Ziopharm said the FDA granted Fast Track designation for its Ad-RTS-hIL-12 plus veledimex, which is being evaluated for the treatment of recurrent or progressive glioblastoma multiforme, or rGBM in adults.
Ad-RTS-hIL-12 plus veledimex is being tested for several indications, and for rGBM, it is being evaluated in an early stage study.
Why It's Important
The cancer of the central nervous system is often life-threatening, has few treatment options and no cure.
The Fast Track designation facilitates the development and expediting of the review of drugs to treat serious conditions. It bestows several benefits such as frequent meetings and communications with the FDA, and if relevant criteria are met, allows accelerated approval, priority review or rolling review of a BLA.
Ziopharm recently expanded the Phase 1 trial evaluating its Ad-RTS-hIL-12 plus veledimex monotherapy for the treatment of rGBM. The company is monitoring a total of 51 patients with rGBM treated with a 20mg veledimex dose and to assess the impact of systemic dosing of steroids.
The company expects to report preliminary data from the sub-study at medical meetings this year.
Ziopharm shares were up 3.38 percent at $3.98 at the time of publication Monday.
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