Program Includes AIRFLOW-1 Trial; Need for New Therapies in COPD;
Long-term Safety of TLD
Amsterdam, Sept. 28, 2015 – Holaira, Inc., a developer of medical devices to treat obstructive lung diseases,announced it will host a mini-symposium on Targeted Lung Denervation* (TLD) in patients with moderate to severe COPD, at the European Respiratory Society International Congress, Sept. 28. The program will be co-chaired by Professors Felix Herth, M.D., Ph.D., FCCP, Chairman, Division of Pulmonology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, and Alvar Agustí, M.D., Ph.D., Director of the Thorax Institute at Hospital Clinic in Barcelona. Four scientific experts will present their findings on topics including: Cholinergic Pathways and the Need for New Therapies in COPD; Mechanism of Action and the Holaira™ Lung Denervation System; Long-term Safety and Efficacy of TLD in 37 COPD Patients, and Early Experience from the AIRFLOW-1 Clinical Study.
“The two-year findings from our Phase I prospective, multicenter study found that bronchoscopic TLD, based on the concept of ablating parasympathetic pulmonary nerves, was feasible, safe and well tolerated in patients with moderate to severe COPD,” said Dirk-Jan Slebos, M.D., Ph.D., principal investigator and pulmonary physician, University Medical Center, Groningen, The Netherlands. “The potential for a sustained long-term therapeutic effect would be a promising development for the management of patients with advanced COPD.”
The company also announced that three new clinical abstracts would be presented during the 25th annual ERS Congress, Sept. 26-30, in Amsterdam, highlighting use of its Lung Denervation System during TLD procedures in patients with COPD. The three abstracts, published this month in European Respiratory Journal, look at long-term safety of bilateral TLD in a single procedure, two-year safety of TLD, and the additive effect of TLD plus anticholinergic medication in COPD patients.
“Our research indicates that Targeted Lung Denervation potentially provides increased bronchodilation when used in combination with inhaled anticholinergic medication,” said Professor Coenie Koegelenberg, M.D., Ph.D., University of Stellenbosch and Tygerberg Academic Hospital, South Africa. “Evidence from our prospective multi-center study of 22 patients showed lung function was significantly improved when comparing the effect of 20-watt TLD plus an inhaled anticholinergic to the baseline use of ipratropium alone.”
Encouraged by these early results, Holaira plans to evaluate this further in a large-scale randomized study according to Jim Pavliska, vice president clinical affairs.
Holaira is developing a novel catheter-based system to address COPD by treating the overactive airway nerves during TLD, a one-time bronchoscopic procedure that provides an ablative therapy that opens obstructed airways to improve breathing, and has the potential to provide lasting whole lung improvement. COPD is one of the leading, yet under-recognized, causes of morbidity and mortality. It is characterized by a persistent airflow limitation due to a progressive narrowing of the airways interfering with normal breathing, resulting in shortness of breath (dyspnea), wheezing, chest tightness, and a productive cough. A progressive disease, it is estimated that COPD affects 4 to 10 percent of all adults in European countries. Worldwide, nearly 190 million people have COPD, with more than 15 million adults diagnosed in the United States.
AIRFLOW-1(NCT#02058459) is an ongoing Phase II multicenter trial to evaluate safety after Targeted Lung Denervation in patients with moderate to severe COPD using the Holaira System with the dNerva™ Dual Cooled RF Catheter. Currently involving a broad range of investigators from Austria, Belgium, France, Germany, The Netherlands and the United Kingdom, the study’s principal investigators are Dr. Slebos and Arschang Valipour, M.D., Ph.D., FCCP, Group Leader at the Ludwig-Boltzmann Institute for COPD and Respiratory Epidemiology, Otto Wagner Spital.
About Holaira – Holaira, Inc., is a privately held lung denervation company developing minimally invasive products to make breathing easier for patients suffering from obstructive lung diseases. Founded in 2008, Holaira is currently working on a novel catheter-based system that has the potential to improve lung function, exercise capacity and quality of life for patients with chronic obstructive pulmonary disease. More information can be found by visiting www.holaira.com.
Information about Holaira’s educational symposium and clinical abstracts are referenced below:
Targeted Lung Denervation in Patient with Moderate to Severe COPD
Program Chairs: Alvar Agustí & Felix Herth
28 September 2015
Room E102 (E Area)
Additive effect of targeted lung denervation plus drug in patients with COPD
Coenraad Koegelenberg, Johan Theron, Dirk-Jan Slebos, Karin Klooster, Martin Mayse, Chris T Bolliger
29 September – 12:50
Long-term safety of bilateral targeted lung denervation in patients with COPD in a single procedure
Arschang Valipour, Christophe Pison, Romain Kessler, Gaetan Deslee
27 September – 12:50
Two-year safety of targeted lung denervation in patients with moderate to severe COPD
Dirk-Jan Slebos, Karin Klooster, Coenraad Koegelenberg, Johan Theron, Martin Mayse, Chris T Bolliger
27 September – 12:50
 COPD, May 2013, TDR, Inc.
 CDC MMWR, Nov 23 2012, Vol 51, No.46
*Targeted Lung Denervation (TLD) is currently under clinical investigation for chronic obstructive pulmonary disease and is not yet commercially available.
Holaira and dNerva are trademarks of Holaira, Inc.