BERLEX TO EVALUATE LEUKINE IN NHL

Berlex Oncology has announced that a national clinical study is under way investigating a new approach to treating follicular B-cell lymphoma, a sub-type of non-Hodgkin's lymphoma (NHL).

The trial, called PREMIER is evaluating the efficacy and safety of combining therapy with the monoclonal antibody rituximab and the cytokine sargramostim compared with treatment with rituximab alone in patients with relapsed follicular B-cell lymphoma. The randomized, open-label, Phase II trial will be conducted at approximately 45 study sites across the United States. Twenty-five of these sites are open and actively screening patients.

Patients participating in the study will receive either four doses of rituximab 375 mg/m2 administered intravenously once weekly for four weeks or the same rituximab regimen plus Leukine 250 micrograms administered subcutaneously, three times weekly for eight weeks.

Sargramostim, currently marketed in the U.S. as Leukine, is a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. Leukine was approved in the United States in 1991, and is the only growth factor approved in the United States for use following induction chemotherapy in older adults with acute myelogenous leukemia to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine has also been approved in the United States for use in for additional indications.