CMV Treatment Granted Orphan Drug Designation by FDA

Viralym-C is a ready-to-administer T cell immunotherapy product
Viralym-C is a ready-to-administer T cell immunotherapy product

ViraCyte has announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to its candidate cytomegalovirus (CMV) treatment, Viralym-C.

Viralym-C is a ready-to-administer T cell immunotherapy product, specifically intended to treat CMV in severely compromised patients. It is 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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“In our Phase I clinical trial (# NCT02313857), all 8 patients who previously failed conventional therapy had positive clinical responses to Viralym-C, including 6 patients who were completely cleared of the virus,” said Dr. Sunitha Kakarla, PhD, program manager at ViraCyte, speaking about the trial's interim results. ViraCyte expects to complete the Phase 1 trial in early 2017, and begin advanced trials immediately thereafter. 

The Orphan Drug designation for Viralym-C follows the FDA's decision earlier this month to grant Viralym-C Fast Track status. 

For more information visit Viracyte.com.