SIGA Announces $2.3 Million in New Contracts with the U.S. Air Force
Friday November 10, 7:30 am ET
and
SIGA Passes Another Milestone with Smallpox Drug SIGA-246
Thursday November 9, 1:17 pm ET
(i am long siga)
NEW YORK--(BUSINESS WIRE)--SIGA Technologies, Inc. (NASDAQ: SIGA - News) today announced receipt of two contracts from the U.S. Air Force for a total of $2.3 million. SIGA received a one-year, $1.4 million contract with the Air Force Medical Service for the development of counter-measures against important potential biowarfare pathogens, the Dengue viruses, and other water-related viral agents. SIGA also received a one-year, $900,000 contract to aid the USAF Special Operations Command (USAFSOC) in its development of specific anti-viral agents, focusing on orthopoxvirus targets distinct from the target that is the focus of SIGA-246, the Company's lead smallpox drug.
"We appreciate the opportunity to continue the development of these critical biological defense capabilities with our colleagues from the Air Force," said Dr. Dennis E. Hruby, Chief Scientific Officer of SIGA.
Dengue fever and Dengue hemorrhagic fever are acute febrile mosquito-borne diseases caused by one of four closely related virus serotypes of the genus Flaviviridae. The two diseases affect tens of millions of people worldwide every year and present a biodefense threat in the U.S. Currently, there is no approved drug or vaccine against Dengue, leaving troops vulnerable overseas and in areas affected by flooding.
SIGA recently announced a breakthrough in its SIGA-246 program with the successful completion of a preliminary primate trial in which the drug completely prevented smallpox disease.
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).
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SIGA Passes Another Milestone with Smallpox Drug SIGA-246
Thursday November 9, 1:17 pm ET
NEW YORK--(BUSINESS WIRE)--SIGA Technologies, Inc. (NASDAQ: SIGA - News) announced today the successful results of two independent primate trials of its smallpox drug SIGA-246. Last month, SIGA announced that SIGA-246 provides complete protection against human smallpox virus in nonhuman primates. The current trials involve infection with high doses of monkeypox virus, which may be lethal in primates if left untreated. SIGA-246 again afforded complete protection against disease symptoms. As with the primate trial last month and the human safety trial announced earlier this year, the current trials also demonstrate that SIGA-246 should be safe as well as effective.
The first monkeypox virus study was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and conducted at the Lovelace Respiratory Research Institute in Albuquerque, NM. In this study, all monkeys in the two groups receiving SIGA-246 (different dosages) were completely protected from disease.
The second study was conducted at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and was funded by the Department of Defense's Defense Threat Reduction Agency under the supervision of Dr. John Huggins, Chief of the Viral Therapeutics Branch. In the second study, two groups of nonhuman primates received SIGA-246 orally starting either one day post-infection or three days post-infection. Again both treatment groups were completely protected from disease.
"Taken together with the recent breakthrough results from the smallpox virus study, the data continue to support the use of SIGA-246 as the first drug available to prevent and treat disease caused by pathogenic poxviruses without significant side effects," said Dr. Dennis E. Hruby, Chief Scientific Officer of SIGA. He added, "These are very important results for two reasons. First, in many respects monkeypox infections in non-human primates are more aggressive than infection with smallpox virus (normally a human pathogen), so protection by SIGA-246 represents a higher hurdle. Second, SIGA will likely use SIGA-246's performance against monkeypox infection in monkeys, along with the results in all of the several animal species tested to date, to satisfy FDA's efficacy requirements, so success here bodes well."
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 results from 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.
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.
In addition to smallpox, SIGA has antiviral programs targeting other Category A viral pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and LCM), flaviruses (Dengue), and the filoviruses (Ebola and Marburg), each of which presents a substantial, unmet medical need.
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 is a leading company in the discovery of pharmaceutical agents to fight emerging pathogens. SIGA leverages its proprietary technologies 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. |
