 2023 to 2029.
  • The global ventilators market is one of the fastest-growing segments in the medical devices market.
  • The changing healthcare services in emerging markets and significant achieved development with developed countries consistently drive the ventilator market growth.
  • KoninKlijke Philips, Hamilton Medical, Resmed, Medtronic plc, & GE Healthcare are some leading players currently dominating the global ventilators market.

Manuscript Discussing the Benefit of SeaStar Medical’s Selective Cytopheretic Device in Patients with Heart Failure and Hyperinflammation Published in European Journal of Heart Failure

Retrieved on: 
Tuesday, February 27, 2024
Cardiorenal syndrome, Division, Inflammation, FDA, Food, SCD, Emeritus, Manuscript, Hospital, Heart failure, European Journal, University, SeaStar, Internal medicine, Glucocorticoid, Acute kidney injury, Michigan Medicine, Drug, Monocyte, FACC, Acute respiratory distress syndrome, LVAD, Mortality, Heart, Pharmaceutical industry

DENVER, Feb. 27, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces publication of a manuscript discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the adult Selective Cytopheretic Device, part of the Quelimmune™ product family, in enabling previously ineligible patients with severe disease to receive a left ventricular assist device (LVAD) or heart transplant in the peer-reviewed European Journal of Heart Failure February 2024, Pitt, B., Iyer, S.P.N. and Humes, H.D. (2024), Eur J Heart Fail. https://doi.org/10.1002/ejhf.3177.

Key Points: 
  • The manuscript, titled “New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation” cites increasing evidence of the role of chronic systemic inflammation in patients with heart failure and discusses the Adult SCD’s potential to improve hypertensive heart failure and mortality following hospitalization for acute or worsening heart failure.
  • Following treatment with the Adult SCD, this patient was effectively bridged to LVAD three days after discontinuing treatment and was subsequently discharged without further complications.
  • “Prior attempts targeting singular proinflammatory factors as well as systemic immunosuppression with glucocorticoids in patients with acute heart failure have yielded unclear results, raising the need to identify new strategies.
  • “While our manuscript discusses a positive outcome in one patient following treatment for six hours daily over six consecutive days, the results suggest that more study with Adult SCD is warranted for patients with heart failure and hyperinflammation.”

Therapeutic Solutions International Announces Landmark Finding Regarding Mechanism of Action of its JadiCell Stem Cell Product

Retrieved on: 
Thursday, February 29, 2024
Health, Stem Cells, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, FDA, TSOI, Standard of care, Cell, GM-CSF, Safety, COVID-19, Patent, Patient, Monocyte, Acute respiratory distress syndrome, Survival, Phase, Science, TGF, Brain, Pharmaceutical industry

Depletion of either of these cells significantly reduced therapeutic effects of JadiCells.

Key Points: 
  • Depletion of either of these cells significantly reduced therapeutic effects of JadiCells.
  • Additionally, transfer of monocytes and T cells from JadiCell treated mice was able to protect naïve mice from lung injury.
  • The therapeutic effect of JadiCells was amplified by administration of Leukine (GM-CSF), which is known to increase circulating monocytes.
  • We are dedicated to curing this terrible disease1 and making our cells the new standard of care.”

RedHill's Opaganib Selected for Evaluation by BARDA and NIH Countermeasures Programs

Retrieved on: 
Tuesday, March 5, 2024
Infection, MCM, NIAID, NIH, ARS, TEL, FDA, SPHK2, Food, Acute radiation syndrome, RNCP, Bronchiolitis obliterans, Radiation, Mustard gas, HHS, Administration, COVID-19, Chem, ASPR, CCRP, Fibrosis, Acute respiratory distress syndrome, Development, White lung, Opaganib, Pharmaceutical industry

The overall evaluation will also include assessment of opaganib's efficacy against sub-chronic fibrosis and acute respiratory distress syndrome (ARDS) resulting from Sulfur Mustard exposure.

