BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

GeNO LLC Initiates Study of Inhaled NITROSYL(TM) Nitric Oxide in Idiopathic Pulmonary Fibrosis (PH-IPF) and Pulmonary Arterial Hypertension (PAH) Patients


3/22/2011 9:45:20 AM

COCOA, Fla., March 22, 2011 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held, advanced development-stage technology company, today announced commencement of the PHiano Study: A Phase 2, Dose-Escalation Trial for the Treatment of Pulmonary Hypertension in patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF) using Inhaled NITROSYL nitric oxide (NO). The first patient was successfully dosed at Creighton University Medical Center. This trial will be conducted at multiple clinical sites in the US, and is expected to enroll up to 75 patients. It is designed to investigate the safety and efficacy of various doses of inhaled nitric oxide (NO), up to a maximum of 80 ppm, delivered for up to 150 minutes with GeNO's stand-alone NITROSYL system in subjects with WHO Group 1 PAH and WHO Group 3 PH-IPF undergoing right heart catheterization (RHC).

The primary objective of the PHiano study is to identify the minimally effective dose and the maximum effective dose (dose beyond which no further effect on pulmonary vascular resistance is seen) of inhaled NITROSYL nitric oxide as compared to placebo. Secondary objectives include assessing the safety and tolerability of inhaled nitric oxide and evaluating the pharmacokinetics of total nitrates/nitrites and methemoglobin produced following inhalation. Additional study details can be found on http://clinicaltrials.gov/ ClinicalTrials.gov Identifier: NCT01265888.

GeNO's stand-alone gas cylinder stores premixed nitric oxide as nitrogen dioxide in either air or oxygen; however, this study will administer nitrogen dioxide only in air. 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.

"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 10 patient Pilot Study to obtain preliminary safety and feasibility data from short term (15 minute) administration of inhaled nitric oxide via the GeNO Nitrosyl delivery system. Additional study details can be found on http://clinicaltrials.gov/ ClinicalTrials.gov Identifier: NCT01092559.

"This trial has provided important information regarding preliminary safety and feasibility data from short term (15 minute) administration of inhaled NITROSYL nitric oxide," said Fine. "We are pleased with the performance of the system and to date, no adverse events (AEs), or unanticipated adverse device effects (UADE's) have been reported."

With the diagnostic trial ongoing, today's Phase 2 PHiano study will help GeNO establish the optimal dose for further product development (including the ambulatory system), and helps GeNO prepare to move from a diagnostic to a treatment setting.

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 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 an IND 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.

Media Contacts:


Carla Burigatto, 610-457-2178

Brian Heffron, 781-799-9568

cburigatto@gmail.com

bheffron@ctpboston.com



SOURCE GeNO LLC


Read at BioSpace.com

GeNO LLC
 
 

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->