ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that Dr. Claire Verschraegen of the University of New Mexico, Albuquerque and first author of the abstract, "A phase II randomized controlled trial of palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO)," (Abstract #10004) presented in an oral session today updated positive data from PICASSO. The presentation was part of the 46th Annual American Society of Clinical Oncology (ASCO) meeting being held in Chicago, IL, from June 4th to 8th. The abstract has also been selected as part of the 2010 Best of ASCO® which features high-impact abstracts from the ASCO Annual Meeting that represent the most relevant, cutting-edge science in oncology today.
“We are very thankful to all who have contributed to the success of the PICASSO study and preparation for the initiation of the Phase III trial (PICASSO III)”
"The conclusions from the PICASSO study are that palifosfamide in combination with doxorubicin is well tolerated, easy to administer and can be given in the outpatient setting, and is active in soft tissue sarcoma," commented Dr. Verschraegen. "We look forward to the initiation of the pivotal Phase III study, which is designed based on the PICASSO study, and pending regulatory clearance by FDA through the Special Protocol Assessment process."
As previously announced, a total of 67 patients with soft tissue sarcoma (STS) were randomized with 66 treated and 62 eligible for evaluation. The study was powered to show a difference in progression free survival (PFS) between doxorubicin in combination with palifosfamide versus doxorubicin alone. The initial analysis demonstrated that the hazard ratio (HR) met the specified endpoint and after consultation with the Data Committee, independent sarcoma experts, and the Medical Advisory Board, enrollment was stopped and results were subsequently reported at the 2009 CTOS Annual Meeting. A second and subsequent analysis was conducted for an end-of-Phase-II meeting with the Food and Drug Administration (FDA) and those data were reported in the recently published ASCO abstract.
The updated study results presented to the FDA reported a hazard ratio of 0.43 favoring the palifosfamide combination with a statistically significant and clinically meaningful 3.4 month difference in median PFS. An analysis of the same data, presented today, consisting of those patients receiving either doxorubicin or doxorubicin in combination with palifosfamide for 6 cycles or less (the standard treatment period for doxorubicin) reported a hazard ratio of 0.39s Syndrome.
"We are very thankful to all who have contributed to the success of the PICASSO study and preparation for the initiation of the Phase III trial (PICASSO III)," added Jonathan Lewis, MD, PhD, of ZIOPHARM.
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