Acute respiratory distress syndrome

MediciNova Announces Results of Studies under BARDA Contract to Develop MN 166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury

Retrieved on: 
Thursday, September 28, 2023
ASPR, Code, ALI, Human services, United States Department of Health and Human Services, White lung, Development, MCM, Chlorine, Tokyo Stock Exchange, Biomedical Advanced Research and Development Authority, Acute respiratory distress syndrome, Standard Market Design, BARDA, Safety, Pharmaceutical industry

Two different nonclinical models were used to investigate the potential clinical utility of MN-166 (ibudilast) for the treatment of chlorine-induced lung damage.

Key Points: 
  • Two different nonclinical models were used to investigate the potential clinical utility of MN-166 (ibudilast) for the treatment of chlorine-induced lung damage.
  • The primary endpoint was the pulmonary function measure PaO2/FiO2, which is the ratio of arterial oxygen partial pressure to fractional inspired oxygen.
  • In the pilot design single-dose treatment regimen, the test subjects were treated only once after the Cl2 gas challenge was completed.
  • There is a great unmet medical need for treatments for chlorine gas exposure as there is no drug approved specifically for this indication.

Chrysalis Receives FDA Approval to Initiate Clinical Trials with Chrysalin™ (TP508)

Retrieved on: 
Tuesday, September 26, 2023
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Acute respiratory distress syndrome, Tissue, Pupa, US Foods, Radiation, Biomedical Advanced Research and Development Authority, Bone fracture, University, Office of Inspector General, U.S. Department of Health and Human Services, Human services, Safety, National Institute of Allergy and Infectious Diseases, Infection, Brain, COVID, Inflammation, Lung, Pulmonary fibrosis, UTMB, Fibrosis, Development, Ischemia, Patient, Diagnosis, Chronic radiation syndrome, Carney, NIAID, Trauma, UTHealth School of Dentistry, BARDA, IND, Food, White lung, Pharmaceutical industry

Chrysalis BioTherapeutics, Inc. announced today that the US Food and Drug Administration (FDA) has given the company permission to initiate human clinical trials aimed at treating acute lung failure.

Key Points: 
  • Chrysalis BioTherapeutics, Inc. announced today that the US Food and Drug Administration (FDA) has given the company permission to initiate human clinical trials aimed at treating acute lung failure.
  • Other animal studies show potential TP508 benefit in treating acute lung injury, chronic smoke inhalation, and mitigating radiation effects on brain and other tissues.
  • “TP508 is a natural regenerative peptide that accelerates tissue repair and revascularization while modulating the inflammatory response.
  • Chrysalis is using UTMB, Houston-area, and national advisors to advance TP508 for treating pulmonary indications.

Alloksys reports interim results of its clinical phase IIb trial with Alkaline Phosphatase therapy RESCAP® in critical care patients

Retrieved on: 
Thursday, August 24, 2023
Extrapyramidal system, EEA, Trauma, Human, Probability, Therapy, Chronic kidney disease, Accident, Prevalence, New Drug Application, NDA, AP, Inflammation, Marketing, AKI, Sepsis, Intensive care medicine, Alkaline phosphatase, ITMS, Incidence, Acute kidney injury, Patient, Disease, Acute respiratory distress syndrome, Mortality, Nursing care plan, MAA, Burns, Intensive care unit, CKD, III, Calf, Dentistry, Pharmaceutical industry, Hospital, Vaccine

The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery.

Key Points: 
  • The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery.
  • These outcomes warrant a follow-up clinical phase III trial with a total of 400 patients, to commence Q3 2023.
  • Ruud Brands, Founder and CEO of Alloksys, comments on the interim results of the APPIRED-III study, which focuses on patients undergoing cardiothoracic surgery.
  • RESCAP® (RESCuing Alkaline Phosphatase), is a proprietary medication developed by Alloksys, based on the enzyme alkaline phosphatase (AP).

Alloksys reports interim results of its clinical phase IIb trial with Alkaline Phosphatase therapy RESCAP® in critical care patients

Retrieved on: 
Thursday, August 24, 2023
Extrapyramidal system, EEA, Trauma, Human, Probability, Therapy, Chronic kidney disease, Accident, Prevalence, New Drug Application, NDA, AP, Inflammation, Marketing, AKI, Sepsis, Intensive care medicine, Alkaline phosphatase, ITMS, Incidence, Acute kidney injury, Patient, Disease, Acute respiratory distress syndrome, Mortality, Nursing care plan, MAA, Burns, Intensive care unit, CKD, III, Calf, Dentistry, Pharmaceutical industry, Hospital, Vaccine

The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery.

