US FDA grants orphan status for Ziopharm's Zinapar; approves manufacturing plan for Bionovo's Menerba

The US Food and Drug Administration has granted Orphan Drug designation for Ziopharm Oncology’s (Nasdaq; ZIOP) Zinapar (darinaparsin, or ZIO-101) for the treatment of peripheral T-cell lymphoma (PTCL).

"Peripheral T-cell lymphomas represent a distinct subgroup of aggressive lymphomas that have been ignored in most lymphoma studies, creating a population whose treatment needs remain largely unaddressed in the front line setting,” said James Armitage, Professor of Internal Medicine, Division of Hematology and Oncology, University of Nebraska Medical Center, quoted by Ziopharm. "Darinaparsin has demonstrated early signs of activity and tolerability in this population, with a mechanism of action that differentiates it from other existing therapeutic options,” he added.

Ziopharm reported favorable results from a Phase II trial with IV-administered darinaparsin in lymphoma, particularly PTCL, at the 2009 Annual Meeting of the American Society of Clinical Oncology. 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 PTLC, to confirm the tolerability of the combination.