SIGA Announces Lead Smallpox Drug is in Preclinical Development

NEW YORK -- SIGA Technologies, Inc. has announced that its smallpox drug, SIGA-246, has entered preclinical development. Based on an emerging understanding of the mechanism of action and protective efficacy in four different murine challenge models, SIGA-246 has progressed to preclinical lead status. SIGA has initiated IND-enabling scale-up synthesis, formulation, pharmacology, and toxicology studies on the drug in order to allow primate efficacy and human safety studies to be performed later this year.

"To date, all the data we've generated indicates that SIGA-246 is a very promising smallpox antiviral drug candidate. Therefore, with the advice and support of the National Institutes of Health (NIH), we are aggressively pursuing pre-clinical development of the drug to enable advancing it towards human clinical studies as soon as possible," said Dr. Dennis E. Hruby, chief scientific officer of SIGA.

Smallpox virus is considered one of the most significant threats for use as a bioterrorism agent due to the fact that since 1972 people in the United States have not been vaccinated against it. Smallpox is very easily transmitted from person to person, and has high mortality rates (30 percent to 60 percent) with 90 percent morbidity. It is classified as a Category A agent by the Centers for Disease Control and Prevention (CDC). Mass immunizations of the general population using the current live vaccine are not recommended, as there are known complications in certain individuals from vaccination (including encephalitis, myocarditis, disseminated vaccinia virus infection, and death). At present there is no treatment for smallpox that can be safely administered to the general population without significant risk of adverse reactions.

In addition to smallpox, SIGA also has antiviral programs targeting other Category A pathogens which cause hemorrhagic fevers, including the arenaviruses (Lassa Fever Virus, Junin, Macupo, Guanarito, and Sabia), Lymphocytic choriomeningitis virus (LCMV), Dengue, and the filoviruses, Ebola and Marburg.

SIGA's CEO, Bernard L. Kasten, MD, stated, "SIGA's continued success in the development of SIGA-246 as a safe and effective drug for the treatment of smallpox, along with SIGA's progress in advancing other critical BioShield drugs needed to provide national and international protection against Category A bioterrorist threats, positions SIGA as an emerging leader in the biodefense sector."

Source: SIGA Technologies, Inc.