EmphyCorp Clinical Development Program Update
Latest News on FDA NDA Submission
New Non-Steroidal Treatment for Pulmonary Fibrosis (IPF) to improve Patient Quality of Life.
EmphyCorp 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 nasal spray demonstrated a statistically and clinically significant increase FEV-1, SaO2, FVC, FEV-1/FVC ratios (52% to 86%),and nitric oxide, (needed to increase bronchial dilation and fight infections), and a significant reduction of coughing, nasal erythema and inflammation and congestion, in all patients tested with Idiopathic pulmonary fibrosis.
Interstitial lung diseases, encompass a large group of chronic lung disorders, including Pulmonary Fibrosis, associated with excessive tissue remodeling, scarring, fibrosis, decreased FEV-1/FVC values, decreases in nasal nitric oxide, and a decrease in total lung capacity. 96.88% of Pulmonary Fibrosis patients have congestion caused by nasal inflammation by age 60, which decreases the ability of nasal nitric oxide to maintain normal lung functions leading to increased lung and nasal infections, a reduced SaO2 level, post nasal drip that causes coughing, mouth breathing, and reduced FVC levels. Nasal steroids and other nasal treatments shut down the synthesis of nasal nitric oxide, which leads to decreased lung function and a 34% increase in infections.
There were 32,381 complaints to the FDA that nasal steroidal products and all the over-the-counter products have failed to provide efficacy in the relief of nasal inflammation and have failed to increase lung function in patients with Pulmonary Fibrosis.
EmphyCorp globally patented nasal delivery system, with sodium pyruvate which is a naturally occurring antioxidant of the human body, has been shown to significantly reduce inflammatory agents throughout the human body, including the lungs as demonstrated in eight Phase I/II and Partial Phase III human studies and eight human nasal studies submitted to the FDA in patients with, COPD, Pulmonary fibrosis, and CF patients for our NDA submission.
Over one and a half million nasal spray units have been used to treat patients in over 100 hospitals, including an estimated 150,000 patients with COPD, and patients with “Unmet Needs”, which includes Pregnant Women, small children, diabetics, and hypertensive who suffer from nasal congestion, nasal drip, Inflammation, but cannot take any nasal sprays with steroids.
The “Unmet Needs” patients represents between 30 to 60 Million patients in America alone without a nasal spray they can use. In some cases, not having a nasal spray product can be life threatening. In China we have treated over 60,000 pregnant women, thousands of newborn children, and thousands of diabetic and hypertensive patients, while demonstrating both safety and efficacy, with no adverse events reported.
Two recently approved drugs for the treatment of Pulmonary Fibrosis have a Patient cost of approximately $100,000 per year. The market size for the treatment of Pulmonary Fibrosis is estimated to reach 4 Billion Dollars per year by 2023.
Interstitial Lung Disease
Interstitial lung diseases encompass a large group of chronic lung disorders associated with excessive tissue remodeling, scarring, fibrosis, decreased FEV-1, FVC, PEF, FEV1/FVC, SaO2, and nitric oxide. Currently 128,000 patients have Pulmonary Fibrosis with 48,000 new cases each year. Over 40,000 of these patients die each year. 96.88% of patients by age 60 with Pulmonary Fibrosis have nasal inflammation and congestion, which decreases the ability of nitric acid to maintain normal lung functions.1
Unfortunately, available over-the-counter nasal spray products fail to provide relief from nasal or lung inflammation, and drugs containing steroids often have serious side-effects and may eventually lose their efficacy.
There have been over 32,381 patient complaints to the FDA from patients with Idiopathic Pulmonary Fibrosis, stating that Rx, OTC, and steroid-based inhalation products, have failed to provide relief from nasal or lung inflammation2. (Data from FDA Reports and the FDA Voice of the Patient publication.
The upper and lower airways form one contiguous and functionally related organ that is critical to normal lung functions. The nasal cavity produces 900-1, 100 parts per billion of nitric oxide, which is used to kill invading bacteria, fungi, and viruses compared to the lungs which produce 4-48 parts per billion nitric oxide. Nasal Nitric Oxide also produces clinically useful broncodilation and has been shown to reduce pulmonary fibrosis (Djupesland et al. 2001). Blockage of nasal nitric oxide by inflammation reduces the amount of nitric oxide reaching the lungs, which reduces critical lung functions, leading to increased lung and nasal infections, a reduced SaO2 level, reduced FEV-1 levels also leading to mouth breathing and coughing. Nasal steroids and other OTC nasal treatments shut down the synthesis of nasal nitric oxide, which leads to decreased lung functions and a 34% increase in infections (Westerveld et al. 2000).
Numerous studies have shown oxidative stress to be associated with many nasal and interstitial lung diseases and that antioxidants are effective in attenuating fibroproliferative responses in the lungs of animals and humans. Sodium Pyruvate is a natural antioxidant of the human body and as an antioxidant it has been shown to significantly reduce inflammatory agents throughout the body, including the lungs and nasal passages.
