May 6, 2013

Chimerix reported results from a phase II trial of CMX001 for the treatment of life-threatening infection with adenovirus (AdV). This open label, expanded access study enrolled 57 patients infected with AdV. Subjects received oral CMX001 twice weekly. The median duration of CMX001 treatment was 12 doses over seven weeks, with the longest duration of treatment of 43 weeks. Data demonstrated that 34/57 patients (79%) had at least a 90% decrease in the amount of virus in the blood at the end of treatment. Subjects who had a 90% decrease in AdV blood levels had overall better outcomes, with 9% AdV-associated deaths, compared to a 27% mortality rate for patients who had less than a 90% decrease in viral levels. Subjects who began CMX001 therapy as soon as virus was detected in the blood and before symptoms were present, had a lower mortality rate of less than 7%, while patients who were treated after virus was detected in the blood and symptoms had developed had a mortality rate of 37% during the one-month follow-up period. The drug was well tolerated. Based on these results, Chimerix initiated a phase II study of CMX001 as an early treatment for AdV infection in young adults and children who have received a stem cell or bone marrow transplant.

September 7, 2004

Oscient published two studies of once-daily Factive, for the treatment of respiratory infections including community-acquired pneumonia and bacterial exacerbations of chronic bronchitis. The studies found that Factive offered a superior option to two other approved antibiotic regimens (gemifloxacin and amoxicillin/clauvulanate): Factive was significantly more efficacious than treatment with gemifloxacin and produced fewer adverse events, and significantly fewer subjects withdrew from Factive treatment than amoxicillin/clauvulanate due to lack of efficacy. Factive also offered a les frequent and/or shorter dosing schedule than either other therapy.