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
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).