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STGI - PROGRAMS AND PROJECTS
CLINICAL STUDIES WITH ANTICORT™
There are three clinical studies in progress at the present time in the US, Canada, and Romania.
1. US. A clinical project with ANTICORT™, under FDA approval (IND# 52,663), is being carried out by the AIDS Research Alliance in Los Angeles. This study, type Ib/Ila, has two phases. Phase lb is to determine the most effective dosage of ANTICORT™, followed by a Ila double blind study. The purpose of this study in HIV positive patients under anti-HIV therapy, is to stimulate or bring back to life an immune system severely damaged by cortisol. As it is now known, the most updated HIV therapies, resulting in taking the level of HIV down to below detectable levels, are very often not being able to repair or strengthen a very weakened immune system, leaving the patient in danger of a new virus proliferation, and/or the appearance of opportunistic infectious diseases and cancers of Kaposi sarcoma type and others. Should this study show good or very good results STGI will request the FDA to grant ANTICORT™ a fast track status.
2. CANADA. We have been informed by ALTACHEM Pharm, our licensee for ANTICORT™ in Canada, that following approval #059618 from the Health Protection Branch (HPB), the Canadian equivalent of the US FDA, that a clinical study with ANTICORT™ will begin soon, following the same protocol as used in the US. The purpose of the Canadian study is to support and extend the results of the US study, expected to be favorable, and lead to an eventual approval of ANTICORT™ in Canada. This approval, if and when obtained, would be used to apply for ANTICORT™ approval in other countries of the British dominion, and for other countries of the European Economic Community; the UK being a part of it. ALTACHIEM obtained the Canadian rights to ANTICORT™ by paying licensing fees of $300,000 to STGI, plus other royalty fees to follow.
3. ROMANIA. A clinical study using ANTICORT™ infacaps, the junior version of ANTICORT™ for adults, is in progress in Romania, following approval in October 1998, by the Romanian equivalent of the FDA (COMISIA de MEDICAMENTE si ETICA). This study, being carried out in five groups of children HIV positives (four groups on variable doses and one placebo) is intended to boost the immune system of these children, damaged by the HIV and elevated cortisol.
It is estimated that this study will take 8-10 months, and if as favorable as we expect then an approval would be sought from the appropriate Romanian authorities. |
