This is absurd. Doxy curve is well known. You can't just pull 8 patients off a study then say the lines will match and call it a day. And he calls himself a doctor? Who is this guy? If Pali didn't get in cells, why would the guy that got IFOS approved for TC want to use it? Why wouldn't it work as a control in BC? Senseless drivel. While statistical anomalies are always a danger in this sport, after many years I've found it best to follow the data and the math. I believe Lewis and Ziopharm have done that as near as I can tell. If I was sure of a short position
Phase II results supportive of positive Phase III outcome
Ziopharm conducted a randomized, controlled Phase II trial (PICASSO; NCT00718484) evaluating palifosfamide in patients with soft tissue sarcoma. The trial enrolled 67 patients randomized (1:1) to receive treatment with palifosfamide (150mg/m2) in combination with doxorubicin (75 mg/m2) or doxorubicin alone. Patient demographics and baseline characteristics were similar in both arms with no notable imbalances. The median age was 57 years in both arms with approximately two thirds of patients over 65 years. Roughly 70% of patients were treatment naïve and 30% had received prior therapy. The trial was powered to demonstrate a PFS hazard ratio of 0.75 and, given the cross over design, a difference in overall survival was not expected between treatment arms.
Results from the trial were presented at CTOS in 2009 and ASCO in 2010. The ASCO presentation included data from 62 eligible patients evaluated for PFS. There were a total 28 confirmed PFS events included in the analysis. The trial demonstrated a statistically significant improvement in PFS with palifosfamide, with a hazard ratio of 0.43 (95% confidence interval 0.19-0.95, p=0.019). Treatment with palifosfamide resulted in a median PFS benefit over doxorubicin of 3.4 months, with a median PFS of 4.4 months in the doxorubicin alone arm and 7.8 months in the palifosfamide plus doxorubicin.