About ITV-1 - ImmunH

Our company Immunotech Laboratories BG Ltd. owns the rights for production and distribution of the medicinal product ITV-1 with trading name ImmunH, a drug compound made for the treatment of the HIV-1/AIDS infection. Find more information about ITV and its mechanism as a Fusion Inhibitor and Immunomodulator.

The HIV-1 epidemic

Currently, there are officially around 40 million people suffering from AIDS across the world, but realistically they are more than 400 million, because less than 10% of the world population has been tested for AIDS and many cases are underreported due to stigma and other factors. All other medicinal products, which are applied as a therapy for AIDS do not cure the disease and only suppress it to prolong the life of the patient; these treatments cost around 30,000 EUR each year and are used daily throughout the lifespan of the patient. Many of them hold a myriad of side effects, and the fact that they need to be administered on daily basis presents a significant difficulty, because not a single day can be missed.

registration process and CLINICAL TRIALS

We have completed Phase I, which is a toxicology study of ITV-1 - ImmunH on mice, rabbits, rats, Guinee pigs and the medicine has shown complete absence of toxicity. We have also completed Phase II, which includes Pharmacodynamics and the application of the medicine to more than 500 volunteers as part of preclinical trials.

Most importantly, we have successfully completed Phase III for ITV-1 – ImmunH, which is comprised of a clinical trial (see Final Report) conducted in Specialized Hospital for Active Treatment of Infectious and Parasitic Deceases “Professor Ivan Kirov”, Sofia on 31 patients suffering from AIDS in the advanced stages of the disease. The results of the clinical trial can be summarized as follows:

  • improvement in the immune indices in the absolute number of Ly, CD3 T, CD4 T, CD8 T, B Ly, NK and in the percentage of CD3 T, CD4 T, CD8 T, B Ly, NK, and of the index CD4/CD8, 

  • decrease in the viral load, 

  • a good treatment effect on opportunistic infections, 

  • very good compatibility with all of the other modern antiretroviral drugs, 

  • very good tolerance in all patients and complete absence of side effects

We are currently working on completing the final Phase IV and receiving a Permit for Mass Use on the territory of Bulgaria and complete the registration process of ITV-1 – ImmunH and bring the medicine to the market. After we have registered the medicine in Bulgaria, we will be able to register ITV-1 - ImmunH in different countries across the globe with a shortened registering process due to the Mutual Recognition Agreement (MRA) for medicinal products,

Other diseases

We have tested ITV-1 – ImmunH on volunteers suffering from other diseases such as Cancer, Chronic Hepatitis B and C, Diabetes A and B, Rheumatoid Arthritis, and other severe illnesses with tremendous healing results, as the medicine stimulates the immune answer and strengthens the immune system of the human being. 

 

"The clinical trial results show that ITV-1 – ImmunH has a significant place in the treatment of AIDS. We have reasons to believe that ITV-1 - ImmunH cures AIDS in depth, meaning not solely in the blood stream, but also in the depots, the lymph and on a DNA level. Our medicine is not only significantly useful in terms of treatment effect, but compared to current treatments in terms of cost to the patient, ITV-1 - ImmunH is dozens of times cheaper."

— Dimitar Savov, President of Immunotech Laboratories BG

 

DOSAGE, STORAGE, AND ADMINISTRATION

ITV-1 – ImmunH is presented in the form of 16 injections, which are administrated biweekly on consecutive days for eight weeks using an intramuscular method.

One vial of the medicine contains 3 ml of the active compound per injection and must be stored in a surrounding with a temperature between +2°C to +8°C.

Before administering an injection, the vial must be shaken and temperate to ambient temperature. 

CONTRAINDICATIONS AND DRUG INTERACTIONS

ITV-1 – ImmunH can not be used with other vaccines or other protein containing treatments.
ITV-1 – ImmunH can not be used in parallel with any immunosuppressive drugs.

SIDE EFFECTS AND OVER DOSAGE

Some patients have demonstrated mild flue like symptoms with occasional low-grade fever, malaise and arthralgias.
Animal safety studies have demonstrated no toxic effects.
ITV-1 – ImmunH appear to be safe and does not impair the ability of people to operate machinery.