The drug was tested on animals infected with monkeypox-it's similar to smallpox and can be weaponized just like smallpox.
Here's a snip from drugs.com about early testing results on their new product.
The idiots at the CDC got rid of the doses of Dryvax before this drug was approved. Idiots. And Dryvax was still a viable vaccine when they did it-it wasn't expired and CDC did testing to stretch the available supply to boot. Idiots.
SIGA Completes 21 Day Multi-Dose Human Clinical Safety andDose-Ranging Trial of Its Lead Smallpox Drug ST-246
Facebook Twitter Google Plus Email to a friend Print this page
SIGA Completes 21 Day Multi-Dose Human Clinical Safety and Dose-Ranging Trial of Its Lead Smallpox Drug ST-246
NEW YORK, Dec. 6, 2007 (PRIME NEWSWIRE) -- SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens and protect the population at large, today announced that its lead drug candidate, ST-246, has successfully completed another human clinical trial.
Although the final study report is not yet available, preliminary results indicate that the drug is safe and well-tolerated at all tested doses when administered orally for 21 days to healthy human volunteers. In addition, blood level exposures were dose-dependent, and the levels obtained in the volunteers were the same as those previously shown to protect monkeys from disease and subsequent death in challenge models. Furthermore, the drug's half-life was sufficient to support once-a-day dosing. This data reinforces SIGA's ability to establish that ST-246 will be not only a potent therapeutic drug against smallpox, but a safe and reliable one as well.
"We are very pleased with the results of this second safety study with ST-246. The data obtained here will be an important and helpful part of our full submission for FDA approval," said Dr. Eric A. Rose, Chief Executive Officer of SIGA.
The clinical trial, considered a "Phase I" trial by the FDA, was performed at the Orlando Clinical Research Center in Orlando, Florida. The study was a double-blind, randomized, placebo-controlled, ascending multiple-dose study in healthy volunteers.
SIGA believes that ST-246 is the most advanced smallpox treatment currently in development. ST-246 represents a new approach to achieve a novel, orally active, antiviral therapeutic. It has demonstrated significant antiviral activity in various animal models of poxvirus disease, including the complete protection of primates from lethal doses of monkeypox and smallpox virus. SIGA will use animal efficacy data as part of its full FDA approval submission under the FDA's "Animal Efficacy Rule." In December 2005, the FDA granted "fast-track" status to ST-246. In December 2006, the FDA granted to ST-246 an orphan drug designation.
This project has been funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, in conjunction with the National Institute of Allergy and Infectious Disease, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN266200600014C.
In addition to smallpox, SIGA has antiviral programs targeting other Category A viral pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg).
About SIGA Technologies, Inc.
SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense. SIGA believes that it is a leader in the development of pharmaceutical agents to fight potential biowarfare pathogens. In addition to smallpox, SIGA has antiviral programs targeting other Category A pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg). For more information about SIGA, please visit SIGA's Web site at
www.siga.com.
The SIGA Technologies, Inc. logo is available at
http://www.primenewswire.com/newsroom/prs/?pkgid=4504
