Delving into the Latest Updates on Calfactant with Synapse

Overview

Basic Info

Drug Type

Biological products

Synonyms

Bovactant, Calf lung surfactant extract (CLSE), Calfactant (USAN)

+ [1]

Target-

Mechanism

Cell membrane permeability enhancers

Therapeutic Areas

Respiratory DiseasesOther Diseases

Active Indication

Respiratory Distress Syndrome, NewbornRespiratory Distress Syndrome

Inactive Indication

Acute Lung InjuryBronchiolitis

Originator Organization

ONY, Inc.

Active Organization

ONY, Inc.

Inactive Organization

ONY Agency LLC

Drug Highest PhaseApproved

First Approval Date

US (01 Jul 1998),

Respiratory Distress Syndrome

RegulationOrphan Drug (US)

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Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.
The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.

Start Date01 Jul 2013

Sponsor / Collaborator

University of Missouri

100 Clinical Results associated with Calfactant

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100 Translational Medicine associated with Calfactant

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100 Patents (Medical) associated with Calfactant

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140

Literatures (Medical) associated with Calfactant

01 Oct 2024·American Journal of Physiology-Lung Cellular and Molecular Physiology

Comparative biophysical study of clinical surfactants using constrained drop surfactometry

Article

Author: Zuo, Yi Y.

A thorough investigation into the biophysical properties of four animal-derived clinical surfactant preparations was conducted through constrained drop surfactometry under physiologically relevant conditions. This comparative study unveiled unique in vitro biophysical characteristics among these clinical surfactants, establishing correlations between their chemical composition, lateral film structure, and biophysical functionality. The acquired knowledge offers essential insights for the precise and personalized design of clinical surfactant for the treatment of respiratory distress syndrome and other respiratory conditions.

01 Sep 2023·Archives of Medical Science

Comparative efficacy of pulmonary surfactant in respiratory distress syndrome in preterm infants: a Bayesian network meta-analysis

Review

Author: Fan, Nana ; Ma, Cui ; Zhang, Xiaoyu ; Zheng, Guofeng ; Qiu, Caihong

IntroductionThe comparative efficacy of pulmonary surfactant in the treatment of respiratory distress syndrome in preterm infants remains unclear. We aimed to evaluate the effectiveness of different pulmonary surfactant in the treatment of respiratory distress syndrome in preterm infants and to provide an evidence-based reference for clinical use.Material and methodsMEDLINE, Embase, The Cochrane Library, and Clinical Trials databases were electronically searched from inception to January 2019. Two reviewers independently screened literature and extracted data, and then R and RevMan 5.3 software packages were used to perform network meta-analysis.ResultsThe relative risk of respiratory distress syndrome in preterm infants associated with six different pulmonary surfactant was analysed, including beractant (Survanta), surfactant A (Alveofact), calfactant (Infasurf), poractant (Curosurf), lucinactant (Surfaxin), and colfosceril (Exosurf). Patients with the following drugs appeared to have significantly reduced mortality of respiratory distress syndrome compare with beractant: surfactant A (OR = 0.53, 95% CI: 0.31–0.90), calfactant (OR = 0.91, 95% CI: 0.85–0.97), poractant (OR = 0.72, 95% CI: 0.67–0.77), lucinactant (OR = 0.80, 95% CI: 0.71–0.90), and colfosceril (OR = 0.93, 95% CI: 0.87–0.99). The SUCRA (surface under the cumulative ranking) values for each of the drugs were: beractant (8.9%), surfactant A (93.8%), calfactant (40.3%), poractant (65.4%), lucinactant (59.8%), and colfosceril (31.6%).ConclusionsCompared with beractant, other pulmonary surfactants are more effective to reduce the mortality of respiratory distress syndrome in preterm infants. Surfactant A drugs appeared to have the best efficacy in reducing mortality of respiratory distress syndrome in preterm infants.

31 Aug 2023·mBio

A new tractable method for generating human alveolar macrophage-like cells in vitro to study lung inflammatory processes and diseases.

