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AIT’s Phase II Clinical Trial for Cystic Fibrosis Adds Schneider Children’s Medical Center of Israel as Second Site in Expanded Trial

February 10, 2014

Study Aims To Evaluate Improvement in Lung Function after Treatment with NOxCureCF

REHOVOT, Israel, February 10, 2014 /PRNewswire/ –

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.

About AIT

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.

        Contact Information
        Racheli Vizman, COO, AIT
        2 Derech Meir Weisgal
        Rehovot 9632605, Israel
        E-mail: racheli@ait-pharm.com
        Direct: +972-8-684-3313 [tel:%2B972-8-684-3313 ]

SOURCE Advanced Inhalation Therapies (AIT)


Source: PR Newswire



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