tetrachlorodecaoxide and HIV-Infections

WF 10 [TCDO, Oxoferin, Immunokine, Macrokine] is a 1:10 dilution of tetrachlorodecaoxide formulated for IV delivery. It was developed by Oxo Chemie in Switzerland as an adjunctive therapy to combination antiretroviral and opportunistic infection prophylaxis regimens in AIDS patients. WF 10 specifically targets macrophages. Oxo Chemie has worldwide patent rights to WF 10 and Dimethaid Research has an exclusive licence for marketing and distribution in Canada. In May 2002, Oxo Chemie was acquired by Dimethaid Research. Oxo completed a trial in 72 cervical cancer patients undergoing radiation therapy in 1989. Results from this trial demonstrated complete remission in 75% of patients receiving WF 10. A follow-up placebo controlled trial in 1996 produced similar results. WF 10 has received regulatory approval in Thailand for postradiation cystitis following a trial completed in 1998 in 20 patients following radiation treatment for cervical carcinoma. This authorisation also allows limited availability of WF 10 at the physician's request in Germany. WF 10 is also available under Health Canada's Special Access Program. Oxo Chemie has completed a controlled randomised, crossover study in France in 1991 that examined the effects of 103 patients with acute radiation dermatitis and radiation- or chemotherapy-induced mucositis. Results demonstrated that WF 10 significantly improved lesions and accelerated recovery without side effects. Topical tetrachlorodecaoxide in a less concentrated formulation (1:55) is marketed in many countries as Oxoferin for wound healing. WF 10 is approved for use in Thailand under the name IMMUNOKINE in patients with postradiation chronic inflammatory disease including cystitis, proctitis and mucositis. In July 2003, the European examiners informed Oxo Chemie that they intend to grant the company additional patents to the technology platform that supports WF 10, extending the European protection granted in 1992 to cover a much broader range of diseases. The patents will be granted in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, the Netherlands, Portugal, Spain, Sweden, Switzerland and the UK. Patent claims cover potential treatment for autoimmune disease, organ transplant or graft rejection, lymphoma and inflammation manifested as hepatitis or chronic obstructive pulmonary disease.

Topics: Adjuvants, Immunologic; Administration, Cutaneous; Chlorine; Clinical Trials, Phase II as Topic; HIV Infections; Humans; Injections, Intravenous; Oxides; Randomized Controlled Trials as Topic

WF10 represents a new class of drug involved in regulating macrophage function both in vitro and in vivo. In the US, WF10 is being evaluated in patients with advanced HIV infection as an adjunct to highly active antiretroviral therapy (HAART). To date, most therapeutic efforts to treat HIV infection have focused on inhibition of viral replication with the goal of decreasing viral load. The introduction of HAART was associated with a dramatic decline in AIDS-related mortality; however, recent indications suggest that the trend maybe changing. WF10, which contains chlorite as the active principle, causes profound changes in macrophage function and activation of gene expression, and appears to downregulate inappropriate immunological activation. The loss of T-cell function observed in HIV-infected patients likely requires the involvement of chronically activated macrophages. Therefore, the persistently activated macrophage represents a therapeutic target that is, unlike HIV, not highly mutable. With this target as a focus, WF10 is being developed for use in advanced HIV disease. WF10 is currently being studied in the US, Europe and Asia for treatment of late-stage HIV disease, as well as recurrent prostate cancer, late post-radiation cystitis, autoimmune disease and chronic active hepatitis C disease.

Topics: Chlorine; Clinical Trials, Phase III as Topic; Drug Approval; Gene Expression; HIV Infections; Humans; Immunity, Cellular; Legislation, Drug; Macrophage Activation; Macrophages; Oxides; United States