Developing a Respiratory Drug for:

Asthma

Chronic Obstructive Pulmonary Disease (COPD)

Chronic Bronchitis

Emphysema

Cystic Fibrosis (CF)

Interstitial Lung Disease (ILD)

Regulation of Nitric Oxide (NO)

Sodium Pyruvate

Phase I/II Study of Mild Asthmatics

Phase I/II Nitric Oxide (NO) Study

Phase I/II Study in Severe COPD Patients

Phase I/II Double Blinded Placebo Controlled Study in Severe COPD Patients

Anti-Viral Effects of Nitric Oxide (NO)

Pyruvate in Cancer Prevention & Treatment

Sarcoidosis


Phase I/II Study in Severe COPD Patients

Study #3: 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).

The effect of the inhalation of a single dose of sodium pyruvate (0.5mM and 5.0mM) or placebo (0.9% sodium chloride) was studied in a double-blinded protocol on five patients. Each patient inhaled all three solutions at different time points in a blinded manner.

The inhalation of 0.5mM sodium pyruvate decreased Nitric Oxide (NO) levels by -35.87 % in 80% of the patients, while the 5.0mM concentration of sodium pyruvate increased NO levels by +19.5 in 100% of the patients producing a statically significant number. Inhalation of saline increased NO in 40% of the patients, and decreased NO in 60% of the patients averaging a decrease in NO. Figure 5

The FDA has determined that N115 has sufficient safety toxicology and clinical data to proceed with the multi-dose, extended use, clinical trials. Phase II studies will focus on asthmatics and COPD patients. On the basis of existing clinical data, EmphyCorp is confident that its Investigative New Drug, N115, can and will be used for maintenance or continuous treatment of patients over extended periods of time. The Company believes that N115 will set the standard in the pharmaceutical industry for the treatment of major pulmonary diseases.

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