CAMBRIDGE, Mass., July 2 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today reported that new data were
presented on the comparative Phase III clinical trial evaluating a VELCADE
based therapy in newly diagnosed multiple myeloma (MM) patients. As
induction therapy prior to stem cell transplantation (SCT), the VELCADE
based therapy produced a high complete remission / complete response(1)
(CR) rate of 20 percent, which led to a post SCT CR rate of 43 percent.
These results were substantially stronger than those of a commonly used
induction chemotherapy regimen vincristine, adriamycin and dexamethasone
(VAD), which served as the comparative therapy in the trial. The data
showed that the VELCADE based therapy, compared to VAD, nearly doubled the
CR rate as induction therapy and provided a greater than 50 percent
improvement in CR rate following SCT. Achievement of CR is the goal of SCT
therapy because achievement of CR increases both progression-free and
overall survival. The data were presented in conjunction with the
prestigious 11th International Myeloma Workshop (IMW) in Kos, Greece.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"Historically, stem cell transplantations generated similar response
rates regardless of the induction therapy due to the limited efficacy of
these therapies. With VELCADE, we now have a powerful agent that has
consistently delivered high complete remission rates during induction and
has allowed physicians to mobilize stem cells successfully. These benefits
have translated to post-transplantation complete remission rates that are
significantly higher than what has ever been achieved before," said
Professor Jean-Luc Harousseau, M.D., Hospital Hotel-Dieu. "We know that
high complete remission rates following transplantation lead to longer
progression-free survival and overall survival. These data position VELCADE
as an important therapy for front-line patients."
The multi-center, randomized Phase III trial is being conducted by the
IFM cooperative group. The trial was designed to compare VELCADE in
combination with dexamethasone to VAD as induction therapy prior to SCT in
480 newly diagnosed MM patients. The presentation during IMW included new
data from 161 patients who received induction therapy, of which 137
patients received SCT. Results presented by Dr. Harousseau showed:
* As induction therapy prior to SCT, the VELCADE based therapy showed
a CR rate of 20 percent compared to 7 percent for VAD.
* Following SCT, the VELCADE based therapy demonstrated a CR rate of
43 percent and a very good partial response + CR (VGPR + CR) rate of 75
percent. VAD showed a CR rate of 28 percent and a VGPR + CR
rate of 46 percent following SCT.
* The VELCADE based therapy was well tolerated; the most common adverse
events included neurologic toxicities, fever/infection and neutropenia.
Patients on the VELCADE based therapy received four standard cycles of
VELCADE at 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21-day cycle. Patients
also received dexamethasone at 40 mg on days 1 through 4 during cycles one
through four and on days 9 through 12 during cycles one and two only.
Patients on VAD were treated for four cycles with vincristine at 0.4 mg/m2
on days 1 through 4; adriamycin at 9 mg/m2 on days 1 through 4; and
dexamethasone 40 mg on days 1 through 4, days 9 through 12 during cycles
one through four and on days 17 through 20 during cycles one and two only.
Some patients received consolidation therapy. Response was assessed by the
European Group for Blood and Marrow Transplant criteria.
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 MM 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 otherwise.
(1) Complete remission / complete response includes both immunofixation
positive and negative readouts
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 444-1439 (857) 498-0818
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:
Media, Jennifer Snyder, +1-617-444-1439;
Investors, Kyle Kuvalanka, +1-857-498-0818, both of Millennium
Pharmaceuticals, Inc.
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