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ZIOPHARM Announces Interim Results in ZIO-101 Phase I Solid Tumor Cancer Trial; Clinical Activity in Several Cancers

Posted on: Friday, 2 June 2006, 15:00 CDT

ZIOPHARM Oncology, Inc. (OTC BB: ZIOP) announced today publication of an abstract discussing interim results of an ongoing phase I solid tumor cancer trial with its lead product candidate, ZIO-101, a novel organic arsenic. Six of 24 patients treated (number updated after abstract submission) had clinical benefit. Five have stable disease including 2 each with renal cell cancer and colorectal cancer, and 1 with head and neck cancer. One of these with previously rapidly progressing metastatic renal cell cancer had complete resolution of a brain metastasis and stable disease elsewhere. A sixth with pancreas cancer had a mixed response with a substantial decrease of a liver metastasis. The abstract is published in the 2006 American Society of Clinical Oncology Annual Meeting Proceedings and is available online.

In abstract 13041 titled "Phase I Trial of ZIO-101, a novel organic arsenic, in patients with advanced cancers," Luis Camacho, M.D. and colleagues at The University of Texas M. D. Anderson Cancer Center discusses clinical and pharmacokinetic data. The preliminary results show ZIO-101 is well-tolerated at daily doses greater than 50-fold higher than those approved by the U.S. Food and Drug Administration for arsenic trioxide.

"These interim results with ZIO-101 are encouraging, particularly in light of the relative lack of toxicity," commented Dr. Camacho. "I am optimistic about the early signs of clinical activity and look forward to definitively establishing the maximum tolerated dose and exploring new schedules."

ZIO-101 is a small molecule licensed from The University of Texas M. D. Anderson Cancer Center and Texas A&M University. ZIO-101 is also in phase I/II studies in patients with advanced myeloma. The Company expects to initiate an additional phase II study in other blood and bone marrow cancers and to explore alternative dosing schedules in the near future. The Company anticipates reporting final data from the study reported here at upcoming medical meetings.

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.

Source: Business Wire

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