To date, eight human clinical studies have been conducted on the effect of inhaled sodium pyruvate on the lungs, and seven human sodium pyruvate nasal inhalation studies have been conducted. All studies demonstrated the ability of inhaled sodium pyruvate to reduce inflammation and improve lung functions.
1 data from FDA reports and the FDA Voice of the Patient publication
2 data from FDA reports and the FDA Voice of the Patient publication
In addition to Pulmonary Fibrosis, Other Worldwide Patented Pipeline Prescription Products ready to complete final clinicals include:
- Prescription Nasal Spray with no known side effects for the "Unmet Needs" Market - (Pregnant Women, Small Children, Diabetics, High Blood Pressure – 30 to 60 Million people in the US without a product they can safely use for congestion/inflammation relief...these Patients suffer with congestion and presently cannot/should not take drugs with Steroids...and without congestion relief can be life threatening.
- Nasal Spray and/or Oral Inhaler for COPD with no known side effects
- Nasal Spray for Cystic Fibrosis (Orphan Drug) with no known side effects
- Oral COPD Inhaler (China – 3+ years in Final Clinicals) with no known side effects
- Nasal Spray for Alzheimer’s with no known side effects
- Nasal Spray for Concussions with no known side effects
- Drug Free Pre-Treatment for Cancer - that protects healthy cells before Chemo or Radiation Therapy (Pill or Drink)
- Prescription and/or OTC Smoking Cessation Spray (seeking a large Pharmaceutical company Partner)
Safety of Pyruvate for Nasal Products and list of Products with Pyruvate
Sodium Pyruvate is a natural and ubiquitous biochemical antioxidant component of the human mammalian system that is critical to cells and the survival of mitochondria, the power house of all living cells. It is involved in a myriad of biochemical reactions, and is a critical and necessary component involved in the biochemical cascade leading to the Krebs Cycle reactions.
Sodium Pyruvate is biochemically classified as an α-ketoacid and is part of the body’s natural endogenous anti-oxidant defense system. It is secreted by cells, readily enters cells, and can directly react to detoxify detrimental compounds such as H2O2 and peroxynitrites.
Sodium Pyruvate has been shown to significantly reduce inflammatory agents in all parts of the human body including the lungs and the nasal cavities. The inflammatory agents being reduced include hydrogen peroxide, nitric oxide, IL-8, TNF, and other inflammatory cytokines, that are produced by oxygen radicals.
Sodium Pyruvate is normally metabolized through this cycle that provides energy to the cells. Sodium Pyruvate has been studied for over 100 years with over 33,000 publications in peer review journals, providing ample data as to its safety and mechanism of actions that demonstrate Sodium Pyruvate is an anti-oxidant and is critical to all cellular function and morphology.
Sodium Pyruvate can immediately be used in OTC Nasal Products as an antioxidant. Many products contain sodium Pyruvate (Neosporin, Lubriderm, Vaginal Products, Viva Eye Drops, Ringers Solution, Human IV Solutions, and solutions to store red blood cells by the Red Cross and store human organs for transplant.
Sodium Pyruvate is considered GRAS (Generally Regarded as Safe) by the FDA and it has been administered to patients for a variety of medical disorders by oral, intravenous, or topical administration and applications including:
- Therapeutically and diagnostically in the treatment of Friedreich’s ataxia
- As a constituent in a therapeutic solution used in open heart surgery, kidney surgery, and eye surgery
- Hyperkeratotic disorders, to treat mitochondrial diseases and as an oral dietary Supplement
· Sodium Pyruvate is also a component in organ transplant media that is being used to preserve human lungs, hearts, and other organs for human transplants
EmphyCorp, Inc. has discovered and patented the use of Sodium Pyruvate as an inhaled antioxidant that reduces the levels of oxygen radicals that are produced from the use of many compounds including nasal saline.
Sodium Pyruvate reduces nasal irritation (sting) from nasal saline formulas and can safely treat sinus diseases including congestion.
Sodium Pyruvate is a natural antioxidant and as an antioxidant it has been shown to significantly reduce inflammatory agents throughout the human body including the lungs and nasal cavities. The inflammatory agents that are reduced include hydrogen peroxide, nitric oxide,IL-6, IL-8, TNF, and other inflammatory agents produced by oxygen radicals.
Over three million units have been distributed for sale globally, especially in China. Our affiliate in China is manufacturing and distributing the Nasal spray to over 200 hospitals and 6,000 Chinese Pharmacies. Three of the hospitals are specifically designed to treat allergies and sinus diseases, while another is the premiere Chinese hospital for children in Beijing, which purchases over three thousand units per month.
To date the Chinese hospitals reported that the pyruvate nasal spray has demonstrated both efficacy and safety, with no adverse events reported.