"We believe CMX001's rapidly evolving antiviral and safety profile provides strong support for this candidate's broad-spectrum, preemptive usage, which includes the often-overlooked pediatric population," said Kenneth I. Moch, Chimerix President and CEO. "To date, CMX001 has been administered to more than 550 subjects and has demonstrated activity against a broad spectrum of dsDNA viruses. It has been well tolerated and has not shown toxicity in the kidneys or on bone marrow function."
The AdV HALT Trial/CMX001-202 Design
The primary objective of the Phase 2 clinical study is to evaluate the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of AdV disease in hematopoietic stem cell recipients with asymptomatic AdV viremia. The multi-center, placebo-controlled study, which will be conducted at approximately 30 centers, is expected to enroll 48 pediatric and adult patients who have undergone hematopoietic stem cell transplant and have evidence of infection but no symptoms of disease. Under the protocol, subjects will be randomized to receive CMX001 or placebo once or twice weekly for at least six, but no more than 12, weeks. The dose of CMX001 or placebo given during the randomized treatment phase will be based upon the age and weight of the subject at the time of enrollment.
The primary endpoint will be "treatment failure", consisting of progression to AdV disease or increasing AdV viremia. Secondary endpoints include safety and tolerability of CMX001, as well as other measurements that include the percentage of subjects who have emergence or progression of cytomegalovirus(CMV), Epstein-Barr virus (EBV), or BK virus (BKV) viremia or disease during therapy. Drug pharmacokinetics and the development of viral resistance will also be assessed.
Additional information on study objectives, enrollment cri
|SOURCE Chimerix, Inc.|
Copyright©2010 PR Newswire.
All rights reserved