AIT Ltd. and Clalit Health Services Expand Strategic Alliance and Plan Phase II Clinical Trial for Respiratory Diseases

  • AIT focuses on treatments for infectious respiratory diseases including, bronchiolitis, cystic fibrosis, and pneumonia.
  • With 4 million members, Clalit Health Services is Israel's largest HMO and the second-largest HMO in the world.
  • Schneider Children's Medical Center of Israel (SCMCI) is the only children hospital in Israel, with over 250 beds, of which 43% are assigned to critical care (intensive care units, neonatology and burns).
  • Soroka University Medical Center is the largest Pediatric Medical Center in the south of Israel with 190 admission beds and 35,000 visits at the Pediatric ER, 14,500 admissions and 42,000 ambulatory visits.

REHOVOT, Israel, Sept. 2, 2013 (GLOBE NEWSWIRE) -- Israeli biomed company AIT Ltd. (Advanced Inhalation Therapies), a leader in the development of nitric oxide therapeutics for the treatment of infectious respiratory diseases such as Respiratory Syncytial Virus (RSV) /bronchiolitis, Cystic Fibrosis (CF), Pneumonia, and asthma announced today that their successful collaboration with Clalit Health Services has expanded to include Schneider Children's Medical Center of Israel (SCMCI) as an additional clinical study site.

Under this agreement, AIT will lead clinical development strategy in cooperation with Schneider's renowned opinion leaders in the field of respiratory care. As well, experts from Schneider will contribute to AIT's future clinical trial performance.

Prof Yossef Av Gay, AIT's CSO and a professor of microbiology at the University of British Columbia, Canada, said, "It is very encouraging that this top-tier center of excellence will now play an important role in our research and clinical studies and strengthen our already successful alliance with Clalit Health Services."

AIT focuses on the development of nitric oxide formulations for the treatment of respiratory infections and diseases, mainly in children. The company is currently performing a Phase II clinical study for RSV /bronchiolitis at Soroka Medical Center in Beer sheva, Israel. "We now have the opportunity to develop additional innovations," Av Gay notes, "supported by high-quality clinical studies and led by Clalit's finest researchers and facilities, which will give us a solid foundation for positive developments in the future."

Bronchiolitis is a viral infection of the small airways in the lungs. It is the most common Acute Lower Respiratory Infection (ALRI) in early infancy, and is a leading cause of child mortality, with an estimated 64 million cases worldwide; up to 200,000 children age 5 and younger die annually from respiratory syncytial virus-associated ALRI.

It ranks as the most common reason for pediatric hospital admissions (~400,000 annually in the United States), a $2 billlion burden for the United States, with hospital charges alone in excess of $1 billion. These charges in part reflect hospital Length Of Stay (LOS). The mean LOS for bronchiolitis in the United States is 3.3 days.

"Clalit recognizes the critical need for improving treatment of respiratory infections, especially those with antibiotic-resistant pathogens," says Prof. Asher Tal, head of Pediatrics at Soroka Medical Center. "Respiratory infections," he observes, "are on the rise, especially during the winter months, leading to patient overflow and hospital overcrowding. With greater cooperation between medical centers and technology companies, we can improve patient health and potentially reduce patient overflow in hospitals."

AIT's Ongoing Clinical Development

As part of its ongoing clinical development, AIT will begin a multicenter Phase II study in Israel for CF at Soroka Medical Center and SCMCI. SCMCI is one of the three large centers for cystic fibrosis treatment in Israel. The CF Center is led by Prof. Hannah Blau and Dr. Huda Mussaffi.

CF is a life-threatening genetic disease that causes the abnormal transport of salts across cells, most critically affecting the lungs. Approximately 100,000 individuals in Europe and North America suffer from CF, making it the most common life-threatening autosomal recessive disease. CF patients are highly prone to opportunistic bacterial infections that lead to prolonged, chronic lung infections. This results in shortened life expectancy due to significant destruction of lung tissue.

"While treatment options for CF patients have advanced in recent years, a significant unmet need remains for treating bacterial infections in CF patients," said David Greenberg, MD, Chief Medical Officer of AIT. "We are pleased that our Phase II trial which has commenced at SOROKA Medical Center has established the safety profile and we are advancing in clinical development to further evaluate it as a potential treatment option for patients who are in need of more effective therapies. The addition of the CF research group from Schneider children's hospital will expand our ability to explore our technology in CF patients and to improve the treatment for infectious diseases in these patients."

About Clalit Health Services

Schneider Children's Medical Center is a member of Clalit Health Services, the largest HMO 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. It is also the only health fund with a countrywide network of 425 state-of-the-art pharmacies, 70 dental clinics, 80 clinical laboratories, 35 separate radiology facilities, as well as computerized diagnostic equipment at a number of central laboratories.

Clalit has 4 million insured members in Israel (>52% market share).

Clalit is the only health organization that has an extensive network of hospitals throughout the country. Clalit maintains a total of 14 general and special care hospitals which are all university affiliate.

In the long-term interest of the entire population, Clalit conducts clinical, biomedical, and social science research in its own facilities, or in cooperation with Israel's universities and scientific institutions.

About Schneider Children's Medical Center of Israel

Dedicated exclusively to the well-being of all children and adolescents, Schneider Children's Medical Center of Israel (SCMCI) is the only comprehensive, highly specialized care hospital of its kind in the country and in the Middle East.

Since its establishment in 1991, Schneider Children's Medical Center has become recognized as an institution of medical and academic excellence. Providing a full range of pediatric subspecialties and comprehensive services to all children from newborn through age 18, SCMCI also operates special adult clinics to ensure follow-up care for those born with congenital disorders. The medical center serves as the national referral center for hematology-oncology, endocrinology and childhood diabetes, and cardiology. It is Israel's leading institution in the field of bone marrow and organ transplants. Approximately 43% of its 250 beds are assigned to critical care (intensive care, neonatology, burns, and others).

The Graub cystic fibrosis center, part of the Pulmonary Institute at SCMCI, was established in 1993 and is known internationally for both clinical excellence and research into early CF diagnostic methods and interventions.

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.

About AIT

AIT ( is an Israeli biomed company focused on the development and commercialization of formulations from nitric oxide for the treatment of infectious diseases. The company was founded in 2011 by Mor Research Applications, a subsidiary of Clalit Health Services, Israel's largest health management organization.

The company is conducting Phase II trials on bronchiolitis, after successful completion of Phase I trials. AIT develops products for the treatment of bronchiolitis, cystic fibrosis, pneumonia, and asthma.

CONTACT: Racheli Vizman, COO, AIT 2 Derech Meir Weisgal Rehovot 9632605, Israel E-mail: Direct: +972 8 684 3313 Mobile: +972 52 565 9922Source:AIT LTD