COCOA, Fla., Nov. 2, 2010 /PRNewswire/ — GeNO LLC (www.genollc.com) a privately
held, advanced development-stage technology company announced today
that it has submitted an Investigational New Drug (IND) application
to the US Food and Drug Administration (FDA) for the GeNO NITROsyl
(Inhaled Nitric Oxide) System for the treatment of pulmonary
hypertension in patients with pulmonary arterial hypertension (PAH)
and in patients with pulmonary hypertension secondary to idiopathic
pulmonary fibrosis (PH-IPF). If accepted, the IND will enable
GeNO to begin a Phase 2 dose escalation study in which both patient
populations will receive up to a maximum of 80 ppm NO delivered for
up to 150 minutes with its stand-alone NITROsyl platform.
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.
In contrast to PAH, 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%. There is a significant unmet medical need in this
patient population for a potent and selective pulmonary vasodilator
that can reduce pulmonary arterial pressure (PAP) and pulmonary
vascular resistance (PVR) and improve oxygenation.
“The submission of this IND is a major milestone for the
company,” said GeNO’s founder and president, David Fine, Ph.D. “We
have worked hard to develop an approach of delivering inhaled
Nitric Oxide therapy as an efficient and effective treatment to
chronic illness.”
Following the dose escalation study, it is planned to study
these two populations for 12 weeks in a multicente
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