ST-246 Used to Treat Complications From Exposure to Recombinant Vaccinia Virus

September 15, 2009 at 8:31 AM EDT

NEW YORK, Sep 15, 2009 (GlobeNewswire via COMTEX News Network) -- SIGA Technologies Inc. (Nasdaq:SIGA) announced that its smallpox antiviral drug, ST-246, has been used to treat a Pennsylvania patient suffering from complications due to exposure to a live vaccinia-vectored rabies vaccine. Following consultation with the Pennsylvania Health Department, the Centers for Disease Control and Prevention, and the Food and Drug Administration, an eIND (Emergency Investigational New Drug) was approved to permit the use of ST-246, an investigational drug, in the patient. After a single 14-day course of oral ST-246 therapy (2 capsules once per day), together with vaccinia immunoglobulin (VIG), the infection was resolved and the patient was discharged from the hospital.

In an effort to control wildlife rabies, bait sachets containing recombinant vaccinia virus expressing rabies antigens are distributed in the rural areas of the Eastern United States. The intent is to allow wildlife to self-vaccinate by ingesting the vaccine-laden bait sachets. They do not pose an immediate health risk to humans or pets, but should not be handled. In this particular case, through an unfortunate set of circumstances, an individual acquired an infection through direct contact with a bait sachet.

"This case illustrates the potential of ST-246 to treat orthopoxvirus-related infections, to treat vaccine complications and to diminish the threat posed by poxvirus bioweapons," said Dr. Eric A. Rose, SIGA's Chief Executive Officer.

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 to fight potential bio-warfare pathogens. SIGA has antiviral programs targeting smallpox and other Category A pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg). For more information about SIGA, please visit SIGA's web site at http://www.siga.com/.

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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 continued development and possible eventual approval 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 SIGA's control. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that (i) 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, (ii) SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products, (iii) SIGA may not be able to obtain anticipated funding for its development projects or other needed funding, (iv) SIGA may not be able to secure funding from anticipated government contracts and grants, (v) SIGA may not be able to secure or enforce sufficient legal rights in its products, including sufficient patent protection for its products, (vi) regulatory approval for SIGA's products may require further or additional testing that will delay or prevent approval, (vii) the Biomedical Advanced Research & Development Authority may not complete the procurement set forth in its solicitation for the acquisition of a smallpox antiviral for the strategic national stockpile, or may complete it on different terms; (viii) SIGA's proposed drug candidate for responding to any governmental solicitation for purchase may not meet the requirements of the solicitation; (ix) the volatile and competitive nature of the biotechnology industry may hamper SIGA's efforts, (x) changes in domestic and foreign economic and market conditions may adversely affect SIGA's ability to advance its research or its products, and (xi) changing federal, state and foreign regulation on SIGA's businesses may adversely affect SIGA's ability to advance its research or its products. 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, 2008, 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.

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SOURCE: SIGA Technologies, Inc.

CONTACT:  KCSA Strategic Communications
Marybeth Csaby
212-896-1236
mcsaby@kcsa.com
Todd Fromer
212-896-1215
Tfromer@kcsa.com

 

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