ZIOPHARM Presents ZIO-201 Lymphoma Data at ISH
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 realizing 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.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements for ZIOPHARM Oncology, Inc. that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of the Company's development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of the Company's product candidates, the risk that the results of clinical trials may not support the Company's claims, and risks related to the Company's ability to protect its intellectual property and its reliance on third parties to develop its product candidates. The Company assumes no obligation to update these forward-looking statements, except as required by law.
Posted: March 2007