NEW PULMONARY FIBROSIS TREATMENT

Written by Super User on . Posted in Conditions

Latest News:  FDA NDA Submission

New 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.  In all  patients, the test results were compared to their previous three-week screening and baseline data (there 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 data from these clinical studies showed that coughing was significantly (p=0.007) reduced in all patients; a significant (p=0.010) improvement in nasal irritation/erythema with most patients being free of irritation by day 22 (p=0.000); and a significant (p=0.010) increase in the group average expelled-NO by day 8. Unexpectedly a significant (p=0.010) improvement in lung function (breathing) was observed in all patients with Idiopathic Pulmonary Fibrosis by day eight, increasing to p=0.0005 by day 22 compared to baseline, as determined by changes in FVC, FEV1, PEF, and FEV1:FVC ratios.

The improved FEV1/FVC ratio from 52% to 86% was clinically significant and indicated that current therapies in use are inadequate to treat patient 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 OTC 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 increas 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.   

Bacterial

Written by Super User on . Posted in Conditions

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.

There is an immensely wide range of organisms that are capable of being able to infect the respiratory tract such as those including viruses, bacteria, fungi, and various parasites. Wouldn't you like something that can eliminate your side effects after being exposed? First, you have to understand the anatomy of your body and how it works. You can't solve the problem if you didn't know what was making this happen in the first place.

The anatomy of the upper respiratory tract is a semi-complex unit that contains several structures to help rid the respiratory system of particles and foreign bacteria’s. The nasal cavity has a mucociliary lining, which is considered similar to that of the lower respiratory tract. The inside of the nose is lined with hairs that act as a filter to eliminate larger particles that are inhaled, and the turbinate bones are covered with mucus that collects particles that are not filtered by the nasal hairs.

After one's inhaled air moves through the nasal passages, the actual anatomy of the upper airway changes direction and causes many of the larger airborne particles to impinge on the back of the throat. The adenoids and tonsils are the lymphoid organs in the upper respiratory tract, and absolutely are vital in the developing of an immune response to bacteria. These are located in an area where many of these airborne particles make contact with the mucosal surface over the adenoids and tonsils. As common locations for being exposed to bacteria, you wonder why you get sick!

For this very reason, EmphyCorp has developed an amazing form of treatment that can effectively help those who suffer from chronic or frequent bacterial respiratory infections. With EmphyClear, patients who suffer from the many hardships involved with common pathogens are able to overcome and live out their daily lives with grace and ease. By releasing anti-inflammatory properties, EmphyClear is capable of clearing up any congestion that was once possessed. No more swollen glands and no more stuffed up nasal passages. Your respiratory system will feel as good as new when you used EmphyClear as your go-to option to fend off any upper respiratory infections or bacterial infections.

Viral Infection

Written by Super User on . Posted in Conditions

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.

There is an immensely wide range of organisms that are capable of being able to infect the respiratory tract such as those including viruses, bacteria, fungi, and various parasites. Wouldn't you like something that can eliminate your side effects after being exposed? First, you have to understand the anatomy of your body and how it works. You can't solve the problem if you didn't know what was making this happen in the first place.

The anatomy of the upper respiratory tract is a semi-complex unit that contains several structures to help rid the respiratory system of particles and foreign bacteria’s. The nasal cavity has a mucociliary lining, which is considered similar to that of the lower respiratory tract. The inside of the nose is lined with hairs that act as a filter to eliminate larger particles that are inhaled, and the turbinate bones are covered with mucus that collects particles that are not filtered by the nasal hairs.

After one's inhaled air moves through the nasal passages, the actual anatomy of the upper airway changes direction and causes many of the larger airborne particles to impinge on the back of the throat. The adenoids and tonsils are the lymphoid organs in the upper respiratory tract, and absolutely are vital in the developing of an immune response to bacteria. These are located in an area where many of these airborne particles make contact with the mucosal surface over the adenoids and tonsils. As common locations for being exposed to bacteria, you wonder why you get sick!

For this very reason, EmphyCorp has developed an amazing form of treatment that can effectively help those who suffer from chronic or frequent bacterial respiratory infections. With EmphyClear, patients who suffer from the many hardships involved with common pathogens are able to overcome and live out their daily lives with grace and ease. By releasing anti-inflammatory properties, EmphyClear is capable of clearing up any congestion that was once possessed. No more swollen glands and no more stuffed up nasal passages. Your respiratory system will feel as good as new when you used EmphyClear as your go-to option to fend off any upper respiratory infections or bacterial infections.

Sarcoidosis

Written by Super User on . Posted in Conditions

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).

What Are Symptoms of Sarcoidosis

The symptoms of sarcoidosis can vary greatly, depending on which organs are involved. Most patients initially complain of a persistent dry cough, fatigue, and shortness of breath. Other symptoms may include:

  • Tender reddish bumps or patches on the skin.
  • Red and teary eyes or blurred vision.
  • Swollen and painful joints.
  • Enlarged and tender lymph glands in the neck, armpits and groin.
  • Enlarged lymph glands in the chest and around the lungs.
  • Nasal stiffness and hoarse voice.
  • Pain in the hands, feet or other bony areas due to the formation of cysts (an abnormal sac-like growth) in bones.
  • Kidney stone formation.
  • Enlarged liver.
  • Development of abnormal or missed beats (arrhythmias), inflammation of the covering of the heart (pericarditis) or heart failure.
  • Nervous system effects, including hearing loss, meningitis, seizures or psychiatric disorders (for example, dementia, depression, psychosis).

In some people, symptoms may begin suddenly and/or severely and subside in a short period of time. Others may have no outward symptoms at all even though organs are affected. Still others may have symptoms that appear slowly and subtly, but which last or recur over a long time span.

Who Gets Sarcoidosis?

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.

What Causes Sarcoidosis?

The exact cause of sarcoidosis is not known. The disease is associated with an abnormal immune response, but what triggers this response is uncertain. How sarcoidosis spreads from one part of the body to another is still being studied.

Drug treatments are used to relieve symptoms and reduce the inflammation of the affected tissues. The oral corticosteroid prednisone is the most commonly used treatment. Fatigue and persistent cough are usually improved with steroid treatment. If steroids are prescribed, you should see your doctor at regular intervals so that he or she can monitor the disease and the side effects of treatment. Other treatment options include methotrexate and Plaquenil and other drugs.

What Can Happen as the Disease Progresses?

In many people with sarcoidosis, the disease appears briefly and then disappears without the person even knowing they have the disease. Twenty to 30% of people have some permanent lung damage. For 10% to 15%, sarcoidosis is a chronic condition. In some people, the disease may result in the deterioration of the affected organ. Sarcoidosis can be fatal in 5% to 10% of patients.

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