FDA Clears GeNO LLC's Investigational New Drug Application for Clinical Trials With Its NITROSYLâ„¢ Inhaled Nitric Oxide System
COCOA, Fla., Dec. 2, 2010 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held, advanced development-stage technology company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a clinical trial with the GeNO NITROSYL™ (Inhaled Nitric Oxide) System for treatment of pulmonary hypertension in patients with Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis, (PH-IPF WHO Group 3) and Pulmonary Arterial Hypertension, (PAH, WHO Group 1).
This FDA clearance enables GeNO to begin a US, multicenter, Phase 2 dose escalation study in which both patient populations will receive up to a maximum of 80 parts per million (ppm) of Nitric oxide (NO) delivered for up to 150 minutes with GeNO's stand-alone NITROSYL™ platform. The study is subject to Institutional Review Board (IRB) approval.
"The clearance of this IND is a major milestone for the company as we are committed to developing treatment for these grave chronic conditions," commented GeNO LLC Founder and President David Fine, Ph.D. "Today's development also lays the groundwork for our patented ambulatory platform, which has the potential to greatly expand the use of inhaled nitric oxide to many new chronic indications due to its simplicity and ease-of-use."
GeNO's stand-alone gas cylinder stores premixed nitric oxide as nitrogen dioxide in either air or oxygen. The gas is allowed to flow through a proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation. A second cartridge is provided for redundancy. The company has also developed 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 attached to a hip or arm holster and provides up to a four-day con