Timothy M. Shannon, M.D., Executive Vice President and Chief Medical Officer of CuraGen commented, "Treatment of ovarian cancer cell lines with belinostat, both as a single agent and in combination with carboplatin and paclitaxel, represented some of our more compelling preclinical data. It is gratifying to see this research translating into potential clinical benefit for patients with advanced ovarian cancer. We look forward to continuing to generate data in ovarian cancer and determining potential registrational opportunities based on the results in the second half of this year."
CLN-4: Phase Ib/II trial evaluating intravenous belinostat in combination with 5-fluorouracil (5-FU)
Phase Ib dose-escalation results on 25 patients with advanced solid tumors were presented at ASCO and indicate that the combination of intravenous belinostat plus 5-FU is generally well tolerated. Two dose limiting toxicities, including one Grade 3 stomatitis and one Grade 3 angina were reported in the highest dose group evaluating 1000 mg/m2/day belinostat plus 1000 mg/m2/d 5-FU. All patients received extensive pre- and post-treatment ECG monitoring with no Grade 3 QTc prolongation noted.
Of the 23 evaluable patients, a total of seven patients achieved SD (range 2 - 8 cycles), with 2 patients currently on treatment, and no objective responses noted. No consistent effect has been seen on the expression of thymidylate synthase (TS) in peripheral blood mononuclear cells from this population. Enrollment of patients is continuing into the 1000 mg/m2/d belinostat and 500 mg/m2/d 5-FU dose cohort. Six additional patients are planned to be enrolled at this dose to determine whether there is any effect on the expression of TS in tissue samples.
Conference Call Details and Dial-in Information Date: Tuesday, June 12, 2007 Time: 8:30 a.m. ET Dial-in: 877-272-5391 (domestic)
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