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BookmarkScienceDaily (May 27, 2008) — Researchers from SIGA Technologies, TransTech Pharma, and INC Research developed a new single-dose antiviral drug against orthopoxvirus that was safely tolerated in humans during phase I trials and could potentially be used to prevent and treat smallpox.
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Prior to eradication, variola virus, the causative agent of smallpox and member of the orthopoxvirus family, was estimated to have killed, crippled, or disfigured up to 10% of the human population. Highly communicable with an exceptionally high morbidity rate, smallpox currently poses a threat as an instrument of biowarfare placing it at the forefront of focus for effective preventative and treatment therapies.
In this phase I study fasting healthy volunteers were administered single oral doses of 500, 1,000, and 2,000 mg of the drug ST-246 and non-fasting healthy volunteers received 1,000 mg. No adverse reactions were observed and no subjects were withdrawn from the study, overall ST-246 was found to be generally well tolerated.
Upon further testing, researchers found absorption to be greater in nonfasting volunteers at a rate of approximately 2 to 3 hours and exposure levels to be sufficient for inhibiting orthopoxvirus replication.
"In conclusion, ST-246 is safe and well tolerated when administered orally as a single dose to healthy human volunteers in a fasting state or non-fasting state," say the researchers.
Journal reference:
- R. Jordan, D. Tien, T.C. Bolken, K.F. Jones, S.R. Tyavanagimatt, J. Strasser, A. Frimm, M.L. Corrado, P.G. Strome, D.E. Hruby. 2008. Single-dose safety and pharmacokinetics of ST-246, a novel orthopoxvirus egress inhibitor. Antimicrobial Agents and Chemotherapy, 52. 5: 1721-1727. doi:10.1128/AAC.01303-07
