Ziopharm Oncology (NASDAQ:ZIOP) traded higher Thursday after announcing Orphan Drug Designation of its drug used as a potential treatment for peripheral T-cell Lymphoma.
The Food & Drug Administration granted the designation, which is given as treatments for diseases that affect less than 200,000 people in the United States, to Ziopharm's darinaparsin.
The approval provides eligibility for a seven-year period of market exclusivity after product approval, accelerated FDA review process, grant funding and tax benefits.
James Armitage, MD, professor of internal medicine in the division of hematology and oncology at the University of Nebraska Medical Center, said that peripheral T-cell lymphomas represent a small subgroup of aggressive lymphomas that have often been ignored general lymphoma studies.
The often neglected lymphomas have created a “population whose treatment needs remain largely unaddressed in the front line setting,” he said.
“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,” Armitage said.
Ziopharm reported last year favorable results from a Phase II trial with IV-administered darinaparsin in lymphoma, particularly PTCL.
The company said it expects in late 2011 to begin enrolling patients in a Phase I study of the drug in combination with CHOP, the current standard of care for front lien PTLC, to confirm to tolerability of the combination.
There are currently no FDA-approved therapies for the front-line treatment of advanced PTCL.