The first poster, presented on Tuesday June 26th by Larry Boise, PhD from the Sylvester Comprehensive Cancer Center at the University of Miami highlighted preclinical data demonstrating darinaparsin (ZIO-101) may have activity in myeloma patients who have already been treated with and no longer respond to arsenic trioxide.
The second poster, presented today by James R. Berenson, M.D., Berenson Oncology, Inc., West Hollywood, CA, and principal investigator, reiterates interim phase II data from two ongoing studies recently presented at the American Society of Clinical Oncology (ASCO) Meeting in Chicago. The two ongoing phase II studies are evaluating the preliminary efficacy and safety profile of different treatment schedules (5 consecutive days every four weeks; twice weekly for 3 weeks, every four weeks) in patients with advanced/progressive myeloma (patients to date have had a median of 7 prior therapies). As reported, of the 14 patients treated 5 consecutive days, there are 10 patients evaluable for efficacy, with 4 out of the 10 (40%) achieving stable disease greater than 4 months duration. Data from the twice weekly study is not yet evaluable (3 patients treated). Darinaparsin has been well tolerated and no clinically relevant QT prolongation, bone marrow suppression or neuropathy has been observed with either treatment schedule.
"With the passage of time it bec omes ever clearer that progressive steps in the treatment of myeloma are going to be made with agents that are complimentary to the current standard of care," commented Dr. Berenson. "With its unique mechanism of action, coupled with a continued benign safety profile, we are hopeful that darinaparsin will find a place in our treatment armamentarium."
Preclinical studies in myeloma cell lines have indicated synergy of darinaparsin with Velcade(R), which would serve as the basis for exploring the use of darinaparsin in a combination clinical study. This study is in the advanced stages of planning. The Company is also in late stage planning to extend the twice weekly myeloma trial to Eastern Europe in order to treat patients with less advanced disease.
ZIOPHARM is also enrolling patients in phase II trials of darinaparsin for the treatment of primary liver cancer and diverse hematological cancers. Phase I trials with an oral form of darinaparsin are expected to be underway soon. For more details on these trials please see www.clinicaltrials.gov.
About Darinaparsin (ZIO-101)
Darinaparsin is a proprietary small molecule organic arsenic licensed from The University of Texas M. D. Anderson Cancer Center and Texas A&M University. Darinaparsin induces cell cycle arrest and cell death by targeting several cellular pathways essential for cell survival. Exposure to darinaparsin has a direct as well as indirect effect on mitochondrial functions, resulting in depletion of energy supply to the cell and induction of apoptosis (programmed cell death). Increase in intra-cellular Reactive Oxygen Species enhances this effect on mitochondrial functions and consequently the activation of the signal transduction pathway leading to apoptosis. In addition, darinaparsin interrupts the cell cycle at the G2/M phase of tumor cells inducing cell death through this pathway.
About ZIOPHARM Oncology, Inc.
ZIOPHARM Oncology, Inc. is a biopharmaceutical c ompany 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.