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news.Gilead Sciences has announced the dosing of first patient in a Phase III clinical trial evaluating GS-1101 (formerly CAL-101) for the treatment of chronic lymphocytic leukemia (CLL).
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The Study 116, a randomized, double-blind study, will enroll 160 patients to evaluate the utility of GS-1101 in combination with various chemoimmunotherapies in previously treated CLL patients.
The primary efficacy endpoint of the placebo controlled study is the progression-free survival.
Gilead oncology and inflammation therapeutics senior vice president Roy Baynes said, "Based on the promising clinical data we’ve seen thus far, we believe GS-1101 could represent a much needed advance in the treatment of CLL and we look forward to working with study investigators to further our understanding of this potentially important new therapy."
GS-1101 is an investigational, specific inhibitor of the phosphoinositide-3 kinase delta isoform.