CytImmune Sciences has received notification from the FDA to begin a Phase I clinical trial to evaluate the safety, pharmacokinetics and clinical benefit of its lead drug candidate, CYT-6091, a TNF-bearing pegylated colloidal gold nanoparticle, in patients with advanced cancer.
Up to 42 patients with advanced cancer whose disease has failed to respond to existing therapies or where no approved therapy is available may be enrolled in the study. The intravenously administered, dose- escalation study will be conducted at the National Cancer Institute in Bethesda, Md.