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Ontak (denileukin diftitox) Achieves 49.1% Overall Response Rate in,Phase III Trial of Cutaneous T-Cell Lymphoma (CTCL)

Preliminary Results of Largest Randomized, Placebo-controlled Trial Ever Conducted in CTCL Presented at the American Society of Clinical Oncology

CHICAGO, June 04, 2007 /PRNewswire/ -- Preliminary results of the largest randomized, placebo-controlled clinical trial ever conducted in patients with cutaneous T-cell lymphoma (CTCL) showed that ONTAK was more than twice as effective as placebo in eliciting a clinical response in patients with CTCL. [Abstract number 8026] The primary endpoint of this study was to measure the total percentage of documented responders based on improvement in tumor burden in skin, blood and lymph nodes in each treatment arm, confirmed over three consecutive cycles. Secondary endpoints included progression-free survival, which is defined as the time from the first day of treatment to the first observation of tumor progression or death due to any cause up to 30 days after the last dose of study drug. The results were presented here today at the annual meeting of the American Society of Clinical Oncology (ASCO).

ONTAK is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the IL-2 receptor. The safety and efficacy of denileukin diftitox in patients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor have not been examined. ONTAK was granted accelerated approval in February 1999.

CTCL is a rare disease in which certain cells of the lymph system known as T lymphocytes become cancerous and affect the skin. CTCL can progress to the lymph nodes, spleen, liver and other organs. About 10% of CTCL sufferers will experience progressive disease with lymph node and/or internal involvement with serious complications. There is no known cure for CTCL.

"The preliminary results of this study show that ONTAK achieved its primary endpoint, which was t
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