Smallpox drug does well in first human safety test
Robert Roos News Editor
(snips from the article)
May 8, 2008 (CIDRAP News) ? An antiviral drug being developed to provide protection against smallpox and related viruses performed well in the first test of its safety and activity in humans, according to a report in the May issue of Antimicrobial Agents and Chemotherapy.
The drug, called ST-246, was generally well tolerated and caused no serious adverse events in a study involving 38 volunteers, the report says.
In preclinical studies, ST-246 protected mice from lethal infection with vaccinia virus, cowpox virus, and ectromelia virus, according to the new report. Also, in unpublished studies, the drug was active against monkeypox in squirrels and against both monkeypox and smallpox viruses in monkeys, the report says.
ST-246 was used on an emergency basis last year in a 2-year-old boy who became critically ill with eczema vaccinatum, a form of vaccinia virus infection. The boy, who survived, was infected through exposure to his father, a soldier who had received a smallpox shot.
Given the plasma concentrations observed in this study, the authors predict that ST-246 doses ranging from 400 to 800 mg will provide nonfasting humans with protection comparable to that seen in a study in nonhuman primates that received a high dose of monkeypox virus. In the animal subjects, an ST-246 dose of 10 mg/kg provided full protection from death.
"Administration of ST-246 resulted in exposure levels predicted to be sufficient for inhibiting orthopoxvirus replication compared to exposure levels in nonhuman primates in which ST-246 protected animals from lethal orthopoxvirus nfection," the report states.
Jordan R, Tien D, Bolken TC, et al. Single-dose safety and pharmacokinetics of ST-246, a novel orthopoxvirus egress inhibitor. Antimicrobial Agents Chemo 2008 May;52(5):1721-7 [Abstract]
Full article http://www.cidrap.umn.edu/cidrap/content/bt/smallpox/news/may0808poxdrug.html
Robert Roos News Editor
(snips from the article)
May 8, 2008 (CIDRAP News) ? An antiviral drug being developed to provide protection against smallpox and related viruses performed well in the first test of its safety and activity in humans, according to a report in the May issue of Antimicrobial Agents and Chemotherapy.
The drug, called ST-246, was generally well tolerated and caused no serious adverse events in a study involving 38 volunteers, the report says.
In preclinical studies, ST-246 protected mice from lethal infection with vaccinia virus, cowpox virus, and ectromelia virus, according to the new report. Also, in unpublished studies, the drug was active against monkeypox in squirrels and against both monkeypox and smallpox viruses in monkeys, the report says.
ST-246 was used on an emergency basis last year in a 2-year-old boy who became critically ill with eczema vaccinatum, a form of vaccinia virus infection. The boy, who survived, was infected through exposure to his father, a soldier who had received a smallpox shot.
Given the plasma concentrations observed in this study, the authors predict that ST-246 doses ranging from 400 to 800 mg will provide nonfasting humans with protection comparable to that seen in a study in nonhuman primates that received a high dose of monkeypox virus. In the animal subjects, an ST-246 dose of 10 mg/kg provided full protection from death.
"Administration of ST-246 resulted in exposure levels predicted to be sufficient for inhibiting orthopoxvirus replication compared to exposure levels in nonhuman primates in which ST-246 protected animals from lethal orthopoxvirus nfection," the report states.
Jordan R, Tien D, Bolken TC, et al. Single-dose safety and pharmacokinetics of ST-246, a novel orthopoxvirus egress inhibitor. Antimicrobial Agents Chemo 2008 May;52(5):1721-7 [Abstract]
Full article http://www.cidrap.umn.edu/cidrap/content/bt/smallpox/news/may0808poxdrug.html