cision-logo

EmphyCorp Inc. Non-Steroidal N115 Nasal Spray Completed Phase III Clinical Trial for COVID-19, Long COVID-19 (Long Haulers), and Pulmonary Fibrosis

 

cision-logo

EmphyCorp Inc. Non-Steroidal N115 Nasal Spray Completed Phase III Clinical Trial for COVID-19, Long COVID-19 (Long Haulers), and Pulmonary Fibrosis

NEWS PROVIDED BY

EmphyCorp Inc. 

Oct 05, 2021, 08:43 ET

FLEMINGTON, N.J., Oct. 5, 2021 /PRNewswire/ -- EmphyCorp Inc. www.EmphyCorp.com, a private corporation, specializes in Rx Non-Steroidal Nasal Spray Technology. Their flagship product, 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, and Flu.

In 17 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.

Given our success in treating Pulmonary Fibrosis patients and the other respiratory diseases, our research focused on treating the symptoms in COVID-19 infected patients and in long hauler patients including: hypoxemia (low SaO2), fatigue, coughing/sneezing, trouble breathing, body aches, headaches, and Pulmonary Fibrosis.

These EmphyCorp (Cellular Sciences, the research arm of EmphyCorp) Clinical Trials included:

  1. Phase III in COVID-19 infected patients
  2. Phase III in COVID-19 Long Haulers (patients that had a COVID-19 infection and have persistent symptoms)
  3. Phase III in patients with Pulmonary Fibrosis

There are approximately 12 million Americans with COVID-19 Long Hauler Symptoms, including athletes, which are at serious risk of developing Pulmonary Fibrosis (7-10% JAMA). Conversely, patients with Pulmonary Fibrosis have an increased risk and susceptibility to COVID-19 infection, which can reach a mortality rate of 50%. Thus, N115 is poised to help protect patients from severe COVID-19 infections by improving Pulmonary Fibrosis lung function and for helping COVID-19 Long Haulers recover from this disease.

  1. In a Phase III Clinical Trial in Miami, FL with active COVID-19 infected patients, N115 lowered viral numbers below 10,000 viral genome copies by day 6.4, vs 10.3 days as reported for untreated patients. As reported in the literature, a reduction of viral numbers from over 100,000 to below 10,000 significantly decreases transmission of the virus. N115 clinically and significantly reduced coughing/sneezing, fatigue, and increased SaO2 levels.
  2. In a Phase III Clinical Trial in Springfield, MO and Miami, FL with COVID-19 Long Haulers, N115 clinically and significantly reduced coughing/sneezing, reduced headaches and body aches, increased SaO2 levels, and improved breathing.
  3. In a Phase III Clinical Trial with patients with Pulmonary Fibrosis, there was a statistically and clinically significant improvement in all lung functions, compared to baseline, including an increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%) and a reduction in coughing and fatigue.

EmphyCorp N115 Nasal Sprays have been used to treat over 3.5 million patients globally in 200 hospitals, with no adverse events. The clinical trials and summary results have been submitted to the FDA www.Clinicaltrials.gov (# NCT04824365 and # NCT04824365) website and will be available for public viewing soon. We were also invited to submit our results in the peer reviewed prestigious European Journal of Respiratory Medicine.

Dr. Alain Martin (CEO) believes:

"Based upon the results of our three Phase III Clinical Trials, EmphyCorp Rx N115 Non-Steroidal Nasal Spray could be used as a safe, effective treatment to help alleviate the symptoms associated with COVID-19 infections, Pulmonary Fibrosis, and Long COVID-19 (Long Hauler) symptoms."

"Being a Non-Steroidal spray that increases nasal nitric oxide is key, because nasal steroids and other OTC nasal treatments shut down the synthesis of nasal nitric oxide, which then leads to decreased lung function and a 12%-34% increase in infections, depending upon age or underlying disease."

EmphyCorp would like to enter into a Licensing Agreement and/or Joint Venture with a pharmaceutical company or company 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.

