ZIOPHARM Oncology Announces Orphan Drug Designation for Ad-RTS-hIL-12 in the Treatment of Malignant Glioma Print E-mail
By William Kent   
Friday, 24 July 2015 14:57

Biopharmaceutical firm ZIOPHARM Oncology Inc.(NASDAQ:ZIOP) Oncology has confirmed that U.S. Food and Drug Administration (FDA) has given approval to Orphan Drug Designation for Ad-RTS-hIL-12 + veledimex in treating the ones who suffer from malignant glioma.

 

Ad-RTS-hIL-12 is novel gene therapy that would be for controlled expression of IL-12, a key protein for stimulating anti-cancer T cell immune response.

 

FDA's Office of Orphan Products gives orphan drug status for supporting development of medicines for underserved patient populations that impact less than 200,000 people. The U.S. Orphan Drug Designation gives eligibility for seven-year period of market especially in US after approval of the product.

 

Laurence J. N. Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, opined that bad glioma is aggressive cancer having less treatment options. Cooper added that the designation supports the effort for advancing Ad-RTS-IL-12, a novel immuno-oncology therapy that showed promising preclinical efficacy in brain cancer.

 

He stated that enrollment in Phase 1 study is doing well and it is looking forward to early results from the clinical trial later in the year.

 

Ad-RTS-hIL-12 + veledimex is now in Phase 1 trial designed to examine a gene therapy treatment strategy for high grade gliomas, with aim of getting an anti-tumor T cell immune response. The first objective of study is to assess and determine the safety and tolerability of a single intra-tumoral Ad-RTS-hIL-12 injection plus escalating oral veledimex doses. Secondary objectives are to determine the veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 and veledimex, and investigator assessment of response, including the tumor objective response rate and progression-free survival, and determine overall survival, among other measures. The study is expected to enroll up to 72 subjects at up to 12 leading treatment centers.




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