Data presented at ISH yesterday highlighted that ZIO-201 was 10 to 30 fold more active than IFOS in most in vitro and in vivo models of lymphoma. ZIO-201 also killed IFOS-resistant lymphoma in cancer-bearing mice. In a phase I clinical study, there was little bone marrow toxicity and no hemorrhagic cystitis (bladder toxicity) or central nervous system (CNS) toxicity (confusion). The dose limiting toxicity was characterized by renal electrolyte imbalances. The maximum dose administered was equivalent to high-dose IFOS. Because of the modest bone marrow toxicity, ZIO-201 can be given to patients with bone marrow failure, an important distinction from IFOS in the treatment of patients with lymphoma. A phase II study of ZIO-201 in the treatment of lymphoma will begin later this year.
"These results with ZIO-201 are encouraging," commented Dr. Brian Schwartz, Chief Medical Officer at ZIOPHARM. "Avoiding the more serious toxicities associated with the administration of ifosfamide in addition to having the potential to treat resistant lymphoma patients with ZIO-201 could be an important step forward in r ealizing the broader therapeutic potential for this novel agent."
ZIO-201, the active moiety of IFOS, is a bi-functional alkylator that causes irreparable inter-strand DNA cross-linking resulting in cell death. ZIO-201 is equal to or more active than IFOS in diverse cancer models. Unlike IFOS which is a pro-drug, ZIO-201 is directly active against cancer cells. Also, unlike IFOS, ZIO-201 is not metabolized to acrolein or chloracetaldehyde which cause bladder or central nervous system toxicities. ZIO-201 continues in a phase I trial in diverse cancers exploring maximum tolerated dose at alternate schedules. A phase II trial in advanced sarcoma continues to enroll patients. Trials in lymphoma and pediatric cancers are in the advanced planning stage. An oral form of ZIO-201 is in advanced preclinical development.
About ZIOPHARM Oncology, Inc.
ZIOPHARM Oncology, Inc. is a biopharmaceutical company engaged in the development and commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer drugs to address unmet medical needs. The Company applies new insights from molecular and cancer biology to understand the efficacy and safety limitations of approved and developmental cancer therapies and identifies proprietary and related molecules for better patient treatment. For more information, visit www.ziopharm.com.
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