November 15, 2002
Phase II data support Cell Therapeutics’ (NASDAQ: CTIC) ongoing phase II and III efforts to bring Xyotax to market for the treatment of women with ovarian cancer. Dr. Paul Sabbatini from Memorial Sloan-Kettering Cancer Center presented data at the plenary session of the 20th annual Chemotherapy Foundation Symposium. The results were from a study of 100 heavily pretreated women with recurrent ovarian cancer who had failed one or more treatments with paclitaxel and platinum-based agents.
For taxane-sensitive study subjects who had failed one or two regimens, 8 of 25 (32%) demonstrated a partial remission, and another 8 of 25 (32%) achieved stable disease after Xyotax administration. For subjects who had failed three or more regimens, 2 of 24 (8%) had a partial remission and 10 of 24 (42%) achieved stable disease. For patients with platinum resistant/refractory ovarian cancer who had failed one or two prior regimens, 3 of 20 (15%) achieved a partial remission and 4 of 20 (20%) achieved stable disease. For those who failed three or more regimens, 1 of 29 (3%) achieved a partial remission and 12 of 29 (41%) achieved disease stabilization.
Another phase II study has been initiated that will assess higher dose, third-line Xyotax for less heavily pretreated women with refractory ovarian cancer. Xyotax is also slated for a 12-month, 1,000-patient, phase III trial to be initiated in 2003 for the first-line treatment of ovarian cancer.
Xyotax combines paclitaxel, the active ingredient in Taxol, with a biodegradable polyglutamate polymer. Preclinical investigation suggests that the polymer enhances tumor tissue targeting at the expense of non-tumor tissue targeting. Such preferential targeting may both increase the conjugate’s therapeutic effects and diminish its toxic adverse effects. Xyotax trials are ongoing over a broad spectrum of solid tumor indications. Available data are limited, but there is some suggestion that solid tumor response rates will translate into quality of life or survival advantages, at least in some populations.
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