Respiratory distress syndrome

BioAegis Therapeutics Announces FDA Clearance of IND for its ‘Inflammation Regulator Protein,’ Gelsolin, for the Treatment of ARDS

Retrieved on: 
Thursday, January 26, 2023

ARDS is a serious inflammatory condition for which there are severe consequences with no current therapies other than supportive care.

Key Points: 
  • ARDS is a serious inflammatory condition for which there are severe consequences with no current therapies other than supportive care.
  • Its genesis can be from various etiologies, with severe infection being a frequent cause.
  • BioAegis is collaborating with the BARDA DRIVe Solving Sepsis program, to further develop plasma gelsolin for ARDS.
  • Plasma gelsolin is critically depleted in ARDS patients and has been shown to address both injurious and infectious inflammation in multiple studies.

Beyond Cancer® Publishes Pre-Clinical Data in Cancer Cell International Demonstrating Its Tumor Ablation Method Utilizing Ultra-High Concentration Nitric Oxide (UNO) Induced a Systemic Response that Prevents Metastases

Retrieved on: 
Tuesday, December 13, 2022

The data were published in an article entitled, “Gaseous Nitric Oxide Tumor Ablation Induces an Anti-Tumor Abscopal Effect,” in the peer-reviewed journal Cancer Cell International (“CCI”).

Key Points: 
  • The data were published in an article entitled, “Gaseous Nitric Oxide Tumor Ablation Induces an Anti-Tumor Abscopal Effect,” in the peer-reviewed journal Cancer Cell International (“CCI”).
  • “Beyond Cancer’s novel implementation of ultra-high concentrations of nitric oxide to treat solid tumors has repeatedly resulted in data demonstrating an immunostimulatory response,” stated Dr. Hila Confino, Chief Scientific Officer.
  • Two weeks post gas treatment, the tumors were resected and a week later a secondary tumor was induced in the contralateral flank.
  • In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models.

Chiesi USA Announces Publication of Health Economics Analysis of Selective Early Rescue Surfactant Administration vs. Standard Surfactant Administration for Premature Infants with Respiratory Distress Syndrome

Retrieved on: 
Tuesday, November 29, 2022

CARY, N.C., Nov. 29, 2022 (GLOBE NEWSWIRE) -- Chiesi USA (key-ay-zee), the U.S. affiliate of Chiesi Farmaceutici, an international research-focused healthcare group (Chiesi Group), today announced the publication of an article describing a health economic model comparing selective early rescue surfactant administration versus standard surfactant administration for infants with respiratory distress syndrome (RDS).

Key Points: 
  • CARY, N.C., Nov. 29, 2022 (GLOBE NEWSWIRE) -- Chiesi USA (key-ay-zee), the U.S. affiliate of Chiesi Farmaceutici, an international research-focused healthcare group (Chiesi Group), today announced the publication of an article describing a health economic model comparing selective early rescue surfactant administration versus standard surfactant administration for infants with respiratory distress syndrome (RDS).
  • Early selective surfactant administration, such as use of the INtubation SURfactant Extubation (INSURE)* technique was compared to a base case of standard surfactant administration via endotracheal intubation and mechanical ventilation.
  • CUROSURF Intratracheal Suspension is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of respiratory distress syndrome (RDS) in premature infants.
  • The authors conclusions suggest that selective early rescue surfactant administration strategies are associated with a lower healthcare burden in premature infants with RDS.

Windtree Therapeutics Reports Third Quarter 2022 Financial Results and Provides Key Business Updates

Retrieved on: 
Monday, November 14, 2022

WARRINGTON, Pa., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for cardiovascular disorders, today reported financial results for the third quarter ended September 30, 2022 and provided key business updates.

Key Points: 
  • WARRINGTON, Pa., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for cardiovascular disorders, today reported financial results for the third quarter ended September 30, 2022 and provided key business updates.
  • The Company had several notable deliverables this quarter and continues to focus on progressing its planned development of istaroxime.
  • With all that we are executing, we look forward to providing our shareholders with updates on our plans and progress.
  • General and administrative expenses for the third quarter of 2022 were $2.7 million, compared to $3.5 million for the third quarter of 2021.

Beyond Cancer™ Presents Promising New In Vivo Data Showing Ultra-High Concentration Nitric Oxide Therapy (UNO) in Combination with Anti-PD-1 During the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting

Retrieved on: 
Thursday, November 10, 2022

GARDEN CITY, N.Y. and HAMILTON, Bermuda, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is focused on developing ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced promising new in vivo combination data that support the potential of the company’s novel gaseous nitric oxide (gNO) therapy to treat various types of solid tumors in combination with immune checkpoint inhibitor (ICI) therapies, including anti-PD-1. These data were published in an abstract by the Society for Immunotherapy of Cancer (SITC) and will be presented in a poster presentation today at the 37th Annual SITC Meeting in Boston, MA.

