Indibulin is one of a class of cancer therapeutics that includes the taxanes (paclitaxel and docetaxel) and Vinca alkaloids, some of the most widely used anti-cancer agents in the world today. In spite of their effectiveness, all of the commercially available agents exhibit some degree of neurotoxicity that in many cases can be dose limiting.
Indibulin, like the taxanes and vinca alkaloids, interferes with the function of microtubules by binding to their building blocks, tubulin. However, the specific tubulin binding site for indibulin is different from that of taxanes and Vinca alkaloids. The observed lack of neurotoxicity in animals receiving indibulin treatment is thought to be related to this difference in binding site, and in particular to the observation that indibulin does not bind to neuronal-specific tubulin. Indibulin is active across a diverse range of human, mouse, and rat tumor cell lines in vitro and in human tumor xenografts, including glioblastoma and in drug-resistant tumor cell lines.
"We are very excited about indibulin's potential," commented Brian Schwartz, M.D., Chief Medical Officer at ZIOPHARM. "The fact that it is orally available and shows no signs of the neurotoxicity in preclinical models associated with other agents i n this class is particularly intriguing. If no neurotoxicity is seen in ongoing clinical trials, indibulin will clearly distinguish itself from other marketed agents in this class."
ZIO-301 (indibulin) is a novel synthetic anti-mitotic agent that binds to tubulin, destabilizes microtubulin polymerization, and arrests tumor cell growth at the G2/M phase. Microtubulins are well-established targets for anti-cancer drug development and tubulin-binding drugs such as taxanes and Vinca alkaloids are currently widely used to treat cancer. Indibulin is in a phase I dose-ranging and safety study in Europe. The Company expects to begin phase I/II trials in the U.S. soon.
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 risk s 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.