CV6 Announces Initiation of Patient Dosing in Phase 1a Clinical Trial Evaluating
the Investigational First-In-Class, Specific dUTPase Inhibitor CV6-168.
CV6 Therapeutics (NI) Ltd. (“CV6”), a clinical-stage pharmaceutical company dedicated to improving the lives of patients with cancer and inflammatory diseases by developing novel, first-in-class, small molecules targeting Uracil-DNA metabolism, today announced the successful dosing of the second patient in its Phase 1a study evaluating CV6-168 + infusional 5-fluorouracil (5-FU) in cancer patients.
This Phase 1 part of this modular, first-in-human Phase 1a clinical trial (ISRCTN12434145) is a multicenter, open-label, dose-escalation study of CV6-168 in patients with advanced metastatic solid tumors refractory to standard treatment. The primary objectives of the study are to determine the following parameters for CV6-168: safety profile, potential optimal biologically relevant doses, maximum tolerated dose, and anti-tumor activity.
CV6-168 is a novel, targeted, small molecule, dUTPase-specific inhibitor in development for the treatment of multiple, high-incidence cancers. In preclinical studies, it has demonstrated robust anti-tumor activity in cell line and animal models with no added toxicity. CV6-168 targets the nucleotide metabolism enzyme dUTPase, with high specificity, avoiding drug-drug interactions with its drug combination partners that include thymidylate synthase (TS) inhibitors like 5-fluorouracil (5-FU).
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