- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie, InfasurfAero (calfactant aerosolized) / Ony Biotech
Trial completion date, Trial primary completion date: Aero-05: InfasurfAero (clinicaltrials.gov) - Nov 18, 2024
P3, N=220, Not yet recruiting,
This work identifies a novel role for surfactants and suggests their importance in modulating the severity of S. aureus lung infections. Trial completion date: Dec 2025 --> Apr 2026 | Trial primary completion date: Jan 2025 --> Jan 2026
- |||||||||| Curosurf (poractant alfa) / Chiesi, Alveofact (bovactant) / Lyomark Pharma, InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Journal: Comparative Biophysical Study of Clinical Surfactants using Constrained Drop Surfactometry. (Pubmed Central) - Oct 4, 2024
At 10 mg/mL, Infasurf, Curosurf, and Survanta all demonstrated excellent dynamic surface activity, whereas Alveofact exhibited the poorest quasi-static and dynamic surface activity...Understanding the diverse biophysical behaviors of clinical surfactants provides crucial insights for precision and personalized design in treating RDS and other respiratory conditions. The findings from this study contribute valuable perspectives for development of more efficacious and fully synthetic surfactant preparations.
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie, InfasurfAero (calfactant aerosolized) / Ony Biotech
Trial completion date, Trial initiation date: Aero-05: InfasurfAero (clinicaltrials.gov) - May 1, 2024
P3, N=220, Not yet recruiting,
Overall, nebulization did not significantly compromise the physicochemical properties as well as therapeutic efficacy of the prepared nanotherapeutics. Trial completion date: Sep 2025 --> Dec 2025 | Initiation date: Apr 2024 --> Jul 2024
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie, InfasurfAero (calfactant aerosolized) / Ony Biotech
Trial initiation date: Aero-05: InfasurfAero (clinicaltrials.gov) - Feb 15, 2024
P3, N=220, Not yet recruiting,
Trial completion date: Sep 2025 --> Dec 2025 | Initiation date: Apr 2024 --> Jul 2024 Initiation date: Oct 2023 --> Apr 2024
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
SURFACTANT COMPONENT SUPPRESSES STAPHYLOCOCCUS AUREUS TOXIN EXPRESSION (Carmel Women's Club) - Dec 13, 2023 - Abstract #WRMC2024WRMC_491;
Because palmitate is a component of healthy surfactant, this data could explain why S. aureus is not a primary agent of community-acquired pneumonia. Instead, the pathogen strikes the post-IAV lung environment when surfactant has been disrupted.
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Trial completion date, Trial suspension, Trial primary completion date: Administration of Surfactant Through an Instillation Device Infasurf (clinicaltrials.gov) - Nov 1, 2023
P2, N=55, Suspended,
Instead, the pathogen strikes the post-IAV lung environment when surfactant has been disrupted. Trial completion date: Dec 2021 --> Mar 2026 | Active, not recruiting --> Suspended | Trial primary completion date: Oct 2020 --> Dec 2025
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie, InfasurfAero (calfactant aerosolized) / Ony Biotech
New P3 trial: Aero-05: InfasurfAero (clinicaltrials.gov) - Jul 27, 2023
P3, N=220, Not yet recruiting,
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Journal: Development and characterization of lung surfactant-coated polymer nanoparticles for pulmonary drug delivery. (Pubmed Central) - May 15, 2023
Trial completion date: Dec 2021 --> Mar 2026 | Active, not recruiting --> Suspended | Trial primary completion date: Oct 2020 --> Dec 2025 The anti-cancer drug gemcitabine hydrochloride encapsulated in the PLGA core was released in a sustained manner while the paclitaxel loaded in the LS shell demonstrated a rapid or burst release profile over 21
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Journal: Phase Transitions of the Pulmonary Surfactant Film at the Perfluorocarbon-Water Interface. (Pubmed Central) - Apr 12, 2023
Here we reported the first detailed biophysical study of phospholipid phase transitions in two animal-derived natural pulmonary surfactant films, Infasurf and Survanta, at the PFC-water interface using constrained drop surfactometry (CDS)...The pulmonary surfactant film at the PFC-water interface undergoes continuous phase transitions at surface pressures less than the equilibrium spreading pressure of 50 mN/m, and a monolayer-to-multilayer transition above this critical pressure. These results provided not only novel biophysical insight into the phase behavior of natural pulmonary surfactant at the oil-water interface but also translational implications into the further development of liquid ventilation and liquid breathing techniques.
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Battle of the Surfs: Comparing Calfactant and Poractant Alfa () - Mar 14, 2023 - Abstract #PAS2023PAS_4961;
78 infants received Calfactant and 74 infants received Poractant Alfa. There was no statistical difference in the demographics of the two groups, except for birth weight and antenatal steroids (Table 1).