Dr. Alain Martin (7 US Drug Patents including Hypoxemia; 70+ Global Drug Patents) is the creator of our Worldwide Patented N115 Rx Non-Steroidal Nasal Spray Technology for COVID-19, COVID-19 Long Haulers, Pulmonary Fibrosis, Flu, and other OTC/Rx Respiratory Drugs. He also invented Advanced Neosporin, Neosporin Cold Sore Treatment, Advanced Therapy Lubriderm, Rx Rezulin (Rx Drug for Type II Diabetes), an FDA approved medium for lung and heart transplantation and Cool Mint Listerine.

SOURCE EmphyCorp Inc.

Related Links

www.emphycorp.com


The Market of Emphycorp

New Non-Steroidal Treatment for Lung Diseases to Improve Patient Quality of Life

The Centers for Disease Control and Prevention (CDC) estimates there are 30 million plus Americans with COPD and an additional 30 to 60 Million patients in America alone called  “Unmet Needs” patients which  cannot use steroids and thus are without a safe nasal or inhalation spray they can use.

In some cases, not having an oral inhalation or nasal spray product can be life threatening. The Unmet Needs group represents Pregnant Women, thousands of newborn children, and millions of diabetic and hypertensive patients, including patients with pulmonary fibrosis.

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).

In addition to the U.S. market, there is a significant worldwide need for an effective non-toxic, non-steroid pulmonary disease drug. The combined populations of Europe, Japan, Canada and the United States equal 1.135 billion people. Of this population group, 5%, or 56.75 million people suffer from COPD  and related lung diseases.

EmphyCorp globally patented nasal and oral 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  and nasal cavity and produced statistically  and clinically significant increases in  lung function measurements, including FEV-1, FVC, PEF, SaO2, and FEV-1/FVC ratios, Nitric oxide and reduced nasal and lung inflammation. 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 Cystic Fibrosis (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. No adverse events were reported.

EmphyCorp has the proprietary technology to penetrate this market and secure a major market share. EmphyCorp     will target the U.S. market first and then the worldwide markets by entering into Sublicense Agreements and/or       Joint Venture or outright sale with respiratory drug manufacturers or companies seeking to enter the respiratory drug market, both in the U.S. and foreign countries.


Emphycorp proprietary N115

Emphycorp Proprietary N115

Latest News – EmphyCorp Proprietary Non-Steroidal N115

Up until the recent acclaim of EmphyCorp's proprietary technology, N115, the primary treatment for Pulmonary Fibrosis, Cystic Fibrosis, Allergic Rhinitis, Unmet Needs and Chronic Obstructive Pulmonary Disease (COPD) Patients was the use of Corticosteroids. Corticosteroids are typically involved in a very wide range of physiological processes such as the body's stress response, immune response and regulation of inflammation, carbohydrate metabolism, protein catabolism, blood electrolyte levels and overall behavior.

However, Corticosteroids are certainly not a reliable form of treatment, as well documented studies have shown that any prolonged use of Corticosteroids may have serious side effects including the potential for fatality. Other marketed drugs that directly treat pulmonary diseases are also reported to produce substantial damage to the body, mainly in areas such as the central nervous system, cardiovascular system, respiratory system and an abrupt disruption within the gastrointestinal system.

Until this day, EmphyCorp N115 remains one of the most effective and one of the safest on the entire market. With this form of unique technology, patients are no longer prone to experiencing the common complications to that of Corticosteroids.

Each treatment involving synthetic pharmaceutical drugs that feature Corticosteroid-like effects should come with a flamboyant warning label. These Corticosteroid-like effects are used to "treat" a variety of conditions, mainly ranging from brain tumors to that of an individual's case of skin disease.

Both clinical and experimental evidence has indicated that Corticosteroids are capable of causing permanent eye damage by inducing a form of central serous retinopathy, also recognized as central serous chorioretinopathy that causes an optical disease which causes visual impairment in one eye.

EmphyCorp globally patented Non-Steroidal Technology, is a naturally occurring antioxidant of the human body, has been shown to significantly reduce inflammatory agents throughout the human body, including the lungs  and nasal cavity and produced statistically  and clinically significant increases in  lung function measurements, including FEV-1, FVC, PEF, SaO2, and FEV-1/FVC ratios, Nitric oxide and reduced nasal and lung  inflammation and congestion.

Eight Phase I/II and partial Phase III human studies and Eight human nasal studies were submitted to the FDA in Patients with, COPD, Pulmonary Fibrosis, and Cystic Fibrosis (CF) 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. No adverse events were reported.