SIGA Technologies, Inc., a company specializing in the development of pharmaceutical agents to fight bio-warfare pathogens, has received a phase II grant of approximately $3 million from the National Institutes of Health (NIH), to continue exploring the use of ST-246 as an adjunct to the current smallpox vaccine for prevention of smallpox vaccine-related adverse events.
SIGA will evaluate the efficacy of ST-246 in preventing smallpox vaccine-related adverse events in non-human primate models of immunodeficiency and evaluate the impact of concurrent ST-246 administration on ACAM2000 vaccination efficacy in a monkeypox challenge in non-human primate models of immunodeficiency.
"The NIH has been very supportive of our ST-246 programme and through its funding has helped us enhance our development efforts. This grant will help SIGA advance understanding of the use of ST-246 as an adjunct to the smallpox vaccine. We expect that an Investigational New Drug application for use of ST-246 as an adjunct to vaccine can be filed with the Food and Drug Administration upon completion of the proposed studies," noted Dr. Eric Rose, SIGA's chief executive officer. "This potential new indication for ST-246 complements our NIH and BARDA (Biomedical Advanced Research and Development Authority) supported pursuit of therapeutic and post-exposure prophylaxis use of ST-246," Dr. Rose added.
SIGA continues its active pursuit of a contract in response to BARDA's Request for Proposals to supply the Strategic National Stockpile with a therapeutic smallpox anti-viral drug.
Commenting on the award, Dr. Dennis E. Hruby, SIGA's chief scientific officer added, "The current smallpox vaccination program has reminded us of some of the potentially lethal effects that smallpox vaccine can have on a portion of the population. We hope that further studies, funded in part through grants such as this, will confirm our belief that ST-246 can reduce or eliminate the incidence of serious side effects that occasionally afflict certain individuals that receive the vaccine."
This grant is a phase II continuation of initial studies supported by Award Number R44AI075747 from the National Institute of Allergy And Infectious Diseases (NIAID), an institute within the NIH.
SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modelling 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.