ViraCyte Completes Phase 1 Clinical Trial of Viralym-C
- Category: DNA RNA and Cells
- Published on Wednesday, 12 July 2017 10:16
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HOUSTON, TX, USA I July 11, 2017 I ViraCyte, LLC, a clinical stage biopharmaceutical company developing cellular immunotherapies for severe infections, today announced the successful completion of a Phase I clinical trial using Viralym-C, a "ready to administer" T cell immunotherapy product for the treatment of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant (HSCT) recipients. Viralym-C received Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration earlier this year.
The open-label, fixed-dose Phase 1 clinical study (NCT02313857) evaluated the safety and preliminary efficacy of Viralym-C banked allogeneic CMV-specific T cells in a total of 10 adult and pediatric HSCT recipients with refractory CMV infections that failed conventional antiviral therapy. ViraCyte's proprietary algorithms for donor selection and patient treatment enabled the use of only eight "ready to administer," cryopreserved cell banks to match all HSCT patients referred for therapy. In these patients, aged 3-70 years, Viralym-C was well-tolerated with no severe adverse events reported. One patient developed a mild and transient fever following infusion which resolved spontaneously.
Based on viral load and/or clinical signs and symptoms, Viralym-C controlled infections within six weeks of infusion for all ten patients with drug-refractory CMV infection. Eight patients received only a single infusion, and two patients required two infusions for sustained benefit. One patient with CMV retinitis had complete resolution of disease after Viralym-C infusion. Dr. Brett Giroir, M.D., President and Chief Executive Officer, said, "Combined with our previously reported data using multi-virus specific T cells (Viralym-M) in Phase 2 trials, this study provides additional confirmation of the safety and efficacy of T cell therapy for life threatening viral infections in patients following stem cell transplantation."
About ViraCyte, LLC
ViraCyte's current products restore natural immunity against life threatening viruses in patients with severely weakened immune systems, such as adults and children who have recently undergone a hematopoietic stem cell transplant (HSCT). ViraCyte's lead T cell products are in Phase 1 and Phase 2 clinical trials, with effectiveness rates of greater than 90% in patients who have failed conventional therapy. More information can be found at www.viracyte.com
ViraCyte is a resident company at JLABS @ TMC, Houston, Texas.