SIGA'S SMALLPOX DRUG CANDIDATE GIVEN TO HUMAN PATIENT

Siga Technologies announced that a toddler who contracted eczema vaccinatum has been treated with ST-246, the company's lead smallpox drug candidate, pursuant to an emergency investigational new drug application granted by the FDA, and the child is now improving.

Due to the absence of smallpox disease in the human population, the efficacy of ST-246 has been investigated in animals. However, the federal Centers for Disease Control and Prevention (CDC) was recently notified that a child had contracted eczema vaccinatum, a potentially deadly illness that can manifest as a generalized skin rash similar to smallpox, following accidental contact with an open skin lesion on a relative who had been vaccinated for smallpox using a live vaccinia virus vaccine. The patient developed late-stage manifestations of the disease, including hemorrhagic lesions, respiratory failure, shock and high viral loads in the blood. The CDC facilitated communication between Siga and the FDA, resulting in the provision of ST-246 for the patient.

"There is a clear need for an effective therapeutic against smallpox and other orthopox virus diseases," Eric Rose, CEO of Siga, said. "We will continue to work closely with the CDC and FDA to obtain the earliest possible approval for ST-246 so that it can be purchased and widely available whenever needed."

Siga believes that ST-246 is the most advanced-stage treatment for smallpox currently in development. The drug has been shown to lead to significant antiviral activity in animal trials, including the complete elimination of human smallpox virus or the related monkeypox virus in several primate studies. The company has not yet filed for final regulatory approval for ST-246, although the FDA has granted the product fast-track status.

The NIH, the CDC and the Department of Defense have supported the development of ST-246, the company said.