![]() Additionally, delivery of three doses of enadenotucirev over 5 days optimized pharmacokinetic and chemokine profiles in the circulation over time. The frequency of all TEAEs (notably pyrexia and chills) was highest within 24 h of the first enadenotucirev infusion and decreased upon subsequent dosing. The most commonly reported treatment-emergent adverse events (TEAEs) of grade 3 or higher were hypoxia, lymphopenia, and neutropenia. ![]() ResultsĮnadenotucirev displayed a predictable and manageable safety profile at doses up to the MTD of 3 × 10 12 vp, irrespective of infusion time or dosing schedule. Subsequent treatment cohorts (phase 1a, n = 6 and phase 1b, n = 24) examined the feasibility of repeated dosing cycles in either 3-weekly or weekly dosing regimens. During the phase 1a dose escalation ( n = 22) and expansion ( n = 9), delivery of enadenotucirev between 1 × 10 10 and 1 × 10 13 viral particles (vp) on days 1, 3, and 5 (single cycle) was used to determine an appropriate MTD. Sixty-one patients with advanced epithelial tumors unresponsive to conventional therapy were enrolled and received enadenotucirev monotherapy as part of this study. This phase 1 dose escalation study assessed intravenous (IV) dose escalation with enadenotucirev to establish the maximum tolerated dose (MTD) and subsequently identify a suitable schedule for repeated cycles. Further clinical mechanism of action data showed that enadenotucirev can gain access to and replicate within different types of epithelial tumors. ![]() Enadenotucirev is a chimeric adenovirus with demonstrated preclinical tumor-selective cytotoxicity and a short half-life.
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