AVI-6003: Phase I data

Additional data from 5 healthy volunteers in the sixth dose cohort of a double-blind, placebo-controlled Phase I trial showed that single doses of 9 mg/kg IV AVI-6003 led to no safety concerns or treatment-related changes in kidney function. In all 30 subjects, the most common adverse events were headache and dizziness. Data were presented at the European Congress of Clinical Microbiology and Infectious Diseases in London. Last November, AVI reported data from 25 healthy volunteers in the first 5 cohorts of the trial showing no safety concerns for single ascending-doses of 0.01, 0.1, 1, 3 or 6 mg/kg AVI-6003 (see BioCentury, Nov. 7, 2011). In February, the company said it will discontinue development of AVI-6003 after AVI-7287, 1 component of the compound, did not show efficacy in studies. Instead, the company plans to begin a Phase I trial to evaluate multiple ascending-doses of AVI-7288, the active component of AVI-6003, but did not disclose a time frame (see BioCentury, March 5). ...