Key Points: 
  • The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery.
  • These outcomes warrant a follow-up clinical phase III trial with a total of 400 patients, to commence Q3 2023.
  • Ruud Brands, Founder and CEO of Alloksys, comments on the interim results of the APPIRED-III study, which focuses on patients undergoing cardiothoracic surgery.
  • RESCAP® (RESCuing Alkaline Phosphatase), is a proprietary medication developed by Alloksys, based on the enzyme alkaline phosphatase (AP).

Revive Therapeutics Announces Initiation of Novel Bucillamine Formulation Development

Retrieved on: 
Tuesday, August 22, 2023
ASPR, Defence Research and Development Canada, Cell biology, CSE, University, Biomedical Advanced Research and Development Authority, Therapy, Biochemistry, Doctor of Philosophy, HHS, U.S. Department of Defense Strategy for Operating in Cyberspace, Public, Office of Inspector General, U.S. Department of Health and Human Services, University of Saskatchewan academics, Injury, Research, Infection, Postgraduate education, Central Department of Chemistry, Tribhuvan University, Disorder, DRDC, Assistant, Inflammation, RVV, Development, Graduate, Administration, Organ transplantation, Administration for Strategic Preparedness and Response, Acute respiratory distress syndrome, FDA, BARDA, Dean (education), Pharmaceutical industry, Science, Bucillamine

In addition, the Company may explore the use of the novel Bucillamine formulation as a potent antioxidant and anti-inflammatory treatment for orphan indications in rare inflammatory disorders such as ischemia-reperfusion injury resulting from solid organ transplantation.

Key Points: 
  • In addition, the Company may explore the use of the novel Bucillamine formulation as a potent antioxidant and anti-inflammatory treatment for orphan indications in rare inflammatory disorders such as ischemia-reperfusion injury resulting from solid organ transplantation.
  • The Company has entered into a sponsored research agreement with the University of Waterloo to develop a novel lyophilized Bucillamine injectable formulation for public health medical emergencies and rare inflammatory disorders.
  • Upon completion of the formulation development, which is expected by end-2023, the Company will seek to initiate research studies in line with the Company’s commitment to advancing the clinical and commercial development of Bucillamine through the following strategic initiatives:
    Target Indications: Novel Bucillamine in an injectable version to expand on its potential therapeutic utility targeting rare disorders such as ischemia-reperfusion injury (i.e.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.

SeaStar Medical Reports Second Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Monday, August 14, 2023
Insurance, Shareholder, Neutrophil, Humanitarian Device Exemption, Chronic kidney disease, Marketing, HDE, SCD, Clinical trial, Center for Biologics Evaluation and Research, G&A, Sale, AKI, Dialysis, Sepsis, Acute kidney injury, CKRT, Hospital, Monocyte, PIN, Patient, Standard of care, Manuscript, Risk, Nephrology, Physician, HIV disease progression rates, Clinical study design, Nephron, Acute respiratory distress syndrome, Mortality, ICU, R, FDA, Letter, Safety, Pharmaceutical industry, Nursing, Life insurance, Research

DENVER, Aug. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and six months ended June 30, 2023 and provides a business update.

Key Points: 
  • Management to hold a business update conference call on August 22 beginning at 4:00 p.m. Eastern time
    DENVER, Aug. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and six months ended June 30, 2023 and provides a business update.
  • SeaStar Medical anticipates approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The net loss for the second quarter of 2023 was $3.7 million, or $0.25 per share, compared with a net loss of $0.9 million, or $0.12 per share, for the second quarter of 2022.
  • SeaStar Medical management will host a business update conference call on Tuesday, August 22, 2023 beginning at 4:00 p.m. Eastern time (1:00 p.m. Pacific time) to provide a business update and answer questions.

Omega Therapeutics Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Thursday, August 3, 2023
OMEGA, MYC, Liver disease, OEC, G&A, NSCLC, COVID, Part, Lung cancer, Strategic planning, Messenger, Multiple, Annual general meeting, ASCO, Investigational New Drug, Patient, Standard of care, Acute respiratory distress syndrome, Regional Security System, Relative biological effectiveness, R, Research, Therapy, Tumor microenvironment, IND, Potential, HCC, Safety, Pharmaceutical industry, Tolerability, Pharmacology

Continued Enrollment in Monotherapy Dose Escalation Stage of Phase 1/2 MYCHELANGELO™ I Study; Preliminary First-in-Human Safety, Tolerability, Pharmacologic and Translational Data Anticipated in the Fourth Quarter of 2023

Key Points: 
  • Continued Enrollment in Monotherapy Dose Escalation Stage of Phase 1/2 MYCHELANGELO™ I Study; Preliminary First-in-Human Safety, Tolerability, Pharmacologic and Translational Data Anticipated in the Fourth Quarter of 2023
    CAMBRIDGE, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, today announced financial results for the second quarter ended June 30, 2023, and highlighted recent Company progress.
  • Research and development (R&D) expenses for the second quarter of 2023 were $25.0 million, compared to $19.4 million for the second quarter of 2022.
  • General and administrative (G&A) expenses were $6.2 million for the second quarter of 2023 and 2022.
  • Net loss for the second quarter of 2023 was $29.7 million, compared to $25.9 million for the second quarter of 2022, driven predominantly by increased R&D expenses to support the Company’s growth.

