September 23, 2010
Orphan drug designation granted to Zinapar for peripheral T-cell Lymphoma (PTCL)ZIOPHARM was granted orphan drug designation by the FDA for Zinapar (darinaparsin or ZIO-101) for the treatment of peripheral T-cell Lymphoma (PTCL). Peripheral T-cell Lymphoma represents a subgroup of aggressive lymphomas that develop from T-cells in different stages of maturity. ZIOPHARM previously reported favorable results from a Phase 2 trial with IV-administered Zinapar in lymphoma, particularly PTCL. ZIOPHARM expects to begin enrolling patients in a Phase 1 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. Subject to the outcome of this Phase 1 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.
Zinapar is a novel mitochondrial-targeted agent (organic arsenic) being developed for the treatment of various hematologic and solid cancers.
For more information call (646) 214-0700 or visit www.ziopharm.com.