Full Press Release Details
ANNOUNCES SMALLPOX TREATMENT BREAKTHROUGH
DRUG COMPLETELY PREVENTS SMALLPOX DISEASE
PRELIMINARY PRIMATE TRIAL
NY, October 18, 2006 -- SIGA
SIGA) announced today that its lead drug, SIGA-246, is the first drug ever
demonstrate 100% protection against human smallpox virus in a primate trial
conducted at the federal Centers for Disease Control and Prevention (CDC).
this study, once-daily, oral administration of SIGA-246 protected cynomolgus
monkeys from smallpox disease following intravenous high dosing with smallpox
virus. The drug prevented symptoms of disease whether delivered at the same
as the virus or 24 hours later, supporting the drug's use for both post-exposure
prophylaxis and treatment. SIGA-246 completely prevented lesion formation and
reduced viral load to non-threatening levels in treated animals with no obvious
toxicity. The study was conducted under rigorous bio-safety and -security
conditions at the World Health Organization Collaborating Centers for Smallpox
and Other Poxvirus Infections' BSL-4 laboratory located at the CDC in Atlanta
and was funded by the Department of Health and Human Services, the CDC and
Department of Defense's Defense Threat Reduction Agency under the supervision of
Dr. John Huggins, Chief of the Viral Therapeutics Branch, U.S. Army Medical
Research Institute of Infectious Diseases.
Huggins commented, "This drug holds great promise as a therapy for poxvirus
infections." Donald Drapkin, Chairman of SIGA, added, "Smallpox is one of the
great biowarfare threats, and SIGA-246 demonstrates SIGA's leadership in efforts
to counteract that threat."
particularly pleased," said Dr. Dennis E. Hruby, Chief Scientific Officer of
SIGA, "because the amount of virus used in this study is equivalent to the level
present in late-stage disease in humans, which we believe signals that SIGA-246
can be used to prevent disease in humans even several days after initial viral
exposure." He added, "This test in non-human primates is as close as anyone can
get to the real thing because there has not been any natural occurrence of
smallpox since 1977."
is considered one of the most significant biowarfare threats. The CDC classifies
variola, the virus that causes smallpox, as a "Category A" (highest level
threat) bioterrorism agent. Smallpox is readily transmitted between humans,
has significant mortality rates and the population is no longer vaccinated
against it. Mass immunizations of the general population using the current
vaccine are not recommended, as there are known complications affecting some
individuals, which may include encephalitis, myocarditis, and death.
Immunocompromised individuals receiving this vaccine are at particular risk
a systemic infection. At this time, there is also no approved treatment for
Department of Homeland Security has designated smallpox a "material threat" to
our national security, so SIGA-246 will be eligible for purchase for the
Strategic National Stockpile under Project Bioshield.
previously announced that SIGA-246 has been shown to be safe to administer
humans as a once-a-day pill. SIGA-246 has also demonstrated 100% disease
protection in several mouse models of infection, which results SIGA will use,
along with additional tests yet to be completed, to fulfill the U.S. Food and
Drug Administration's "Animal Efficacy Rule." In December 2005, the FDA granted
"fast-track" status to SIGA-246.
Technologies, Inc. Smallpox Trial 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). SIGA's
product development programs also emphasize the increasingly serious problem
drug resistant bacteria.
information about SIGA, please visit SIGA's Web site at www.siga.com.
the Defense Threat Reduction Agency
Defense Threat Reduction Agency (DTRA) is an agency of the U.S. Department
Defense that safeguards America and its allies from weapons of mass destruction
by providing capabilities to reduce, eliminate, and counter the threat, and
mitigate its effects. DTRA headquarters is located at Fort Belvoir, Virginia,
and it also operates field offices worldwide. The DTRA has identified an
orthopox therapeutic as a critical need in its ongoing threat reduction
the U.S. Army Medical Research Institute of Infectious Diseases
located at Fort Detrick, Maryland, is the lead medical research laboratory
the U.S. Biological Defense Research Program, and plays a critical role in
national defense and in infectious disease research. The Institute's mission is
to conduct basic and applied research on biological threats resulting in medical
solutions (such as vaccines, drugs and diagnostics) to protect the warfighter.
USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and
information contained in this press release does not necessarily reflect the
position or policy of the U.S. government, and no official endorsement should
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
continued development of such products. Forward-looking statements are based
management's estimates, assumptions and projections, and are subject to
uncertainties, many of which are beyond the control of SIGA. Actual results
differ materially from those anticipated in any forward-looking statement.
Factors that may cause such differences include the risks that
(a) potential products that appear promising to SIGA or its collaborators
cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical
trials, (b) SIGA or its collaborators will not obtain appropriate or
necessary governmental approvals to market these or other potential products,
(c) SIGA may not be able to obtain anticipated funding for its development
projects or other needed funding, (d) SIGA may not be able to secure
funding from anticipated government contracts and grants, (e) SIGA may not
able to secure or enforce adequate legal protection, including patent protection
for its products and (f) regulatory approval for SIGA's products may
require further or additional testing that will delay or prevent approval.