Berlex Oncology Evaluating Combination Therapy for Common Form of Non-Hodgkin's Lymphoma
October 31 2006 - 7:00AM
PR Newswire (US)
- Twenty-five study centers currently open across the U.S. - WAYNE,
N.J., Oct. 31 /PRNewswire/ -- 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 LEUKINE(R), 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. DATASOURCE: Berlex
CONTACT: Kimberly Wix, Berlex, Inc., , +1-973-305-5258; or Kelly
Thornicroft, GCI Group, , +1-312-229-8711 Web site:
http://www.berlex.com/ http://www.nhl.onctrials.com/
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