Acute respiratory distress syndrome

Diffusion Pharmaceuticals Announces FDA Accelerated Review of TSC Clinical Development Plan to Treat COVID-19 Patients with ARDS

Retrieved on: 
Tuesday, May 5, 2020

Diffusion believes that TSCs novel oxygen-enhancing mechanism of action could provide an important new treatment option for this life-threatening condition.

Key Points: 
  • Diffusion believes that TSCs novel oxygen-enhancing mechanism of action could provide an important new treatment option for this life-threatening condition.
  • Clinical trial preparations at multiple potential sites are continuing as the Company awaits the FDAs expedited response.
  • This news of accelerated FDA review of the proposed clinical development plan for our lead compound TSC in a COVID-19 ARDS program is most welcome, said David Kalergis, chief executive officer of Diffusion.
  • Diffusion undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 Athersys Announces Commencement of Patient Enrollment in the MACOVIA Study, a Pivotal Phase 2/3 Trial Evaluating MultiStem® Cell Therapy for COVID-19 Induced ARDS

Retrieved on: 
Tuesday, May 5, 2020

We are pleased to partner with Athersys to advance this important clinical study to evaluate treatment of critically ill patients with COVID-19-induced ARDS, concluded Dr. Jacono.

Key Points: 
  • We are pleased to partner with Athersys to advance this important clinical study to evaluate treatment of critically ill patients with COVID-19-induced ARDS, concluded Dr. Jacono.
  • MultiStem cell therapys potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit.
  • For more detailed information on the Companys ARDS program, please visit the ARDS page on the Athersys website .
  • Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

Athersys and University Hospitals Cleveland Medical Center Announce Activation of the First Clinical Site for the MACOVIA Study, a Pivotal Phase 2/3 Study Evaluating MultiStem® Cell Therapy for COVID-19 Induced ARDS

Retrieved on: 
Friday, May 1, 2020

UH Cleveland has completed trial start-up activities enabling commencement of patient screening and enrollment in this important randomized, double-blind, placebo-controlled study.

Key Points: 
  • UH Cleveland has completed trial start-up activities enabling commencement of patient screening and enrollment in this important randomized, double-blind, placebo-controlled study.
  • The MACOVIA trial aims to confirm the safety and efficacy of MultiStem therapy as a treatment for patients with moderate to severe ARDS due to COVID-19.
  • UH Cleveland is a leading pulmonary critical care center in the United States and participated in Athersys completed Phase 1/2 MUST-ARDS study.
  • The systems flagship academic medical center, University Hospitals Cleveland Medical Center, located in Clevelands University Circle, is affiliated with Case Western Reserve University School of Medicine.

Phase 2/3 Randomized Controlled Trial of Remestemcel-L in 300 Patients With COVID-19 Acute Respiratory Distress Syndrome Begins Enrollment

Retrieved on: 
Thursday, April 30, 2020

Mesoblast Chief Executive Dr Silviu Itescu stated: There are limited treatment options for ventilator-dependent patients with acute respiratory distress syndrome, the principal cause of mortality in COVID-19 infection.

Key Points: 
  • Mesoblast Chief Executive Dr Silviu Itescu stated: There are limited treatment options for ventilator-dependent patients with acute respiratory distress syndrome, the principal cause of mortality in COVID-19 infection.
  • The specific clinical protocol for use of remestemcel-L in patients in this trial was informed by the previously reported positive results from the emergency compassionate use protocol patients with COVID-19 ARDS.
  • These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
  • Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain.

Global Therapeutic Landscape for Acute Respiratory Distress Syndrome: Drug Profiles for Pipeline Products - ResearchAndMarkets.com

Retrieved on: 
Thursday, April 30, 2020

This pharmaceutical and healthcare disease pipeline guide provides an overview of the Acute Respiratory Distress Syndrome (Respiratory) pipeline landscape.

Key Points: 
  • This pharmaceutical and healthcare disease pipeline guide provides an overview of the Acute Respiratory Distress Syndrome (Respiratory) pipeline landscape.
  • The pipeline guide also reviews of key players involved in therapeutic development for Acute Respiratory Distress Syndrome and features dormant and discontinued projects.
  • The pipeline guide provides a snapshot of the global therapeutic landscape of Acute Respiratory Distress Syndrome.
  • Formulate corrective measures for pipeline projects by understanding Acute Respiratory Distress Syndrome (Respiratory) pipeline depth and focus of Indication therapeutics.

Citius Announces Pre-IND Submission to FDA Under the Coronavirus Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) in COVID-19

Retrieved on: 
Monday, April 27, 2020

The iPSCs are then further differentiated into a mesenchymal stem cell (MSC) therapy.

