SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development of pharmaceutical agents to combat bio-warfare pathogens, announced today the successful completion of its fourth human clinical trial, supporting the safety and tolerability of the anticipated clinical dose of ST-246®, SIGA's lead smallpox antiviral drug candidate. Analyses of the trial's results are consistent with findings from previous studies of ST-246 and together show that the drug will likely be found to be a safe and well-tolerated therapeutic for the treatment of orthopoxvirus infections.
The trial was conducted at three sites: Orlando Clinical Research Center (Orlando, FL), Apex Research Institute (Santa Ana, CA) and Hawaii Clinical Research Center (Honolulu, HI). A total of 107 healthy volunteers were enrolled in the study and were randomly placed into one of three different groups, each of which received either 400 or 600 mg of ST-246 or a placebo, once a day, for 14 days. All adverse events reported during the study that were considered related to ST-246 were mild to moderate. There were no severe adverse events.
"We are very satisfied with SIGA's progress in completing the studies needed to demonstrate the safety, bio-availability and efficacy of ST-246," said Dennis E. Hruby, SIGA's Chief Scientific Officer. "In addition to reaffirming the strong safety profile of ST-246, the trial results suggest an appropriate dose that we will use as we complete the remaining New Drug Application studies and a study to test its pharmacologic effects on cardiac repolarization."