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EmphyCorp Inc. FDA Submission for Rx New Non-Steroidal Nasal Spray for Pulmonary Fibrosis w/ No Known Side Effects
FLEMINGTON, N.J., Aug. 15, 2019 /PRNewswire/ -- EmphyCorp Inc. www.EmphyCorp.com, a Private Corporation, is proud to announce the completion of a clinical trial to define medical endpoints as requested by the FDA for the NDA marketing application in patients with Pulmonary Fibrosis, under its Orphan Drug Designations for the treatment of Interstitial Lung Diseases (ILD), which includes Pulmonary Fibrosis and Cystic Fibrosis.
The Clinical trials with our Non-Steroidal Nasal Spray demonstrated a statistically and clinically significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (52% to 86%), and nitric oxide, (needed to increase bronchial dilation and fight infections) in patients with Idiopathic Pulmonary Fibrosis. In all patients with Idiopathic Pulmonary Fibrosis and in all patients with Pulmonary Fibrosis and COPD, the inhalation of our nasal spray demonstrated a significant reduction of coughing (p=0.007), a significant (p=0.010) improvement in nasal irritation/erythema, inflammation and congestion, with most patients were free of irritation by day 22 (p=0.000.
In all patients, the test results were compared to their previous three-week screening and baseline data (their current therapies) as the placebo control for each variable including all their lung functions, FEV-1, FVC, PEF, FEV-1/FVC ratios, SaO2, Nitric oxide, coughing rates, nasal inflammation. The statistically and clinically significant increase FEV-1, SaO2, PEF, FVC, especially the improved FEV1/FVC ratio from 52% to 86% was clinically significant since these patientsremained on their current therapies (Steroids), while using our non-steroidal nasal spray, which demonstrated that current therapies in use are inadequate to treat patient with Idiopathic Pulmonary Fibrosis.
When patients were removed from their medication and only used the nasal spray, our Non-Steroidal Nasal Spray demonstrated a statistically and clinically significant increase in all lung functions including FEV-1, SaO2, PEF, FVC, and nitric oxide. This would indicate that the nasal spray can reduce the need for inhaled steroids.
EmphyCorp senior management is very pleased with the results, Dr. Martin (CEO) commented, "The most important conclusion we see from this Phase III Clinical Trial is that our Non-Steroidal Nasal Spray for Pulmonary Fibrosis with No Known Side Effects has greatly improved Patient Quality of Life by allowing these patients to breathe through the nose, sleep better, reduce inflammation and congestion, increase Nitric Oxide for improved bronchial dilation and help prevent infections, improve vital breathing ratios, reduce coughing, increase Oxygen levels from below normal to normal. We are not surprised at the results, since our Patented Non-Steroidal Nasal Spray has been used by over (2) Million Patients in Chinese Hospitals over the past 3 years that includes "Unmet Needs" Patients (Children, Pregnant Women, Diabetics, Hypertensive), and others with Chronic Breathing conditions."
EmphyCorp has a Pipeline of Global Patented Rx Technology that includes Orphan Drug Designations for Interstitial Lung Disease (ILD – Pulmonary Fibrosis) and Cystic Fibrosis, along with Phase III Ready Non-Steroidal COPD Nasal Spray, Phase III Ready Non-Steroidal "Unmet Needs" Nasal Spray. Other EmphyCorp Patented Rx Nasal Spray Technology includes Nasal Sprays for Alzheimer's, Concussions, Smoking Cessation, and a Pre-Treatment for Cancer.
"Our goal is to get our portfolio of Non-Steroidal Nasal Sprays into the market as quickly as possible to help provide immediate improvement in "Quality of Life" for millions of Patients suffering from chronic breathing diseases. Of special interest is providing 30 to 60 million "Unmet Needs" Pregnant Women, Children, Diabetic and Hypertensive Patients that should not take Steroids with a totally safe alternative to daily use of Steroid Nasal Sprays and Steroid COPD Sprays." Robert Millar (President)."
EmphyCorp products are Worldwide Patented Rx Technology, including China. EmphyCorp has the Proprietary Non-Steroidal Rx Technology with no Known Side Effects to penetrate the Chronic Breathing Diseases market and secure a major market share. EmphyCorp will enter into sublicense agreements and/or joint ventures or outright sale with respiratory drug manufacturers or companies seeking to enter the respiratory drug market, both in the U.S. and foreign countries.
SOURCE EmphyCorp Inc.