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news.The FDA has given Siga Technologies the go ahead to begin phase I clinical trials of SIGA-246, its lead smallpox treatment. The agency also granted the drug fast-track status.
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The primary objective of the phase I study will be to evaluate the safety and tolerability of single escalating doses of SIGA-246, and will be performed at the Biodefense Clinical Research Branch of the National Institute of Allergy and Infectious Diseases.
SIGA-246, an orally active compound, has demonstrated significant antiviral activity in various animal models of poxvirus disease, including the complete protection of golden ground squirrels from lethal doses of monkeypox virus.
Smallpox virus is considered one of the most significant threats for use as a biowarfare agent. It is easily transmissible from person to person, is hardy in the environment, and can be readily delivered. Routine smallpox vaccinations were discontinued in the US in 1972 meaning more than 223 million Americans have never been vaccinated.
The use of current live vaccines for mass immunizations of the general population is not recommended because available vaccines are known to cause complications in certain individuals, including encephalitis, myocarditis, disseminated vaccinia virus infection, and death.