Definition

A lyophilized formulation containing cultures of the low-virulent Su strain of group A Streptococcus pyogenes, treated and killed with penicillin G, with potential immunostimulating and antineoplastic activities. Upon intravesical administration, lyophilized inactivated group A Streptococcus TARA-002 may, as an immunostimulant, activate both the innate and adaptive immune system. This enhances neutrophils, monocytes and lymphocyte tumor infiltration and increases the production of key immune mediators, including interleukins IL-6, IL-8, IL-12, interferon (IFN)-gamma and tumor necrosis factor (TNF)-alpha, and vascular endothelial growth factor (VEGF), thereby inducing antitumor immune responses. TARA-002 is based on the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432.