NEW YORK, Oct. 04, 2018 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). This CRADA will focus on Good Laboratory Practice (GLP) studies of TPOXX® for post-exposure prophylaxis (PEP) using a U.S. Food and Drug Administration (FDA)-approved non-human primate model of TPOXX efficacy against smallpox infection. PEP regimens are designed to prevent infection in individuals who have known or potential exposure to an infectious agent but are not symptomatic. Such regimens have been used successfully to reduce the impact of other infections.
“The studies included in this CRADA build on a strong history of collaboration between USAMRIID and SIGA, and we are pleased to have the opportunity to again work with USAMRIID to further explore how TPOXX could be used in the event of a smallpox outbreak,” said Dr. Phil Gomez, CEO of SIGA. “We believe these studies will be important in supporting a possible label expansion filing with the FDA for approval of TPOXX for PEP. The continued evaluation of TPOXX in potential additional indications is evidence of the broad potential of the TPOXX pipeline.”
The FDA has already approved the oral formulation TPOXX for the treatment of smallpox, and its use in the PEP setting could provide significant potential benefit in the event of an outbreak. While vaccines would play an important role in containing the spread of smallpox, they are only effective if administered prior to infection or no later than four days after infection. However, symptoms of smallpox do not typically appear until approximately 14 days post-infection, and there is currently no diagnostic test to determine infection prior to symptom onset. Given the uncertainty of an individual’s infection status in that two-week period, the administration of vaccine in combination with TPOXX could potentially be an important strategy for reducing morbidity and mortality in a smallpox outbreak.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug of which 2 million oral courses have been delivered to the Strategic National Stockpile under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox on July 13, 2018. In September 2018, SIGA signed a new contract with Biomedical Advanced Research and Development Authority (BARDA) for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit www.siga.com.
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally-occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of the current vaccine’s side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.
About the United States Army Medical Research Institute of Infectious Diseases
USAMRIID’s mission is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents. Research conducted at USAMRIID leads to medical solutions—vaccines, drugs, diagnostics, and information—that benefit both military personnel and civilians. The Institute plays a key role as the lead military medical research laboratory for the Defense Threat Reduction Agency’s Joint Science and Technology Office for Chemical and Biological Defense. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. For more information, visit www.usamriid.army.mil
This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. 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, 2017, and in other documents that SIGA has filed with the SEC. SIGA urges investors and security holders to read those documents free of charge at the SEC’s web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements are current only as of the date on which such statements were made, and except for our ongoing obligations under the United States of America federal securities laws, we undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events, or otherwise.
The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.