First Patient Dosed in Phase III Trial for CAL-101

Biotech firm Gilead Sciences Inc. has announced that the first patient has been dosed in a Phase III trial evaluating the safety and efficacy of the company's experimental drug for the treatment of chronic lymphocytic leukemia, GS-1101 (formerly, and more popularly known as CAL-101).

GS-1101 is an investigational, first-in-class specific inhibitor of the phosphoinositide-3 kinase (PI3K) delta isoform and is being examined in combination with Rituxan in patients with previously treated chronic lymphocytic leukemia (CLL).

This Phase III trial (Study 116) has an enrollment target of 160 patients across 70 sites in the United States and Europe.

Said Roy D. Baynes, MD, PhD, Senior Vice President, Oncology and Inflammation Therapeutics at Gilead, “Initiation of our first Phase III study in oncology is an important step as we seek to develop therapies across a broad range of cancers. 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.”

Source: Therapeutics Daily