Key Developments For SIGA Technologies Inc
SIGA Technologies Inc (SIGA.O) (Consolidated Issue listed on NASDAQ Global Market)
SIGA Technologies, Inc. Completes Nonclinical Toxicology Studies Supporting Safety In Humans For ST-246
SIGA Technologies, Inc. announced that the U.S. Food and Drug Administration (FDA) has advised that it does not anticipate requiring further nonclinical toxicology studies in support of an ST-246 NDA filing. SIGA submitted its final reports on multiple ST-246 nonclinical toxicology studies to the FDA on March 25, 2009. ST-246 is SIGA's smallpox antiviral drug candidate, and an NDA filing is the usual method by which pharmaceutical companies seek from the FDA approval to market a drug in the United States. The results from the nonclinical studies conducted on ST-246 show it to have favorable pharmacokinetic and safety properties. SIGA submitted to the FDA studies that include pharmacokinetics, general toxicology (acute and repeat dosing), safety pharmacology, ADME, genotoxicity and reproductive toxicology. Standard in vitro and in vivo models in accordance with appropriate ICH (International Conference on Harmonization) guidelines were used for all critical studies, which were performed using established good laboratory practices. All of the studies were funded by the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health.
SIGA Technologies, Inc. Changes Title Of Ayelet Dugary From Acting CFO to CFO-Form 8-K
SIGA Technologies, Inc. reported in its Form 8-K tha on April 29, 2009, it entered into a letter agreement with Ayelet Dugary changing her title from Acting Chief Financial Officer to Chief Financial Officer.
SIGA Technologies, Inc. Produces FDA Registration Batches of ST-246 Drug Product
SIGA Technologies, Inc. announced that it has completed the steps needed to demonstrate its ability to manufacture commercial quantities of ST-246, its smallpox antiviral. The process involved producing three batches of ST-246 using FDA-established manufacturing practices. SIGA's work was funded in part by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority of the U.S. Department of Health & Human Services.
SIGA Technologies, Inc. Announces ST-246 In Combination With The Smallpox Vaccine ACAM2000 Confers Protective Immunity In Primates
SIGA Technologies, Inc. announced the results of a non-human primate study by the Southern Research Institute (SRI) that suggests that ST-246 can be used in combination with a well-known smallpox vaccine and may improve the safety profile of the vaccine. The study investigated the efficacy of concurrent administration of ST-246, SIGA's smallpox antiviral candidate drug, and Acambis' ACAM2000 smallpox vaccine in non-human primates. When concurrently administered, ST-246 appears to reduce the size and intensity of the lesion formed at the vaccine administration site while the vaccine still confers similar levels of protection in the test animals compared to animals given vaccine alone, based on a subsequent challenge with lethal doses of monkeypox virus. Pending immunological evaluations will shed further light on the overall impact of concomitant ST-246 administration on vaccine efficacy. This favorable initial primate data should spur further studies to investigate this drug/vaccine combination approach.
SIGA Technologies, Inc. Announces Resignation Of Thomas N. Konatich As Chief Financial Officer-Form 8-K
SIGA Technologies, Inc. announced in its Form 8-K that Thomas N. Konatich, Chief Financial Officer, agreed not to extend the current term of employment agreement, and therefore his employment with the Company terminated effective January 31, 2009. As of February 1, 2009, Ayelet Dugary became acting Chief Financial Officer of the Company.
