NEW YORK, June 23, 2010 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development of pharmaceutical agents to combat bio-warfare pathogens, announced today the successful completion of its fourth human clinical trial, supporting the safety and tolerability of the anticipated clinical dose of ST-246®, SIGA's lead smallpox antiviral drug candidate. Analyses of the trial's results are consistent with findings from previous studies of ST-246 and together show that the drug will likely be found to be a safe and well-tolerated therapeutic for the treatment of orthopoxvirus infections.
The trial was conducted at three sites: Orlando Clinical Research Center (Orlando, FL), Apex Research Institute (Santa Ana, CA) and Hawaii Clinical Research Center (Honolulu, HI). A total of 107 healthy volunteers were enrolled in the study and were randomly placed into one of three different groups, each of which received either 400 or 600 mg of ST-246 or a placebo, once a day, for 14 days. All adverse events reported during the study that were considered related to ST-246 were mild to moderate. There were no severe adverse events.
"We are very satisfied with SIGA's progress in completing the studies needed to demonstrate the safety, bio-availability and efficacy of ST-246," said Dennis E. Hruby, SIGA's Chief Scientific Officer. "In addition to reaffirming the strong safety profile of ST-246, the trial results suggest an appropriate dose that we will use as we complete the remaining New Drug Application studies and a study to test its pharmacologic effects on cardiac repolarization."
"The results of this latest trial support our belief that ST-246 is likely to meet the FDA's requirements for being safe and well-tolerated. We are now in the planning stage for our expanded safety study of approximately 450 volunteers and are working with the FDA on establishing a protocol for the trial. Enrollment is expected to begin once the procedures have been determined," said Dr. Eric Rose, SIGA's Chief Executive Officer.
"As we move toward the goal of commercializing ST-246, our efforts are now directed towards completing the human and animal studies needed for regulatory approval. We are also advancing our efforts to obtain approval on additional indications for ST-246. Separately, we continue to make progress with our clinical pipeline of novel antivirals and apply for non-dilutive government grants and funding," Dr. Rose concluded.
This project was funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, in conjunction with the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN266200600014C.
Forward-looking Statements
This press release contains 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 (i) the risk that 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) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products, (iii) the risk that SIGA may not be able to obtain anticipated funding for its development projects or other needed funding, (iv) the risk that SIGA may not be able to secure funding from anticipated government contracts and grants, (v) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including patent protection for its products, (vi) the risk that any challenge to our patent and other property rights, if adversely determined, could affect our business and, even if determined favorably, could be costly, (vii) the risk that regulatory requirements applicable to SIGA' s products may result in the need for further or additional testing or documentation that will delay or prevent seeking or obtaining needed approvals to market these products, (viii) the risk that BARDA may not complete the procurement set forth in its solicitation for the acquisition of smallpox antiviral for the strategic national stockpile, or may complete it on different terms, (ix) the risk that third parties may protest contracts awarded to us through an RFP process which may cause such potential awards to be delayed or overturned, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA's efforts, (xi) the risk that changes in domestic and foreign economic and market conditions may adversely affect SIGA's ability to advance its research or its products, and (xii) the effect of federal, state, and foreign regulation on SIGA's businesses. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this presentation, 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, 2009, 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 of the date they are made, and except for our ongoing obligations under the United States of America federal securities laws, we undertake no obligation to publicly update any forward-looking statements whether as a result of new information, future events or otherwise.
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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