Ziopharm glioblastoma program gets FDA fast track designation
Ziopharm Oncology’s (NASDAQ:ZIOP) controlled IL-12 program received FDA fast track designation for the treatment of recurrent or progressive glioblastoma multiforme (rGBM) in adults.
Controlled IL-12 consists of IL-12 gene therapy delivered to the tumor site, followed by oral administration of 20 mg of veledimex, which dose-dependently activates IL-12 expression.
“This investigational drug has the potential to safely harness the power of interleukin-12, which in turn activates the patient’s own immune system to attack this cancer and extend overall survival,” Laurence Cooper, CEO of Ziopharm, said in a statement.
Phase 1 data demonstrated that the controlled IL-12 program improves median overall survival (mOS) to 12.7 months from the six-to-nine months seen with available therapies.
Ziopharm is currently monitoring 51 rGBM patients treated with controlled IL-12, veledimex and low-dose systemic steroids, which could extend mOS. The company anticipates reporting on preliminary data from this sub-study in 2019.