"Results from this study will provide information necessary to design a Phase 2/3 study for chronic ambulatory administration of nitric oxide," said GeNO LLC Founder and President David Fine, Ph.D. "The combined results from this current Phase 2 study and planned Phase 2/3 chronic study will help to define responses in both populations and further guide Phase 3 development."
"Our Phase 2 program will assess whether nitric oxide improves pulmonary hypertension in both populations, whether there are safety concerns in either group that are unique to that condition (or background treatment) or shared by both, and whether the profile of effect is common," added GeNO Vice President Robert F. Roscigno, Ph.D. "While IPF and PAH are different, GeNO will focus on the one common feature, the pulmonary hypertension, which is a determinant of survival and at least an element or cause of symptoms."
No medications are currently approved for treatment of pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF). IPF is characterized by progressive fibrosis in the lungs with a median survival time from diagnosis of two to five years and a five-year survival rate of approximately 20 percent. Pulmonary arterial hypertension (PAH) is a rare progressive disorder that carries a poor prognosis and is associated with significant morbidity and mortality, having an historical survival rate rarely exceeding five years.
The next version of GeNO's platform to enter the clinic later this year will be the GeNO Ambulatory NITROSYL™ System, which is a hand-held unit with a disposable liquid source. This portable unit snaps into a small, battery operated pump module attaching to a hip or arm holster and provides up to a 4-day continuous supply of inhaled nitric oxide for chronic use.
In December 2010, GeNO initiated its first clinical study, a 1
|SOURCE GeNO LLC|
Copyright©2010 PR Newswire.
All rights reserved