- Building on Phase III registration trial of VELCADE and rituximab,
Millennium initiates new clinical trial with novel combination of VELCADE
with bendamustine and rituximab to further advance treatment of patients
with follicular lymphoma -
CAMBRIDGE, Mass., Feb. 20 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced the initiation of a
multi-center, Phase II trial to evaluate VELCADE in combination with
emerging agent, bendamustine, and current standard of care, rituximab, in
patients with relapsed follicular lymphoma, a subset of non-Hodgkin's
lymphoma (NHL). This trial is part of the Company's comprehensive
development program in NHL, which represents a significant growth
opportunity for VELCADE.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"We designed this trial to combine three active agents in NHL with the
goal of enhancing the clinical outcomes of this patient population," said
Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are hopeful
this novel combination will add to the growing body of data that show the
potential of VELCADE to be part of the standard of care in follicular
lymphoma, similar to what we've seen in multiple myeloma."
The primary endpoint of the open-label trial is complete remission with
secondary endpoints including progression free survival and duration of
remission. The trial is expected to enroll approximately 75 patients.
In previous studies, VELCADE as a single-agent and as part of
combination therapy has shown promising remission rates and time-to-disease
progression in patients with NHL. These trials served as the basis for the
Company to initiate the large, registration-enabling Phase III trial
designed under a special protocol assessment (SPA) with the U.S. Food and
Drug Administration (FDA) of VELCADE and rituximab in patients with
relapsed follicular lymphoma. The Company is on track to complete patient
accrual in this Phase III trial in the first half of 2008, with final data
expected in 2010. VELCADE is already approved by the FDA to treat relapsed
mantle cell lymphoma (MCL). MCL is an aggressive, rapidly progressive
subtype of NHL with median life expectancy for a patient with MCL,
following first relapse, of one to two years.
About Non-Hodgkin's Lymphoma
NHL is the most common hematological cancer, the fifth leading cause of
cancer death and the second fastest-growing form of cancer in the U.S. The
prevalence of NHL in the U.S. is approximately 400,000 patients, including
approximately 200,000 patients with diffuse large B-cell lymphoma, 100,000
patients with follicular and marginal zone lymphoma and 10,000 with MCL.
There are approximately 54,000 new cases of NHL diagnosed in the U.S. per
year, and 19,000 deaths are attributed to the disease annually.
About VELCADE
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium
is responsible for commercialization of VELCADE in the U.S. and
Janssen-Cilag is responsible for commercialization in Europe and the rest
of the world. Janssen Pharmaceutical K.K. is responsible for
commercialization in Japan. For a limited period of time, Millennium and
Ortho Biotech Inc. are co- promoting VELCADE in the U.S. VELCADE is
approved in 85 countries worldwide. More than 85,000 patients have been
treated with VELCADE globally.
In the U.S., VELCADE is indicated for the treatment of patients with
multiple myeloma who have received at least one prior therapy. VELCADE is
also indicated for the treatment of patients with mantle cell lymphoma who
have received at least one prior therapy. VELCADE is contraindicated in
patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE
should be administered under the supervision of a physician experienced in
the use of antineoplastic therapy. In the European Union and many other
countries worldwide, VELCADE is approved for patients with multiple myeloma
after first relapse.
Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy, hypotension observed throughout therapy, cardiac and
pulmonary disorders, gastrointestinal adverse events, thrombocytopenia,
neutropenia and tumor lysis syndrome. Women of childbearing potential
should avoid becoming pregnant while being treated with VELCADE. Cases of
severe sensory and motor peripheral neuropathy have been reported. The
long-term outcome of peripheral neuropathy has not been studied in mantle
cell lymphoma. Acute development or exacerbation of congestive heart
failure, and/or new onset of decreased left ventricular ejection fraction
has been reported, including reports in patients with few or no risk
factors for decreased left ventricular ejection fraction. There have been
rare reports of acute diffuse infiltrative pulmonary disease of unknown
etiology such as pneumonitis, interstitial pneumonia, lung infiltration and
Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of
these events have been fatal. A higher proportion of these events have been
reported in Japan. There have been rare reports of Reversible Posterior
Leukoencephalopathy Syndrome (RPLS) in patients receiving VELCADE. RPLS is
a rare, reversible, neurological disorder which can present with seizure,
hypertension, headache, lethargy, confusion, blindness, and other visual
and neurological disturbances. VELCADE is associated with thrombocytopenia
and neutropenia. There have been reports of gastrointestinal and
intracerebral hemorrhage in association with VELCADE. Transfusions may be
considered. Complete blood counts (CBC) should be frequently monitored
during treatment with VELCADE. Rare cases of acute liver failure have been
reported in patients receiving multiple concomitant medications and with
serious underlying medical conditions.
