Healthcare Industry News:  rituximab 

Biopharmaceuticals Oncology

 News Release - October 31, 2006

Berlex Oncology Evaluating Combination Therapy for Common Form of Non-Hodgkin's Lymphoma

Twenty-five study centers currently open across the U.S.

WAYNE, N.J., Oct. 31 (HSMN NewsFeed) -- Berlex Oncology, a business unit of Berlex Laboratories, a U.S. affiliate of Schering AG, Germany (FSE: SCH; NYSE: SHR), today announced that a national clinical study is underway investigating a new approach to treating follicular B-cell lymphoma, a sub- type of non-Hodgkin's lymphoma (NHL). NHL is the fifth most common form of cancer in the United States, with more than 56,000 new cases diagnosed each year. Follicular B-cell lymphoma is an indolent, or slow-growing, type of NHL that comprises approximately 30% of all diagnosed cases.

The trial, called PREMIER (Primary Evaluation Measuring Improved Efficacy of rituximab with Sargramostim) is evaluating the efficacy and safety of combining therapy with the monoclonal antibody rituximab and the cytokine sargramostim compared to treatment with rituximab alone in patients with relapsed follicular B-cell lymphoma. The randomized, open-label, Phase 2 trial will be conducted at approximately 45 study sites across the United States. Twenty-five of these sites are open and actively screening patients.

"Previous studies have suggested that the combination of sargramostim with rituximab may substantially improve the treatment efficacy of rituximab in indolent lymphomas, without the use of chemotherapy and without increasing toxicity," explains Peter McLaughlin, M.D., lead investigator and professor, Department of Lymphoma/Myeloma at M.D. Anderson Cancer Center in Houston. "This study seeks to generate additional data to further evaluate the efficacy and safety of this combination therapy."

"We are encouraged that patient enrollment is underway for the PREMIER trial," said Richard Nieman, M.D., vice president and head of medical affairs, Berlex Laboratories. "Current approaches to treating this type of cancer include watchful waiting, radiation, chemotherapy and chemoimmunotherapies as appropriate to cell type and disease stage. The goal now is to develop new biologic combination treatment regimens that result in improved response rates and survival."

Patients interested in more information or enrolling in the study may visit http://www.nhl.onctrials.com. Additional information about the PREMIER trial also can be found at http://www.clinicaltrials.gov.

About the Study

The primary objective of the PREMIER study is a comparison of the efficacy of rituximab plus sargramostim to rituximab monotherapy, as measured by confirmed and unconfirmed complete response (CR+CRu) rate at eight weeks. Patients participating in the study will receive either four doses of rituximab 375 mg/m(2) administered intravenously once weekly for four weeks or the same rituximab regimen plus LEUKINE 250 mcg administered subcutaneously, three times weekly for eight weeks.

Patients who are at least 18 years or older with histologically-confirmed, relapsed, follicular B-cell lymphoma are potentially eligible for this trial. Additional criteria will be evaluated to determine patient eligibility. Only a patient's physician can determine his or her suitability for inclusion in this trial.

About Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (non-Hodgkin's lymphoma or NHL) is a cancer of lymphoid tissue, a part of the lymphatic system. Lymph nodes make and store lymphocytes, the white blood cells responsible for immunity or defense against infections or other foreign invaders. Lymphocytes are a type of white blood cell which can be divided into two main types, B lymphocytes and T lymphocytes (also called B-cells or T-cells). In adults, approximately 85 percent of NHL cases are of B-cell origin.

Non-Hodgkin's lymphomas can be divided clinically into two general categories: indolent lymphomas, which tend to grow relatively slowly, and aggressive lymphomas, which grow more rapidly. Indolent lymphomas include follicular NHL and were formerly classified as "low-grade." The average age for people with this lymphoma is about 60. It is rare in very young people. The 5-year survival rate (the percentage of people surviving at least 5 years) is around 60% to 70%. Often these lymphomas are not treated at the time of initial diagnosis if the patient has no symptoms from the disease. Over time, about one third of follicular lymphomas change into a fast growing diffuse B-cell lymphoma. Because indolent lymphomas are usually not curable, patients need new treatment alternatives.

About Sargramostim

Sargramostim, currently marketed in the U.S. as LEUKINEŽ, 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 marketed by Berlex, Inc. LEUKINE is the only growth factor approved in the United States for use following induction chemotherapy in older adults with acute myelogenous leukemia (AML) 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 four additional indications: myeloid reconstitution following allogeneic and autologous bone marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization and subsequent myeloid reconstitution in patients undergoing PBSC transplantation, and bone marrow transplantation failure or engraftment delay.

Patients taking LEUKINE may experience some side effects, most of which are mild to moderate. In controlled clinical trials across all indications, no significant differences were observed between LEUKINE and placebo-treated patients in the type or frequency of adverse events with the exception of an increase in skin-associated events in the LEUKINE group in the pivotal AML trial. There were occasional reports of fluid retention, dyspnea (labored breathing), supraventricular tachycardia (accelerated heart rate), and laboratory abnormalities (increases in creatinine, bilirubin, and liver enzymes). Other adverse events have been reported.

LEUKINE has not been FDA-approved for use in treating follicular B-cell lymphoma.

For full prescribing information, please visit http://www.berlex.com.

About Berlex

Berlex is committed to addressing unmet medical needs through research and development in the areas of oncology, gastroenterology, women's health, diagnostics and neurology. Berlex also markets diagnostic imaging agents, innovative treatments in the areas of female health care and oncology, as well as specialized therapeutics for life-threatening and disabling diseases of the central nervous system and cardiovascular system. Berlex has business operations in New Jersey, California and Washington. For more information, please visit http://www.berlex.com.

Berlex Oncology is building a prominent leadership position through research and development of a range of hematological and solid tumor treatments, and is strongly invested in bringing to market an innovative and broad oncology R&D portfolio of systemic and targeted therapies, potentially offering novel therapeutic options for people with cancer.

Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Berlex's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Berlex, Inc. undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.


Source: Berlex

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