Sodium Pyruvate Nasal Spray Treatment of COVID-19 and Influenza Infections
Sodium Pyruvate Nasal Spray Treatment of COVID-19 and Influenza Infections
Cellular Sciences Inc has submitted over 17 human clinicals (phase I, II, III including
 animal safety data) to the FDA for the reduction of respiratory inflammation and inflammatory
 cytokines including IL-6 the cause of the cytokine storm in COVID patients. These clinicals
 demonstrated a reduction of inflammation in all lung and sinus diseases, in patients with
 COPD, Pulmonary fibrosis, CF, asthma, sinusitis , the flu and nasal inflammation and
 congestion. Inhaled sodium pyruvate reduces inflammation, congestion and in our phase III
 clinical study with Idiopathic Pulmonary Fibrosis patients we demonstrated statistically and
 clinical significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (form 52% to 86%) and a
 decrease in hypoxemia, and a reduction in coughing. Inhaled sodium pyruvate alleviated the
 symptoms associated with COVID-19 patients in Pulmonary Fibrosis, and may be a solution to
 the lingering COVID-19 symptoms in patients that had the COVID-19 infection for example long
 haulers. In flu and COVID infected mice, nebulized sodium pyruvate decreased morbidity,
 weight loss, inflammatory cytokines and decreased viral titers compared to placebo controls.
 The study to be done at Missouri State University is titled ( Two week sub-chronic
 double-blinded placebo controlled trial designed to determine if sodium pyruvate nasal spray
 will reduce the symptoms, duration and replication of COVID-19 and influenza infections)
Inhibition of Viral Replication, Reduction of the "Cytokine Storm" and reduction of COVID-19
 symptoms- Potential Treatment and Preventative for COVID-19 and Flu

 In numerous human clinical trials (17, phase I, II, III clinical trials) submitted to the
 FDA, with Pulmonary Fibrosis, COPD and Cystic Fibrosis patients, inhaled sodium pyruvate
 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. Cellular Sciences received Orphan Drug Designations for Pulmonary Fibrosis and
 Cystic Fibrosis. Mice studies conducted by Dr. Lupfer at Missouri State University
 substantiated our finding by testing nebulized sodium pyruvate 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. 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. Furthermore, we have preliminary data that suggest it may work
 similarly during other respiratory virus infections including COVID19/SARS-CoV-2.

 In a Phase III Placebo Controlled Clinical Trial with Idiopathic Pulmonary Fibrosis Patients,
 inhaled sodium pyruvate, a Non-Steroidal Nasal Spray (N115) demonstrated a statistically and
 clinically significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%), and
 a statistically and clinically significant reduction in coughing, hypoxemia and a reduction
 in nasal and lung inflammation. Inhaled sodium pyruvate alleviated the symptoms associated
 with the COVID-19 infections in Patients with COPD and Pulmonary Fibrosis. Nasal Nitric Oxide
 reduces the rate, duration and severity of viral infections in healthy young children and in
 healthy adults from the Flu, Rhinovirus and Coronavirus. The literature has reported that
 Nitric Oxide is elicited and inhibits viral replication in pigs infected with porcine
 respiratory coronavirus. Additionally Nasal Nitric Oxide levels decreases from normal levels
 found in healthy adults, in patients with asthma (87%), COPD (73%) CF (44%) and Primary
 Ciliary Dyskinesia (7%). The rate of infections increases with decreasing levels of nasal
 nitric oxide. Young children, 6-17 years of age, produce (142%) more nitric oxide than
 healthy adults, which may explain their resistance to COVID-19. Recently, researchers
 announced that a high percentage of COVID-19 infected patients that were hospitalized were
 Diabetics or were Pre-Diabetic. The literature has reported that 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 their susceptibility to COVID-19. Sodium
 pyruvate increases nitric oxide and is safe for use by Patients with Diabetes. The inhalation
 of nasal sodium pyruvate increased the synthesis of nasal nitric oxide to normal levels in
 patients with low levels of nitric oxide to increase all lung functions and decrease the rate
 of infections.

 A clinical survey of 367 patients who took a nasal spray similar to EmphyCorp' s N115
 formula, over a two-year period demonstrated a statistically significant decrease in the
 number, symptoms, and severity of seasonal flu respiratory tract infections. 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. It has been used successfully by
 over 2 million patients globally in over 200 hospitals during the past 5 years to treat nasal
 and lung inflammation, congestion in Patients with COPD, Allergic Rhinitis, Pulmonary
 Fibrosis, sinusitis, the flu and Cystic Fibrosis, with no adverse events reported. It has
 been used by Children, Diabetics, and Hypertensives, with efficacy and with no known side
 effects. It has even been shown to be safe for use by Pregnant Women, for whom steroids are
 contraindicated as they increase the risk of low birth-weight babies.

 Proactive treatments with sodium pyruvate are not toxic and could be of benefit to children
 that are afflicted by many respiratory viruses and as a potential treatment for COVID long
 haulers.
Inclusion Criteria:

 1. Individuals with a confirmed COVID-19/influenza viral infection, as determined by a
 qualified laboratory test. A nasal swab or saliva test analyzed by qPCR for COVID19 or
 rapid flu test from nasal swab for influenza.

 2. Individuals who agree to abstain from sexual intercourse, or agree to use condoms or
 vaginal diaphragms or other devices designed to prevent contraception, during the
 entire course of the study

 Exclusion Criteria

 1. Viral infections other than COVID-19 or influenza.

 2. Clinically significant cardiac disease including uncontrolled congestive heart failure
 and unstable angina

 3. Pregnancy

 4. Females of child bearing potential age not on adequate contraception or lactating

 5. Subjects receiving systemic corticosteroid treatment within one month of Screening
 Visit

 6. Subjects Less than 18 years of age

 7. Hospitalization within last 6 months due to acute exacerbation of airway disease

 8. Subjects with a clinically significant abnormal chest x-ray within past 12 months

 9. Medication changes within one month of study entry

 10. Subjects who have participated in another investigation drug treatment study within
 the previous month.

 11. Subjects with a current history of alcohol or recreational drug abuse.

 12. Subjects who have taken dietary supplements containing pyruvate within 24 hours prior
 to the screening visit.

 Inclusion of Women and Minorities Every attempt will be made to include all genders, and
 minorities that present with an active COVID-19 or flu infection that are not exempted due
 to exclusion criteria.

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