US FDA gives Ziopharm go-ahead to test oral cancer drug
This article was originally published in Scrip
Cancer drug maker Ziopharm Oncology said the US FDA accepted the New York firm's investigational new drug application (IND) to test oral dosing of palifosfamide (ZIO-201), a novel DNA cross-linker, which is in class with bendamustine, ifosfamide and cyclophosphamide.
An intravenous (IV) formulation of palifosfamide currently is being evaluated in a randomized, double-blinded, placebo-controlled Phase III trial, known as PICASSO 3, as a treatment for metastatic soft tissue sarcoma in the front-line setting. That formulation also is completing a Phase I study in solid tumours, including small-cell lung cancer (SCLC), and is entering into an adaptive Phase III trial in extensive SCLC, which is expected to initiate in the second half of this year, according to Ziopharm.
Clinical study with the oral formulation, tested preclinically in multiple tumour types, is expected to follow, the firm reported.
Ziopharma CEO Dr Jonathan Lewis said the oral formulation would offer patients the advantage of being treated in the outpatient setting.
"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," he explained.
Dr Lewis also said an oral formulation of palifosfamide would provide his firm with a broader range of development options.
In preclinical testing, palifosfamide was shown to bypass resistance mediated by aldehyde dehydrogenase, in addition to conferring a favourable toxicity profile, compared with other in-class agents.