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Small Pox Drug Enters Pre Clinical Stage
Mar 16, 2005, 11:33, Reviewed by: Dr.
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"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"
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By Akanksha, Pharmacology Correspondent,
SIGA Technologies, Inc. today announced that their 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 (mouse) 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 (30-60%) with 90% 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." 
- SIGA Technologies
SIGA
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 has the potential of becoming a significant force in the discovery of vaccine and pharmaceutical agents to fight emerging pathogens. SIGA's product development programs emphasize the increasingly serious problem of drug resistant bacteria and emerging pathogens. SIGA's vaccine and drug platforms are based on its pioneering research into the structure, function and processing of bacterial surface proteins. SIGA is leveraging these platforms through multiple strategic partners, including the National Institutes of Health and TransTech Pharma, Inc. For more information about SIGA, please visit SIGA's Web site.
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