Ziopharm Oncology, Inc. announced that the Japanese Patent Office has issued a patent, Patent No. 4,571,408, with claims covering pharmaceutical compositions, including oral formulations, of various organic arsenic compounds, including darinaparsin (Zinapar or ZIO-101), and the use of these compositions and the organic arsenic compounds for the treatment of cancer, including as part of a combination therapy.
Ziopharm recently announced that it has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for darinaparsin in the treatment of peripheral T-cell Lymphoma (PTCL). Darinaparsin demonstrated favourable results in a phase II trial in lymphoma, particularly PTCL.
The company expects to begin enrolling patients imminently in a phase I study of darinaparsin in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone), the current standard of care for front-line PTCL, to confirm the tolerability of the combination. Subject to the outcome of this study and further dialogue with the FDA, the company expects to move forward with a registration study of the darinaparsin and CHOP combination for the front-line treatment of PTCL in late 2011. Ziopharm has also recently reinitiated a phase I study of oral darinaparsin in advanced solid tumours.
Palifosfamide (Zymafos or ZIO-201) is a novel DNA cross-linker in class with bendamustine, ifosfamide, and cyclophosphamide. Ziopharm is currently enrolling patients in a randomized, double-blinded, placebo-controlled phase III trial with palifosfamide administered intravenously for the treatment of metastatic soft tissue sarcoma in the front-line setting. The company expects to initiate additional studies in the near-term, including a phase I IV study of palifosfamide in combination with standard of care addressing small cell lung cancer and a Phase I study of oral palifosfamide.
Darinaparsin (Zinapar or ZIO-101) is a novel mitochondrial-targeted agent (organic arsenic) being developed intravenously for the treatment of peripheral T-cell lymphoma with a pivotal study expected to begin in late 2011, following the outcome of a supporting trial. An oral form is in a phase I trial in solid tumours.
Indibulin (Zybulin or ZIO-301) is a novel, oral tubulin binding agent that targets both mitosis and cancer cell migration. Indibulin is expected to have several potential benefits including oral dosing, application in multi-drug resistant tumors, no neuropathy and minimal overall toxicity. It is currently being studied in phase I/II in metastatic breast cancer.
Ziopharm Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer drugs.