Full Press Release Details
SMALLPOX DRUG CANDIDATE
TO CRITICALLY ILL HUMAN PATIENT
SIGA) announced today that a toddler who inadvertently contracted eczema
vaccinatum has been treated with ST-246, SIGA's lead smallpox drug candidate,
pursuant to an Emergency Investigational New Drug Application (IND) granted
the U.S. Food and Drug Administration (FDA), and is now improving.
the absence of smallpox disease in the general human population, the efficacy
ST-246 has been investigated in animals to date. However, the federal Centers
for Disease Control and Prevention (CDC) was recently notified that a child
contracted eczema vaccinatum, a potentially deadly illness that can manifest
with a generalized skin rash similar to smallpox, following accidental contact
with an open skin lesion on a relative who had recently 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. CDC facilitated
communication between SIGA and FDA resulting in provision of ST-246 for the
patient under an Emergency IND.
a clear need for an effective therapeutic against smallpox and other orthopox
virus diseases," said Dr. Eric A. Rose, Chief Executive Officer of SIGA and
Executive Vice President for Life Sciences at MacAndrews & Forbes Holdings
Inc., SIGA's largest shareholder. "We will continue to work closely with CDC and
FDA to obtain the earliest possible approval for ST-246, so that it can be
purchased and widely available whenever needed."
believes that ST-246 is the most advanced-stage treatment for smallpox currently
in development. ST-246 represents
a new approach to achieve a novel, orally active, antiviral therapeutic. It
already demonstrated significant
antiviral activity in various animal trials, including the complete elimination
of human smallpox virus or the related monkeypox virus in several primate
studies. SIGA has not yet filed for final regulatory approval for ST-246,
although FDA has granted "fast-track" status for the development and FDA review
of ST-246 has been supported by grants from the National Institute of Allergy
and Infectious Diseases of the National Institutes of Health, the CDC and the
Department of Defense.
Technologies, Inc. March 19, 2007 Press Release Page
SIGA Technologies, Inc.
Technologies is applying viral and bacterial genomics and sophisticated
computational modeling in the design and development of novel products for
prevention and treatment of serious infectious diseases, with an emphasis on
products for biological warfare defense. SIGA believes that it is a leader
the development of pharmaceutical agents and vaccines to fight potential
biowarfare pathogens. In
addition to smallpox, SIGA has antiviral programs targeting other Category
pathogens, including arenaviruses (Lassa
fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis),
dengue virus, and the filoviruses (Ebola and Marburg).
information about SIGA, please visit SIGA's Web site at www.siga.com.
Press Release contains or implies certain "forward-looking statements'' within
the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including statements regarding the efficacy of potential products, the timelines
for bringing such products to market and the availability of funding sources
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