Sub Filer Id
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 18, 2006
SIGA
TECHNOLOGIES, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
0-23047
|
13-3864870
|
(State
or other jurisdiction of
incorporation
or organization)
|
(Commission
file number)
|
(I.R.S.
employer
identification
no.)
|
420
Lexington Avenue, Suite 408
New
York, New York
(Address
of principal executive offices)
|
|
10170
(Zip
code)
|
Registrant’s
telephone number, including area code: (212) 672-9100
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see
General
Instruction A.2. below):
r
Written
communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
r
Soliciting
material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
r
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
r
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
8.01. Other
Events.
On
October 18, 2006, SIGA Technologies, Inc. (“SIGA”) announced that its lead drug,
SIGA-246, is the first drug ever to demonstrate 100% protection against human
smallpox virus in a primate trial conducted at the federal Centers for Disease
Control and Prevention (“CDC”). In 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 time 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 the 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.
On
October 18, 2006, SIGA issued a press release announcing the above described
results. A copy of the press release is attached hereto as Exhibit
99.1.
Item
9.01. Financial Statements and Exhibits.
(c)
Exhibits
Exhibit
No.
|
Description
|
99.1
|
Press
Release dated October 18, 2006.
|
SIGNATURE
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
Name:
Thomas
N.
Konatich
Title: Acting
Chief Executive Officer & Chief
Financial
Officer
Date: October
18, 2006
Exhibit 99.1 Press Release
Exhibit
99.1
Contact:
Debbie
Raskin
Rubenstein
Associates, Inc.
(212)
843-8028
draskin@rubenstein.com
SIGA
ANNOUNCES SMALLPOX TREATMENT BREAKTHROUGH
SIGA
DRUG COMPLETELY PREVENTS SMALLPOX DISEASE
IN
PRELIMINARY PRIMATE TRIAL
New
York,
NY, October 18, 2006 -- SIGA
Technologies, Inc.
(NASDAQ:
SIGA) announced today that its lead drug, SIGA-246, is the first drug ever
to
demonstrate 100% protection against human smallpox virus in a primate trial
conducted at the federal Centers for Disease Control and Prevention (CDC).
In
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
time
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
the
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.
Dr.
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.”
“We
are
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.”
Smallpox
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,
it
has significant 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 receiving this vaccine are at particular risk
from
a systemic infection. At this time, there is also no approved treatment for
smallpox.
The
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.
SIGA
previously announced that SIGA-246 has been shown to be safe to administer
to
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.
SIGA
Technologies, Inc. Smallpox Trial Press Release
0; Page
2
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 and vaccines 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). SIGA's
product development programs also emphasize the increasingly serious problem
of
drug resistant bacteria.
For
more
information about SIGA, please visit SIGA's Web site at www.siga.com.
About
the Defense Threat Reduction Agency
The
Defense Threat Reduction Agency (DTRA) is an agency of the U.S. Department
of
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
efforts.
About
the U.S. Army Medical Research Institute of Infectious Diseases
(USAMRIID)
USAMRIID,
located at Fort Detrick, Maryland, is the lead medical research laboratory
for
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
Material Command.
The
information contained in this press release does not necessarily reflect the
position or policy of the U.S. government, and no official endorsement should
be
inferred.
Forward-looking
Statements
This
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
for
continued development of such products. Forward-looking statements are based
on
management's estimates, assumptions and projections, and are subject to
uncertainties, many of which are beyond the control of SIGA. Actual results
may
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
be
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.
More
detailed information about SIGA and risk factors that may affect the realization
of forward-looking statements, including the forward-looking statements in
this
Press Release, 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, 2005, and in other documents that SIGA has filed with the
Commission. SIGA urges investors and security holders to read those documents
free of charge at the Commission's Web site at http://www.sec.gov. Interested
parties may also obtain those documents free of charge from SIGA.
Forward-looking statements speak only as to the date they are made, and, except
for any obligation under the U.S. federal securities laws, SIGA undertakes
no
obligation to publicly update any forward-looking statement as a result of
new
information, future events or otherwise.