CAMBRIDGE, Mass., May 29 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that new clinical data
for VELCADE in hematological and solid tumors will be featured at the 43rd
American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago,
June 1-4, 2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"VELCADE is the market-leading therapy with unsurpassed single-agent
efficacy for previously treated multiple myeloma and mantle cell lymphoma
patients," said Deborah Dunsire, M.D., President and Chief Executive
Officer, Millennium. "With over 35 VELCADE abstracts featured at ASCO, data
will demonstrate that combining the power of VELCADE with other active
agents increases time to disease progression and improves survival. These
clinical trial results are expected to further strengthen the role of
VELCADE in its approved indications and provide exciting new evidence for
the potential of VELCADE in additional disease settings."
Previously Treated Multiple Myeloma
Data are expected to further support the role of VELCADE as the
foundation of combination therapy with both established and emerging
therapies. Clinical trial results will include time to disease progression
and survival updates. Data also will be featured on subcutaneous
administration. This formulation is being evaluated as a new and convenient
administration option for patients and physicians without compromising the
efficacy and well-characterized safety profile of VELCADE. Abstract
highlights include:
-- Effect of the Combination of Pegylated Liposomal Doxorubicin And
Bortezomib on Time to Progression (TTP) and Overall Survival of
Patients with Relapsed/Refractory Multiple Myeloma Compared with
Bortezomib Alone
* Lead investigator: Jean-Luc Harousseau, M.D.,
University Hospital Hotel-Dieu
* Abstract #8002; Clinical Science Symposium:
Monday 4th June, 8:00 a.m.
-- Impact of Prior Thalidomide Therapy on the Efficacy of Pegylated
Liposomal Doxorubicin and Bortezomib in Relapsed/Refractory Multiple
Myeloma
* Lead investigator: Pieter Sonneveld,
University Hospital Rotterdam-Dijkzigt
* Abstract: #8023; Oral presentation: Sunday 3rd June, 3:00 p.m.
-- Tanespimycin and Bortezomib in Multiple Myeloma: Pharmacology,
Safety and Activity in Relapsed/Refractory Patients
* Lead investigator: Paul Richardson, M.D.,
Dana-Farber Cancer Institute
* Abstract #3532; Poster session: Saturday 2nd June, 2:00 p.m.;
Discussion: Saturday 2nd June, 5:00 p.m.
-- Prospective Comparison of Subcutaneous to Intravenous Administration
of Bortezomib in Patients with Multiple Myeloma: Pharmacokinetics,
Efficacy and Toxicity
* Lead investigator: Philippe Moreau, M.D., Hospital Hotel-Dieu
* Abstract #8046; Poster session: Monday 4th June, 2:00 p.m.;
Discussion: Monday 4th June, 5:00 p.m.
Front-Line Multiple Myeloma
Previously presented data have shown that VELCADE based combinations
produce very high complete and near complete response rates in both
transplant and non-transplant settings. Data presented at this conference
are expected to support the emerging evidence that this benefit may lead to
substantial improvement in time to progression and survival for patients
with newly diagnosed multiple myeloma. Abstract highlights include:
-- Phase II Study of Total Therapy 3 (TT3) with Added Bortezomib for
Multiple Myeloma
* Lead investigator: Bart Barlogie, M.D., Ph.D.,
University of Arkansas for Medical Sciences
* Abstract #8020; Oral presentation: Sunday 3rd June, 2:00 p.m.
-- Final Results of a Phase II PETHEMA Trial of Alternating Bortezomib
and Dexamethasone as Induction Regimen Prior to Autologous Stem Cell
Transplantation (ASCT) in Younger Patients with Multiple Myeloma (MM):
Efficacy and Clinical Implications of Tumor Response
* Lead investigator: Laura Rosinol, M.D., Hospital Clinic,
University of Barcelona
* Abstract #8024; Oral presentation: Sunday 3rd June, 3:15 p.m.
-- Bortezomib Prior to and as Maintenance Therapy After Autologous Stem
Cell Transplant in Multiple Myeloma: Long-Term Follow-Up of a
Phase II Study
* Lead investigator: Sagun Goyal, M.D.,
Washington University School of Medicine
* Abstract #8044; Poster session: Monday 4th June, 2:00 p.m.;
Discussion: Monday 4th June, 5:00 p.m.
Non-Hodgkin's Lymphoma (NHL)
Building on the recent approval of VELCADE in patients with previously
treated mantle cell lymphoma, a form of NHL with one of the worst
prognoses, data also will be featured on newly diagnosed patients and on
patients with other subsets of NHL. For the first time, clinical trial
results will be featured for VELCADE based combinations in diffuse large
B-cell lymphoma, the most prevalent form of NHL. Abstract highlights
include:
-- A Feasibility Study of VcR-CVAD with Maintenance Rituximab for
Untreated Mantle Cell Lymphoma
* Lead investigator: Brad Kahl, M.D.,
University of Wisconsin for Eastern Cooperative Oncology Group
* Abstract #8062; Poster session: Saturday 2nd June, 8:00 a.m.
