ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it has received an allowance from the European Patent Office for Patent Application No. 05 821 125.1, entitled "Salts of Isophosphoramide mustard and analogs thereof as anti-tumor agents" with claims directed to pharmaceutical compositions of a novel DNA cross-linker (stabilized active metabolite of ifosfamide), including palifosfamide (Zymafos® or ZIO-201) and their use in treating cancer. A counterpart patent in the United States was issued in March 2010, with rights extending to 2029. The patent estate covering palifosfamide compositions, methods of use and methods of manufacture now include 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 is currently being evaluated in an international, randomized, double-blinded, placebo-controlled Phase 3 trial in front-line metastatic soft tissue sarcoma referred to as the PICASSO 3 Study. Palifosfamide is also being evaluated in a Phase 1 study in combination with the standard of care for addressing small cell lung cancer, and in an oral form in preclinical studies. Orphan Drug Designation for the treatment of soft tissue sarcoma has been obtained for palifosfamide in both the United States and the European Union.
ZIOPHARM has also been granted Patent No. 2005274926 by the Australian Patent Office covering a crystalline form of darinaparsin (Zinapar® or ZIO-101), pharmaceutical compositions containing such compounds, and methods for their use in treating cancer. Darinaparsin is a novel mitochondrial- and hedgehog-targeted agent currently in a solid tumor Phase 1 study with oral administration. Orphan Drug Designation for the treatment of peripheral T-cell lymphoma has been obtained for darinaparsin in the United States and Europe.
"We greatly value a strong intellectual property estate," commented Caesar Belbel, Chief Legal Officer of ZIOPHARM. "Both this allowance and recent issuance are evidence of our continued execution of global development programs."