The Fast Track program of FDA has been designed to develop and expedite the review of drugs for the treatment of serious conditions and complete an unmet medical need.
The clinical stage immuno-oncology company, Ziopharm Oncology, Inc., which develops next-gen gene and cell therapies, has announced to have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its Ad-RTS-hIL-12 plus veledimex (Controlled IL-12 program) to treat progressive or recurrent glioblastoma multiforme (rGBM) in grown-up adults.
According to the press release by ZiopharmOncology, Ad-RTS-hIL-12 program with 20 mg veledimex helps to improve themedian overall survival (mOS) from 6-9 months to 12.7 months, as well asimprove mOS to 17.8 months in a subset of subjects with decrease in cumulativesteroid exposure during veledimex’s active dosing period.
Laurence Cooper, M.D and Ph.D., CEO, Ziopharm, stated that recurrent glioblastoma multiforme is a cancer of the central nervous system which is aggressive and life-threatening. There are few or no treatment options available to cure this cancer. Cooper further stated that the company is pleased the FDA has granted Fast Track designation and believed the potential of its investigational drug to safely leverage the strength of interleukin-12, which subsequently activate the immune system of patient to attack the cancer and extend overall survival.
The Fast Track program of FDA has been designed to develop and expedite the review of drugs for the treatment of serious conditions and complete an unmet medical need. The Fast Track Designation granted drug may be eligible for several benefits, including more frequent communications and meetings with the FDA, and if standards are met, the potential for Priority Review or Rolling Review and Accelerated Approval of a Biologics License Application (BLA).
For the record, Ziopharm Oncology, an immuno-oncology firm, specializes in development of economical solutions for CAR T-cell and TCR therapies, and immune-stimulating gene therapy utilizing its non-viral Sleeping Beauty platform with Controlled interleukin 12 (IL-12).