Respiratory physiology

Mayo Clinic and nference Study Links Pre-Existing Conditions to Short- and Long-Term COVID-19 Complications

Retrieved on: 
Tuesday, July 27, 2021

The researchers found hypertension was the most significant risk factor associated with 10 different complications including pleural effusion, acute respiratory distress syndrome (ARDS), cardiac arrhythmia, and anemia.

Key Points: 
  • The researchers found hypertension was the most significant risk factor associated with 10 different complications including pleural effusion, acute respiratory distress syndrome (ARDS), cardiac arrhythmia, and anemia.
  • "The significance of hypertension as a factor in ARDS, which was not previously known, is quite striking," says Venky Soundararajan, PhD, co-founder and chief scientific officer of nference.
  • Specifically in the case of hypertension patients, healthcare workers should expect more serious short term complications."
  • This indicates an increased need to monitor patients with pre-existing conditions for pleural effusion well beyond the initial period of illness.

Enlivex to Present at the ARDS Drug Development Summit 2021

Retrieved on: 
Wednesday, July 14, 2021

Nes Ziona, Israel, July 14, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the Company), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company will participate in, and present at, the ARDS Drug Development Summit on Thursday, July 15, 2021.

Key Points: 
  • Nes Ziona, Israel, July 14, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the Company), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company will participate in, and present at, the ARDS Drug Development Summit on Thursday, July 15, 2021.
  • Those interested in registering for the summit can do so by visiting https://ards-summit.com.
  • The inaugural ARDS Drug Development Summit brings together industry pioneers to strategize against the drug development challenges in COVID-19/non-COVID-19 associated ARDS and catalyze a new wave of targeted therapies for pulmonary and systemic inflammation.
  • ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs with high mortality and morbidity.

Trevena Announces Initiation of OLINVYK® Respiratory Physiology Study Including Elderly / Obese Subjects

Retrieved on: 
Wednesday, July 7, 2021

That work used clinical utility function analysis methodology based on the original OLINVYK Phase 1 ventilatory response to hypercapnia (VRH) data.

Key Points: 
  • That work used clinical utility function analysis methodology based on the original OLINVYK Phase 1 ventilatory response to hypercapnia (VRH) data.
  • In this study, the integrated inputs of interest are analgesia (benefit) and respiratory depression (risk).
  • The study aims to recruit ~50% of subjects who are 65 years old and ~30% of subjects with a BMI > 30 kg/m2.
  • Respiratory depression will be assessed using the VRH measure, which is widely recognized as a precise method to assess respiratory physiology in humans.

Newborn Screening Test for Sickle Cell Disease Now Supported by Gazelle 8-Minute, Point-of-Care Diagnostic

Retrieved on: 
Monday, June 14, 2021

The upgrade, free to those with the Gazelle device, also includes printing enhancements and a variety of ease-of-use features.

Key Points: 
  • The upgrade, free to those with the Gazelle device, also includes printing enhancements and a variety of ease-of-use features.
  • Sickle cell disease (SCD) is one of the most common and severe of all inherited hematological disorders, causing substantial morbidity and mortality worldwide.
  • According to the Sickle Cell Disease Foundation, SCD is responsible for between 5% and 16% of all infant deaths in sub-Saharan Africa.
  • Hemex improvements enable the Gazelle test to identify these low levels for sickle cell disease and trait, Barts, and other important hemoglobinopathies at birth, continued Dr. Obaro.

Agios Announces Updated Data from ACTIVATE and ACTIVATE-T Phase 3 Studies of Mitapivat in Pyruvate Kinase (PK) Deficiency at the European Hematology Association Virtual Congress

Retrieved on: 
Friday, June 11, 2021

Data from the studies will be featured in oral presentations on Tuesday, June 15, at the European Hematology Association (EHA) Virtual Congress.

