SHORT PRESENTATION OF ITV-1
By Dr. Darena Zlateva
NIKA Pharmaceuticals, Inc. (OTCMKTS: NKPH) offers to your attention a product that is the result of many years of development, research, clinical trials and significant results! For the last 30 years, there have been many developments in this field, but our product ITV-1 - ImmunH has ten main advantages, namely:
The product is obtained entirely from natural biological sources, i.e. it has no side effects from added chemical compounds.
ITV-1 can be combined freely and without side effects with the known so far available preparations for the treatment and maintenance of AIDS.
The anti-retroviral effect of our product is observed at three different stages of the virus's action - from the entry of the virus into the cell to its replication.
The main and most important effect of ITV-1 is observed in the phase of entry of the virus, which makes it part of the most effective medicinal forms known as fusion immunomodulators.
Our product is effective against both HIV subtypes, HIV-1 and HIV-2; although the second subtype is observed much less often, it covers a larger number of people worldwide.
Unlike the previously known drugs from different groups, ITV-1 has a treatment effect exhibited also in the deposits and Lymph nodes.
The patients undergoing a clinical trial tolerate the treatment easily and without side complications.
The large number of diseases accompanying HIV infection are known to result mainly due to the greatly reduced ability of the immune system to respond, ex: Tuberculosis. ITV-1 not only does no harm, but also supports the treatment of such accompanying diseases.
After the end of the treatment cycle and after a 6-year period from the initial observation, the condition of the clinical trial patients is extremely good.
The drug is patented in the U.S. and ready for wide use all over the world.
This presentation aims to provide a brief overview of the the main points in the research and scientific evidence of the healing properties of ITV-1.
A. Technological summary.
The immune system has various components for a quick and adequate immune response. CD56 is the most actively researched protein that binds lipids and glycolipids, as a result of which NK cells /natural killer cells/ are activated and cause an immune response. We isolated an irreversible peptin fraction from porcine pepsinogen and proved its ability to stimulate NK cells, key cytokines, to activate dendritic cells, as well as to bind to CD41 on T lymphocytes. The drug is an aspartate protease of 327 amino acids and a molecular weight of 45,000 kDa, isolated by electrophoresis and purified by liquid chromatography, shows optical activity in the ultraviolet spectrum. It binds the gp41 of the virus selectively and works as an antigen. It works even with mutations of the virus, which makes ITV-1 the only product with such property of the many available drugs. Although the product was created with the aim of fighting against HIV infection, we also suggest its use as an immunotherapeutic agent for the treatment of certain types of cancer, autoimmune diseases and some infectious ones.
B. Clinical Trial Summary
Criteria for the selection of patients: They were divided into three groups according to the established number of CD4+ lymphocytes. The duration of treatment is 16 weeks, consisting of two weekly injections of 3 ml administered on two consecutive days; there is a 10-day break between weeks eight and nine. Control tests are done three times during the course of treatment. There are eleven immunological indicators that are monitored and include CD3, CD4, CD8, p24 antibodies in different serum dilutions and PCR. There are twelve clinical symptoms in the three controls including temperature, weight, headache, fatigue, lack of appetite, local pain, etc.
It is important to emphasize that all patients can undergo the treatment regardless of the number of T lymphocytes, as, naturally, the lower the number of T lymphocytes, the expectations from the treatment decrease proportionally. The most important contraindications are: allergic reactions, as ITV-1 cannot be used together with immunosuppressants. We do not have clinical information for pregnant women. The drug has not been administered to patients under 18 years of age, and the above groups are close following guidelines in our study of the drug. Laboratory analyzes in our clinical studies briefly showed the following:
• an increase in CD56 at the third week after the start of treatment.
• increase in HLA-DR monoclonal antibodies already after the first week, proving that the preparation is recognized by the patient's immune system
• an increase in the gamma / delta chains of T cells after the second week and a decrease after the fifth, giving reason to assume that lymphokines are involved
• slow increase of T cells during and after treatment to normal levels
• antibodies against HIV increase two-fold or more after the fourth week of treatment
• reduces the quantitative viral load in the plasma proven by laboratory tests, namely below 40 viral copies per ml. blood
After the end of the treatment cycle, the mononuclear cells were practically equal to 0, the PCR test showed a decrease in the viral load up to 86%, logarithm 10 /1log indicates a 10-fold decrease / and this level was maintained more than 22 months after the cessation of treatment.
