Cell Therapeutics Inc is to begin Phase III clinical trials with lisofylline, its proprietary supportive care oncology product.
The randomized, double-blind, placebo-controlled pivotal trial will be conducted in multiple centers and will enroll an estimated 106 patients with advanced hematological malignancies who are currently undergoing allogenic bone marrow transplantation from sibling donors. Approximately equal numbers of patients will be allocated to both the lisofylline-treated and the placebo groups.
Lisofylline's primary activity as an adjunctive cancer therapy is to inhibit the production of inhibitors of hematopoiesis, such as transforming growth factor beta, tumor necrosis factor and MIP-1-alpha, post chemotherapy, although it also has other beneficial effects.
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