Viral and Bacterial Infections

VIRAL AND BACTERIAL INFECTIONS

The human body’s respiratory tract is one of the most common sites of infection by foreign bacteria-based pathogens.

Each year children acquire between two and five upper respiratory tract infections and adults acquire one or two infections. If there’s anything that can be common, it would be a bacterial respiratory infection.

The human respiratory tract is also a frequent site of infection because it comes in direct contact with one’s physical environment on a constant basis.

We are exposed to airborne microorganisms constantly, especially based upon our surroundings. The ability to increase the nasal synthesis of Nitric oxide will treat most infections.

N115 Nasal Spray with no known side effects increases the synthesis of nasal nitric oxide.


FLU

FLU

Influenza A virus (IAV) causes seasonal epidemics and periodic pandemics with significant morbidity and mortality.

In the 2019-2020 flu season, the United States Center for Disease Control and Prevention (CDC) estimated 38 million IAV infections and 22,000 deaths.

The most prevalent virus of the 2019-2020 season was the 2009 pandemic IAV (H1N1). Notably, during this season, was a higher rate of infections among children aged 0-4 and adults aged 18-49 years than in other recent seasons.

During pandemics, the emergence of a novel virus can cause severe complications with increased morbidity and mortality.

Due to the novelty of the pandemic virus, vaccines must be redesigned. Anti-viral therapies exist to treat IAV. However, viral resistance to these therapies are always possible. Therefore, treatments that alter the host response to IAV infection and are less likely to result in evolution of resistance are desirable.


COVID LONG HAULERS

COVID LONG HAULERS

There are approximately 12 million Americans with COVID-19 Long Hauler symptoms (also called “Long COVID”).

These are Patients that had COVID, but still have lingering symptoms including hypoxemia (low SaO2), fatigue, headaches, coughing, trouble breathing and shortness of breath (dyspnea).

Many with respiratory issues like Pulmonary Fibrosis and Interstitial Lung Disease.


COVID-19

COVID-19

COVID-19 is a disease caused by the novel SARS-CoV-2 virus.

In the last 1.5 years since the spread of this virus began a world-wide pandemic, hundreds of millions of people have become infected and millions have died. Although the advent of any novel pathogen is likely to result in widespread infection and mortality, SARS-CoV-2 induces a particularly severe and rapid form of pneumonia in some patient’s concomitant with an overall cytokine storm, but diminished interferon responses.

Although case severity varies by sex, age and comorbidities, some of the most severe comorbidities include high blood pressure, diabetes and interstitial lung disease.

COVID-19 viral infections also decrease lung functions and increase hypoxemia and dyspnea, coughing, fatigue, headaches, chills, fever, trouble breathing and shortness of breath (dyspnea).


PULMONARY FIBROSIS

PULMONARY FIBROSIS

Interstitial Lung Diseases encompass a large group of chronic lung disorders associated with excessive tissue remodeling, scarring, fibrosis, hypoxemia, 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 nasal nitric oxide to maintain 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. Nasal nitric oxide also produces clinically useful bronchodilation and has been shown to reduce Pulmonary Fibrosis (Djupesland et al. 2001).

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 inflammation.


Hypoxemia

HYPOXEMIA

Hypoxemia is a condition caused by injury to the lungs, which can be caused by nasal and respiratory diseases, infections, cancer, toxic chemicals, ozone, and many medications all of which reduces oxygen levels to the whole body, producing fatigue, coughing, trouble breathing and shortness of breath (dyspnea) and a decrease in lung functions.

Hypoxemia is manifested in COVID-19 infected patients, in patients with Long COVID, Pulmonary Fibrosis and Flu.

Worldwide Patented N115 Non-Steroidal Nasal Spray Drug with no known side effects:

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 (N115 Nasal Spray) is a natural antioxidant of the human body and as an antioxidant it has been shown to significantly reduce inflammatory agents throughout the human body including the lungs and nasal passages.

To date, N115, has demonstrated efficacy, with no known side effects, for all lung and sinus diseases tested including:  COPD, Pulmonary Fibrosis, CF, Allergic Rhinitis, Chronic Rhinitis, Sinusitis, COVID-19, long COVID, and Flu.

In 19 Human Clinicals (Phase I, II, III including animal safety data) submitted to the FDA, N115 produced statistically significant increases in all lung functions with the reduction in nasal and respiratory inflammation, a reduction in oxygen radicals, congestion, coughing, fatigue, and a reduction of inflammatory cytokines including IL-6, a cause of the cytokine storm in COVID-19 patients.

N115 also increases the synthesis of nasal nitric oxide, a natural defence molecule that kills invading bacteria, fungi, and viruses to prevent and reduce the severity of infections.

