MOLECULAR EXPRESS, INC — Department of Health and Human Services SBIR Phase II: DESCRIPTION (provided by applicant): This competitive renewal SBIR proposal extends our cu

Description

DESCRIPTION (provided by applicant): This competitive renewal SBIR proposal extends our current Phase II translational research on novel synthetic lipid/peptide lung surfactants containing the highly active Super Mini-B (S-MB) peptide incorporating crucialfunctional regions of human surfactant protein (SP)-B, the most active apoprotein in biologic surfactant. Our initial Phase II grant focused on S-MB synthesized by solid-state chemistry, and documented the high activity of synthetic Minisurf surfactantcontaining solid-state S-MB combined with lipids. This renewal application continues the commercial development of Minisurf surfactant. This proposal will scale-up the production of the S-MB peptide and the Minisurf surfactant product, develop effective QA/QC methods for analyzing the S-MB peptide and Minisurf surfactant product, and demonstrate biological equivalency to laboratory research scale batches of Minisurf surfactant. Pilot lots of the Minisurf surfactant product will be manufactured andteste to ensure that the process is robust, the analytical controls are appropriate and the efficacy is maintained. Samples from selected pilot lots of Minisurf surfactant will be placed on stability and sent to a contractor to conduct GLP-compliant pharmacology and toxicology studies. The proposal also provides for active consultation with the FDA during the grant to facilitate successful IND preparation. Successful execution of these activities will lead to the development of a novel, commercially-attractive Minisurf synthetic surfactant product having significant advantages in manufacturing economy, activity, and inhibition resistance over current animal and synthetic surfactant drugs. PUBLIC HEALTH RELEVANCE: This SBIR competitive renewal grant will continue the development of a synthetic exogenous lung surfactant product having significant advantages in manufacture, activity and inhibition resistance compared to current drugs. This innovative surfactant product is expected to have great future utility in treating patients with severe acute respiratory failure from the neonatal respiratory distress syndrome (NRDS), clinical acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). The synthetic surfactant in this grant canalso potentially be used in novel delivery systems for other pulmonary therapeutic agents such as antibiotics, anti-inflammatory drugs, or genetic materials (gene therapy).