Emphycorp Clinical Development Program
July 21, 2004 - Emphycorp has just committed to performing three more clinical studies with their Phase II investigational new respiratory drug, N115.
- Study #1 is a Phase II, double blind, six week multi-dose study with COPD patients. One of the primary clinical end-points will the amount of bronchodilator rescue therapy used. A battery of lung function tests will also be included. The protocol has already been submitted to the FDA. The investigators will be John Votto, D.O., CEO Clinical Affairs, and Roger Thrall, Ph.D., Director of Research, Hospital for Special Care, New Britain, CT.
- Study #2 is 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 is currently being developed. The principal investigator is Thomas F. Scanlin, MD, Professor of Pediatrics and Director, Cystic Fibrosis Center, Children's Hospital of Philadelphia, Philadelphia.
- Study #3 is 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 will be a first study to test this observation. The protocol has already been submitted to the FDA. The investigators will be John Votto, D.O., CEO Clinical Affairs and Roger Thrall, Ph.D., Director of Research, Hospital for Special Care, New Britain, CT.
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