N115 produces statistically and clinically significant reduction of the symptoms in patients with hypoxemia, fatigue, headaches, coughing, trouble breathing and shortness of breath (dyspnea), while reducing viral titers in COVID-19 and FLU patients.

Thousands of Patients have been tested in 19 Phase I,II,III Human Clinical Trials and the results submitted to the FDA.


Interstitial Lung Disease

INTERSTITIAL LUNG DISEASE

EmphyCorp has been granted Orphan Drug status by the FDA to develop N115 for the treatment of Interstitial Lung Disease. Interstitial lung diseases are typically characterized by a marked inflammation at the site of the lung injury. 

This inflammatory process leads to further destruction of surrounding healthy lung tissue, and a continuation and expansion of the sites of inflammation. 

This inflammatory process results in the production of reactive oxygen species, including superoxide anions and hydrogen peroxide, at the site of inflammation.

The functional changes reflect a restriction of airflow manifest by:

  • Decreased vital capacity
  • Decreased total lung capacity
  • Decreased residual volume
  • Decreased lung compliance
  • Cyanosis (sign of severe hypoxemia; attributed to ventilation-perfusion mismatching)
  • Late in the disease, one may see pulmonary hypertension due to destruction of the alveolar capillary bed

Nitric oxide is a known bronchodilator. It has been used successfully in this regard to treat patients with various pulmonary diseases, including the interstitial lung diseases. 

Reactive oxygen species, especially superoxide anions, are known to compromise lung function by increasing bronchoconstriction’s. 

As a result of the increasing inflammation and the production of reactive oxygen species, and the decrease in nitric oxide that occurs with the interstitial lung diseases, healthy tissue is damaged and lung function is compromised.

Sodium pyruvate is a reactive oxygen species (ROS) antagonist that has been shown to neutralize oxygen radicals (specifically lowering the overproduction of superoxide anions), reduce the production and level of other inflammatory agents including inflammatory cytokines like Interleukin 6, reduce hypoxemia and coughing and upregulate the synthesis of nitric oxide. 

Sodium pyruvate also increases cellular levels of glutathione, a major cellular antioxidant, which is reduced dramatically in lung disease patients.


Chronic Bronchitis

CHRONIC BRONCHITIS

Though less well known than emphysema, there are 14 million adult Americans that suffer from chronic bronchitis, which is the ninth-ranking chronic condition in our nation.

Like emphysema, many who suffer from it are subject to periodic attacks of obstructed breathing, when airways of the lungs become inflamed and clogged with mucus, often in response to environmental irritants.

Early symptoms include inflammation,  shortness of breath (dyspnea), Hypoxemia, fatigue, low SaO2,, low synthesis of nasal nitric oxide and coughing


Cystic Fibrosis

CYSTIC FIBROSIS (CF)

EmphyCorp has been granted Orphan Drug status by the FDA to develop N115 for the treatment of Cystic Fibrosis. Cystic Fibrosis is a genetic disease afflicting nearly 30,000 persons in the United States and Canada and nearly 250,000 worldwide.

It is the most common life-shortening genetic disease in the white population, occurring in the USA in about 1/3,300 white births, in about 1/15,300 black births, and in about 1/32,000 Asian-American births. Fifty percent of CF patients present with pulmonary manifestations, usually chronic cough and wheezing associated with recurrent or chronic pulmonary infections.

Cough is the most troublesome complaint, often accompanied by sputum, gagging, vomiting, and disturbed sleep.

Early symptoms include inflammation, shortness of breath (dyspnea), Hypoxemia, fatigue, low SaO2,, low synthesis of nasal nitric oxide and coughing.

The ability to up regulate the synthesis of Nitric oxide is critical to treat lung infections.  N115 Nasal Spray with no known side effects increases the synthesis of nasal nitric oxide.


Sarcoidosis

SARCOIDOSIS

Sarcoidosis is an inflammatory disease that affects multiple organs in the body, but mostly the lungs and lymph glands.

In people with sarcoidosis, abnormal masses or nodules (called granulomas) consisting of inflamed tissues form in certain organs of the body. These granulomas may alter the normal structure and possibly the function of the affected organ(s). Sarcoidosis most often occurs between 20 and 40 years of age, with women being diagnosed more frequently than men.

The disease is 10 to 17 times more common in African-Americans than in Caucasians. People of Scandinavian, German, Irish or Puerto Rican origin are also more prone to the disease. It is estimated that up to 4 in 10,000 people in the U.S. have Sarcoidosis.

Early symptoms include inflammation, shortness of breath (dyspnea), Hypoxemia, fatigue, low SaO2, and coughing.