Key Points: 
  • These data were published in an abstract by the Society for Immunotherapy of Cancer (SITC) and will be presented in a poster presentation today at the 37th Annual SITC Meeting in Boston, MA.
  • We believe these promising data provide a strong rationale for the continued advancement of this program in combination with immune checkpoint therapies.
  • Our combination data presented today at the SITC 2022 Annual Meeting show an effect on the primary tumor and, importantly, can treat metastatic disease and not just prevent it.
  • Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease.

Beyond Air® Announces Positive Data for Inhaled Nitric Oxide (NO) to Treat COVID-19 with LungFit® PRO in a Poster Presentation at IDWeek 2022

Retrieved on: 
Monday, October 24, 2022

GARDEN CITY, N.Y., Oct. 24, 2022 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced positive data from the LungFit® PRO pilot study of high-concentration inhaled NO in Viral Community-Acquired Pneumonia (VCAP), including COVID-19.

Key Points: 
  • The Company has received FDA approval for its first system, LungFit PH for persistent pulmonary hypertension of the newborn.
  • Nitric Oxide is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions.
  • Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia.
  • In adults, viruses have been identified as the causative agents in approximately 100 million cases of community-acquired pneumonia per year.

SIME strengthens board to prepare for commercialisation

Retrieved on: 
Wednesday, October 19, 2022

LONDON, Oct. 19, 2022 /PRNewswire/ -- SIME Diagnostics, a pioneer in point-of-care respiratory diagnostics in the ICU, today announced the appointment of Morten Henneveld to the company's Board of Directors.

Key Points: 
  • Morten Henneveld, a life science executive with decades of commercial and operations experience, joins SIME board as company prepares for Clinical AI Platform product launch in 2023.
  • LONDON, Oct. 19, 2022 /PRNewswire/ -- SIME Diagnostics, a pioneer in point-of-care respiratory diagnostics in the ICU, today announced the appointment of Morten Henneveld to the company's Board of Directors.
  • The board looks forward to working closely with Morten as we prepare to commercialise our Clinical AI Platform."
  • The company's technology is now reaching full maturity, and I'm committed to supporting the team as they prepare for market entry in 2023."

Beyond Cancer™ to Present Pre-Clinical Data for Ultra-High Concentration Nitric Oxide Therapy at the 2022 SITC Annual Meeting

Retrieved on: 
Wednesday, October 5, 2022

Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease.

Key Points: 
  • Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease.
  • Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer.
  • Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease.
  • In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models.

Beyond Air® Announces that Annals of the American Thoracic Society Published a Review of the Third Pilot Study of High Dose Nitric Oxide for Bronchiolitis

Retrieved on: 
Monday, October 3, 2022

The manuscript in the Annals of the American Thoracic Society is available at (https://doi.org/10.1513/AnnalsATS.202103-348OC).

Key Points: 
  • The manuscript in the Annals of the American Thoracic Society is available at (https://doi.org/10.1513/AnnalsATS.202103-348OC).
  • This multicenter, double-blind, randomized-controlled study enrolled 89 patients under the age of 12 months who were hospitalized with moderate-severe bronchiolitis.
  • The patients were randomized equally across three arms: standard supportive therapy (SST); 85 ppm NO + SST and 150 ppm NO + SST.
  • The primary endpoint was time to fit-to-discharge (FTD), a composite of the modified TAL score and sustained oxygen saturation on room air.

Windtree Therapeutics Announces KL4 Surfactant and AEROSURF® Global License Agreement

Retrieved on: 
Tuesday, August 23, 2022

WARRINGTON, Pa., Aug. 23, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular disorders, today announced it has entered into a global licensing agreement with Lee’s Pharmaceutical (HK) Limited, (Lee’s) and its affiliate Zhaoke Pharmaceutical (Hefei) Co. Ltd., (Zhaoke) for the development and commercialization of Windtree’s acute pulmonary pipeline treatments KL4 surfactant and drug/device combination, AEROSURF®, for the treatment of preterm infants with respiratory distress syndrome (RDS) and other potential applications. RDS often occurs in preterm infants when the lung is not fully developed with natural lung surfactant and may require surfactant therapy to sustain life.

Key Points: 
  • Given the clinical potential of KL4 surfactant and AEROSURF to help preterm infants with RDS, we desired a partner who was capable of fully assuming execution of the platform and could build value.
  • Under terms of the global license agreement, Lees and Zhaoke will receive a global license to develop and commercialize Surfaxin, lyophilized lucinactant and AEROSURF for any potential indications and applications.
  • Windtree had previously granted a regional license to Lees and Zhaoke for KL4 and AEROSURF for the territory of Greater China for which Windtree received an upfront payment, and this new agreement expands that territory globally.
  • With the execution of this agreement, Windtree will no longer have ongoing maintenance and operating costs for the KL4 platform.