Gilead commences GS-1101 Phase 3 trial in CLL

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the first patient has been dosed in a Phase 3 clinical trial evaluating the efficacy and safety of GS-1101 (formerly CAL-101). GS-1101 is an investigational, first-in-class specific inhibitor of the phosphoinositide-3 kinase (PI3K) delta isoform and is being evaluated in combination with rituximab in previously treated chronic lymphocytic leukemia (CLL) patients. The Phase 3 trial (Study 116) will enroll 160 patients at approximately 70 sites in the United States and Europe.    

"Initiation of our first Phase 3 study in oncology is an important step as we seek to develop therapies across a broad range of cancers," said Roy D. Baynes, MD, PhD, Senior Vice President, Oncology and Inflammation Therapeutics at Gilead. "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."

CLL is a type of cancer in which the bone marrow overproduces lymphocytes, leaving less room in the blood and bone marrow for other blood cells. CLL is the second most common form of leukemia, according to the National Cancer Institute, which estimates there will be 16,000 new diagnoses and approximately 4,500 deaths in the United States from the disease in 2012.

Study 116 is the first of several planned Phase 3 studies exploring the utility of GS-1101 in combination with various chemoimmunotherapies in previously treated CLL patients. A Phase 3 study examining GS-1101 in combination with bendamustine and rituximab is anticipated to begin enrolling patients later this quarter. A third study evaluating GS-1101 in combination with ofatumumab is anticipated to begin enrollment in the second half of this year.

GS-1101 is also in Phase 2 evaluation as a potential treatment for indolent non-Hodgkin's lymphoma (iNHL).