Ziopharm granted orphan designation for palifosfamide

The orphan drug designation provides eligibility for a seven-year period of market exclusivity in the US after product approval, an accelerated review process, grant funding, tax benefits and an exemption from user fees.

Jonathan Lewis, CEO of Ziopharm, said: “Palifosfamide has demonstrated activity against sarcomas in heavily pre-treated patients as well as evidencing fewer side effects than similar treatments used in this setting. We are pleased to have received orphan drug designation and look forward to continuing to work closely with the FDA in advancing palifosfamide toward commercialization.”