Medicine to eradicate Virus: PATHWAY TOWARDS A CURE BY ENABLING HOST IMMUNITY

by Enrique Gutierrez

Vanadium complex have virucidal activity against HIV, RNA virus, Glyburide can inhibits pyroptosis( self destruction ) of HIV infected CD4+ cells. Combination of these drug can potentiate HAART drugs.
Saint Cloud, FL United States Drug Development Infectious Disease WarOnCOVID challenge WarOnCOVID challenge

All Team Company Patients Physicians Hospital Partners Mission Innovation Details Supporters Comments Updates

About our project

The problem we solve: Current HAART therapy reduces the viral load to undetectable level. But virus persists as provirion in CD4+ and other infected T lymphocytes. Currently there is no drug that targets this provirion. Also decreased CD4 cells and CD4/CD8 cell ratios persists in spite of treatment causing increased infection, malignancy and non-aids morbidity and mortality. Coronavirus infection is also characterized by immune cell dysregulation. decreased Cd4 and Cd8 with lymphopenia, and neutropenia.

About our solution: This treatment raises CD4 T cells and normalizes CD4/CD8 T cell ratios. We want to start feasibility study to show if these drugs are effective in small group of patients. We need to come up with a chemical entity and we have already spoken with a team of scientist who have agreed to work on this project. In our small observation in few patients we have found vanadium compounds are highly active against HIV and hepatitis B,coronavirus,SARS,influenza and parainfluenza and dengue. We would like to develop and start a new clinical trial to test our product.

Progress to date:

We did observational studies in small pool of 13 subjects  and they have shown dramatic increases in CD4+ cells count quickly in subjects who were taking vanadium complexes than in patients who were not. Also the CD4/CD8 T cell ratio improved  quickly than  cohorts. Also increases and normalizations of other cell lines such as platelets, neutrophils, monocytes and erythroid cells.The cellulal immune parameter improvement is sustained and persist even after discontinuing the oral treatment in some patients.These effects resulted in reduced frequency of other bacterial,fungal and viral infections. Patients are able to lead normal life with less visits to the hospital visits. Please see our video for discussion on this topic.

About Our Team

Creator: Enrique Gutierrez

Location: Florida

Education: Medical,Tulane University, USA & U.Central

Bio: Physician practicing in Kissimmee for over 20 years. Specialize in treating patients with HIV. Completed a specialty fellowship in Allergy and Immunology and Endocrinology at the prestigious Tulane University. Tulane University is one of the top endocrinology programs in the nation attending Tulane gave him the opportunity to train under Nobel Prize winning academicians.Also trained under the founder of the American Academy of Allergy and Clinical Immunology. During his time there he conducted and published ground breaking research in the area of neuro endocrinology and neuro immunology. He has led many pharmaceutical clinical trials and collaborated in developing new drugs with different pharmaceutical companies . His present research is primarily focused on vanadium compound and micronized glyburide for the treatment of HIV and other viral diseases.

Hospital Affiliation: Epigene Channel

Title: Founder & President

Advanced Degree(s): MD

About Team Members

Dawood Subhani
Dr., M.B.B.S., C.T.D.M
Biography: Dr.Dawood is a Physician and Clinical researcher. He has experience in managing several investigator-initiated studies and held research job positions at USC, UCSC, VA SFO, collaborated on many research/clinical trials with reputed universities like Stanford, Harvard etc., expert in managing day- to-day clinical trial activities, and providing support for regulatory filings.
Title: Dr.
Advanced Degree(s): M.B.B.S., C.T.D.M
LinkedIn: www.linkedin.com/in/dawood-subhani-03aa337

Javier Mota
Life Sciences Scientist-Virology, Tropical Diseases, immunology Research, PhD
Biography: Professor at the University of Texas, in San Antonio Texas. He has a particular interest in virology and tropical diseases.
Title: Life Sciences Scientist-Virology, Tropical Diseases, immunology Research
Advanced Degree(s): PhD
LinkedIn: linkedin.com/in/javier-mota-065a47173

About Our Company

Epigene Channel LLC

Location: 5100 Plymouth Turtle Circle
Saint Cloud, FL 34772

Founded: 2011

Website: https://epigenechannel.com/

Twitter: @epigenechannel

Facebook: http://facebook.com/epigenechannelllc

Product Stage: Prototype/MVP

YTD Sales: Working on it

Employees: 1-2

How We Help Patients

RNA viral infections suppress the cellular immune system which then results in lymphopenia and neutropenia and a deregulated immune system. The treatment advocated destroys the virus directly and restores the cellular immune cell innate and adaptive immunity with the ability to overcome the virus quickly. This action is broad spectrum and immediate acting which is what is needed.. The treatment can be administered i.v.

How We Help Physicians

The enhanced efficacy of this treatment can restore the overall health of the person therefore decreasing hospitalizations, and other morbidities.

How We Help Hospitals

Can decrease hospitalization rates and in the case of a pandemic can prevent the exhaustion of medical resources. The treatment would provide protection to health care workers in case of acquiring the disease.

