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

More Articles

More Articles

Amazon.com is pleased to have the Lymphoma Information Network in the family of Amazon.com associates. We've agreed to ship items...

The question ought to be what are myelodysplastic syndromes (MDS), since this is a group of similar blood and bone marrow diseases that...

Merkel Cell Carcinoma (MCC) is a very rare and aggressive skin cancer that usually develops when a person is in his or her 70s. It is...

Radiation Therapy Topics

...

At some point, the Seattle biotech company Cell Therapeutics Inc (CTI) should earn an entry in the Guinness Book of World Records for utter and...

Site Beginnings

This site was started as Lymphoma Resource Page(s) in 1994. The site was designed to collect lymphoma...

Three papers appearing in the journal Blood and pointing towards a regulator-suppressor pill could offer hope to blood cancer...

The US Food and Drug Administration (FDA) has granted a third so-called Breakthrough Therapy Designation for the investigational oral...

The US Food and Drug Administration today has approved an expanded use of Imbruvica (ibrutinib) in patients with...

The U.S. Food and Drug Administration has announced that it has granted "Breakthrough Therapy Designation" for the investigational agent...

According to a new study published in the Proceedings of the National Academy of Sciences, a team from the University of California, San...

Pharmacyclics has announced that the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for...

New research suggests that frontline radioimmunotherapy...

Gilead Sciences has announced results of the company's Phase II study of its investigational compound idelalisib, an oral inhibitor of...

Sitemap