Palifosfamide (Zymafos) effective to treat sarcomas

Palifosfamide (Zymafos), a new treatment which shows potential to treat soft tissue sarcoma is currently undergoing clinical trials.

The experimental drug Palifosfamide (Zymafos) will be tested at approximately 150 centers in North America, Europe, South America, Australia, Israel and Korea under a clinical trial programme termed PICASSO 3.

The study will estimate the safety and efficacy of the new treatment in as many as  424 patients with metastatic soft tissue sarcoma who have never been treated with chemotherapy for metastatic disease.

The efficacy levels of palifosfamide will be compared when administered with doxorubicin – another drug currently used to treat soft tissue sarcoma.

“Metastatic soft-tissue sarcoma is a disease for which we have seen few advances in treatment and no U.S. regulatory approvals in over two decades. Palifosfamide has demonstrated promising activity and tolerability in Phase II, including a clinically meaningful improvement in PFS [progression free survival], ” stated Dr. Robert Maki, immediate past president of CTOS (Connective Tissue Oncology Society) and Co-leader of Adult Sarcoma Disease Management Team at Memorial Sloan-Kettering Cancer Center, New York, USA .

Palifosfamide (Zymafos), which has been developed by Ziopharm  has Orphan Drug status in both Europe and the United States.

Palifosfamide (Zymafos or ZIO-201) references a novel composition (tris formulation) that comprises the functional active metabolite of ifosfamide, a standard of care for treating sarcoma, lymphoma, testicular, and other cancers. Palifosfamide delivers only the cancer fighting component of ifosfamide. It is expected to overcome the resistance seen with ifosfamide and cyclophosphamide, two of the most commonly used DNA-alkylating drugs used to treat cancers.

Orphan Drug designation is granted to medicines intended for treatment of life-threatening or chronically debilitating pathologies that affect no more than 5 in 10,000 people .

The designation could accelerate the approval process of the sarcoma medicine.

Soft tissue sarcomas are cancers of the body’s soft tissues, including cartilage, muscle, fat, nerves, blood vessels and other connective tissue. Sarcomas may develop in any part of the body, but are most common in the trunk, arms and legs. No new therapies have been approved for use in sarcoma in the U.S. in over 20 years.