Enlivex Announces Peer-Reviewed Publication in Frontiers in Immunology of Clinical Data Details Resolution of Acute Respiratory Distress Syndrome (ARDS) from two Phase I/II Trials Evaluating Allocetra in Patients with COVID-19

Retrieved on: 
Wednesday, August 2, 2023
Rebecca Sieff Hospital, Frontiers, University Medical Center, COVID-19, Inflammation, Immunotherapy, Patient, Barzilai Medical Center, Hadassah Medical Center, Viral, Acute respiratory distress syndrome, Mortality, ICU, Trial of the century, Paper, Chemokine, Phase, Therapy, Disease, Pharmaceutical industry, Data, Immunology

Nes-Ziona, Israel, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the peer-reviewed publication of clinical and exploratory data from a Phase Ib and a Phase IIa clinical trial in Frontiers in Immunology. The paper, entitled “Apoptotic cells for treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19” describes a multicenter study that was published in collaboration with researchers at Hadassah-Hebrew University Medical Center, Barzilai Medical Center and Ziv Medical Center Israel.

Key Points: 
  • The Phase I/II clinical trials evaluated the safety profile of Allocetra treatment as well as recovery from ARDS, intensive care unit (ICU) and hospital length-of-stay inflammatory parameters and cytokine/chemokine profile.
  • The mortality rate was compared to a matched control group hospitalized during the same period at Hadassah Medical Center.
  • All patients had elevated pro- and anti-inflammatory cytokines, chemokines, and additional immune modulators that steadily decreased following AllocetraTM treatment.
  • No serious related adverse events were reported with AllocetraTM treatment with an overall favorable safety profile.

Direct Biologics Announces Publication of Significant Survival Benefit with ExoFlo™ in its Phase 2 Randomized Controlled Clinical Trial in the Journal CHEST

Retrieved on: 
Wednesday, July 12, 2023
Other Health, Research, General Health, Pharmaceutical, Infectious Diseases, Clinical Trials, Science, COVID-19, Biotechnology, Stem Cells, Other Science, Health, Therapy, Overalls, Clinical trial, Trial of the century, Regenerative medicine, EVS, Incidence, Respiratory failure, Seminal vesicles, Patient, Risk, Acute respiratory distress syndrome, Mortality, VFD, Ageing, FDA, Death, Treatment, Safety, Pharmaceutical industry

“A critical finding of this study was the safety profile of ExoFlo.

Key Points: 
  • “A critical finding of this study was the safety profile of ExoFlo.
  • There was a lack of adverse or serious adverse events in this very sick patient population.
  • Over the duration of the clinical trial, no treatment-related adverse events were reported.
  • In addition, a trend in dose response was observed for VFDs in both moderate and severe ARDS in this age group.

Innovation Pharmaceuticals Provides Update on U.S. Patent Applications Covering Use of Brilacidin in Inflammatory Bowel Diseases, Coronaviruses and Fungal Diseases

Retrieved on: 
Wednesday, June 21, 2023
Patent, Biomedical Advanced Research and Development Authority, Gastrointestinal tract, ALI, COVID-19, Infant respiratory distress syndrome, Nature Communications, OTCQB, HDP, Development, Patient, Ulcerative colitis, Biomarker, Acute respiratory distress syndrome, Host, BARDA, Pharmaceutical industry

Brilacidin is a Host Defense Protein-mimetic drug candidate with broad-spectrum immunomodulatory and antimicrobial properties.

Key Points: 
  • Brilacidin is a Host Defense Protein-mimetic drug candidate with broad-spectrum immunomodulatory and antimicrobial properties.
  • The Company out-licensed Brilacidin in UP/UPS to Alfasigma S.p.A. Brilacidin has also been evaluated in Phase 2 testing in moderate-to-severe hospitalized cases of COVID-19 (by intravenous delivery), with beneficial treatment effects observed in patient subgroups.
  • A separate patent application has been submitted to the USPTO for use of Brilacidin in fungal diseases.
  • Additional in vivo testing in efficacy models against two hard-to-treat fungal pathogens is scheduled for 3Q2023.