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


EmphyCorp Granted Four U.S. Patents, with Three More Pending

July 28, 2003 - The Company has been granted four U.S. patents and three additional are pending with respect to its new drug “N115.” The Food and Drug Administration (“FDA”) has given EmphyCorp approval to begin Phase 11 Clinical testing of humans.Key distinctions that set N115 apart from current treatments for pulmonary diseases are:

  • There is a significant worldwide medical need and market for a safe and effective treatment for asthma and similar pulmonary diseases. N115 has been shown to be effective as a dual acting bronchodilator and anti-inflammatory, and increases pulmonary function in patients in acute stages of pulmonary disease.
  • N115 is a natural component of the human body and “non-toxic” in comparison to current methods of treatment for asthma and other major respiratory diseases (such as steroids or albuterol), which are toxic and destructive to the body, especially in children.
  • The FDA has granted EmphyCorp Orphan Drug designation for a class of rare (but often fatal) pulmonary diseases known as Interstitial Lung Disease (ILD). EmphyCorp is the only company to have received such a designation by the FDA for this class of diseases. This designation attests to the FDN's recognition of N1l5 as one of a new class of drugs known as Reactive Oxygen Species (ROS) Antagonists, for the treatment of pulmonary disease.
  • The FDA has granted EmphyCorp a second Orphan Drug designation for the use of N115 in the treatment of Cystic Fibrosis a class of pulmonary disease. EmphyCorp is the only company to have received such a designation by the FDA for this class of disease for a small molecule. This designation attests to the FDA's recognition of N115 as one of a new class of drugs known as Reactive Oxygen Species (ROS) Antagonists, for the treatment of pulmonary disease.
  • Currently, N115 is the only known dosing method of using sodium pyruvate for respiratory diseases by inhalation into the lung i.e., by a nebulizer. This dosing method is strongly protected in the patents. Other dosing routes like oral administration, topical administration or injection are not known to be effective in this application.
  • Estimates of the Costs of N115 production and application will make it the most cost-effective pulmonary disease treatment on the market.
  • The patent suite for the pharmaceutical usage of sodium pyruvate in the lungs is as strong as the strongest possible pharmaceutical patent position.

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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