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 of Mild Asthmatics

Clinical Studies

An initial human Phase I/II study was conducted at the University of Connecticut Health Center, Farmington, CT, and the Hospital for Special Care, New Britain, CT. This trial was a combination safety and efficacy study that evaluated safety parameters in normal volunteers, and evaluated safety and efficacy parameters in patients diagnosed with mild bronchial asthma (60-80% predicted FEV1 or >12% reversibility to broncho-dilator).


Summary of Results

In summary the treatment of mild asthmatics, with 0.5mM concentration of pyruvate increased FEV1 values in 93% of the patients tested averaging 12%. (See Figures 1 and 2) In this same group of 15 patients, H2O2 levels were decreased on average by 51%, with 80% of the patients obtaining decreased H2O2 levels in their expired breath. The same patients treated with saline had no increase in FEV values and had a 61% increase in exhaled H2O2 levels. Patients treated with the 1.5mM concentrations had very little change in averaged FEV values. This group showed a 65% overall decrease in H2O2 levels with 86% of the patients obtaining a decrease in H2O2 levels. Patients treated with the 5mM concentrations had no significant change in FEV values. 67% of the patients showed a decrease in H2O2 by 50%. In summary inhalation of sodium pyruvate decreased lung inflammation as evidenced by decreasing H2O2 levels and increasing FEV values. Figure 3

 

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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