SIGA Technologies Inc.
SIGA Technologies Completes Human Pharmacokinetic Bridging Study Validating Commercial Formulation
Tuesday 02 December 2008
New York, New York, December 2, 2008 - SIGA Technologies, Inc. (NASDAQ: SIGA), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens and protect the population at large, today announced the completion of a Phase I investigational trial to evaluate the pharmacokinetics of various forms of ST-246, the Company's smallpox anti-viral candidate drug.
The primary objective of the trial was to validate the equivalence of absorption of crystalline isoform I, the most stable crystalline form of the drug substance, compared to isoform V, which has been employed in prior human and animal studies. The secondary objective of the trial was to measure the safety and tolerability of both forms in healthy human volunteers. The trial was a randomized, double-blind, crossover, exploratory study of the pharmacokinetics of the two forms of ST-246, enrolling 12 healthy men and women between the ages of 18 and 50.
The preliminary data indicate that both forms of ST-246 provide similar exposure in these volunteers. In addition, ST-246 was again well tolerated when given to healthy volunteers, with no reported serious adverse event.
Dr. Dennis E. Hruby, SIGA's Chief Scientific Officer, commented on the trial results: “Preliminary data from this Phase I pharmacokinetics trial are very encouraging and should provide validation of the final formulation of ST-246. Evidence of the successful formulation, coupled with the continued proof of safety and tolerability, bring us another step closer to receiving full regulatory approval for this drug candidate.”
A large-scale double-blinded, randomized, placebo-controlled, multi-center trial to evaluate safety and tolerability of ST-246 isoform I is being scheduled for 2009. Approximately 400 to 500 healthy male and female volunteers will be enrolled in the study.
This project has been 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.
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/.
Contact:
KCSA Strategic Communications
Todd Fromer / Marybeth Csaby / David Burke
212-896-1215 / 1236 / 1258
Tfromer@kcsa.com / mcsaby@kcsa.com / dburke@kcsa.com