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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________________________
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): October 5, 2004
__________
SIGA Technologies, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware 0-23047 13-3864870
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(State or other Jurisdiction of (Commission File (I.R.S. Employer
Incorporation or Organization) Number) Identification Number)
420 Lexington Avenue, Suite 601, New York, New York 10170
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(Address of Principal Executive Offices) (Zip Code)
(212) 672-9100
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(Registrant's telephone number, including area code)
ITEM 7.01. Regulation FD Disclosure.
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On October 5, 2004, SIGA Technologies, Inc., a Delaware corporation,
issued a press release pursuant to which it announced that the Company's lead
smallpox compound, SIGA-246, has demonstrated significant antiviral activity
against several mouse models of poxvirus disease. A copy of the press release is
attached hereto as Exhibit 99.1, which is incorporated in this Item 7.01 by
reference.
ITEM 9.01 Financial Statements and Exhibits
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(c) Exhibits
Exhibit No. Description
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99.1 Press Release dated October 5, 2004.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
SIGA TECHNOLOGIES, INC.
By: /s/ Thomas N. Konatich
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Thomas N. Konatich
Chief Financial Officer
Date: October 5, 2004
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EXHIBIT INDEX
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Exhibit Number Description
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99.1 Press Release dated October 5, 2004.
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EXHIBIT 99.1
Contact: Investor Contact:
Dr. Bernard Kasten Dianne Will
SIGA Technologies, Inc. Willstar Consultants, Inc.
Chief Executive Officer (518) 398-6222
(212) 672-9100
dwill@willstar.net
SIGA announces SUCCESS of its Smallpox Compound in Mice
New York, October 5, 2004 -- SIGA Technologies, Inc. (NASDAQ: SIGA) today
announced that the company's lead smallpox compound, SIGA-246, has demonstrated
significant antiviral activity against several mouse models of poxvirus disease.
In one of these studies, oral administration of SIGA-246 protected mice from
lethal doses of ectromelia virus. Ectromelia virus is closely related to human
smallpox virus and causes a similar type of disease in mice (i.e. mousepox).
SIGA-246 also was found to reduce disease spread and lesion formation in treated
mice with no obvious toxicity.
"These results demonstrate that SIGA-246 is an orally active antiviral compound
that can prevent the systemic spread of Poxvirus while protecting mice from
developing cutaneous lesions and poxvirus-induced systemic disease associated
with viremia" said Dr. Dennis E. Hruby, Chief Scientific Officer of SIGA.
Smallpox virus is considered one of the most significant biowarfare threats. It
is classified as category A bioterrorism agent by the Centers for Disease
Control and Prevention (CDC). Smallpox is very easily transmitted, it has very
high mortality rates and the population is no longer vaccinated against it. Mass
immunizations of the general population using the current live vaccine are not
recommended, as there are known complications affecting some individuals, which
may include encephalitis, myocarditis, and death. Immunocompromised individuals
are at particular risk from dissemination and systemic spread of the live virus
in the presently available smallpox vaccine. At present there is no treatment
for smallpox that can be safely administered to the general population without
significant risk of adverse reactions.
Bernard L. Kasten, M.D., SIGA's Chief Executive Officer, commented that "This
new data strongly supports the continued development of SIGA's lead compound as
an antiviral for treatment and prevention of smallpox virus infection in humans.
The results enhance SIGA's position as a leader in biowarfare countermeasures."
About SIGA Technologies, Inc.
SIGA Technologies is applying bacterial genomics 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 at www.siga.com.
This news release contains certain "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
statements, including statements regarding the efficacy and intended utilization
of SIGA's technologies under development, are not guarantees of future
performance. Actual results may differ materially from the expectations
contained in the forward-looking statements. Factors that may cause such
differences include the risk that potential products that appeared promising in
early research or clinical trials to SIGA or its collaborators do not
demonstrate efficacy or safety in subsequent pre-clinical or clinical trials,
and the risk that SIGA or its collaborators will not obtain appropriate or
necessary governmental approvals to market products tested in such trials. More
detailed information about SIGA and the factors discussed above is set forth in
SIGA's filings with the Securities and Exchange Commission, including SIGA's
Annual Report on Form 10-K for the fiscal year ended
December 31, 2003, and in other documents that SIGA has filed with the U.S.
Securities and Exchange Commission. Investors and security holders are urged to
read those documents free of charge at the Commission's web site at www.sec.com.
Those documents may also be obtained free of charge from SIGA. SIGA does not
undertake to publicly update or revise its forward-looking statements as a
result of new information, future events or otherwise.
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