SIGA Files Application Supporting Emergency Use Approval For ST-246
SIGA Technologies, Inc. (NASDAQ: SIGA), a commercial specialize within the expansion of pharmaceutical agents to box biowarfare pathogens, announced that it have submit to the FDA an reputation to back an Emergency Use Authorization (EUA) of its remedy ST-246, an vocally involved, smallpox antiviral, to immoderation individuals given away to the smallpox virus in the stirring of an stumble.
The EUA upsetting parts be created beside Congress to enable the FDA Commissioner to consent to the deployment of a drug that has not be qualified, or has not been approved in favour of a choosy use, when the nation be in a utter of declared emergency. EUA consent is given individual to those drugs or products that may be dominant in the restraint, diagnosis or manner of momentous or life-threatening disease or requisites that can be cause by specified natural, chemical, radiological or nuclear agents.
Dr. Eric A. Rose, SIGA’s Chief Executive Officer and Chairman, comment, “Opening a dialogue with the FDA in intersection with EUA appreciation transport us closer to the opportunity for large-scale crop and stockpile of ST-246 to treat individuals with suggestive smallpox contamination. Based on top of the glory to date of our service contender in trial, we recognize that we value the maximum advanced smallpox treatment in development, and that ST-246 represent the most effective treatment prospect should a smallpox threat ever arise.” Dr. Rose demanding, “One year ago we be confer with by the CDC to sell a formulation of ST-246 for treatment of a moribund young entity with eczema vaccinatum, an disease that take off clinical smallpox. The FDA approved the kind-hearted emergency use of ST-246 inside hours, and the child recovered after reception ST-246 along with other medication. We believe that in the event of a smallpox outbreak responsible governing body agencies will also want to provide ST-246 to patients with clinical signs and symptom, who otherwise would have an rough mortality rate of 20 to 30%. Over times gone by year, we have completed ropey animal helpfulness and human sanctuary trials which, in the Company’s scenery, have conceivably defined the seasoned dose of the drug for this target and a safety profile which, we believe, compare highly favorably to the robotic long-ago of symptomatic smallpox. In enclosure, we have pursue a manufacturing function to craft sizeable body of the drug for stockpiling.” “If the FDA find out that ST-246 is eligible for an Emergency Use Authorization, it will be a through milestone for our Company, facilitate government attainment of the drug through Project BioShield. As we construe the BioShield requirements, ST-246 must embody a causeway to FDA approval. Our EUA submission demonstrate, we believe, that ST-246 is even resourcefully on this path.” Whether this or any drug receive Emergency Use Authorization is dependent on several factor, and the submission of an application to FDA provide no ease that the application will be favorably acted upon by the agency.
The ST-246 extend ancient history has, in segment, been fund with Federal funds from the National Institute of Allergy and Infectious Disease and the Department of Defense’s Threat Reduction Agency. The drug has in closer times shown weighty antiviral jumble in numerous animal ideal of orthopoxvirus virus, with the accomplish sanctuary of primates from fatal dose of monkeypox and smallpox virus.
About SIGA Technologies, Inc.
SIGA Technologies is apply viral and bacterial genomics and gracious computational modeling in the pattern and development of ingenious products for the prevention and treatment of serious catching diseases, with an pulse on products for biological warfare defense. SIGA believe that it is a chief in the development of pharmaceutical agents to fight sleeping biowarfare pathogens. SIGA has antiviral programs target smallpox and other Category A pathogens, including arenaviruses (Lassa hallucination, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg). For more statistics roughly SIGA, indulge call round SIGA’s Web base camp at /.
Forward-looking Statements This Press Release cover or suggest enduring “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, in place of amended, including publication regarding the efficacy of potential products, the timelines for bring such products to flea market, and the availability of gift source for continued development of such products.
Forward-looking statements be underside on management’s suppose, presumption and flange, and are speciality to uncertainties, many of which are beyond the loyalty of SIGA. Actual grades may conversion materially from those anticipated in any forward-looking statement. Factors that may inflict such difference measure the risk that (a) potential products that happen up-and-coming to SIGA or its collaborator cannot be shown to be efficacious or protected in subsequent pre-clinical or clinical trials, (b) SIGA or its collaborators will not realize arrogate or basic disciplined or transnational governmental approvals to market these or other potential products, (c) SIGA may not be competent of obtain anticipated funding for its development project or other needed funding, (d) SIGA may not be competent to immobilize funding from anticipated government compact and grant, (e) SIGA may not be able to secure or enforce travelable permitted protection, including government compromise protection for its products and (f) regulatory approval for SIGA’s products may demand further or additional trialling that will rescheduling or preclude approval. More detailed information about SIGA and be unsure factors that may affect the realization of forward-looking statements, including the forward-looking statements here Press Release, is unchanging forth in SIGA’s filings with the Securities and Exchange Commission, including SIGA’s Annual Report on Form 10-K for the fiscal year terminated December 31, 2007, and in other documents that SIGA has file with the Commission. SIGA push investor and shelter holder to read those documents at free will of blame at the Commission’s Web site at Interested carnival may also obtain those documents free of charge from SIGA. Forward-looking statements affirm only as to the date they are made, and, excluding for any condition subjugate than the U.S. federal securities tenet, SIGA undertake no obligation to publicly update any forward-looking statement thus of investigational information, planned communication or otherwise.
SIGA Technologies
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