Animal Safety Studies: Rat Study for 180 Days - Nose Only Inhalation Study

Animal Safety Studies

The rats were given more than 10X the 5mM dosages used in human inhalation studies. If you include the difference in body weights of humans vs. rats the concentrations tested were 100X the 5mM concentrations. After 180 days, the remaining rats from each group were sacrificed. As before, at necropsy, gross morphological observations on lung, liver, kidney, heart, and body weights were recorded. Histopathological evaluations were performed on lung, trachea, larynx, nose, liver, heart, and kidneys.

The study report concluded: “…inhalation of target concentrations of 5.76 mg sodium pyruvate/m3, 85 minutes/day, 7 days/week for 180 days resulted in no clinical signs of toxicity attributable to administration of the test article, minimal effects on body weight in females, and no compound-related microscopic lesions.”

The results of this study were submitted to the FDA’s Division of Pulmonary and Allergy Drug Products. The FDA concluded that, based on the results of this study, the company, could proceed with multiple dose testing of Sodium Pyruvate solution drug products in subjects with lung diseases, subject to approval of submitted protocols.

The company has completed five Phase I/II clinical studies of compounds, which it has developed and patented for the treatment of COPD, Cystic Fibrosis, Asthma and Sinus Diseases. The Company has also received Orphan Drug designation from the FDA for its compound for the treatment of Cystic Fibrosis and Interstitial Lung Diseases. The compound (Sodium Pyruvate) is a natural antioxidant and a non-steroid anti-inflammatory that has been shown to significantly increase FEV-1 and significantly reduce inflammatory agents in the lungs including hydrogen peroxide, nitric oxide, IL-8, TNF, and other inflammatory cytokines.

Numerous animal nasal inhalation safety studies have been performed and no adverse events were found, both histologically or physically. To date over 308 patients have inhaled Sodium Pyruvate with no adverse events reported.