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June 8, 2009
Keryx reported positive results from a phase II trial of perifosine for the treatment of colon cancer. This US, randomized, double-blind, placebo-controlled study enrolled 38 subjects with 2nd or 3rd line metastatic colon cancer. The subjects received capecitabine (Xeloda; standard of care) at a dose of 825 mg/m2 twice daily (total daily dose of 1650 mg/m2) on days 1-14 every 21 days, plus either perifosine or placebo at 50 mg daily. Treatment continued until disease progression. Of the 38 enrolled subjects, 35 were evaluable for response. The primary endpoints were time to progression (TTP), overall response rate (ORR) and the clinical benefit rate (CBR). The median time to progression was 28.9 weeks in the perifosine/capecitabine arm compared to 11 weeks in the capecitabine /placebo arm (p-value&equiv0.0006). In addition, perifosine/capecitabine more than doubled the ORR and almost doubled the Clinical Benefit Rate versus capecitabine/placebo. Treatment was well tolerated.
June 1, 2009
The Burzynski Research Institute reported positive results from a phase II trial of antineoplaston (ANP) therapy for the treatment of colon cancer. This study enrolled 65 subjects with metastatic colon cancer at the Kurume University School of Medicine, Japan. The subjects were randomized to receive intrahepatic infusion of 5-FU or intrahepatic infusion of 5-FU plus intravenous (IV) ANP therapy. ANP therapy consisted of a 50-100 g IV infusion of Antineoplaston A10 given daily for seven days following hepatic resection and 10 g of oral Antineoplaston AS2-1 given daily for one year. The primary endpoint was the difference in overall survival between the two groups. The five-year survival rate was significantly higher in the 5-FU plus ANP therapy arm, at 62% versus 32% in the 5FU-only arm. The mode of recurrence was also different in the two study arms. In the 5FU-only arm, recurrences affected multiple organs in 69% of the subjects, while in the 5-FU plus ANP therapy arm, recurrences affected multiple organs in only 34% of subjects. This provided for a higher complete second resection rate in the 5-FU plus ANP therapy arm (61% versus 35%).