Viralym-C Granted Fast Track Status for Refractory CMV Infection
ViraCyte announced that the Food and Drug Administration (FDA) has granted Fast Track designation to its T cell immunotherapy, Viralym-C, for the treatment of refractory cytomegalovirus (CMV) infections in patients following a stem cell transplant.
The Company is currently investigating Viralym-C in a Phase 1 clinical trial which is expected to conclude in early 2017. Interim results from the study, presented at the American Society of Hematology Annual Meeting in December 2016, showed that Viralym-C achieved a positive clinical response in all 7 CMV patients treated, and was shown to be safe and well tolerated. Six of the 7 patients, all of whom failed conventional treatment, showed a complete elimination of the infection.
Viralym-C (virus-specific lymphocytes against CMV) is a ready-to-administer T cell immunotherapy made up of a generated bank of third-party, partially HLA-matched CMV-directed T cells that have been activated from CMV exposure.
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