You may find specialized information regarding ITV-1 on our website at https://www.nikapharmaceuticals.com/products/itv-1. There you may also find quantitative and qualitative characteristics of the drug in the form of ampoules, composition, indications, as well as information about packaging, durability, storage, method of delivery, informed consent, etc.
C. The place of ITV-1 among modern anti-HIV therapies
A few words about the modern therapy known to us so far. It is based on different target levels in the course of infection with the virus. The products are:
▪ Nucleotide and nucleoside reverse transcriptase inhibitors ▪ Inhibitors of entry fusion of the virus through the cell membrane
▪ Anti-integrase inhibitors
▪ Anti-protease inhibitors.
They activate the own production of immune cells from the bone marrow and this is due to their immunomodulating mode of action. Which category does ITV-1 fall under? Our product combines three of these levels of action, as ITV-1 is an entry inhibitor, i.e. prevents the entry of the virus into the cell /its transmembrane penetration/ by acting on two receptor proteins gp41-transmembrane and gp120-extracellular receptor by blocking them /film by Boehringer Mannheim/, a protease inhibitor, and immunomodulator. In our research, we have repeatedly determined the levels of CD56 /NKmarker/, anti p24antibody and HIV-1 glycoproteins studied with Dot blot, Western blot, ELISA and immunocytochemistry.
- coCSR5 inhibitors
- mixed with several actions.
This is exactly what makes ITV-1 a universal, multipotent, Fusion/of entry/immunomodulator.
D. Conclusory remarks
So far, it has been proven that a large percentage of cancers are viral in origin. Some publications talk about 40, 80% and even 100%/ we know that we carry in our genome about 7 percent viral genome, accumulated in the course of evolution/. Research on ITV-1 was done on 5 types of virus-activated pancreatic cancer, of the prostate, of the uterus, of the colon and leukemia. Important results have been documented thanks to the proven immunomodulating effect of the product and activation of the own immunity from the bone marrow. We can share them upon interest.
Thank you for your attention!
Dr. Darena Zlateva
Chief Science Officer
Nika Pharmaceuticals, Inc.
About Nika Pharmaceuticals, Inc.
Nika Pharmaceuticals, Inc. (NIKA) is a pharmaceutical company, which specializes in the treatment of HIV/AIDS, Hepatitis B and C, Rheumatoid Arthritis, Cancer, Diabetes, and all diseases, for which strengthened cell immunity is of vital importance. NIKA's intellectual property includes six drugs in injection form - two of which have successfully undergone clinical trials with good treatment results - three drugs in tablet form, and nine dietary supplements. NIKA’s goal is to not only achieve corporate profits, but to provide better and easier access to life-saving medicinal drugs and useful dietary supplements. Find more on www.nikapharmaceuticals.com.
About Dr. Darena Zlateva
Dr. Darena Zlateva was born on the 15th of November, 1962 in the city of Plovdiv, Bulgaria. Dr. Zlateva became a medical doctor in 1986 when she graduated from the Plovdiv Medical University, after which she pursued a PhD degree in Immunology in the Moscow Immunology Institute, which she successfully completed in 1991. Dr. Zlateva's hunger for knowledge is further exemplified by her post-doctoral qualification in Biochemistry (1994) from the Sofia Medical Academy, and her mastery of English, Spanish, Russian along with a fluency in French and Italian.
Dr. Zlateva has since worked as an assistant professor in the Biochemistry Department in the Sofia Medical Academy between 1995 and 2008, after which she relocated to the heart of the European Union - Brussels, where she has been working as a Scientific and Administrative Manager for the European Medical Association and an Expert Evaluator for the Research Executive Agency (REA), which is part of the European Commission. Due to her vast academic and practical experience, Dr. Zlateva has an expertise in Project Management, an in-depth knowledge of European Union policies, and an ability to easily adapt to multicultural environments and work at an international level.