In the Name of God Almighty

Investigations of IMOD TM in Management of HIV / AIDS

History: In 2001, an idea about treatment of HIV infected and AIDS patients was proposed. From the first stage, a scientific group was formed including some experts and scientists to conduct the research process. At first, a complete toxicology analysis of the component was preformed in the toxicology laboratories. After the completion of toxicology studies, next phases of preclinical and clinical researches were performed.

Structure of Presentation Overview of AIDS: History of the component: Toxicology of the component: Phase I clinical trial: To determine the Maximum Tolerated Dose (MTD) Phase II clinical trial: To determine the effects of (and side effects of) the component in HIV/AIDS patients in a controlled study Phase III clinical trial: To approve the results of Phase II in a Multi Centre study

History of the Component: In 2001 a report was received by Iran Health Care System which indicated the efficacy of a component in HIV/AIDS patients. This case series study had been carried out in one of the university research centers. This report indicated the ability of the component to increase the number of CD4 in treated patients.

The Involved institutes in this project Islamic Republic of Iran: more than 11 research institutes and Universities of Medical Sciences and about 70 experts (academic staff) are involved in this project. RussiaCanadaSweden

Toxicology stages 1- Acute toxicology studies 2- Assessment of Geno-toxic effects (by comet test) 3- Apoptotic effects 4- Sub-acute toxicity effects 5- Mutagenic effects 6- Evaluation of embriotoxic effects 7- Evaluation of allergic effects

IMOD TM toxicology studies Toxicology studies were designed by intramuscular and intravenous injection of IMOD TM to BALB/c mice, Wistar rats, rabbits and dogs. Evaluation for aute, sub- acute, mutagenic, embryotoxic, teratogenic, allergic, and also reproductive effects was performed.

IMOD TM toxicology studies (cont.) The results of all steps of toxicology studies indicated no sever toxicity or side effect. After approval of the toxicology studies by the Ministry of Health, the permission for the first and second phases of clinical trials was granted to Pars Roos co.

Clinical Studies 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.

Clinical Trials Phase Ι Clinical Trial (Determination of Maximum Tolerated Dose of IMOD TM ) Phase 2 Clinical Trial (to determine the effects of IMOD TM on HIV/AIDS patients) Phase 3 Clinical Trial (To approve the results of Phase II in a Multi Centre study)

Some Results Trend of Mean changes in CD4 count up to 8 and 20 months

IFN - gamma

IL- 2

INF-g IL-2

Advantages of IMOD TM No side effects Highly effective Durable effects (even after finishing the course of treatment)

Considering the high cost and side effects of standard available drugs which cause a huge burden on the health system of developing countries, IMOD TM could be used in these countries as a first choice and step of treatment.