N115 History and Background

Until now the primary treatment for asthmatic bronchitis and chronic obstructive pulmonary diseases is the use of corticosteroids (67%). It is well documented that prolonged use of corticosteroids for the treatment of pulmonary diseases has serious side effects including death. Other marketed drugs for the treatment of pulmonary diseases can produce central nervous system, cardiovascular, respiratory and gastrointestinal problems.

“Thirteen (13) publications from major independent research institutes during 1998 have confirmed the initial scientific premise on the origin of lung diseases upon which the Nl15 proprietary technology and delivery system are based.”

An increased content of hydrogen peroxide, a marker of inflammation, is found in the condensate of exhaled air from adults and children with inflammatory lung disorders, including asthma. Airway inflammation is important in the development and progression of many lung diseases, including bronchiectasis. The more severe the lung disease, the more elevated the hydrogen peroxide level in the exhaled air.

Thus, the ability of inhaled alpha keto acids, including inhaled sodium pyruvate, to "up regulate" or "down regulate" nitric oxide levels in the lungs, and to protect nitric oxide from being destroyed by hydrogen peroxide and other oxygen radicals, will reduce lung inflammation. Nitric oxide is also used by the body to kill bacterial infections, fungal infections, viral infections and tumors.

FDA Submissions: Clinical Findings for N115

  1. Rat Study: Effect of Intratracheal Injection of a Single Dose of Sodium pyruvate on the Lungs
  2. Rabbit Study: Effect of a Single Dose and Multiple Doses of Inhaled Sodium Pyruvate on the Lungs
  3. Rat Study: Effect of Multiple Intratracheal Administrations of Sodium Pyruvate on Lung Injury Caused by Bleomycin
  4. Rat Study: Multiple Dose Toxicity Study of Aerosolized Sodium Pyruvate in Sprague-Dawley Rats
  5. Rat Study: 180-Day Nose-Only Inhalation Study of Sodium Pyruvate in Charles River Rats
  6. Inhaled Sodium Pyruvate for the Treatment of Bronchial Asthma, a Phase I/II Study A) Human Volunteer Safety Phase B) Safety and Efficacy Testing in Patients with Mild Bronchial Asthma
  7. Sodium Pyruvate/Nitric Oxide Pilot Study in Human Subjects with Lung Disease
  8. Orphan Drug Designation Petition for N115 and Interstitial Lung Disease (granted)
  9. Orphan Drug Designation Petition for N115 and Cystic Fibrosis (granted)
  10. Use of Inhaled Sodium Pyruvate for the Treatment of Subjects with Cystic Fibrosis (study pending)
  11. Sodium Pyruvate/SaO2 Pilot Study in Subjects with COPD (Dr. John Votto, Hospital for Special Care and the University of Connecticut Health Center, and Roger S. Thrall, PhD. Hospital for Special Care, New Britain, Connecticut).
  12. A Double Blinded Placebo Controlled Study in Severe COPD Patients with Inhaled Sodium Pyruvate.