SIGA PRESENTS DATA ON SMALLPOX DRUG TO WHO

Siga Technologies announced it has made a presentation to the World Health Organization's (WHO) Smallpox Advisory Committee on Variola Virus Research on the progress of SIGA-246. This is the second year in a row the company has been invited to make a presentation to WHO on the status of its smallpox antiviral drug.

Siga announced in October that SIGA-246 completely protected nonhuman primates from lethal doses of smallpox. SIGA-246 is the first drug ever to demonstrate 100 percent protection against human smallpox virus in a primate trial, which was conducted at the U.S. Centers for Disease Control and Prevention, according to the company. The company also announced that oral dosing with SIGA-246 completely protected nonhuman primates from lethal doses of monkeypox virus, even when treatment started three days after infection and at doses equivalent to the potential human dose.

"These monkeypox studies are important in that the disease in nonhuman primates recapitulates smallpox disease seen in humans, and this model will be used as one of the definitive animal models the FDA will use to evaluate this drug," Dennis Hruby, Siga's chief scientific officer, said. "These results also confirm that SIGA-246 can be used both to treat smallpox and in the event of a monkeypox or related outbreak, such as the multistate monkeypox outbreak in June 2003."

Smallpox is considered one of the most significant threats for use as a biowarfare agent, due to the fact that people in the U.S. have not been vaccinated against it since 1972, according to Siga. Available vaccines are known to cause complications in certain individuals, including encephalitis, myocarditis, disseminated vaccinia virus infection and death, and there is currently no treatment that can be safely administered to the general population without significant risk of adverse reactions.