The United States Patent and Trademark Office (USPTO) has granted US patent No. 8,232,262 to Ziopharm Oncology, Inc. The patent entitled "Salts of Isophosphoramide Mustard and Analogs Thereof as Anti-Tumor Agents" with claims directed to pharmaceutical compositions, methods of treatment and methods of making a novel DNA cross-linker, including palifosfamide (ZIO-201). This newly issued patent provides subject matter exclusivity through 2027.
The patent estate covering palifosfamide compositions, formulations, methods of use and methods of manufacture now includes issued patents in the United States, Australia, Europe, New Zealand and South Africa, as well as pending applications in the United States and various foreign jurisdictions.
Palifosfamide (ZIO-201), a novel DNA-targeted cancer treatment that bypasses drug resistance mediated by ALDH (aldehyde dehydrogenase), an enzyme associated with cancer stem cells, and has a favorable toxicity profile.
Ziopharm is evaluating palifosfamide in an international, randomized, double-blinded, placebo-controlled phase 3 trial in first-line metastatic soft tissue sarcoma referred to as the PICASSO 3 Study. The company is also evaluating palifosfamide in a pivotal Phase 3 study in first-line metastatic small cell lung cancer. Orphan Drug Designation for the treatment of soft tissue sarcoma has been obtained for palifosfamide in both the United States and the European Union.
"The issuance of this patent further strengthens our US patent position for our lead candidate, palifosfamide, which already has composition of matter exclusivity through 2029," said Caesar J. Belbel, executive vice president and chief legal officer of Ziopharm. "The further strengthening of our robust patent portfolio specifically for this compound is important to Ziopharm as we move forward with pivotal and other studies in soft tissue sarcoma, small cell lung cancer and other potential indications."
Ziopharm Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies.