Rx Globally Patented Non-Steroidal Nasal Spray for All Lung Diseases including Pulmonary Fibrosis, CF, COPD, Unmet Needs with No Known Side Effects that can also be used to Deliver Antivirals, Antimicrobials, Insulin, and other Drugs
FLEMINGTON, N.J., Jan. 14, 2020 /PRNewswire/ -- EmphyCorp Inc. www.EmphyCorp.com, a Private Corporation, was proud to announce on August 12, 2019, 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), and Cystic Fibrosis.
EmphyCorp has 6 Existing U.S. Drug Patents plus 2 New U.S. Composition Drug Patents Pending for Pulmonary Fibrosis, Cystic Fibrosis and All Lung Diseases with clinical safety and efficacy data on human testing completed. This Pipeline of Globally Patented Rx Technology (74 Worldwide Drug Patents) also has clinical data to support the use of our N115 Nasal Spray for delivery of antivirals, antimicrobials, insulin, and a host of other drugs to treat a host of other diseases around the world.
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 and other 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.
The New Breakthrough Therapy, Nasal delivery of N115, reduces nasal inflammation that causes congestion, hypoxemia, coughing, mouth breathing, while increasing lung functions in all patients with lung diseases including patients with COPD, Pulmonary Fibrosis, or Cystic Fibrosis. An EmphyCorp Patent Pending propriety formulation was shown to reduce mucus production in patients with Cystic Fibrosis.
In human Clinical Trials submitted to the FDA, inflammatory cytokines were reduced in Patients with Allergic Rhinitis, Cystic Fibrosis, Pulmonary Fibrosis and COPD. In rat bleomycin injured lungs (a chronic fibrotic animal model), treatment with N115 produced a significant (p<0.01) reduction in total cells found in the bronchoalveolar lavage, indicating a reduction in airway inflammation. It was concluded that N115 was effective in reducing inflammation and lung damage in this chronic fibrotic stage of the lung injury and appeared to reduce fibrosis caused by myofibroblasts - possibly by activation of myofibroblast apoptosis. It should be noted that this type, of injury with the subsequent fibrotic infiltration, is typical of the fibrosing group of interstitial lung diseases in humans.
N115 is a natural, safe anti-inflammatory component of the human body, which has been administered to patients for a variety of medical disorders by oral, intravenous, or topical administration plus applications including: the treatment of Friedreich's ataxia, as a constituent in a therapeutic solution used in open heart surgery, kidney surgery, eye surgery, mitochondrial diseases, as an oral dietary supplement, and as a component in organ transplant media that is being used to preserve human lungs, hearts, and other organs for human transplants.
In U.S. Phase III Clinical Trials with Idiopathic Pulmonary Fibrosis Patients, our N115 Rx 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 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 being 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 patients remained on their current therapies (Steroids), while using our Non-steroidal Nasal Spray, which demonstrated that current therapies in use are inadequate to treat patients with Idiopathic Pulmonary Fibrosis.
Currently 128,000 patients have Idiopathic Pulmonary Fibrosis (Interstitial Lung Disease) with 48,000 new cases each year. Over 40,000 of these patients die each year. There have been over 38,381 complaints to the FDA that Nasal Steroids and all the Over the Counter (OTC) products have failed to provide efficacy or increase lung functions, which confirms our results.
When Patients were removed from their medication and only used the N115 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 N115 Nasal Spray can reduce the need for inhaled steroids.
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, and increase Oxygen levels from below normal to normal.
The results are not surprising since our Patented Non-Steroidal Nasal Spray has been used by over 2 Million Patients Globally in over 200 Hospitals over the past 5 years that includes COPD patients, "Unmet Needs" Patients (Children, Pregnant Women, Diabetics, Hypertensive), and others with Allergic Rhinitis and Chronic Breathing conditions with efficacy and no known side effects.
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. Please contact Robert Millar for more information at 973-586-4421 or EmphyCorp@optonline.net.
EmphyCorp Inc. www.EmphyCorp.com is a Private Corporation located in Flemington, New Jersey (USA) that is devoted to creating Breakthrough Drugs with its Global Patented N115 Non-Steroidal Nasal Spray Technology Platform with no known side effects for treating Chronic Breathing Diseases including Pulmonary Fibrosis (Orphan Drug – Phase III FDA submitted), Cystic Fibrosis (Orphan Drug Phase III Ready), COPD (Phase III Ready), Unmet Needs/COPD (Phase III Ready) and for Alzheimer's (Phase III Ready), Concussions (Phase III Ready), Cancer Pre-Treatment (Help Protect Healthy Cells before Chemotherapy and Radiation Therapy – Phase III Ready). N115 Non-Steroidal Nasal Spray Technology can now be used to Deliver Antivirals, Antimicrobials, Insulin, and other Drugs.
Dr. Alain Martin (70+ Global Drug Patents) is the creator of our Worldwide Patented N115 Rx Non-Steroidal Nasal Spray Technology and is also the creator of Advanced Neosporin, Lubriderm, Rx Rezulin (Type II Diabetes), Cool Mint Listerine, Early Pregnancy Test (EPT), and our sister company's (20) new Patented Drug Free Skincare Products ready to launch, Drug Free Post Laser Aftercare Products for Dermatologists/Plastic Surgeons ready to launch, and Rx Drugs for Topical Melanoma, Eczema, and Injectable for Inoperable Tumors.
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