AIT initiates Phase II clinical trial of NOxCureCF for patients with cystic fibrosis

Advanced Inhalation Therapies (AIT Ltd.), an Israeli drug development company, announced today that it has begun enrollment in Israel for a multicenter, open label, Phase II clinical trial of NOxCureCF, a respiratory treatment for patients with cystic fibrosis (CF). NOxCureCF is a specialized formulation of inhaled Nitric Oxide (NO) delivered using AIT's patented drug delivery system.

David Greenberg, M.D., AIT's Chief Medical Officer and a professor of pediatrics and infectious diseases at Soroka Medical Center in Beersheva, Israel, said: "This study, in combination with the continuation of our Phase II trial of the use of NO for treatment of infants with RSV/bronchiolitis, will allow us to substantiate and enhance the use of inhaled NO in the treatment of respiratory disease and distress."

Prof. Asher Tal, head of the Pediatrics Department at Soroka University Medical Center, adds: "The NOxCureCF treatment may serve as a major improvement in the quality of life for CF patients, and may significally contribute to their life expectancy." The study  takes place at Soroka's CF Clinic, which is led by Dr. Micha Aviram.

CF is a life-threatening genetic disease that causes the abnormal transport of salts across cells and most critically affects the lungs. CF patients are highly prone to opportunistic bacterial infections that often lead to prolonged, chronic lung infections, reducing life expectancy due to significant destruction of lung tissue. Approximately 70,000 individuals in Europe and North America suffer from CF, making it the most common life-threatening autosomal recessive disease.

The aim of the study is to assess the improvement in lung function after treatment with NOxCureCF in CF patients 10 years old and older. The study will also allow continuous testing of the safety and tolerability of the dosage and delivery system.

Prof Yossef Av Gay, AIT's CSO and a professor of microbiology at the University of British Columbia, Canada, states: "The ongoing studies, an outgrowth of the strategic alliance between Clalit Health Services and AIT, will strengthen the research and development in the critically important area of treatment of acute and chronic respiratory illness treatment with NO solutions."