Integrated Safety Data: Safety data from Phase II and III studies of
single-agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a
10- day rest period in 1163 patients with multiple myeloma (N=1008) and
mantle cell lymphoma (N=155) were integrated and tabulated. In these
studies, the safety profile of VELCADE was similar in patients with
multiple myeloma and mantle cell lymphoma. In the integrated analysis, the
most commonly reported adverse events were asthenic conditions (including
fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%),
constipation (41%), peripheral neuropathy NEC (including peripheral sensory
neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia
and appetite decreased (including anorexia) (each 36%), pyrexia (34%),
vomiting (33%), and anemia (29%). Twenty percent (20%) of patients
experienced at least 1 episode of >/= Grade 4 toxicity, most commonly
thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients
experienced serious adverse events (SAEs) during the studies. The most
commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea
(5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia
(each 3%). Adverse events thought by the investigator to be drug-related
and leading to discontinuation occurred in 22% of patients. The reasons for
discontinuation included peripheral neuropathy (8%), asthenic conditions
(3%) and thrombocytopenia and diarrhea (each 2%). In total, 2% of the
patients died and the cause of death was considered by the investigator to
be possibly related to study drug: including reports of cardiac arrest,
congestive heart failure, respiratory failure, renal failure, pneumonia and
sepsis. This integrated analysis does not include the Phase III, VELCADE
plus DOXIL study.
For more information about VELCADE clinical trials, patients and
physicians can contact the Millennium Medical Product Information
Department at 1-866-VELCADE (1-866-835-2233).
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company
based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has
a robust clinical development pipeline of product candidates. Millennium's
research, development and commercialization activities are focused in two
therapeutic areas: oncology and inflammation. By applying its knowledge of
the human genome, understanding of disease mechanisms and industrialized
drug discovery platform, Millennium is developing an exciting pipeline of
innovative product candidates. Millennium's website is http://www.millennium.com.
This press release contains "forward-looking statements," including
statements about the Company's growth and development of products. Various
important risks may cause the Company's actual results to differ materially
from the results indicated by these forward-looking statements, including:
adverse results in its drug discovery and clinical development programs;
failure to obtain patent protection for its discoveries; commercial
limitations imposed by patents owned or controlled by third parties; the
Company's dependence upon strategic alliance partners to develop and
commercialize products and services based on its work; difficulties or
delays in obtaining regulatory approvals to market products and services
resulting from its development efforts; product withdrawals; competitive
factors; difficulties or delays in manufacturing the Company's products;
government and third-party reimbursement rates; the commercial success of
VELCADE and INTEGRILIN(R) (eptifibatide) Injection; achieving revenue
consistent with internal forecasts; and the requirement for substantial
funding to conduct research and development and to expand commercialization
activities. For a further list and description of the risks and
uncertainties the Company faces, see the reports it has filed with the
Securities and Exchange Commission. The Company disclaims any intention or
obligation to update or revise any forward- looking statements, whether as
a result of new information, future events or otherwise.
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com.
Contacts:
Dion Warren (investors) Jennifer Snyder (media)
(617) 577-3588 (617) 444-1439
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
http://www.prnewswire.com/comp/114562.html/
CONTACT:
Dion Warren (investors), +1-617-577-3588, or
Jennifer Snyder (media), +1-617-444-1439, both of Millennium
Pharmaceuticals, Inc.
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