New Non-Steroidal Treatment for Pulmonary Fibrosis

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 former affiliate in China has sold the Nasal spray to over 200+ hospitals and many 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 purchased over three thousand units per month.

To date the Chinese hospitals reported that the Patented pyruvate nasal spray has demonstrated both efficacy and safety, with no adverse events reported.  

by Emphycorp

EMPHYCORP INFLUENZA AND COVID-19 ANIMAL AND HUMAN STUDIES

EMPHYCORP INFLUENZA AND COVID-19 ANIMAL AND HUMAN STUDIES

      Reducing the number of cases, symptoms,and severity of seasonal flu respiratory tract infections and for COVID-19  

      Flu and COVID-19 are known to cause mortality and morbidity in the elderly who are immunocompromised. However, it is often forgotten that both disease afflict children, usually with mild symptoms. In rare cases, there is mortality caused by complications during Flu infection.     

 Since 2010, Flu has caused between 7,000-26,000 hospitalizations annually in children under five years old. Compared to that of COVID-19 which has accumulated a total of 3,240 hospitalizations in school-aged children. To date, 51 children, aged less than 18, have died in the United States from complications with COVID-19. Comparatively, the CDC has reported a range of 37-188 deaths annually in children under five years of age from complications caused by Flu.  

      Potential proactive treatments, such as N115 (sodium pyruvate), would be of benefit to all Populations, especially children that are afflicted by both viruses. In both animal and human trials, N115 reduced viral titers (number of viruses), and reduced the number, symptoms, and severity of seasonal flu respiratory tract infections in pregnant women, children, diabetic, and patients with COPD by over 52% annually. This would prevent the strain on Hospitals.         

 I     Inhibition of Viral Replication and Reduction of the “Cytokine Storm” with EmphyCorp’s

      Proprietary Compounds - Potential Treatment and Preventative for COVID-19 and Flu

1.   1. In tissue culture studies, in human studies and in animal studies when inhaled or applied  topically, sodium pyruvate inhibited the ability of many viral strains from replicating due to the ability of Sodium Pyruvate to increase the synthesis of Nitric Oxide that is needed to kill infections. Mice studies conducted by Independent University Virologists, substantiated our finding by testing nebulized N115 in Flu (influenza A H1N1 virus) infected mice that decreased morbidity, weight loss, proinflammatory cytokines, and decreased viral titers (virus numbers) compared to the Placebo Control.1.     

Furthermore, they stated “we have preliminary data that suggest it may work similarly during other respiratory virus infections including COVID19/SARS-CoV-2. Proactive treatments with sodium pyruvate is not toxic and could be of benefit to children that are afflicted by many respiratory viruses”.    

Sodium Pyruvate Ameliorates Influenza A Virus Infection

In Vivo - on BioRxiv: 

https://www.biorxiv.org/content/10.1101/2020.11.25.396978v1

2. Independent University Research Virologists just completed a Clinical Study, where Nebulizing Mice with sodium pyruvate that were infected with the Influenza A Virus decreased morbidity and weight loss compared to the Placebo Control. 

       Additionally, treated mice consumed more chow during infection indicating improved symptoms (same results reported in a pilot mice COVID-19 study).

     There were notable improvements in pro-inflammatory cytokine production (IL-1β) and lower virus titers (viral numbers) on days 7 post infection in mice treated with Sodium pyruvate compared to the Placebo Control animals. As pyruvate acts on the host immune response, metabolic pathways and not directly on the virus, our data demonstrate that sodium pyruvate is a promising treatment option that is safe, effective, and unlikely to elicit antiviral resistance.

1.     3. A clinical survey of 367 patients over a two-year period demonstrated a statically significant decrease in the number, symptoms, and severity of seasonal flu respiratory tract infections after using the 20mM sodium pyruvate nasal spray (EmphyCorp, N115).  The number of Flu or Colds was reduced by 70% in Children and approximately 52% in Pregnant Women, Patients with Allergic Rhinitis, Diabetes, and Pulmonary Fibrosis.
2.     4. In numerous human clinical trials (17, phase I, II, III clinical trials) submitted to the FDA, with Pulmonary Fibrosis, COPD and Cystic Fibrosis patients, N115 reduced nasal and lung inflammation and congestion by reducing inflammatory cytokines including the IL-6 cytokine that causes the so-called cytokine storm with no known adverse reactions.
3.     5. In a Phase III Placebo Controlled Clinical Trial with Idiopathic Pulmonary Fibrosis Patients, N115 Non-Steroidal Nasal Spray demonstrated a statistically and clinically significant increase in Nasal Nitric Oxide, FEV-1, SaO2, FVC, FEV-1/FVC  ratios (52% to 86%), and a significant reduction in coughing, nasal and lung inflammation.

N115 alleviated the symptoms associated with the COVID-19 infections in Patients with COPD and Pulmonary Fibrosis

N115 increases Oxygen by reducing hypoxemia, and it also reduces lung inflammation, inflammatory cytokines, and coughing. These are critical benefits for treating the symptoms of Covid-19, as lung inflammation leads to pneumonia and death.

4.     6. Reducing the Rate and Spread of COVID-19 Among Patients with Pulmonary Fibrosis, Cystic Fibrosis and Diabetics is important. As cited in hundreds of peer reviewed publications, naturally occurring nitric oxide in the nasal cavities is a primary defense in humans. Nitric Oxide is needed to kill invading bacteria, fungi, and viruses, and prevents/reduces the rate and severity of viral infections, viral replication from the Common Cold, Rhinoviruses, Flu, and Coronavirus. 
5.     7. Most Diabetic, Hypertensives, Pulmonary Fibrosis and Cystic Fibrosis Patients have extremely low nasal nitric oxide which makes them more susceptible to viruses and lung infections. The rate of infection increases with decreasing levels of Nitric Oxide making them more susceptible to all infections including COVID-19 and Flu. Elevated levels of glucose in patients with diabetes mellitus cause a deficiency in the production of nitric oxide by blunting nitric oxide synthesis, which may explain why diabetics have a high susceptibility to COVID-19 and the  Flu.
6. 8. EmphyCorp Global Patented N115 Technology, including China, has been used to treat over 3 million Patients worldwide in 200+ hospitals with no adverse events. 17 human clinical trials that have been submitted to the FDA to support our NDA Phase III marketing application.

by Emphycorp