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PD-616 + cytarabine is an investigational combination therapy consisting of PD-616 (also known as GM-CT-01) and the antimetabolite cytarabine. PD-616 is a galactomannan, a complex carbohydrate derived from guar gum, that acts as an inhibitor of galectin-3. Galectin-3 is a protein frequently overexpressed in various cancers, including leukemia, where it contributes to tumor cell survival, metastasis, and resistance to chemotherapy. By binding to the carbohydrate recognition domain of galectin-3, PD-616 is intended to disrupt these protective mechanisms and sensitize leukemic cells to cytotoxic agents. Cytarabine is a pyrimidine nucleoside analog that, upon phosphorylation, inhibits DNA polymerase and incorporates into DNA, leading to the termination of DNA synthesis during the S-phase of the cell cycle. The combination was primarily studied in a Phase 1/2 clinical trial (NCT01795924) for patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who were ineligible for standard intensive induction therapy. Development of this specific combination was terminated following a strategic decision by the developer, Galectin Therapeutics, to focus on other indications such as liver fibrosis and NASH.
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