Ziopharm Oncology, Inc, announced that the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion regarding Ziopharm 's application for orphan medicinal product designation for palifosfamide in the treatment of soft tissue sarcoma (STS).

In the European Union (EU), products targeted to treat life-threatening or very serious conditions that affect fewer than five in 10,000 people are eligible for orphan medicinal product designation. Such status provides significant advantages and assistance in obtaining final approval to market palifosfamide in the EU. These include: Ten year market exclusivity in the EU once the product is approved; direct assistance from the EMEA in preparing the final protocol for drug approval; access to EMEA centralized filing procedures for approval in the EU; and, reduced fees for EMEA filings.

"There is a significant unmet need for additional treatments to address soft tissue sarcoma beyond locally effective surgery," said Jonathan Lewis, MD and chief executive and medical officer of Ziopharm . "We are pleased to so soon have orphan drug status in Europe to augment the Orphan Drug Designation received in the United States earlier this year as we initiate patient treatment in our phase-II randomized controlled trial in STS."

Palifosfamide (IPM), the active moiety of ifosfamide (IFOS), is a bi-functional alkylator that causes irreparable inter-strand DNA cross-linking, resulting in cell death.

Ziopharm Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer drugs.