A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.

开始日期2025-02-07

申办/合作机构

ONY, Inc.

NCT05960929 / Not yet recruiting临床3期

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial

The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.

开始日期2024-07-01

申办/合作机构

ONY, Inc.

[+1]

NCT03748173 / Terminated临床1期

Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants

Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.

开始日期2019-01-12

申办/合作机构

ONY, Inc.

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项与 ONY, Inc. 相关的文献（医药）

1997-07-01·Pediatrics2区 · 医学

Comparison of Infasurf (Calf Lung Surfactant Extract) to Survanta (Beractant) in the Treatment and Prevention of Respiratory Distress Syndrome

2区 · 医学

Article

作者: Willett, Lynne D. ; Bloom, Barry T. ; Pramanik, Arun K. ; Laudert, Susan ; Delmore, Paula M. ; Trout, J. Richard ; Hall, Robert T. ; Coghill, Carl H. ; Kattwinkel, John ; Mueller, Dawn H. ; Brown, David R. ; Malloy, Michael H. ; Carlo, Waldemar A. ; Egan, Edmund A. ; Seguin, John H. ; Gratny, Linda L. ; Toubas, Paul L. ; McCaffree, Mary Anne ; Weatherstone, Kathleen B. ; Gutcher, Gary R. ; Holzman, Ian R. ; Topper, William. H

Objective. To compare the relative safety and efficacy of Infasurf (calf lung surfactant extract; ONY, Inc, Amherst, NY, IND #27169) versus Survanta (Beractant, Ross Laboratories, Columbus, OH) in reducing the acute severity of respiratory distress syndrome (RDS) when given at birth and to infants with established RDS.Design. A prospective, randomized, double-blind, multicenter clinical trial.Setting. Thirteen neonatal intensive care units participated in the treatment arm: seven of these concurrently participated in the prevention arm.Patients. The treatment arm enrolled infants of ≤2000 g birth weight with established RDS, and the prevention arm enrolled infants of ≤29 weeks' gestation with birth weights <1250 g.Intervention. Infants were randomly assigned to receive Infasurf (n = 303, treatment arm; n = 180, prevention arm) or Survanta (n = 305, treatment arm; n = 194, prevention arm) in accordance with the Survanta package insert instructions.Outcome Measures. We projected a 25% reduction between groups in the need for a third dose of surfactant for infants with established RDS, and a 25% reduction in the need for a second dose of surfactant for infants who received prophylactic surfactant. Secondary outcomes included the severity of RDS measured by inspired oxygen concentrations and mean airway pressure, air leaks, complications associated with surfactant administration, and survival to 36 weeks' postmenstrual age without the need for oxygen supplementation.Results. In the treatment arm, there was no difference between groups in the number of infants requiring more than two doses of surfactant. The interval between doses was significantly longer for Infasurf, suggesting an increased duration of treatment effect. The inspired oxygen concentration and mean airway pressure were lower in the Infasurf infants during the first 48 hours in the treatment arm.In the prevention arm, there were no differences with respect to the number of surfactant doses. The dosing intervals were longer for Infasurf infants after the second dose. No difference in inspired oxygen or mean airway pressure was noted during the first 72 hours.There were no significant differences in the incidence of air leaks, complications associated with dosing, complications of prematurity, mortality, or survival without chronic lung disease in the prevention or treatment arm.Conclusions. Infants treated with Infasurf have a modest benefit in the acute phase of RDS. Infasurf seems to produce a longer duration of effect than Survanta.

项与 ONY, Inc. 相关的新闻（医药）

2024-02-28

·BioSpace

Oncolytics Biotech® Announces Presentation at the Cancer Advocacy Group of Louisiana's 3rd Annual NeauxCancer Conference

SAN DIEGO and CALGARY, AB, Feb. 28, 2024 /PRNewswire/ -- Oncolytics Biotech, Inc.® (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced that Chief Executive Officer Dr. Matt Coffey will present a corporate overview at the Cancer Advocacy Group of Louisiana's 3rd Annual NeauxCancer Conference. The conference is taking place from February 29 - March 2, 2024, at the Ritz Carlton Hotel in New Orleans, LA. Additional details on the presentation can be found below. Date: Friday, March 1, 2024 Time: 11:30 a.m. ET Location: Ritz Carlton Hotel New Orleans, Acadia Room 2nd Floor Webcast Link: Available by clicking here Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request to the conference organizers or email jpatton@oncolytics.ca A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK). Additional information about the event can be found on the official website by clicking here. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. Logo - Company Codes: Berlin:ONYN, Dusseldorf:ONY, Toronto:ONC, Munich:ONYN, NASDAQ-NMS:ONCY

免疫疗法临床2期快速通道临床结果

2023-09-19

·BioSpace

Oncolytics Biotech® Announces Fireside Chat at the Cantor Global Healthcare Conference

SAN DIEGO and CALGARY, AB, Sept. 19, 2023 /PRNewswire/ -- Oncolytics Biotech, Inc.(NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced its participation in an analyst-led fireside chat at the Cantor Global Healthcare Conference 2023 with Chief Executive Officer Dr. Matt Coffey. The conference is taking place September 26-28, 2023 at the InterContinental Barclay Hotel in New York, NY. Additional details on the fireside chat can be found below. Date: Wednesday, September 27, 2023 Time: 8:35 a.m. ET Location: InterContinental Barclay Hotel New York, Track 1 Webcast Link: Available by clicking here Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your Cantor Fitzgerald representative, or email jpatton@oncolytics.ca. A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: Company Contact Jon Patton Director of IR & Communication +1-858-886-7813 jpatton@oncolytics.ca Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com Logo: Company Codes: Berlin:ONYN, Dusseldorf:ONY, Toronto:ONC, Munich:ONYN, NASDAQ-NMS:ONCY

临床2期免疫疗法临床结果

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