- |||||||||| Curosurf (poractant alfa) / Chiesi, InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie, Survanta (beractant) / Abbott
Journal: Comment on "Bilayer aggregate microstructure determines viscoelasticity of lung surfactant suspensions" by C. O. Ciutara and J. A. Zasadzinski, Soft Matter, 2021, 17, 5170-5182. (Pubmed Central) - Nov 19, 2022
Ciutara and J. A. Zasadzinski, Soft Matter, 2021, 17, 5170-5182.) measured the rheological properties of Infasurf®, Survanta® and Curosurf®, three of the most used pulmonary surfactant substitutes...In contrast, we found that Curosurf® suspensions are viscous Newtonian or slightly shear-thinning fluids, with no evidence of yield stress. The purpose of this Comment is to discuss possible causes for the discrepancy between the two studies, and to suggest that for biological fluids such as surfactant substitutes, the microrheology technique of rotational magnetic spectroscopy (MRS) can provide valuable results.
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Journal: Surface rheological properties alter aerosol formation from mucus mimetic surfaces. (Pubmed Central) - Jun 24, 2021
The concentration of aerosols generated from the DPPC-coated mimetic was higher than that of the Infasurf®-coated mimetic, even though the surface tension of the two interfaces was the same. The experimental results suggest that a balance of surface elastic behavior and surface viscous behavior is required for the generation of aerosols from the viscoelastic surfaces.
- |||||||||| Curosurf (poractant alfa) / Chiesi, InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie, Survanta (beractant) / Abbott
Journal: Bilayer aggregate microstructure determines viscoelasticity of lung surfactant suspensions. (Pubmed Central) - Jun 24, 2021
Here we examine the rheology of three clinical lung surfactant suspensions: Survanta (bovine lung), Curosurf (porcine lung), and Infasurf (calf lung)...While the mass loading of the three clinical surfactants is different, the different bilayer organization causes the particle volume fractions to be similar. Adding polyethylene glycol dehydrates and partially flocculates the bilayer aggregates in all suspensions, leading to smaller particle volume fractions and a reduced suspension viscosity even though the solvent viscosity increases almost six-fold.
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Trial completion: TOLSURF: Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia (clinicaltrials.gov) - May 13, 2021
P3, N=511, Completed,
Adding polyethylene glycol dehydrates and partially flocculates the bilayer aggregates in all suspensions, leading to smaller particle volume fractions and a reduced suspension viscosity even though the solvent viscosity increases almost six-fold. Active, not recruiting --> Completed
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Infasurf (clinicaltrials.gov) - Oct 22, 2020
P1, N=13, Terminated,
These observations indicate a possible role of miR-27b in impaired mitochondrial function in the chronic activation of alveolar macrophages by MWCNT and the development of chronic pulmonary granulomatous inflammation. N=50 --> 13 | Trial completion date: Mar 2020 --> Oct 2020 | Recruiting --> Terminated | Trial primary completion date: Feb 2020 --> Oct 2020; slowdown due to covid
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Enrollment closed, Trial primary completion date: Administration of Surfactant Through an Instillation Device Infasurf (clinicaltrials.gov) - Oct 22, 2020
P2, N=55, Active, not recruiting,
N=50 --> 13 | Trial completion date: Mar 2020 --> Oct 2020 | Recruiting --> Terminated | Trial primary completion date: Feb 2020 --> Oct 2020; slowdown due to covid Not yet recruiting --> Active, not recruiting | Trial primary completion date: May 2020 --> Oct 2020
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Trial completion date, Trial primary completion date: Infasurf (clinicaltrials.gov) - Feb 12, 2019
P1, N=50, Recruiting,
Active, not recruiting --> Completed Trial completion date: May 2019 --> Mar 2020 | Trial primary completion date: Apr 2019 --> Feb 2020
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Enrollment open: Infasurf (clinicaltrials.gov) - Jan 16, 2019
P1, N=50, Recruiting,
Trial completion date: May 2019 --> Mar 2020 | Trial primary completion date: Apr 2019 --> Feb 2020 Not yet recruiting --> Recruiting
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
New P1 trial: Infasurf (clinicaltrials.gov) - Nov 19, 2018
P1, N=50, Not yet recruiting,
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie, NN1213 / Novo Nordisk
Trial completion, Trial completion date, Trial primary completion date: SASSIE: Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial (clinicaltrials.gov) - Aug 28, 2018
P1/2, N=32, Completed,
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Jul 2018 --> Apr 2018 | Trial primary completion date: Jan 2018 --> Apr 2018
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Enrollment closed, Trial completion date, Trial primary completion date: Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients (clinicaltrials.gov) - Jun 28, 2018
P3, N=477, Active, not recruiting,
Recruiting --> Completed | Trial completion date: Jul 2018 --> Apr 2018 | Trial primary completion date: Jan 2018 --> Apr 2018 Recruiting --> Active, not recruiting | Trial completion date: Dec 2018 --> Jul 2018 | Trial primary completion date: Dec 2018 --> Jun 2018
- |||||||||| InfaSurf (calfactant) / Samaritan Pharma, Ony Biotech, AbbVie
Enrollment change: Self-dispersing Liquids as Aerosol Drug Carriers (clinicaltrials.gov) - Sep 2, 2013
P=N/A, N=8, Completed,
Recruiting --> Active, not recruiting N=16 --> 8
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