RESEARCH TRIANGLE PARK, NC, March 9, 2010 – 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.
About CMX001
CMX001 is a new chemical entity created by applying Chimerix’s PIM (Phospholipid Intramembrane Microfluidization) conjugation technology to chemically modify cidofovir, an approved antiviral agent requiring intravenous administration, to produce a highly potent and well-tolerated oral antiviral with broad-spectrum activity.
The enhanced antiviral activity of CMX001 has been characterized in both in vitro and in vivo studies. In clinical testing to date, CMX001 has shown oral bioavailability in humans and has demonstrated a positive safety profile. In cell culture assays, CMX001 is significantly more active than cidofovir against numerous dsDNA families of viruses including orthopoxviruses, herpesviruses and multiple adenoviruses. CMX001 is initially being developed for both commercial and medical preparedness uses. In addition to the Phase 2 clinical trial in stem cell transplant recipients, Chimerix is conducting a multi-dose Phase 1 clinical trial of CMX001 in transplant recipients with BK viruria, which like CMV can cause serious complications in immunocompromised patients.
