Procaine oral stabilised--Samaritan pharmaceuticals: SP-01, SP001

Samaritan Pharmaceuticals (formerly Steroidogenesis Inhibitors) is developing a high-dose oral stabilised formulation of procaine hydrochloride [AnticortSP 01, SP001, Virucort] as an anticortisol drug for the treatment of HIV and AIDS. Preclinical investigations for its potential in the treatment of patients with Alzheimer's disease are also underway with Samaritan. The levels of cortisol, a hormone produced by the adrenal gland, are increased in many diseases, including AIDS. Serum cortisol levels are elevated during all stages of HIV infection, particularly in AIDS patients, whereas dehydroepiandrosterone (DHEA) levels are higher in the early stages of disease rather than in the advanced stages. Anticortisol drugs have been shown to reduce both the infectivity and the production of HIV in vitro. Anticort is available for licensing. Altachem Pharma had an exclusive licence to manufacture, use, distribute and sell oral procaine in Canada with an option to purchase the same rights for other Commonwealth countries. However, this agreement has been terminated. Cato Research in the US has been enlisted to implement a long-range clinical and business development plan to facilitate US FDA approval and manufacturing of the procaine formulation worldwide. Altachem Pharma received approval to begin a phase I trial of Anticort in Canada in HIV-positive patients receiving anti-HIV treatment. In January 2004, Cortisol Research International-Romania filed for orphan drug designation with the US FDA for Virucort 50 for the treatment of depression in children with HIV. A study examining the efficacy of Anticort in children infected with HIV has been conducted in Romania. One aspect of this study will investigate the possibility of reducing the dosage of zidovudine required if it is used in combination with Anticort. Following early indications that children treated with placebo in this trial have deteriorated while some children under the Anticort have shown improvements, especially in the 150-200mg group, Romanian clinicians have asked the Romanian FDA Commissioner for approval to switch children receiving placebo to receive Anticort.