AIT’s Phase II Clinical Trial for Cystic Fibrosis Adds Schneider Children’s Medical Center of Israel as Second Site in Expanded Trial
Study Aims To Evaluate Improvement in Lung Function after Treatment with NOxCureCF
REHOVOT, February 10, 14
Advanced Inhalation Therapies (AIT Ltd.), a drug development company, announced today it 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.
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.”
About Schneider Children’s Medical Center of Israel
Schneider Children’s Medical Center of Israel is the only comprehensive, highly specialized care hospital of its kind in the country and in the Middle East, dedicated exclusively to the well-being of children and adolescents. With a staff over 1,800 employees and 220 pediatricians with advanced specialty and subspecialty pediatric training, Schneider is the largest children’s hospital in Israel, serving a population of more than 2 million people with 275,000 visits and treatments annually. It serves as a center for complicated cases from around the world.
Schneider Children’s is a member of Clalit Health Services, the largest health management organization in Israel with over 4 million members, and receives all HMO patients for treatment and admission.
AIT (http://www.ait-pharm.com) is a drug development company focused on the development and commercialization of NO-based formulations for the treatment of respiratory or infectious diseases such as RSV, bronchiolitis, cystic fibrosis, pneumonia and asthma. NOxCureCF is one of a group of inhaled NO-based therapeutics developed by AIT for the treatment of infectious respiratory diseases such as Respiratory Syncytial Virus (RSV)/bronchiolitis, CF, pneumonia and asthma.
AIT was founded by Mor Research Applications, a subsidiary of Clalit Health Services, Israel’s largest health management organization. The company is headquartered in Rehovot, Israel.
Racheli Vizman, COO, AIT
2 Derech Meir Weisgal
Rehovot 9632605, Israel
SOURCE Advanced Inhalation Therapies (AIT)