KL4 Surfactant for Direct Pulmonary Delivery of Other Therapeutic Proprietary Molecules

KL4 surfactant has the potential to be a very effective in delivering other proprietary therapeutic molecules to the lungs. We have demonstrated that complex molecules can potentially be enveloped in the liposomal structure of KL4 surfactant for either intrapulmonary bolus or aerosol delivery. KL4 surfactant is a cationic peptide and liposomal system with an established safety and tolerability profile, excellent spreading capabilities, and an established cellular uptake profile, which may facilitate efficient delivery and subsequent transfection of payload molecules into pulmonary epithelial cells.

In the future, we plan to investigate aerosol delivery compatibility of KL4 surfactant with a wide range of pharmaceutical compounds, including oligonucleotides, monoclonal antibodies, and small molecules.

Delivery of Aerosolized Large and Small Molecule Drugs with AFECTAIR®

AFECTAIR is our lead aerosolized drug delivery product, a series of novel ventilator circuit/patient interface connectors that is being registered in the United States as a Class 1, exempt medical device. In order to market products in the European Union and many other non-U.S. jurisdictions, we will have to obtain separate regulatory marketing registrations and/or authorizations and comply with numerous and varying regulatory requirements.

We plan to initiate the commercial introduction of the initial AFECTAIR devices in the United States and the European Union in late 2012.

The initial AFECTAIR device is currently registered with the US Food & Drug Administration, but is not available commercially at this time.