• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

ZIO-101 (Darinaparsin) Phase I Advanced Solid Tumor Data Presented at ASCO

Posted on: Saturday, 2 June 2007, 15:00 CDT

ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), announced today the presentation of ZIO-101 (darinaparsin) Phase I data at the 2007 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The poster presented in the Developmental Therapeutics poster discussion session entitled, "Organic arsenic in advanced cancers: Preliminary Phase 1 results of ZIO-101(S-dimethylarsino-glutathione)" was presented by Luis H. Camacho, M.D., M.P.H., University of Texas M. D. Anderson Cancer Center and principal investigator. Darinaparsin is a novel organic arsenic with a multifaceted mechanism of action with preclinical activity previously demonstrated in multiple in vitro and animal models.

The presentation reports results from 37 out of 40 patients (3 patients ongoing) with advanced cancers. Patients received darinaparsin in doses that started at 78 mg/m2 for 5 consecutive days every 4 weeks with dose levels increased in successive cohorts of ≥3 patients per dose level. Therapy was continued until toxicity, disease progression, or completion of 6 cycles. Darinaparsin was well tolerated and the Dose Limiting Toxicity was transient and reversible ataxia and confusion. Most importantly, there was no clinically relevant QTc prolongation or bone marrow suppression. Eighteen patients had advanced colorectal cancer and 4 of these had stable disease. Some of the other tumor types with activity signals included liver metastasis from pancreas cancer (significant reduction in liver metastasis and overall mixed response) and renal cancer (two of three patients with stable disease).

Primary endpoints in the open-label, dose escalation study were to determine toxicities, maximum tolerated dose (MTD), and pharmacokinetic (PK) profile in patients with advanced solid tumors when administered intravenously once daily for 5 consecutive days every 4 weeks. The secondary endpoint was to assess preliminary anti-tumor effects.

"I am greatly encouraged by these results in the Phase I setting, particularly regarding the combination of safety and therapeutic signals," commented Dr. Camacho and principal investigator. "Given the long reported stories of successful arsenic treatment for liver cancer in China, these important safety results from our Phase I trial strongly support the Phase II trial underway in this and other indications."

ZIOPHARM is now enrolling patients in three Phase II trials for the treatment of multiple myeloma, 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 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.

ZIOP-G

Source: Business Wire

More News in this Category