Key Points: 
  • The iPSCs are then further differentiated into a mesenchymal stem cell (MSC) therapy.
  • Citius and Novellus plan to develop NC-MSCs for the treatment of ARDS, and last month the companies signed an exclusive option agreement.
  • There is no proven or FDA-approved treatment for it, other than oxygen therapy, including use of mechanical ventilation, and fluid management.
  • In response to the pandemic, the FDA has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to accelerate the development of treatments for COVID-19.

Diffusion Pharmaceuticals Announces Pre-IND Submission to the FDA of Design for TSC Trials to Treat Acute Respiratory Distress Syndrome in COVID-19

Retrieved on: 
Monday, April 27, 2020

Acute Respiratory Distress Syndrome (ARDS) develops in nearly all patients hospitalized with COVID-19, triggered by lack of sufficient oxygen to vital organs as a consequence of damage to the lungs.

Key Points: 
  • Acute Respiratory Distress Syndrome (ARDS) develops in nearly all patients hospitalized with COVID-19, triggered by lack of sufficient oxygen to vital organs as a consequence of damage to the lungs.
  • In general, ARDS carries a high mortality rate (up to 40% in those on a breathing machine, and likely higher in COVID-19-related ARDS).
  • Although the number, design and projected enrollment of the clinical trials are subject to change, Diffusions pre-IND submission for TSC envisions three studies to be conducted in rapid succession.
  • Diffusion undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Santhera and Cold Spring Harbor Laboratory to Investigate Lonodelestat (POL6014) in COVID-19-related Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Monday, April 27, 2020

Santhera will provide lonodelestat and intellectual support for the scientists at CSHL who will conduct the non-clinical research program.

Key Points: 
  • Santhera will provide lonodelestat and intellectual support for the scientists at CSHL who will conduct the non-clinical research program.
  • Based on previous work with lonodelestat in models of ARDS and acute lung injury, we were very encouraged about the potential of lonodelestat.
  • Under conditions of severe inflammation, neutrophils can expel NETs which can aggravate pulmonary inflammation and may contribute to the development of acute respiratory distress syndrome (ARDS).
  • Founded in 1890, Cold Spring Harbor Laboratory has shaped contemporary biomedical research and education with programs in cancer, neuroscience, plant biology and quantitative biology.

ClinCapture Joins Forces with MediciNova to Support their COVID-19 Research

Retrieved on: 
Friday, April 24, 2020

a leading provider in Electronic Data Capture (EDC) systems, and biopharmaceutical company MediciNova, Inc. have joined forces in COVID-19 research.

Key Points: 
  • a leading provider in Electronic Data Capture (EDC) systems, and biopharmaceutical company MediciNova, Inc. have joined forces in COVID-19 research.
  • "We are excited to support MediciNova in this critical research," said ClinCapture CEOScott Weidley.
  • MediciNova, a biopharmaceutical company pursuing novel therapeutics, will be using Captivate EDC to perform a clinical trial to target severe COVID-19.
  • With plans to further their research with their investigational drug, MN-166 (ibudilast), MediciNova plans to target patients with acute respiratory distress syndrome (ARDS) caused by COVID-19.

Global Acute Kidney Injury (AKI) Epidemiology Report 2020: Patient Pools, Growth Opportunities, Prevalent Countries

Retrieved on: 
Friday, April 24, 2020

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Incident Cases of Acute Kidney Injury, Discharge Diagnosed Cases of Acute Kidney Injury, Stage-Wise Discharged Diagnosed Cases of Acute Kidney Injury, Risk Factor Associated Acute Kidney Injury Cases and Renal Transplantation Associated Delayed Graft Function scenario of Acute Kidney Injury (AKI) in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.

Key Points: 
  • The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Incident Cases of Acute Kidney Injury, Discharge Diagnosed Cases of Acute Kidney Injury, Stage-Wise Discharged Diagnosed Cases of Acute Kidney Injury, Risk Factor Associated Acute Kidney Injury Cases and Renal Transplantation Associated Delayed Graft Function scenario of Acute Kidney Injury (AKI) in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.
  • The Acute Kidney Injury (AKI) report will allow the user to:
    Develop business strategies by understanding the trends shaping and driving the 7MM Acute Kidney Injury (AKI) market.
  • The Acute Kidney Injury (AKI) epidemiology report and model were written and developed by Masters and Ph.D. level epidemiologists.
  • The Acute Kidney Injury (AKI) epidemiology model developed by the publisher is easy to navigate, interactive with dashboards, and epidemiology based on transparent and consistent methodologies.