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news.The US Food and Drug Administration (FDA) has accepted Ziopharm Oncology's investigational new drug (IND) application for the oral dosing of palifosfamide.
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Palifosfamide (Zymafos or ZIO-201) is a novel DNA cross-linker that in preclinical study has shown to bypass resistance mediated by aldehyde dehydrogenase (ALDH), in addition to conferring a favorable toxicity profile compared to other in-class agents.
Palifosfamide, administered intravenously, is currently in a randomized, double-blinded, placebo-controlled Phase 3 trial for the treatment of metastatic soft tissue sarcoma in the front-line setting.
The company is also currently completing a Phase 1 study of palifosfamide in combination with standard of care for addressing small cell lung cancer (SCLC).
Palifosfamide is also entering into an adaptive Phase 3 trial in extensive SCLC, and is expected to start in the second half of 2012.
Ziopharm CEO Jonathan Lewis said oral administration could be ideal for treating children with cancer and for allowing outpatient treatment, particularly in emerging markets where IV hospital administration is either not practical, cost-effective, or even possible.