Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its irinotecan liposome injection, LY01610. The Phase III study, which is multi-center, randomized, open-label, and parallel-designed, aims to evaluate the efficacy and safety of LY01610 in comparison with topotecan for the treatment of recurrent small-cell lung cancer (SCLC).
LY01610 represents an innovative approach to drug delivery, encapsulating irinotecan hydrochloride within liposomes. This encapsulation protects the drug’s active structure and alters its pharmacokinetic behavior and distribution within the body. It significantly enhances the blood drug concentration of the drug and its active metabolites, extending their half-life. The liposomal formulation also results in increased distribution of the drug within tumor tissue, reduces accumulation in other organs, and contributes to reduced toxicity and increased efficacy. In previously completed Phase I and Phase II clinical trials, LY01610 has shown promising efficacy and safety profiles.- Flcube.com
