ZIOPHARM Oncology Says Cancer Drug Promising - Stocks To Watch
10/14/2009 9:00:34 AM(RTTNews) ZIOPHARM Oncology, Inc. (ZIOP) said interim data showed that a mid-stage study evaluating its cancer drug reached a key efficacy milestone. Following a safety and efficacy data review by experts, the company said it has reached a formal decision to stop further enrollment in the trial.
The drug being evaluated is palifosfamide, targeting unresectable or metastatic soft tissue sarcoma, a cancer that can develop from soft tissues such as fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues and cannot be removed through surgery.
In the trial, patients received doxorubicin – the only FDA approved agent in sarcoma or a combination of palifosfamide with doxorubicin. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed for progression-free survival based on a three month median follow-up time.
The hazard ratio is 0.67 favoring palifosfamide + doxorubicin, the company noted. In cancer research, hazard ratios are often used in clinical trials to measure survival at any point in time in a group of patients who have been given a specific treatment compared to a control group given another treatment or a placebo. A hazard ratio of one means that there is no difference in survival between the two groups. A hazard ratio of greater than one or less than one means that survival was better in one of the groups, according to the National Institute of Cancer.
The company also said the addition of palifosfamide does not add to the toxicity of doxorubicin and that Palifosfamide is usually easily administered as an out-patient treatment, and generally well-tolerated.
“The interim results are promising and supportive of a pivotal trial,” said Robert Maki, co-leader of the adult sarcoma program at Memorial Sloan-Kettering Cancer Center, and current President of the Connective Tissue Oncology Society, a multidisciplinary sarcoma specialty group.
by RTT Staff Writer
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