Palifosfamide Approved for the Study of Treatment for Soft-Tissue Sarcoma

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ZIOPHARM Oncology has announced that the United States Patent and Trademark Office has issue a patent for its new cancer drug palifosfamide (ZIO-201). The medication will be used in a trial for a rare cancer known as soft-tissue sarcoma as well as for metastatic small cell lung cancer.

Soft-Tissue Sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body. Tumors can form almost anywhere, but are most common in the arms and legs. Sarcomas often first appear as a painless lump under the skin. Those that begin in the abdomen may not cause symptoms until they are very large. Because these tumors can be hard to diagnoses, they often metastasize to other parts of the body before a person even knows they have cancer.

ZIOPHARM’s palifosfamide is a novel DNA-targeted cancer treatment that bypasses drug resistance mediated by ALDH, an enzyme associated with cancer stem cells. The IV form of the drug is currently being studied in a randomized, double-blinded, placebo-controlled Phase 3 trial known as PICASSO 3 as a first-line treatment for metastatic soft-tissue sarcoma. It will also be used in a Phase 3 trial known as MATISSE for first-line treatment for metastatic small cell lung cancer.

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Zymafos (the brand name for palifosfamide) is composed of the active metabolite of ifosfamide (IFOS). These types of molecules play a major role in the treatment of unresectable sarcoma, per a paper by the Liddy Shriver Sarcoma Initiative. The drug is thought to hinder tumor cell growth by impacting the DNA of the tumor cells, thus leading to apoptosis (cancer cell death).

Palifosfamide has already obtained Orphan Drug Designation in both the United States and the European Union. In addition to the IV drug, the company is also working on the development of an oral capsule form.

The Sarcoma Foundation of America notes that there are about 12,000 new cases of sarcoma diagnosed each year. But although soft-tissue sarcomas account for less than 1% of all cancers, the percentage of cancer-related deaths worldwide is high because although early state STS is generally curable, many of the tumors are not found until the patient develops metastasis. Patients diagnosed with metastatic disease only have a statistical median survival of 8 to 12 months.

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References:
ZIOPHARM Oncology Inc, Boston MA
The Liddy Shriver Sarcoma Initiative, “PALIFOSFAMIDE - A NOVEL MOLECULE FOR THE TREATMENT OF SOFT TISSUE SARCOMA (STS): A PRIMER” BY ROBERT G. MAKI MD PHD, ROBERT A. MORGAN MS, AND JONATHAN J. LEWIS MD PHD.

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