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ATI-1123 is an intravenously administered liposomal formulation of the taxane chemotherapy docetaxel, designed to improve tolerability, reduce hypersensitivity reactions associated with conventional formulations, and potentially broaden the therapeutic index by altering pharmacokinetics and enhancing tumor delivery. It demonstrated linear, dose-proportional pharmacokinetics, with a maximally tolerated dose of 90 mg/m2 every 3 weeks identified in a Phase 1 dose-escalation study in advanced solid tumors; common adverse events included fatigue, nausea, neutropenia, anemia, anorexia, and diarrhea, and antitumor activity included one confirmed partial response and frequent stable disease. The FDA granted orphan drug designation to ATI-1123 for small cell lung cancer, and the program has been described as a substantially redesigned and reformulated docetaxel-based liposomal drug. Mechanistically, ATI-1123 exerts the cytotoxic actions of docetaxel via microtubule stabilization leading to mitotic arrest and apoptosis, delivered within a liposomal carrier stabilized by human serum albumin for tumor targeting.[1][7][5][3][6][10]
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