Celtaxsys Initiates First Clinical Trial of Oral CTX-4430 Therapy in Cystic Fibrosis Patients

ATLANTA, Oct. 10, 2013 /PRNewswire/ -- Pharmaceutical discovery and development company Celtaxsys, Inc. today announced it is now enrolling patients for its first trial of CTX-4430 oral treatment for lung disease in Cystic Fibrosis (CF) patients. In this study, the safety and tolerability of CTX-4430 will be assessed at several dose levels when administered orally once-daily for 2 weeks. Additional assessments will include pharmacokinetics and biomarkers, as well as effects on lung function.

"In our recently completed First-in-Human trial conducted with healthy adult volunteers, CTX-4430 safety and pharmacokinetics were confirmed," said Dr. Ed Philpot, Celtaxsys CMO. "This trial in Cystic Fibrosis patients is designed to help us optimize the dose level for our upcoming Proof-of-Concept study and to give us an early indication of potential effects on lung function in CF."

This first CF study will be conducted at three sites in the U.K. under the oversight of Professor Stuart Elborn, MD, of Queens University, Belfast, and is slated to test four dose levels of oral once-daily CTX-4430 treatment in 36 adult CF patients.

"Having three world-class CF sites conducting our study and Professor Elborn as Chief Investigator provides great confidence for successful advancement of the CTX-4430 program," said Mr. Ralph Grosswald, VP of Operations at Celtaxsys.

Said Dr. Eric Springman, Celtaxsys CSO. "By measuring biomarkers in blood and lung, we can more precisely gauge the dose level of CTX-4430 required for therapeutic effect. The biomarkers also demonstrate effects of CTX-4430 on important mediators of CF lung disease and help set an expectation of therapeutic effect in the upcoming Proof-of-Concept study."

Additional details on this study can be found at http://clinicaltrials.gov/show/NCT01944735

About Cystic Fibrosis: Cystic Fibrosis is the most common life-shortening autosomal recessive disease among Caucasians, and lung disease is the leading cause of hospitalizations and death in adult CF patients. A hallmark of CF lung disease is excessive recruitment of blood polymorphonuclear neutrophils (PMNs) into the small airways (bronchioles) causing inflammation that results in elastic tissue destruction and progressive loss of lung function.

About CTX-4430: CTX-4430 is a once-daily oral drug candidate currently undergoing clinical trials for treatment of CF lung disease. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTA4H and LTB4 are strongly implicated in the pathogenesis of pulmonary inflammation in CF.

About Celtaxsys: Celtaxsys is a privately-held clinical stage drug discovery and development company focused on developing new treatments for inflammatory diseases by modulating innate immunity. The company is building a sustainable pipeline of first-in-class drugs with novel mechanisms of action. For more information, please visit www.celtaxsys.com.

SOURCE Celtaxsys