GeNO LLC a privately held, advanced development-stage technology company, announced commencement of the phase II clinical trial for its stand-alone gas cylinder Nitrosyl System. The initial indication to be studied for nitric oxide delivered via the GeNO Nitrosyl System is as a diagnostic agent for administration as an adjunct to right heart catheterization in patients with Pulmonary Arterial Hypertension (WHO Group 1) to add information to improve clinical decision making. No agents are currently approved for this indication. Prior to conducting a phase III registration study, GeNO LLC will first conduct this phase II, 10-patient pilot study to obtain preliminary safety and feasibility data from short term (15 minute) administration of inhaled nitric oxide via the GeNO Gas Cylinder Nitrosyl system.
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 GeNO's proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation. A second cartridge is provided for redundancy.
Leading researchers from four major medical centres will participate in the Nitrosyl phase II trial, including: Robert C. Bourge, MD, director, division of cardiovascular disease at University of Alabama at Birmingham; Ioana Preston, MD, Assistant Professor of Medicine at the Tufts University School of Medicine and the Co-Director for the Pulmonary Hypertension Centre at Tufts Medical Centre; Robert Schilz, DO, PhD, Medical Director of Lung Transplant and Pulmonary Vascular Disease at UH Case Medical Centre; and Fernando Torres, MD, Associate Professor of Internal Medicine- Pulmonary and Critical Care at The University of Texas South-western Medical Centre.
“As we move forward in our plans for these novel technologies, phase II testing of the Nitrosyl systems in patients is an important milestone for GeNO,” said GeNO LLC founder and president David Fine. “As a clinical-stage organization, this trial not only moves the in-hospital solution forward but also enables us to move our other exciting, patent-protected technologies, such as the GeNO Ambulatory Nitrosyl system, towards clinical development as well.”
Robert F. Roscigno, PhD, vice president of GeNO, commented, “We believe that this system offers the potential to provide PAH patients, as well as the clinicians that treat them, with a safe and effective diagnostic agent. We look forward to seeing the results of this study, and also to filing additional INDs and completing acute and chronic treatment studies. There is a well-established body of clinical evidence suggesting clinical benefit on the use of inhaled nitric oxide for patients with a variety of serious diseases, and the GeNO Nitrosyl systems would add a valuable option for clinicians treating these difficult conditions. GeNO's system would help address cost, complexity and the lack of portability of current treatment regimens and potentially reach a much larger group of patients.”
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. The simplicity and ease-of-use this system has the potential to greatly expand the use of inhaled nitric oxide to many new chronic indications.
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 broad 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 ambulatory and in-home use for potential chronic treatment. GeNO's Nitrosyl systems will be regulated by the FDA as new drugs with their own NDAs. GeNO plans to submit a second IND application to FDA later this year to begin evaluation of the GeNO Ambulatory Nitrosyl system. The company has five US patents with additional patent applications pending.