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AIT Announces Phase II Study of NOxCureCF, a Respiratory Treatment for Cystic Fibrosis Patients Using a Nitric Oxide-Base Formulation

Enrollment in the Multicenter Trial Begins in Soroka Medical Center in Israel

REHOVOT, Israel, January 7, 2014 /PRNewswire/ --

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."

About Nitric Oxide (NO)

Nitric Oxide (NO) is a small, naturally produced gas that acts as an anti-infection agent, making it very effective for the treatment of a wide range of diseases. AIT uses NO in unique dosages and in specialized delivery modes to enable direct, effective access to the lungs.

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 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. The company successfully concluded Phase I trials and is currently conducting Phase II trials on RSV/bronchiolitis.

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.

About Clalit Health Services

Clalit is the major health organization in Israel, and one of the most progressive public health associations in the world. Through its 14 hospitals and more than 1,400 primary and specialized clinics, Clalit provides comprehensive health insurance and highly advanced medical care to the majority of Israel's population. Clalit maintains a total of 14 general and special-care hospitals, all of which are affiliated with Israel's universities, a countrywide network of pharmacies, dental clinics, radiology facilities, as well as computerized diagnostic equipment at a number of central laboratories.

Clalit has 4 million insured members, a >52% market share, and managed an annual budget of more than $6 billion.

About Soroka University Medical Center

The Pediatric Division of the Soroka University Medical Center is one of the largest Pediatric Medical Center is Israel with 190 admission beds, 35,000 visits at the Pediatric ER, 14,500 admissions and 42,000 ambulatory visits. As the only tertiary medical center, which serves the diverse Negev Population, the medical team copes with unique medical conditions in children.

The medical team of 85 staff physicians and 270 nurses provides medical care to almost 300,000 children of the Negev population.

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

SOURCE Advanced Inhalation Therapies (AIT)

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