The US Food and Drug Administration (FDA) has accepted the investigational new drug application for Ziopharm Oncology’s oral Palifosfamide (Zymafos or ZIO-201), which is used as a treatment for metastatic soft tissue sarcoma.
Palifosfamide is an innovative DNA cross-linker in class with bendamustine, ifosfamide, and cyclophosphamide.
In a preclinical study, Palifosfamide has been shown to bypass resistance mediated by aldehyde dehydrogenase (ALDH), while providing a favourable toxicity profile compared with other in-class agents.
Currently, Palifosfamide is being investigated as an intravenous form in a randomised double-blinded placebo-controlled Phase 3 trial, for the treatment of metastatic soft tissue sarcoma in the front-line setting, known as the PICASSO 3 study.
The company is also completing a Phase 1 study, designed to evaluate the safety and efficacy of Palifosfamide in combination with carboplatin and etoposide (PaCE); this will be for addressing small cell lung cancer (SCLC), as well as other cancers. It plans to start an adaptive Phase 3 trial of Palifosfamide in extensive SCLC in the second half of this year.
Ziopharm Oncology chief executive officer 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."
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Ziopharm Oncology is a biopharmaceutical company, focused on the development and commercialisation of small molecule and synthetic biology approaches to new cancer therapies.
The patient enrolment for the PICASSO 3 study is likely to be completed by the end of the first quarter of 2012.
In both US and the European Union, Palifosfamide has received orphan drug status for the treatment of soft tissue sarcoma. Ziopharm was granted a European patent allowance for Palifosfamide in December 2011.