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news.Advanced Inhalation Therapies (AIT) has added Schneider Children's Medical Center of Israel as the second site in its multicenter, open-label, Phase II clinical trial of NOxCureCF, a respiratory treatment for patients with cystic fibrosis (CF). Schneider Children's is the largest children's hospital in Israel.
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NOxCureCF is a specialized formulation of inhaled Nitric Oxide (NO) targeting the Pseudomonas and the Staphylococcus aureus bacteria, the most common bacteria found in CF patients’ lungs and often the cause of severe damage to the patients’ lungs.
The Phase II trial is aimed at measuring bacterial load in the lungs of CF patients 10 years and older and evaluating the improvement in lung functions after treatment with NOxCureCF.
The study will also allow continuous testing of the safety and tolerability of the dosage and delivery system. The study will take place at Schneider Children’s CF Clinic, which is led by Dr. Huda Mussaffi and Prof. Hannah Blau.
AIT expects to present data from the Phase II trial in late 2014. The company anticipates starting Phase III trials in CF patients in early 2015.
"AIT is very pleased to join forces with Schneider Children’s Medical Center in this exciting new area of CF. Our programs in CF show promise. Partnering with Schneider allows us to ramp up our commitment significantly, share development risk and expertise, and increase our chances of bringing best-in-class therapies to CF patients," said David Greenberg, M.D., Chief Medical Officer of AIT.
"We’re pleased to enhance our partnership with AIT to include research in cystic fibrosis, a debilitating disease with significant unmet medical need. Our knowledge of the patient experience, combined with innovative advances in the understanding of disease etiology, offers the potential for new transformational treatments," said Prof. Blau. head of the Pulmonology Department at Schneider Children’s Medical Center of Israel
Initiation of this Phase II trial highlights continued execution of our NOxRespiratory product development and commercialization strategy, which is focused on advancing Nitric Oxide-based therapeutics toward respiratory targets for the treatment of diseases with high unmet medical needs," added Prof. Greenberg. "We believe that this investigational agent has encouraging potential as a new therapeutic option for patients.