Immunomodulatori Ricerca Iraniana

Scienziati Iraniani in collaborazione con la Russia hanno trovato una serie di sostanze che proteggono dall'Hiv, in particolare i s+.
Le hanno chiamate immunomodulatori e alcuni vengono da particolari erbe.
Alcuni di questi diventeranno farmaci seguendo il normale percoso di sviluppo farmacologico.

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IMOD, Iranian medicine for treating HIV positive patients


In 2001, an idea about treatment of HIV infected and AIDS patients was proposed. From the first stage, a scientific group was formed including one Russian and 4 expert Iranian specialists to conduct the research process in Iran. At first, a complete toxicology analysis of the component was preformed in one of the best toxicology laboratories in Moscow (the laboratory was approved by the Ministry of Health and Medical Education). The toxicology studies were repeated in Iran and next phases of preclinical and clinical researches were performed.

IMOD (short for ""Immuno-Modulator Drug"") is the name of an herbal drug that, according to Iranian scientists, protects those already infected by HIV from the spread of AIDS by strengthening the immune system. Though there is a class of real drugs called immunomodulators, which includes treatments such as interferons and interleukins that are effective against a variety of diseases, no evidence has yet been put forward about IMOD's efficacy that can be objectively tested or reviewed by scientists outside Iran. It has been discussed in the medical literature by JJ Amon of Human Rights Watch as an example of unproven AIDS cures. IMOD was made public in February 2007 during Iran's planned ""Great Achievements"" announcements. IMOD, developed by a Russian scientist and tested by the Iranian research center for HIV/AIDS, consists of seven ""completely native"" Iranian herbs and was tested by the Iranian research center for HIV/AIDS.

The medicine has been approved and announced by the Iranian Ministry of Health.

According to Iran, the drug took five years to develop and has been tested on 200 patients. Widespread testing to measure its efficacy has been promised by Iran.

The drug's claimed effect is to control or reduce the spread of HIV infection in the human body, and secondarily to control the infection by the virus. Then Iranian health minister Kamran Baqeri Lankarani is quoted as saying ""The herbal-made medication, we call it IMOD, serves to rein the HIV virus and redouble the body’s immunity. It is not a medication to completely kill the virus, it can be used besides other anti-retroviral drugs. The drug is that effective and safe with no proved side effects."" All news coverage concerning IMOD has cited the Fars News Agency as the origin of any information concerning IMOD.

Drug effects: The herbal extract IMODTM has immune system modulatory effects. In a study on HIV infected patients entering AIDS phase with CD4 count less than 200, after a 1-3 months treatment course, CD4 count increased significantly thus the patients exited through symptomatic phase of AIDS and there was no need for their hospitalization. This effect remained stable for a long period. Since IMOD is said to enhance immune system and self healing mechanisms, it is based on the method of similarity, instead of the method of opposition, experts believe IMOD will be one of the most effective medicines for treating the affected patients. If the Iranian experts try to enhance the efficacy of IMOD by considering other principles of homeopathy medicine, its duration of efficacy will be longer and the chronic toxicity effects will decrease, too.

Administration and Dosage: Daily dosage of IMODTM is a 4 ml vial diluted in 100 ml 0.9% sodium chloride solution (Normal saline) used intravenously. A complete course of treatment is maximum 90 days.

Adverse Effects: No significant adverse effect has been detected so far.

Contraindications: At present according to limitation of studies, this drug is not recommended in pregnant women and in the period of lactation.

Clinical trials in 3 phases and interventions on human subjects were launched after the completion of cellular and animal studies on the mechanisms and toxicology.

1- Phase 1 Clinical Trial (Determination of Maximum Tolerated Dose of the

1- Acute toxicology studies:The results demonstrated no acute toxicity.

2- Assessment of Geno-toxic effects (by comet test on T47D sensitive cells): The results demonstrated that in the evaluated dose (10 times of the administrated dose in humans), IMODTM induced a short tail which is not significant compared to the positive control (with H2O2).

3- Apoptotic effects: The nuclear integrity of cells and DNA condensation were intact in 24 and 48 hours after drug administration in cell culture media in comparison to control (with H2O2).

4- Sub-acute toxicity effects: These studies were done after determination of LD50 in acute toxicity studies. No toxic effect was observed in these studies on BALB/c mice and Wistar rats.

5- Mutagenic effects: To evaluate this property the studies were performed in 4 steps: a) Evaluation of mutations in microorganisms including Salmonella typhimurium TA 98, TA 100 and TA 1537 with Ames test. In concentrations of 0.1 to 1000 µg/ml, no mutation was observed.

b) Evaluation of fatal dominant mutations in murine male gamete cells: These evaluations demonstrated that IMOD™ had no mutagenic effect.c) Assessment of chromosomal defects in mammalian bone marrow cells:In this study chromosomal appearance after staining in metaphase was evaluated with light microscopy. No statistically significant difference was observed in chromosomal defects of bone marrow cells between drug using and control mice groups.d) Evaluation of DNA damage with SOS Chromotest:In this test 10 different concentrations of drug along with standard controls were assessed using EColi PQ37+ LacZ+ sfiA gene. The results showed that IMODTM did not cause any DNA injury and had no mutational effect.

6- Evaluation of embriotoxic effects: According to the results of the study, there was no difference between drug using and control groups on the aspect of the number of live fetus, implantation locations, yellow bodies’ number and status, fetal body weight, skull diameter and fetal cellular and tissue maturation status. There was no change in fertility index and no difference in fatal physical maturation up to one month after birth comparing with normal animals.

7- Evaluation of allergic effects: The drug was mixed with Ferund adjuvant and injected. After 20 days skin tests were performed on posterior trunk. The results showed that there were no skin reactions, erythema, edema, infiltrations, necrosis or delayed sensitivity reactions. (Source: Wikipedia)