Pulmonary Fibrosis Treatment (Patented Rx Technology)

• Patented Rx Technology
• In a Phase III Clinical Trial, in Patients with Pulmonary Fibrosis, there was a statistically and clinically significant improvement in all lung functions, compared to baseline, including an increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%) and a decrease in hypoxemia, along with a reduction in coughing and fatigue.

• Non-Steroidal COPD/Pulmonary Fibrosis Nasal Spray that has shown to relieve clinical symptoms and improve lung functions, decrease coughing, and improve FEV-1, FVC, SaO2, and increase FEV-1/FVC ratios from 52% to 86% in all patients with Idiopathic Pulmonary Fibrosis (IPF).

• Completed US Phase I, Phase II, Phase III Clinical Trials for COPD Pulmonary Fibrosis/Interstitial Lung Disease (ILD).
• Submitted NDA to the FDA defining Medical Endpoints for the NDA Marketing Application.
• Received US FDA Orphan Drug Designation in 2005 for Cystic Fibrosis (CF) and Interstitial Lung Disease (ILD)