- ZIOPHARM Oncology (ZIOP) perks up 5% premarket on light volume on the heels of its announcement that it has received FDA guidance from an End-of-Phase 2 meeting regarding lead gene therapy candidate Ad-RTS-hIL-12, in combination with orally administered veledimex, for the treatment of an aggressive type of brain cancer called recurrent glioblastoma (GBM).
- The company plans to advance the gene therapy, which utilizes its RheoSwitch platform, into Phase 3 development this year. It will release details about the protocol design after completed discussions with clinical advisors and regulators.
- Ad-RTS-hIL-12 is a novel gene therapy candidate for the controlled expression of interleukin-12 (IL-12), an essential protein for stimulating a T cell immune response to cancer. Veledimex is an oral activator ligand or "gene switch" which is used to control the expression of IL-12, a pro-inflammatory cytokine that produces serious side effects if over-expressed.