- Promoted bone growth in patients with bone degeneration -
- Improved overall survival for broad patient population including those
with reduced renal function -
KOS, Greece, June 28 2007 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today reported on data presentations
of VELCADE that showed improved outcomes for multiple myeloma (MM) patients
affected by bone degeneration and renal impairment. MM is a plasma cell
disease and carries significant risk of bone erosion and skeletal
compromise. In addition, kidney function frequently is impaired.
Approximately 50 percent of patients will experience renal dysfunction in
the course of their disease. The clinical findings were presented at the
prestigious 11th International Myeloma Workshop (IMW) in Kos, Greece.
Highlights included:
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
-- In patients affected by MM-related bone degeneration, VELCADE and
dexamethasone combination therapy demonstrated an increase in
biomarkers indicative of bone formation. These results validate
findings from a previously presented study, which measured actual
patient biopsies for improvement in bone volume and thickness and found
that VELCADE promoted bone growth.
-- In a retrospective analysis of a clinical trial, VELCADE showed
comparable positive median overall survival (OS) and overall response
rate (ORR) in patients both with renal impairment and those with normal
renal function. In a supporting study of MM patients with increased
biomarker levels indicating poor renal function and poor survival
prognosis, VELCADE produced a high ORR and improved renal function.
"VELCADE not only demonstrates a survival benefit for previously
treated multiple myeloma patients, but also it can be used in patients with
common disease-related complications, such as bone degeneration and renal
impairment. VELCADE is the only agent that has shown this consistently and
does not require dose modifications," said Nancy Simonian, M.D., Chief
Medical Officer, Millennium. "These data further underscore the need to use
VELCADE broadly, offering comprehensive care for patients."
VELCADE Plus Dexamethasone Therapy Induces Osteoblast Activation in
Responsive Patients with Multiple Myeloma (Abstract #PO-311)
The Phase II trial assessed bone metabolism and efficacy of VELCADE and
dexamethasone combination therapy in patients with relapsed / refractory
MM. The study enrolled 14 patients who received VELCADE at 1.3 mg/m2 on
days 1, 4, 8 and 11 of a 21-day schedule. Patients also received 20 mg of
dexamethasone on days 1, 2, 4, 5, 8, 9, 11 and 12. Results were presented
by Shuji Ozaki, M.D., The University of Tokushima Graduate School of Health
Biosciences, and showed an ORR (very good partial response + partial
response) of 71 percent. A rapid increase of serum alkaline phosphatase
(ALP) was observed in treatment-responsive patients. Bone formation markers
such as serum bone specific ALP and osteocalcin significantly increased in
six and three patients, respectively. Additionally, a radiographic
examination showed fewer bone lesions. These findings suggest that VELCADE
based therapy induced osteoblast activation. Side effects were manageable,
including thrombocytopenia, peripheral neuropathy and ileus.
These results support a previous study presented by Maurizio Zangari,
M.D., University of Arkansas for Medical Sciences, at the 2007 European
Hematology Association meeting. In the study of 10 evaluable relapsed /
refractory MM patients, VELCADE was administered at 1.3 mg/m2 on days 1, 4,
8 and 11 of a 21-day schedule. Patients were treated for three cycles. Bone
biopsies were obtained at baseline and, after treatment, measured bone
volume / total volume in trabecular thickness by micro-computed tomography.
Bone formation also was determined by histomorphometry. Results showed an
increase in bone volume equal to or greater than 40 percent from baseline
in four out of five patients after just 12 weeks of therapy. A parallel
increase in trabecular thickness also was observed, showing a positive
skeletal response to the therapy.
VELCADE in Renally Impaired Multiple Myeloma Patients (Abstract
#PO-1114)
The retrospective analysis of the APEX Phase III study assessed VELCADE
efficacy and safety in patients with varying degrees of renal impairment.
The APEX trial had compared VELCADE to high-dose dexamethasone in MM
patients, who had received one to three prior therapies, and showed 29.8
months median OS for patients on VELCADE, a six-month benefit over
high-dose dexamethasone. The retrospective analysis included data from 313
evaluable patients. Response rate, time to progression (TTP) and OS were
analyzed in four sub- groups of patients, ranging from severe to no renal
impairment as classified by creatinine clearance levels. Results were
presented by Jesus San Miguel, M.D., Ph.D., Hospital Universitario de
Salamanca, and showed that response rate, TTP and OS for patients on
VELCADE were similarly positive across all four patient sub-groups. Time to
response was rapid, which is the goal of treatment for patients with renal
impairment. Given the survival benefit seen in these patients, VELCADE may
overcome poor prognosis associated with renal impairment. Adverse events,
discontinuations and dose reductions also were similar across all four
patient sub-groups.
Cystatin-C: an Early Marker of Renal Impairment and an Independent
Predictive Factor for Survival in Multiple Myeloma. Reduction Post-VELCADE
Therapy (Abstract #PO-227)
The Phase II study was designed not only to evaluate the impact of
VELCADE on serum levels of Cystatin-C, an early biomarker for poor renal
function, but also to explore possible correlations with clinical response,
including survival. Impaired renal function is known to be an indicator of
poor survival prognosis. The study included 155 MM patients who were
treated with VELCADE at 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21-day
schedule. Results were presented by Evangelos Terpos, M.D., General
Airforce Hospital, and showed that VELCADE reduced Cystatin-C levels,
demonstrating effectiveness in patients with decreased renal function, and
the potential ability to improve survival in these patients.
About Multiple Myeloma
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 multiple myeloma and 20,000 new cases are diagnosed
each year. Worldwide there are approximately 74,000 new cases and over
45,000 deaths 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., 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 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 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%) in single-agent VELCADE, 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
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) 448-0281 (857) 498-0818
SOURCE Millennium Pharmaceuticals, Inc.
 back to top
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:
Media, Jennifer Snyder, +1-617-448-0281, or
Investors, Kyle Kuvalanka, +1-857-498-0818, both of Millennium
Pharmaceuticals, Inc.
|
