Largest clinical study ever involving patients with cutaneous T-cell lymphoma on schedule for completion in June 2010
RADNOR, Pa., June 29 /PRNewswire/ -- Yaupon Therapeutics, a privately held specialty pharmaceutical company, has announced it has completed enrollment for a pivotal Phase 2 clinical trial for Clearazide for the treatment of early-stage cutaneous T-cell lymphoma (CTCL - stages 1-2a). The study, which is being conducted under a Special Protocol Assessment (SPA) with the FDA, has enrolled 260 patients in 13 of the top cancer centers in the US. Yaupon expects the last patient to complete treatment in the study by June of 2010 and, assuming positive results, will file its NDA shortly thereafter.
The randomized, double-blind, controlled clinical study is the largest ever undertaken involving patients with cutaneous T-cell lymphoma. Over one percent (1%) of all people with CTCL in the United States have enrolled in the study. There are approximately 16,000 to 20,000 patients with CTCL in the United States and each year approximately 2,000 people are newly diagnosed with the disease. If approved by FDA, Clearazide would be the first new therapy available for the treatment of early-stage CTCL in almost a decade.
"Cutaneous T-cell lymphoma, like all cancers, is a terrible burden on families worldwide. Completion of patient enrollment in this landmark study is a major milestone in our efforts to advance Clearazide through regulatory approval and to help patients with CTCL. We look forward to completing this study and filing our NDA next year," said Robert J. Alonso, Chief Executive Officer of Yaupon.
Cutaneous T-cell lymphoma is a cancer of the T-lymphocytes in the skin. Early-stage CTCL (stages 1-2a) is the most common presentation of the cancer and affects roughly 67% of the 20,000 patients with the disease. CTCL is a low-grade lymphoma and usually develops very slowly. It
|SOURCE Yaupon Therapeutics|
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