Key Points: 
  • The overall evaluation will also include assessment of opaganib's efficacy against sub-chronic fibrosis and acute respiratory distress syndrome (ARDS) resulting from Sulfur Mustard exposure.
  • "With the alarming increase in global geo-political instability, the opportunity to evaluate opaganib as a potential vital protective agent against chemical attack is inspiring.
  • "Opaganib is the first selective sphingosine kinase-2 (SPHK2) inhibitor investigational drug targeting sphingolipid metabolism to be evaluated as a chemical countermeasure.
  • Opaganib, a novel oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute for use against potential chemical weapon attack, if approved by the FDA.

BerGenBio Announces New Preclinical Data Indicating Broadened Potential for Bemcentinib to Treat Severe Respiratory Infections

Retrieved on: 
Wednesday, February 7, 2024
IL-8, COVID-19, Inflammation, Cytokine, Urinary tract infection, Downregulation and upregulation, MD, Therapy, Patient, University, Lung, Rhinovirus, Acute respiratory distress syndrome, Protein, RSV, Infection, Neutrophil, Blood, AXL, IL-6, Viral

The data presented by Dr. Spalluto showed bemcentinib had activity in human in vitro models of infection caused by Respiratory Syncytial Virus (RSV), influenza and rhinovirus.

Key Points: 
  • The data presented by Dr. Spalluto showed bemcentinib had activity in human in vitro models of infection caused by Respiratory Syncytial Virus (RSV), influenza and rhinovirus.
  • In these models, bemcentinib downregulated IL-6 and IL-8, two important inflammatory cytokines associated with the severity of hospitalized respiratory infections.
  • Clinically, patients with viral respiratory infections can develop acute respiratory distress syndrome (ARDS), a life-threatening condition.
  • We look forward to conducting additional preclinical evaluation of bemcentinib's activity in severe respiratory infections to further bolster our understanding in this important area."

BerGenBio Announces New Preclinical Data Indicating Broadened Potential for Bemcentinib to Treat Severe Respiratory Infections

Retrieved on: 
Wednesday, February 7, 2024
IL-8, COVID-19, Inflammation, Cytokine, Urinary tract infection, Downregulation and upregulation, MD, Therapy, Patient, University, Lung, Rhinovirus, Acute respiratory distress syndrome, Protein, RSV, Infection, Neutrophil, Blood, AXL, IL-6, Viral

The data presented by Dr. Spalluto showed bemcentinib had activity in human in vitro models of infection caused by Respiratory Syncytial Virus (RSV), influenza and rhinovirus.

Key Points: 
  • The data presented by Dr. Spalluto showed bemcentinib had activity in human in vitro models of infection caused by Respiratory Syncytial Virus (RSV), influenza and rhinovirus.
  • In these models, bemcentinib downregulated IL-6 and IL-8, two important inflammatory cytokines associated with the severity of hospitalized respiratory infections.
  • Clinically, patients with viral respiratory infections can develop acute respiratory distress syndrome (ARDS), a life-threatening condition.
  • We look forward to conducting additional preclinical evaluation of bemcentinib's activity in severe respiratory infections to further bolster our understanding in this important area."

EQS-News: AATec Medical starts collaboration with the German Federal Agency for Disruptive Innovation SPRIND for alpha-1 antitrypsin

Retrieved on: 
Tuesday, February 6, 2024
Partnership, Alpha-1 antitrypsin deficiency, Research, Inflammation, Lung, Acute respiratory distress syndrome, COPD, AAT, Innovation, Viral, Asthma, Pharmaceutical industry

This project is a key step in the development of the innovative ATL-105 drug platform for the treatment of respiratory diseases.

Key Points: 
  • This project is a key step in the development of the innovative ATL-105 drug platform for the treatment of respiratory diseases.
  • As part of the collaboration with SPRIND, ATL-105 will be tested in various disease models for viral diseases of the respiratory tract.
  • Sigrid Koeth, Innovation Manager at SPRIND, emphasizes the importance of the project: "With SPRIND, we want to create disruptive innovations from Germany.
  • Dr. Rüdiger Jankowsky, co-founder and CEO of AATec, comments on the collaboration: "The partnership with SPRIND enables us to accelerate our research and development work and realize our innovation potential faster.