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Improved Survival in Phase III Trial of Sarcoma Drug Palifosfamide
According to a recent announcement, a phase III trial of intravenous (IV) palifosfamide (ZIO-201, Ziopharm Oncology) as first-line treatment for metastatic soft-tissue sarcoma has reached its target number of progression-free survival (PFS) events.
The PICASSO 3 trial is a randomized, double-blind, placebo-controlled study with PFS as the primary endpoint. In accordance with the protocol and statistical plan, reaching the target number of PFS events led to completion of the blinded data collection process. Topline results are expected to be announced during the last week of March 2013.
Palifosfamide (ZIO-201) is a bifunctional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. The drug is in the same class as bendamustine, cyclophosphamide, and ifosfamide.
In addition to the PICASSO 3 study in patients with soft-tissue sarcoma, IV palifosfamide is being studied in a pivotal phase III trial (MATISSE) for the first-line treatment of metastatic small-cell lung cancer (SCLC).
An oral capsule form of the drug is also being developed.
Source: Ziopharm Oncology; February 12, 2013.