Brincidofovir: Additional Phase III data

Additional data from 85 evaluable pediatric and adult patients with adenovirus infection in the pilot portion of the open-label, U.S. Phase III AdVise trial showed that twice-weekly brincidofovir for 12 weeks led to a mortality rate of 31% across all 3 cohorts, compared to a historical rate of 80%. The mortality rate was 11% in allogeneic hematopoietic cell transplant (HCT) recipients at risk of adenovirus disease progression (cohort A, n=18); 37% in allogeneic HCT recipients with disseminated adenovirus disease (cohort B, n=54) and 31% in non-allogeneic HCT recipients with disseminated adenovirus disease or at risk of adenovirus disease progression (cohort C, n=13).

Of 71 evaluable patients with detectable adenovirus in plasma at baseline, 51% achieved undetectable plasma viral load and 65% achieved undetectable viral load or >=3 log10 reduction in viral load at the last on-treatment assessment. The proportion of patients with undetectable plasma viral load at the last on-treatment assessment was 73% in cohort A, 46% in cohort B and 50% in cohort C. ...