KAER BIOTHERAPEUTICS — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant Acute respiratory distress syndrome ARDS is of multifactorial etiology and afflicts to Americans each year and of all ventilated patients Despite sophisticated intensive care the mortality rate ranges between and with a mean of Patients with ARDS have impaired surfactant function and continued inflammation induced metabolism of surfactant indicating that a single treatment with surfactant is inadequate The delivery of pulmonary surfactant to treat lung diseases such as ARDS and RDS has been via the instillation of to mg ml of suspensions of surfactant at doses generally ranging from mg to mg kg Multiple bolus intrapulmonary instillations of surfactant are traumatic for the patient and physician alike and lead to undesirable peri and post treatment events Aerosolized surfactant may require a considerably lower dose to achieve a similar physiological effect It also eliminates the hypercapnia seen on bolus instillation In neonates aerosolized surfactant has been delivered over hour treatment periods This situation is markedly exacerbated when attempting to deliver the same dose kg of aerosolized surfactant to adults SUPRAER uses a single pass low shear nozzle to generate an m diameter aqueous aerosol This aerosol plume is arrested by a counter flow gas stream and rapidly dried by warm compressed gas and dilution gas as well as infrared radiation The resulting fine particle aerosol is concentrated using a low resistance virtual impactor and delivered at the output on demand Two classes of single pass low shear aerosol generation nozzles that aerosolize of the surfactant will be evaluated We will optimize the heat and mass transfer of the evaporation process as well as the other components of the aerosol processing system to provide aerosols containing a high mass loading of surfactant that can be predicted to deposit in the alveolar regions of the lungs Our target is to demonstrate that clinically relevant doses of surfactant aerosols can be generated and delivered in minutes The delivery of surfactant in a gentler non invasive manner would empower the clinician to provide improved life support and potentially a marked improvement in survival This important new technological innovation will also be applicable to treat other diseases of the lungs that require drugs whose efficacy depends on high doses being delivered in a short time Short treatment times lead to better patient adherence efficacy and improved health care PUBLIC HEALTH RELEVANCE Acute respiratory distress syndrome afflicts to citizens each year Despite intensive care treatment only survive This project aims to treat a major underlying cause of this disease the deficiency of the surfactant in the lungs that enables them to breathe We will provide the technology to deliver clinically relevant doses of aerosolized surfactant to the lungs of these patients This will provide a new treatment modality that will improve their ability to breathe and help cure their devastating disease