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 Double Blinded Placebo Controlled Study in Severe COPD Patients

Study #4: A Double Blinded Placebo Controlled Study in Severe COPD Patients with Inhaled Sodium Pyruvate

Results: These patients were treated three times daily for six weeks. At week 6 the FEV1 were compared to their original base measurements. Inhalation of 0.5mM sodium pyruvate increased FEV1 +17.1 vs Saline +8%. In the pyruvate group 80% of the treated patients had positive FEV1 values, whereas as only 55% of saline treated patients had positive FEV1 values.

Nitric oxide (NO) values cannot be measured over time, because the inflammatory process can vary from day to day, up and down. What is significant is the pre and post treatment with saline or Pyruvate. As expected, on the first pre and post analysis, both saline and pyruvate had approximately the same values, pyruvate reducing NO by -7.2% in 66% of the patients tested, and saline reduced NO by -6.5% in 55% of the patients tested. The most significant results occurred in the six week pre and post NO measurements, where pyruvate reduced NO by – 17.65 with 86% of the patients demonstrating a reduction in NO, and saline increased NO overall by +3.88% with only 42% of the patients demonstrating a reduction in NO. Figures 6

 

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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