ViraCyte Announces Positive Phase 2 Trial Results

ViraCyte announced publication of 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", 3rd party T-cell product that can simultaneously treat up to five viral infections in patents with severely depressed immune systems. In this report, Dr. Ifigeneia Tzannou and colleagues describe 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% overall clinical response after a single infusion and demonstrated efficacy against all five targeted viruses with the following cumulative response rates in infections refractory to standard therapy: 100% for BK virus (n=16), 94% for cytomegalovirus (n=17), 71% for adenovirus (n=7), 100% for Epstein-Barr virus (n=2) and 67% for human herpesvirus-6 (n=3). Thirty-one patients were treated for a single viral infection and seven patients 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 resolved with standard treatment.