Ziopharm Oncology (NASDAQ:ZIOP) reported a clinical victory Monday, with news that the US Food and Drug Administration awarded fast-track status to its controlled IL-12 program or Ad-RTS-hIL-12 plus veledimex, to treat recurrent or fast-growing brain tumors.
The FDA’s fast-track program quickens the pace of the development and review of drugs to treat serious conditions. And if awarded the designation, companies are offered more frequent meetings with the FDA and their chosen drug has more potential for accelerated approval or a priority review.
The clinical data suggest Ad-RTS-hIL-12 with 20mg veledimex improves the median overall survival of a patient with a brain tumor.
Investors applauded the results, sending Ziopharm shares up 3.4% to $3.98 in afternoon trade Monday.
“Recurrent glioblastoma multiforme is an aggressive and life-threatening cancer of the central nervous system for which there are few treatment options and no cure,” said Dr. Laurence Cooper, CEO of Ziopharm.
“We are pleased the FDA has granted Fast Track designation and continue to believe 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,” Cooper added.
The Boston company has treated more than 100 patients, including more than 75 patients with glioblastoma multiforme, with Ad-RTS-hIL-12 plus veledimex, building evidence of its anti-tumor effects.
Ziopharm Oncology is an immuno-oncology company focused on battling cancer via its non-viral Sleeping Beauty platform for T-cell receptors and CAR T-cell therapies and immune-stimulating gene therapy.
Contact Ellen Kelleher at email@example.com