Savmax

What are Viruses

Viruses are special pathogens because they are obligate intracellular parasites which cannot replicate on their own and use the host cell’s machinery to synthesize their protein, DNA, and RNA.

• Viruses containing envelope is antigenic in nature.
• Difficult to kill because they live inside the cells.
• Anti-viral drugs do not kill, only inhibit multiplication so relapse common after stopping treatment.
• Current anti-viral drugs do not affect non-replicating and latent infections.

Viruses are inherently unstable, neither dead nor living. Many environmental conditions such as radiations, chemicals cause mutations in them. They are stealthy, hijack the host for multiplication and part of the problem is host defence itself, “cytokine storm”(excessive immune reaction).

What makes the novel coronavirus so virulent?

SARS-2 virus is very closely related to the SARS-1 but it is much more transmissible. One finding suggests that it is so because this virus binds with the receptor very strongly, about 10 times stronger.

How Viruses Mutate

How does a virus pick up new tricks?

Viruses are not very good at making exact copies of themselves. Each time they replicate — which is every few hours — there is a possibility that something might change. The more Covid cases there are, more the chances of mutation. Over time, mutations that are advantageous for the virus become more common.

Emma Hodcroft, an epidemiologist at the University of Bern, advised that immunocompromised patients are an especially fertile ground for mutations as a Covid infection. “The virus has a really long time to figure out how to co-exist with the human immune system.” The UK variant is believed to have come from such a patient.

Threat of Mutations

In South Africa and Brazil, two variants — called “501.Y.V2” and “501.Y.V3”, respectively — are spreading fast. These variants have mutations that make it harder for antibodies in blood to recognise them.

The mutants are bad news and if the virus continues to spread fast, there will be many more, and “there’s no reason to believe that it won’t become more efficient over time,” according to Cillian De Gascun, director of the National Virus Reference Laboratory at University College Dublin.

SAVMAX Action

• Savmax kills enveloped virus including Influenza Virus and others like SARS COV-2, by disrupting and disintegrating the lipid layer on the viral envelope.
• Savmax is used for Allergic Rhinitis and Upper Respiratory Tract Infections (Tonsilitis, Pharyngitis, Sinusitis, Otitis Media)
• Savmax immediately neutralizes allergens and inhibits IgE antibodies attaching to an allergen.
• Savmax inhibits release of inflammatory chemicals such as histamine from mast cells.
• Savmax reduces symptoms of allergies resemble those of the common cold.

Action on Allergic Rhinitis

• Allergic Rhinitis affects between 10 - 20 % of India's population
• Savmax acts on allergic rhinitis by immediately clearing nasal congestion, stops runny nose, sneezing, nose and eye itching, and tearing of the eyes.
• It checks post nasal dripping of clear mucus which frequently causes a cough.
• It recovers loss of smell and loss of taste.
• Savmax significantly minimizes inflammation of nasal passages caused by allergic reaction to airborne substances.

Action on URTI

• Upper Respiratory Tract Infection (URTI) is an illness caused by an acute infection in the upper respiratory tract, including the nose, sinuses, pharynx, or larynx.
• Savmax can immediately works on nasal obstruction, sore throat, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, and the common cold.
• Savmax is effective on most viral and bacterial infections.

Action on SARS COV 2

• SARS COV-2, an enveloped virus has become a pandemic and is highly contagious.
• The virus spreads through droplets from the mouth and nose of the infected.
• The virus before entering into the lungs remains in the Nostrils / Mouth / Throat for a few hours/ days
• SAVMAX can kill eliminate these viruses in the nostrils, in the mouth cavity, in the throat within few minutes.

Tests Conducted

• Savmax is In Vitro tested for cytotoxicity and virucidal efficacy.
• Savmax has LD 50 >2000 mg per kg of body weight on Rat and white mice and as intraperitoneal dose > 400 mg per kg of body weight.
• Savmax is tested as a pilot clinical trial on humans for URTI, Allergic rhinitis, general influenza, throat sore, cough, cold, fever etc.

Anti-Viral Efficacy Test

SAVMAX is already successfully evaluated (Log₁₀ Reduction 2.12 Log reduction 99. 25% in 5 minutes) for viral killing/inactivation ability on model virus BPI-3 (Bovine ParaInfluenza virus 3) as a part of viral clearance study.

BPI-3 and Corona virus are both enveloped viruses.

In Vivo Acute Toxicity Study

ORAL DOSE: Median Lethal Dose (LD50) is considered to be > 2000 mg/kg body weight.

INTRAPERITONEAL DOSE: Median Lethal Dose (LD50) is considered to be > 400 mg/kg body weight.

SARS COV-2 Viral RNA

Action on SARS COV-2 Viral RNA

• ICMR NIV has reported that SAVMAX post treatment @ 100 fold dilution destroyed > 75% SARS COV RNA tested by qRT PCR and >40% at 1200 fold dilution of savmax.
• The results @ 5 fold to 100 fold dilution is > 75% destruction of RdRp gene viral RNA may be associated with in vitro cell cyto toxicity.
• However, the in vivo study showed zero acute toxicity of the Savmax @ 2000 mg/kg of body wt

Clinical Trial Study Report

Method of the Application:

• Nasal drop/spray: SAVMAX can kill viruses inside nasal cavity
• Mouthwash/spray: SAVMAX liquid is used as mouth wash. Gargle for few minutes to kill the viruses in the mouth and throat
• Oral dose as syrup: SAVMAX syrup can be orally administered eventually killing the virus by disintegrating the envelope of viruses outside the cell before penetration.
• Primary objective: The safety and efficacy of the SAVMAX GARGLE & NASAL DROP and MOUTH PAINT will be assessed by the Clinical AEs, and FAQ assessment.
• Secondary objective: The secondary objective of this trial is to find out efficacy of the investigational products versus Rational therapy in Allergic Rhinitis and or Upper Respiratory Tract Infection including enveloped virus or Oropharyngeal Mucositis.

Results of Clinical Trial

• All AEs were mild in intensity and no patient withdrawn or discontinued from the study due to AE. No SAEs or deaths reported in the study
• Overall, SAVMAX resulted in clinically meaningful and significant reduction in ALLERGIC RHINITIS AND OR UPPER RESPIRATORY TRACT INFECTION compared to the current existing rational therapy.

Safety Summary

• No clinically significant laboratory abnormalities were reported in the study. None of the adverse events lead to an withdrawal or discontinuation in the study. No SAEs were reported in this study. There was no fatal outcome of any event.

Action on Animal Diseases

• Newcastle Disease (ND) / Ranikhet Disease (RD): an acute viral disease of poultry of respiratory system.
• Paramyxoviruses causes diseases in other animal species, for example canine distemper virus (dogs), Newcastle disease virus (birds), and rinderpest virus (cattle).
• Hendra virus (HeV) and Nipah viruses are typical paramyxovirus contagious, highly virulent, and capable of infecting a number of mammalian species and causing potentially fatal disease.