Data from Phase II Clinical Trial of Galiximab in Combination with Rituximab in Patients with Previously Untreated Follicular Lymphoma Presented at International Conference on Malignant Lymphoma

Business Wire, June 7, 2008

LUGANO, Switzerland -- The Cancer and Leukemia Group B (CALGB) today announced data from a phase II clinical trial showing that 70 percent of patients with previously untreated follicular lymphoma responded to treatment with galiximab, an investigational anti-CD80 monoclonal antibody, when given in combination with rituximab. Of the 61 patients in the study, 44 percent achieved a complete response and 26 percent had a partial response. The data were presented at the 10th International Conference on Malignant Lymphoma (ICML).

The results of this open label study suggest that adding galiximab to rituximab may be a promising regimen for patients with follicular lymphoma (FL), a common type of non-Hodgkin lymphoma (NHL), and that further study is warranted. The objective of the CALGB-coordinated study is to determine the overall response rate (ORR) and time-to-progression of the disease after treatment with a combined regimen of galiximab and rituximab. At this point, however, it is too early to assess the time-to-progression endpoint.

"Most non-Hodgkin lymphoma patients receive rituximab, either as a single agent or in combination with chemotherapy," said Myron Czuczman, M.D., Roswell Park Cancer Institute, principal investigator of this study. "Now, 'biologic' agents are being studied in combination to assess the efficacy of dual antibody therapies as potential alternatives to chemotherapy-based regimens."

Patients enrolled in the study had been diagnosed with CD20-positive FL but had not received treatment for the disease. Study patients were given galiximab plus rituximab together once a week for four weeks and then every two months for the next eight months. This "extended induction" schedule was chosen based on results from an earlier Swiss (SAKK) trial using the same schedule with single-agent rituximab. Thirteen percent of patients reported a grade 3 adverse event; no grade 4 toxicities were associated with this combination immunotherapy regimen.

Galiximab is an anti-CD80 monoclonal antibody that has been studied as a single-agent in previously treated FL and in combination with rituximab against relapsed FL. The CD80 molecule is found on the surface of activated macrophages, dendritic cells and cells from various subtypes of NHL. Galiximab's potential mechanisms of action include Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and possible immunomodulatory effects on host effector cells affecting the tumor microenvironment.

The trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health and was led by CALGB, which is one of NCI's Cooperative Clinical Trials Groups. In addition to this trial, CALGB is planning to study galiximab as a single agent in a proof-of-concept trial in relapsed Hodgkin lymphoma. More information about clinical trials involving galiximab is available at www.clinicaltrials.gov.

About Non-Hodgkin Lymphoma

An estimated 360,000 Americans have NHL and more than 58,000 new cases are diagnosed annually. Approximately 85 percent of all cases of NHL involve abnormal immune cells called B-cells. Of those diagnosed with NHL, about 30 percent of patients have a slow-growing, but incurable (low-grade) form of the disease -- the most common type is called follicular lymphoma (FL). Although FL progresses slowly, the median survival time is seven to 10 years. In addition, relapse is common and less than half of FL patients who experience a relapse will survive for five years. Approximately 31 percent of those diagnosed with NHL have DLBCL, a faster-growing subtype of NHL that multiplies and spreads rapidly in the body, and if left untreated, can be fatal.

About CALGB

The Cancer and Leukemia Group B (CALGB) is a national clinical research group sponsored by the National Cancer Institute, with its Central Office headquartered at the University of Chicago and its Statistical Center located at Duke University. The CALGB was founded in 1956 with a goal of bringing together clinical oncologists and laboratory investigators to develop better treatments for cancer. Since 1956, CALGB has grown into a national network of 26 university medical centers, over 225 community hospitals and more than 3,000 oncology specialists who collaborate in clinical research studies aimed at reducing the morbidity and mortality from cancer, relating the biological characteristics of cancer to clinical outcomes and developing new strategies for the early detection and prevention of cancer.