ViraCyte Announces Positive Phase 2 Trial Results
ViraCyte LLC, a clinical stage biopharmaceutical company developing cellular immunotherapies for severe infections, reported positive data from a Phase 2 clinical trial evaluating its T-cell immunotherapy product, Viralym-M. The results were reported by ViraCyte lead investigators at Baylor College of Medicine in the Journal of Clinical Oncology.
Viralym-M is an “off-the-shelf”, third party T-cell product that can simultaneously treat up to five viral infections in patents with severely depressed immune systems. In this report, Ifigeneia Tzannou, M.D., and colleagues described administration of Viralym-M in 38 stem cell transplant patients with 45 different viral infections. All patients had either failed, not responded to or were unable to tolerate standard antiviral therapy.
Viralym-M achieved a 92 percent overall clinical response after a single infusion and demonstrated efficacy against all five targeted viruses. Thirty-one patients were treated for a single viral infection and seven were treated for multiple simultaneous infections. Notably, rapid disease alleviation was reported in patients with BK-associated hemorrhagic cystitis (BK-HC), which can cause incapacitating pain, significant blood loss and potentially renal failure. There are no current FDA-approved therapies for BK-HC. Viralym-M infusions were safe with only two cases of new onset grade 1 graft-versus-host disease observed, both of which were resolved with standard treatment.