-- Efficacy and Toxicity of Two Schedules of R-CHOP plus Bortezomib in
Front-Line B Lymphoma Patients: A Randomized Phase II Trial from the
Groupe d'Etude des Lymphomes de l'Adulte
* Lead investigator: Nicolas Mounier, M.D., Ph.D., Hopital Saint Louis
* Abstract #8010; Oral presentation: Sunday 3rd June, 10:00 a.m.
-- CHOP-R + Bortezomib as Initial Therapy for Diffuse Large B-Cell
Lymphoma
* Lead investigator: John Leonard, M.D., Weill Medical College of
Cornell University for Cancer & Leukemia Group B
* Abstract #8031; Poster session: Monday 4th June, 2:00 p.m.;
Discussion: Monday 4th June, 5:00 p.m.
Solid Tumors and Additional Hematological Cancers
Data are expected to show the potential for VELCADE in combination with
other active agents in patients with solid tumors including colorectal
cancer and glioma. In addition, VELCADE will be featured in Waldenstrom's
macroglobulinemia and amyloidosis, which are disease areas with a high
unmet medical need. Abstract highlights include:
-- A Phase I Study of Vorinostat in Combination with Bortezomib in
Refractory Solid Tumors
* Lead investigator: William Schelman, M.D., Ph.D.,
University of Wisconsin Hospital and Clinics
* Abstract #3573; Poster session: Sunday 3rd June, 8:00 a.m.
-- A Phase I Study of Bortezomib in Combination with 5FU/LV Plus
Oxaliplatin in Patients with Advanced Colorectal Cancer: EORTC 16029
* Lead investigator: Denis Lacombe, M.D., MSc,
European Organisation for Research and Treatment of Cancer
* Abstract #4090; Poster session: Monday 4th June, 8:00 a.m.
-- A Phase I Trial Using the Proteasome Inhibitor Bortezomib and
Concurrent Temazolomide and Radiotherapy for High Grade Gliomas
* Lead investigator: Adam Dicker, M.D., Ph.D.,
Thomas Jefferson University
* Abstract #2061; Poster session: Monday 4th June, 1:00 p.m.;
Discussion: Monday 4th June, 1:00 p.m.
-- Phase I/II Study of Bortezomib in Subjects with Systemic
AL-Amyloidosis
* Lead investigator: Donna Reece, M.D., Princess Margaret Hospital
* Abstract #8050; Poster session: Monday 4th June, 2:00 p.m.;
Discussion: Monday 4th June, 5:00 p.m.
About Multiple Myeloma (MM)
Multiple myeloma is the second most common hematologic malignancy and
although the disease is predominantly a cancer of the elderly (the average
age of onset is 65 to 70 years of age), recent statistics indicate both
increasing incidence and younger age of onset. In the U.S., more than
50,000 individuals have MM, and close to 20,000 new cases are diagnosed
each year. Worldwide there are approximately 74,000 new cases and more than
45,000 deaths annually.
About Non-Hodgkin's Lymphoma (NHL) and Mantle Cell Lymphoma (MCL)
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.
MCL is an aggressive, rapidly progressive subtype of NHL, and is not
curable with standard treatment. The median life expectancy for a patient
with MCL following first relapse is one to two years.
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.; 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. will co-
promote VELCADE in the U.S. VELCADE is approved in more than 80 countries
worldwide.
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
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, 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 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.
Safety Data: In 1163 patients in multiple myeloma and mantle cell
lymphoma studies, the most commonly reported adverse events were asthenic
conditions (64%), nausea (55%), diarrhea (52%), constipation (41%),
peripheral neuropathy (39%), thrombocytopenia (36%), appetite decrease,
including reports of anorexia (36%), pyrexia (34%), vomiting (33%) and
anemia (29%). Twenty percent of patients reported at least one episode of
grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia
(5%) and neutropenia (3%). Fifty percent of patients reported serious
adverse events. The most commonly reported serious adverse events were
pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea,
dehydration, dyspnea and thrombocytopenia (each 3%).
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:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 444-1439 (617) 761-4734
SOURCE Millennium Pharmaceuticals, Inc.
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http://www.millennium.com
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CONTACT:
Media, Jennifer Snyder, +1-617-444-1439, or
Investors, Kyle Kuvalanka, +1-617-761-4734, both of Millennium
Pharmaceuticals, Inc.
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