Ziopharm Oncology (NASDAQ:ZIOP) has been granted orphan drug designation by the US FDA for darinaparsin, a drug used for the treatment of peripheral T-cell Lymphoma (PTCL), an aggressive cancer of the lymphatic system, it said Thursday.
At the 2009 Annual Meeting of the American Society of Clinical Oncology, Ziopharm reported favorable results from a Phase II trial with IV-administered darinaparsin in lymphoma, particularly PTCL.
The company expects to begin enrolling patients immediately for a new Phase I study of darinaparsin in combination with CHOP, the current treatment for patients with PTLC, as a way to test the tolerability of the combination, it said.
Depending on the outcome of this study and on further discussions with the US FDA, Ziopharm plans to move forward with a registration study for the drug combination for treatment of PTCL in late 2011.
Peripheral T-cell Lymphoma is a type of aggressive lymphoma that develops from T-cells in different stages of maturity. According to the Lymphoma Research Foundation, PTCL accounts for approximately 10-15% of the estimated 66,000 new cases of non-Hodgkin's lymphoma diagnosed every year in the Unites States.
The disease generally affects people over the age of 60, and is diagnosed in more men than women.
There are currently no FDA-approved therapies for the treatment of advanced PTCL, as the National Comprehensive Cancer Network recommends the use of experimental drugs at this stage.
The Orphan Drug designation will provide Ziopharm with the 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.
Boston-based Ziopharm develops and commercializes a portfolio of cancer drugs. The company is currently focused on two clinical programs aside from darinaparsin: Palifosfamide, treatment for sarcoma, lymphoma, testicular, and other cancers; and Indibulin, an oral agent that targets both mitosis and cancer cell migration.
Disclosure: no positions