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
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.
