SIGA RELEASES POSITIVE ANIMAL DATA ON SMALLPOX DRUG

Siga Technologies has announced the successful results of two independent primate trials of its smallpox drug SIGA-246. Last month, the company also announced that SIGA-246 provides complete protection against human smallpox virus in nonhuman primates. The current trials involve infection with high doses of monkeypox virus. SIGA-246 again afforded complete protection against disease symptoms. As with the primate trial last month and the human safety trial announced earlier this year, the current trials also demonstrate that SIGA-246 should be safe as well as effective.

The first monkeypox virus study was sponsored by the National Institute of Allergy and Infectious Diseases of the NIH. In this study, all monkeys in the two groups receiving SIGA-246 were completely protected from disease.

The second study was conducted at the Army Medical Research Institute of Infectious Diseases and was funded by the Department of Defense's Defense Threat Reduction Agency. In the second study, two groups of nonhuman primates received SIGA-246 orally starting either one day postinfection or three days postinfection. Again both treatment groups were completely protected from disease.

"These are very important results for two reasons. First, in many respects monkeypox infections in non-human primates are more aggressive than infection with smallpox virus (normally a human pathogen), so protection by SIGA-246 represents a higher hurdle," Dennis Hruby, Siga's chief scientific officer, said. "Second, Siga will likely use SIGA-246's performance against monkeypox infection in monkeys, along with the results in all of the several animal species tested to date, to satisfy FDA's efficacy requirements, so success here bodes well."

In 2005 the FDA granted fast-track status to SIGA-246. The Department of Homeland Security has designated smallpox a material threat to national security, so SIGA-246 will be eligible for purchase for the Strategic National Stockpile under Project Bioshield.