FDA Clears GeNO LLC's Investigational New Drug Application for Clinical Trials With Its NITROSYL™ Inhaled Nitric Oxide System Dose Escalation Clinical Trial for the Treatment of Pulmonary Hypertension in patients with Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF) and Pulmonary Arterial Hypertension (PAH)
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 continuous supply of inhaled nitric oxide for chronic use.
"This IND moves GeNO's product from a diagnostic to a treatment setting, and the planned dose-escalation study with the gas cylinder will inform the final design of GeNO's NITROSYL™ ambulatory platform," said GeNO Vice President Robert F. Roscigno, Ph.D. "This regulatory clearance by the FDA is an important step in our efforts to develop the NITROSYL™ platform and expand our focus on developing and commercializing novel therapeutics for chronic, life-threatening diseases."
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.
In March 2010, the FDA approved the company's IND to test the NITROSYL™ stand-alone gas cylinder as a diagnostic agent in PAH. The resulting Phase 2 trial is ongoing for the diagnostic indication.
ABOUT GENO LLC
GeNO LLC, founded in 2006, is a privately held, advanced development-stage technology company that is developing innovative nitric oxide (NO) generation and delivery platforms to enable the true potential of inhaled nitric oxide to be realized. The company is focused on applying the new technology to deliver inhaled nitric oxide to patients in a wide variety of settings, including acute in-hospital care, ambulatory and in-home use for potential chronic treatment. GeNO's platforms have been designated as Combination Products by the FDA Office of Combination Products, with the Division of Cardiovascular and Renal Products designated as the lead reviewer for PAH. The company has five issued US patents with additional patent applications pending.
SOURCE GeNO LLC