CMV Prevention Drug Fast-Tracked by FDA

Chimerix Inc. announced that the FDA has granted Fast Track designation for CMX001 for the prevention of cytomegalovirus (CMV) infection. CMX001 is a broad spectrum, oral nucleotide analog lipid-conjugate that blocks the replication of double-stranded DNA (dsDNA) viruses including cytomegalovirus (CMV), adenovirus (AdV), BK virus and herpes simplex virus.

Phase 2 clinical development of CMX001, for the prevention of CMV infection in adult hematopoietic stem cell transplant (HSCT) recipients, has been completed. Chimerix is planning on initiating SUPPRESS, a Phase 3 study of CMX001 for the prevention of CMV infection in adult HSCT recipients in 2013. Previously, Chimerix has received Fast Track designation for its CMX001 development programs for preemptive treatment of adenoviral disease in patients post HSCT and for the treatment of smallpox.

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