Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced the initiation of a multi-center Phase 2 clinical trial designed to evaluate CMX001 in stem cell transplant recipients who are seropositive for cytomegalovirus (CMV).
CMX001 is a broad-spectrum antiviral agent with demonstrated activity against double-stranded DNA (dsDNA) viruses. The Phase 2 randomized, double-blind, placebo-controlled, dose-escalation study is designed to assess the safety, tolerability and ability of CMX001 to prevent or control CMV infection in stem cell transplant recipients. CMV, a member of the herpesvirus family of dsDNA viruses, is present in more than two-thirds of the population and typically causes manageable disease in individuals with responsive immune systems. However, in immunosuppressed and immunocompromised transplant recipients, CMV is a major cause of morbidity and mortality.
"Morbidities and organ loss due to CMV have become a significant medical issue as the frequency of organ transplantation has increased and new immunosuppressive regimes have been introduced," said George Painter, Ph.D., President and Chief Executive Officer. "CMX001 has demonstrated broad-spectrum activity in preclinical tests against double-stranded DNA viruses - including CMV - and has been well-tolerated to date among volunteers and patients. We believe that with this combination of potent antiviral activity and tolerability, CMX001 will prove to be a powerful new treatment option for the transplant population and their physicians."
The Phase 2 clinical study is being conducted at approximately 25 leading academic and medical research centers in the United States. Enrollment in the study is under way and will include approximately 120 patients. Study participants will receive CMX001 once weekly following stem cell engraftment through post-transplant week 13, and will be monitored for CMV disease and viremia. Participants will also be monitored for other dsDNA viruses susceptible to CMX001, including adenovirus, BK virus, and Epstein Barr virus. Safety assessments will be conducted throughout the study.