July 21, 2004 - Emphycorp committed to performing five more clinical studies with their Phase II investigational new respiratory drug, N115. With this proprietary formula Emphycorp has introduced to the medical market a new formula that is revolutionary to the medical industry as a multi use product and formula. These clinicals were completed by 2010, with great results and reported to the FDA.
Study #1, 2 and 3 are Phase II, double blind, six week multi-dose study with COPD patients. One of the primary clinical end-points was the amount of bronchodilator or steroid rescue therapy used. A battery of lung function tests included FEV-1 measurements and the measurement of lung inflammatory cytokines. The protocol and final results were submitted to the FDA. The investigators for study 1 were John Votto, D.O., CEO Clinical Affairs, and Roger Thrall, Ph.D., Director of Research, Hospital for Special Care, New Britain, CT. This same procedure, study 2, was completed in Mexico at INER. Again N115 reduced lung inflammation and significantly increased FEV-1 values. Study 3 is now being performed in China at the China medical city. The results from study 1 and 2 produced statistically significant clinical results.
Study #4 was a Phase I/II study of the effect of N115 on Cystic Fibrosis (N115 has been granted Orphan Drug Status for this disease). The protocol was developed and implemented on patients with Cystic Fibrosis. The principal investigators were Thomas F. Scanlin, MD, Professor of Pediatrics and Director, Cystic Fibrosis Center, Children's Hospital of Philadelphia, Philadelphia and Dr. Milla of Stanford University. Again N115 significantly reduced lung inflammatory agents including oxygen radicals and reduced various inflammatory cytokines like IL-6, and tumor necrosis factor alpha.
Study #5 was a Phase I/II exploratory study on the effect of N115 on oxygen saturation in blood. Support that N115 might improve oxygen saturation is deduced from the scientific literature regarding nitric oxide and N115, and the fact that N115 decreases NO levels. This was the first study to test this observation. The results were submitted to the FDA. The investigators were John Votto, D.O., CEO Clinical Affairs and Roger Thrall, Ph.D., Director of Research, Hospital for Special Care, New Britain, CT. Again an increase in FEV-1 results were recorded and was an decrease in lung oxygen radicals.