ZIOPHARM Oncology (NASDAQ: ZIOP) today announced the initiation of a randomized, open label Phase 2 clinical study of Ad-RTS IL-12 in combination with palifosfamide to treat patients with non-resectable recurrent or metastatic breast cancer.
The two-part, multi-center U.S. study will enroll up to 68 patients with non-resectable, recurrent or metastatic breast cancer who have visible lesions or lesions accessible by injection. The study is designed to assess the safety and efficacy of the drug combination of Ad-RTS IL-12 and palifosfamide. Ad-RTS IL-12 is a targeted and controlled DNA-based therapeutic designed to express interleukin-12 (IL-12), a protein important for an immune response to cancer. Palifosfamide is a potent bi-functional DNA alkylating agent.
Part one of the two-part study will consist of a safety assessment for Ad-RTS IL-12 and palifosfamide, alone or in combination. Part two will consist of an efficacy evaluation of the Ad-RTS IL-12 only arm and the combination arm. The primary endpoint of the study is rate of progression-free survival at 16 weeks. Secondary endpoints include objective response rate, duration of response and evaluation of pharmacodynamic tumor markers.
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