Biogen Idec Initiates Phase III Trial of Galiximab for Follicular Non-Hodgkin's Lymphoma

29-Jan-2007

Biogen Idec announced that it has initiated a Phase III randomized, double-blind study of an investigational anti-CD80 monoclonal antibody, galiximab, for patients with lymphoma. The trial will compare treatment with galiximab in combination with rituximab (RITUXAN®) to rituximab in combination with placebo in patients with follicular non-Hodgkin's lymphoma (NHL) that has relapsed or failed to respond to initial therapy.

The study is a registrational clinical trial being conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA) in July 2006. The study enrolled the first patient in November 2006 at Loyola University Medical Center in Chicago, Ill. The study will ultimately enroll approximately 700 patients worldwide at more than 150 centers.

"The median survival time for patients with follicular non-Hodgkin's lymphoma is 7-10 years, and relapses are common, therefore, we're aiming to delay progression as long as possible," said Patrick Stiff, M.D., the director of Loyola University Medical Center's Cardinal Bernardin Cancer Center, and professor of medicine and pathology at Stritch School of Medicine, Loyola University Chicago. "Galiximab may offer an additional therapeutic option for patients, particularly for patients who have failed or relapsed on other therapies."

Because the CD80 target is found uniformly on Reed-Sternberg cells, the malignant component of Hodgkin's disease, as well as the majority of non-Hodgkin's lymphomas, the company will explore expanded proof-of-concept clinical trials, which will begin in 2007, for other indications.

https://www.bionity.com/en/news/61292/biogen-idec-initiates-phase-iii-trial-of-galiximab-for-follicular-non-hodgkin-s-lymphoma.html