June 17, 2009 (FinancialWire) — SIGA Technologies, Inc. (NASDAQ: SIGA) announced that the U.S. Food and Drug Administration has advised that it does not anticipate requiring further nonclinical toxicology studies in support of an ST-246(r) NDA filing.

SIGA submitted its final reports on multiple ST-246 nonclinical toxicology studies to the FDA on March 25, 2009. ST-246 is SIGA’s smallpox antiviral drug candidate, and an NDA filing is the usual method by which pharmaceutical companies seek from the FDA approval to market a drug in the United States.

The results from the nonclinical studies conducted on ST-246 show it to have favorable pharmacokinetic and safety properties.

SIGA submitted to the FDA studies that include pharmacokinetics, general toxicology (acute and repeat dosing), safety pharmacology, ADME, genotoxicity and reproductive toxicology. Standard in vitro and in vivo models in accordance with appropriate ICH (International Conference on Harmonization) guidelines were used for all critical studies, which were performed using established good laboratory practices. All of the studies were funded by the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health.

Additional studies to support an NDA filing, including studies relating to clinical safety, animal efficacy and chemistry, manufacturing and controls, are either ongoing or in the planning stages.

Dr. Eric Rose, SIGA’s CEO, commented, “We view the FDA’s feedback on our submission as a milestone in the commercialization of ST-246, our most advanced drug candidate, and further confirmation of the success of our efforts to transform SIGA into a revenue-generating pharmaceutical company.”

Dr. Dennis Hruby, SIGA’s chief scientific officer, stated, “As expected, the toxicologic results demonstrate that ST-246 has no evident negative effects that might affect its use in human patients either exposed to or suffering from an orthopoxvirus disease.”

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