Article

Author: Jarvis, Natalie ; Arnett, Eusondia ; Lai, Zhao ; Schlesinger, Larry S ; Guerrero-Arguero, Israel ; Pahari, Susanta ; Torrelles, Jordi B ; Lumbreras, Miranda ; Zhang, Hao ; Ye, Chengjin ; Simper, Jan ; Azad, Abul ; Wang, Yufeng ; Maselli, Diego Jose ; Martinez-Sobrido, Luis ; Cai, Hong ; Peters, Jay

Alveolar macrophages (AMs) are unique lung resident cells that contact airborne pathogens and environmental particulates. The contribution of human AMs (HAMs) to pulmonary diseases remains poorly understood due to the difficulty in accessing them from human donors and their rapid phenotypic change during in vitro culture. Thus, there remains an unmet need for cost-effective methods for generating and/or differentiating primary cells into a HAM phenotype, particularly important for translational and clinical studies. We developed cell culture conditions that mimic the lung alveolar environment in humans using lung lipids, that is, Infasurf (calfactant, natural bovine surfactant) and lung-associated cytokines (granulocyte macrophage colony-stimulating factor, transforming growth factor-β, and interleukin 10) that facilitate the conversion of blood-obtained monocytes to an AM-like (AML) phenotype and function in tissue culture. Similar to HAM, AML cells are particularly susceptible to both Mycobacterium tuberculosis and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. This study reveals the importance of alveolar space components in the development and maintenance of HAM phenotype and function and provides a readily accessible model to study HAM in infectious and inflammatory disease processes, as well as therapies and vaccines. IMPORTANCE Millions die annually from respiratory disorders. Lower respiratory track gas-exchanging alveoli maintain a precarious balance between fighting invaders and minimizing tissue damage. Key players herein are resident AMs. However, there are no easily accessible in vitro models of HAMs, presenting a huge scientific challenge. Here, we present a novel model for generating AML cells based on differentiating blood monocytes in a defined lung component cocktail. This model is non-invasive, significantly less costly than performing a bronchoalveolar lavage, yields more AML cells than HAMs per donor, and retains their phenotype in culture. We have applied this model to early studies of M. tuberculosis and SARS-CoV-2. This model will significantly advance respiratory biology research.

100 Deals associated with Calfactant

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External Link

KEGG	Wiki	ATC	Drug Bank
D03317	Calfactant	R07AX	DB06415

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Distress Syndrome, Newborn	TR	-	31 Oct 2018
Respiratory Distress Syndrome, Newborn	MY	-	31 Oct 2018
Respiratory Distress Syndrome	US	ONY, Inc.	01 Jul 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchiolitis	Phase 1	US	ONY, Inc.	12 Jan 2019
Bronchiolitis	Phase 1	US	ONY Agency LLC	12 Jan 2019
Acute Lung Injury	Phase 1	US	-	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02834624 (NEOSURF, CTgov)	Not Applicable	Respiratory Distress Syndrome	30	calfactant (Calfactant)	nuhmchnkfn(rvzowgfhua) = nrxcnzeqvk rjeoubfsmt (gzmsijcgrk, hdggavvbwb - fewbhytkzj) View more	-	06 Jun 2017
				Poractant alfa (Poractant Alfa)	tpvmsrfwok(eobnrenjpa) = rvyfthayzz mcfrpbwhvw (yjfahyipuh, pterpzgvhz - shpmeapbfi) View more
NCT00569530 (TOLSURFPilot, CTgov)	Phase 3	Bronchopulmonary Dysplasia \| Surfactant Dysfunction	85	Infasurf (ONY Inc.) (Treatment Surfactant (Infasurf) ONY, NY)	zuagdqamcw(jkzvqhmyxc) = hqqcaxvfgj zteiyxpomo (qgayieyjmm, rgbxfcvoji - fuvbsjfaiu) View more	-	28 Jun 2016
				Sham (Sham (no Treatment))	zuagdqamcw(jkzvqhmyxc) = kjlyfqlkvi zteiyxpomo (qgayieyjmm, dcekaccyxz - mquhuwntif) View more