Key Points: 
  • Data from the studies will be featured in oral presentations on Tuesday, June 15, at the European Hematology Association (EHA) Virtual Congress.
  • Mitapivat is a first-in-class, investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated pyruvate kinase R (PKR) enzymes.
  • Mitapivat demonstrated a sustained, statistically significant increase in hemoglobin in patients with PK deficiency who are not regularly transfused.
  • 40 percent (n=16) of patients randomized to mitapivat achieved a hemoglobin response, compared to 0 patients randomized to placebo (2-sided p

Kiniksa Outlines Next Steps for the Development of Mavrilimumab

Retrieved on: 
Tuesday, June 8, 2021

Kiniksa believes development of mavrilimumab in COVID-19-related ARDS represents the fastest path to potential registration.

Key Points: 
  • Kiniksa believes development of mavrilimumab in COVID-19-related ARDS represents the fastest path to potential registration.
  • Kiniksa is engaged with theFDA and other government agencies on pathways to accelerate access to mavrilimumab as a potential therapeutic option for COVID-19-related ARDS.
  • Kiniksa received guidance that a single, well-controlled pivotal Phase 3 clinical trial in approximately 450 patients could be sufficient for registration.
  • Kiniksa intends to provide additional updates on the development of mavrilimumab following data from the Phase 3 clinical trial in COVID-19-related ARDS.

MediciNova Initiates Sheep Study under Partnership with BARDA to Develop MN-166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury

Retrieved on: 
Monday, June 7, 2021

Following treatment of the sheep with MN-166 (ibudilast) or control, the study will evaluate pulmonary function, lung injury and edema formation, cardiopulmonary hemodynamics, and systemic vascular permeability.

Key Points: 
  • Following treatment of the sheep with MN-166 (ibudilast) or control, the study will evaluate pulmonary function, lung injury and edema formation, cardiopulmonary hemodynamics, and systemic vascular permeability.
  • Under the FDA Animal Rule, development of medical countermeasures (MCMs) does not require human clinical trials to establish efficacy when these trials would not be ethical or feasible.
  • MN-166 attenuated histological changes observed in an ARDS mouse model, including pulmonary edema in lung tissue, and protected against pulmonary injury by reducing cellular apoptosis in lung tissue.
  • Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof.

Mereo BioPharma Announces Positive Desmosine Biomarker Data from an Interim Analysis of an Investigator Initiated Study of alvelestat in Bronchiolitis Obliterans Syndrome (BOS)

Retrieved on: 
Wednesday, June 2, 2021

Interim data from the first seven patients in this open-label study were presented at the 2020 American Society of Hematology (ASH) Annual Meeting in December 2020.

Key Points: 
  • Interim data from the first seven patients in this open-label study were presented at the 2020 American Society of Hematology (ASH) Annual Meeting in December 2020.
  • In this phase 1 study, maximum-tolerated dose (MTD) was not reached and alvelestat was well tolerated.
  • Notably, two patients had improvement in forced expiratory volume in one second (FEV1) of 9%, and four patients experienced improvement in symptoms.
  • Subsequent analysis of the elastin breakdown biomarker desmosine, has recently been completed.

Citius Pharmaceuticals Selected to Receive Best Poster Award at the International Society for Cell and Gene Therapy 2021 Annual Meeting

Retrieved on: 
Tuesday, May 25, 2021

ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation.

Key Points: 
  • ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation.
  • Survivors of ARDS are often left with severe long-term illness and disability.
  • ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease).
  • Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration.

Veru Enrolls First Patient in Phase 3 Clinical Trial of Sabizabulin (VERU-111) in High Risk Hospitalized COVID-19 Patients

Retrieved on: 
Wednesday, May 19, 2021

Because of better oral bioavailability, the systemic blood levels from the 9mg sabizabulin dosage are similar to the 18mg sabizabulin formulation used in the Phase 2 clinical study.

Key Points: 
  • Because of better oral bioavailability, the systemic blood levels from the 9mg sabizabulin dosage are similar to the 18mg sabizabulin formulation used in the Phase 2 clinical study.
  • The primary efficacy endpoint will be the proportion of patients that die on study up to Day 60.
  • Patients hospitalized with documented evidence of COVID-19 infection and at high risk for ARDS were enrolled.
  • The Company disclaims any intent or obligation to update these forward-looking statements.\nPhase 3 Clinical Trial Contact:\n'