How We Help Partners

The increased safety efficacy of the treatment would make it a favorable choice in the therapeutic armament for the hospitals. Partners in development could benefit intellectual property and profits resulting from benefiting 400-600 million recipients of the therapy.

Challenge Mission

COVID Problem We Address

The main issue with the Covid-19 pandemic is fear of the devastating consequences of the infection due to absence of immediate acting effective treatment. This therapeutic approach results in immediate positive results against Corona Virus(SARS) both in vitro and in vivo and can free us from the fear while defeating the virus.

Our COVID Solution

Vanadium based metalorganic compounds have been shown in vitro and in vivo to be efficacious at destroying Corona Virus (Sars) as published in scientific journals. Vanadium compounds have also been shown to be effective in vitro and in vivo against dengue, influenza and parainfluenza as well as HIV.  The enhanced Vanadium complex being used in this proposal has demonstrated extraordinary efficacy in human subjects with HIV in our pre-clinical study. The treatment can safely destroy corona virus immediately if administered orally and or intravenously.

Innovation Details

Intellectual Property Summary

2 Patents

USA Patent#10624923  Compositions and related methods for treating and preventing viral and retroviral infections   Granted 04/21/2020

European Patent#EP3122190  Compositions and related methods for treating and preventing viral and retroviral infections  Granted 07/31/2019

Disclosed are pharmaceutical compositions and related methods for treating a subject with a viral or retroviral infection. The disclosed compositions and methods comprise and utilize an effective amount of one or more vanadium-containing compounds and an effective amount of one or more sulfonylureas. In certain embodiments, the viral infection is human immunodeficiency virus (HIV) and the compositions and methods improve one or more immunologic cellular parameters, such as viral load, CD4 counts and CD4/CD8 lymphocyte cell ratios in a subject. Also disclosed are methods of improving one or more immunologic cellular parameters that are associated with viral infections such as HIV in a subject, including viral load, CD4 counts and CD4/CD8 lymphocyte cell ratios.

Patent Link
USA http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&d=PALL&s1=10624923.PN. European https://data.epo.org/gpi/EP3122190A2-COMPOSITIONS-AND-RELATED-METHODS-FOR-TREATING-AND-PREVENTING-VIRAL-AND-RETROVIRAL-INFECTIONS

Clinical Information

Patient observation over a period of 5 years was noted and documented. Lab improvement in CD4 T cell count, CD8 T cell count and CD4/CD8 cell  ratio is consistent, varifiable and objective measurement. HIV RNA titer is not only reduces to undetectable levels but also remains undetectable for a long period even after discontinuing antiviral therapy. Delayed viral rebound has been documented for 4 months after discontinuing all treatment without detectable virus. Most of  these patients are already on HAARTherapy with suppressed viral titer except in non compliant patient and in patients who develop adverse effects and become non compliant. Some of the patients were not using HAART or any antivirals however benefited through their own immune response which resulted is dissapearance od detectabl virus for the first time for that patient...

Regulatory Status

We filed an  initial IND application for a pilot exploratory controlled clinical trial however requires toxicology studies.. The animal toxicology studies cost a minimum od $500,000. The clinical trial could cost I estimate between $100,000 -$200,000.

Thera are many basic science and in vitro studies which would be useful. A nonprofit company was created to fund basic research needed for furthering knowledge and understanding.

How we will use the funds raised

1. Manufacture Vanadyl Sulfate according to cGMP specification.

2. conduct animal toxicology studies and cellular in vitro studies as required by the FDA

3. Contract CRO to do stability and microbial testing as per the requirement.

3. Use IRB services and Stasticians and Data Monitoring services.

4. Conduct clinical trial in our facility 

5, conduct basic science structural analysis of chemical complex through afifliated academic institution presntly University of Virginia.

 

Thank You

HIV infected patients are carrying dormant virus which is referred as provirus reservoir. The reservoir contributes to the victim’s cellular immune decompensation. The decompensated immune state contributes to the persistent of disease due to the innate and adaptive immune disablement by the virus. The virus has evasive mechanisms that interfere with the host being able to mount an immune response. Retroviruses hijack the host DNA and suppress the immune defenses then forces the DNA nucleotide to follow virus command and destroy the host cell. This metalloorganic complex negates viral nucleotide action and stops apoptosis while disables the virus evasive mechanisms then enabling the host immune response to combat the virus and defeat it. The combination compound allows and directs appropriate DNA cleavage of the Vanadium ion which disrupts the action of the virus in the DNA. 

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Updates

  • About Elite controllers
    I do have a few Elite controllers who wish to achieve a sterilizing cure with total clearance of the virus. In these patients with only this treatment and without antivirals the Cd4 T lymphocyte counts have risen sometimes over maximum normal as well as monocytes, neutrophils and killer cells while the virus disappears.. I am now waiting to measure rebound times once discontinuation of treatment.

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Enrique Gutierrez
Founder & President
Medical,Tulane University, USA & U.Central

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