FDA assigns orphan drug designation to ZIOP's drug candidate Print E-mail
By Staff and Wire Reports   
Thursday, 23 September 2010 08:28

Shares of  ZIOPHARM Oncology, Inc., (NASDAQ:ZIOP) the company focused on licensing and development of small molecule drug candidates that are related to cancer therapeutics already on the market were up in pre-market trading to $4.07, +0.09, (+2.26%) after it was announced that the FDA has granted Orphan Drug Designation to darinaparsin (Zinapar(TM) or ZIO-101) for the treatment of peripheral T-cell Lymphoma (PTCL).

The Orphan Drug designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, an accelerated review process, accelerated approval where appropriate, grant funding, tax benefits and an exemption from user fees.

Company officials said they expect 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.

"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, MD, Professor of Internal Medicine, Division of Hematology and Oncology, University of Nebraska Medical Center. "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."

On the advice of leading hematology experts and subject to the outcome of this Phase I study and further dialogue with the U.S. Food and Drug Administration, 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. There are currently no FDA-approved therapies for the front-line treatment of advanced PTCL, a setting where the National Comprehensive Cancer Network (NCCN) guidelines recommend the use of experimental drugs.

ZIOPHARM is currently enrolling patients in a randomized, double-blinded, placebo-controlled Phase III trial of intravenous palifosfamide used in the treatment of metastatic soft tissue sarcoma in the front-line setting. Their operations are located in Boston, MA with an executive office in New York City.




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