The components of TL-118 formulation are all approved drugs routinely used for a variety of indications; therefore their safety profiles are well established and documented. Each of the individual components in itself has been reported in scientific literature as possessing mild to moderate anti-angiogenic proprieties, and extensive pre-clinical studies of the combination have demonstrated inhibition of tumor growth through suppression of angiogenesis in the vicinity of cancerous tumors. The doses of the individual drugs comprising TL-118 fall within their acceptable dosing ranges.
Phase I/IIa clinical studies in patients with progressive solid tumors concluded that TL-112 therapy and closely related combination products (Tiltan™) are safe and tolerable.
Since all four agents are FDA approved and marketed globally for use in humans, it is reasonable to expect short time-to-market as well as a favorable safety profile.