Press Release: Biogen Idec Initiates Phase III Trial of Galiximab for Follicular Non-Hodgkinâ€™s Lymphoma
Biogen Idec Initiates Phase III Trial of Galiximab for Follicular Non-Hodgkinâ€™s Lymphoma CAMBRIDGE, Mass. -- Biogen Idec today 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 (RITUXANÂ®) to rituximab in combination with placebo in patients with follicular non-Hodgkinâ€™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. â€œThe median survival time for patients with follicular non-Hodgkinâ€™s lymphoma is 7-10 years, and relapses are common, therefore, weâ€™re aiming to delay progression as long as possible,â€ said Patrick Stiff, M.D., the director of Loyola University Medical Centerâ€™s Cardinal Bernardin Cancer Center, and professor of medicine and pathology at Stritch School of Medicine, Loyola University Chicago. â€œGaliximab may offer an additional therapeutic option for patients, particularly for patients who have failed or relapsed on other therapies.â€ Because the CD80 target is found uniformly on Reedâ€“Sternberg cells, the malignant component of Hodgkinâ€™s disease, as well as the majority of non-Hodgkinâ€™s lymphomas, the company will explore expanded proof-of-concept clinical trials, which will begin in 2007, for other indications. â€œGaliximab represents a new approach with the potential to benefit patients with NHL,â€ said David Parkinson, senior vice president, Oncology Research and Development, Biogen Idec. â€œGaliximab, together with our anti-CD23 monoclonal antibody (lumiliximab) for chronic lymphocytic leukemia, demonstrates Biogen Idecâ€™s leadership in development of therapies for hematological malignancies. The safety profile of galiximab in the early studies, along with its hypothesized novel mechanism with RITUXAN, suggests the potential for a new era of combination antibody therapies as treatments for lymphoma.â€ About the Study The TARGET NHL Trial (Targeted Antibody Therapy with RITUXAN and Galiximab Efficacy Trial) is a randomized, double-blind, global multi-center study (114-NH-301) of galiximab in combination with rituximab compared with rituximab in combination with placebo. The primary study objective is to compare the clinical benefit of each treatment arm in subjects with relapsed or refractory, follicular NHL. Progression-free survival (PFS) is the primary study endpoint. An open-label retreatment study (114-NH-302) with galiximab in combination with rituximab, will be available to subjects who progress on 114-NH-301 after experiencing at least a partial response (PR) with a time to progression (TTP) of six months or greater in either arm of the study. About Non-Hodgkin's Lymphoma Non-Hodgkinâ€™s lymphoma (NHL), a cancer affecting the lymphatic system, has had the second-fastest rate of increase of all malignancies in the United States. The incidence has nearly doubled over the past 30 years. It is estimated that 360,000 Americans are currently living with NHL, and about 58,000 new cases are expected to occur in the United States this year. Of those diagnosed with NHL, about 30 percent of patients have a slow-growing but incurable (low-grade) form of the disease â€“ the most common type is called follicular lymphoma (FL). Although FL progresses slowly, it is ultimately fatal with a median survival time of 7-10 years. In addition, relapse is common, and less than half of FL patients who experience a relapse will survive for five years. About Biogen Idec Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com. Biogen Idec Safe Harbor This press release contains forward-looking statements regarding the development of galiximab and as a potential treatment for various indications. These statements are based on the companies' current beliefs and expectation. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the companies' current expectations include: the risk that unexpected concerns may arise from additional data or analysis, that regulatory authorities may require additional information, further studies, or may fail to approve the drug, or that the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the periodic reports of Biogen Idec Inc. filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.