-Novel Product Candidate in Ulcerative Colitis on Track for Pivotal Trial
in 2008-
CAMBRIDGE, Mass., May 17 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced the initiation of
patient dosing in a clinical program designed to evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of MLN0002 derived from
a newly engineered, commercially scaleable cell line. MLN0002 is a novel
monoclonal antibody that binds to the T-cell integrin alpha 4 beta 7 with
potential in a variety of gastrointestinal diseases, including ulcerative
colitis.
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"MLN0002 is differentiated by its unique mechanism of action that
selectively inhibits trafficking of inflammatory cells to the
gastrointestinal tract. This innovative approach has the potential to
increase the level of efficacy and reduce the risk of unwanted side effects
seen with currently available therapies," said Nancy Simonian, M.D., Chief
Medical Officer, Millennium. "The return of MLN0002 to clinical trials is
exciting for Millennium and ulcerative colitis patients. MLN0002 is one of
only a few novel product candidates being investigated as alternatives to
anti-TNF and other immunosuppressive therapies for ulcerative colitis and
potentially other inflammatory bowel diseases."
"There is clearly a need for new therapeutic options as a substantial
percentage of ulcerative colitis patients either do not respond to current
therapies or have concerns regarding the safety of these therapies," said
Brian Feagan, M.D., Professor of Medicine at the University of Western
Ontario, London, Canada and a leading expert in inflammatory bowel disease.
"Based on the positive experience of patients in the previous Phase II
trial, we are enthusiastic about moving this novel product candidate
forward in the hopes of delivering a new and effective option to patients
for whom ulcerative colitis remains inadequately managed."
The new clinical program for MLN0002 consists of two studies: a Phase
II dose-ranging trial in ulcerative colitis patients and Phase I study in
normal healthy volunteers. These studies were initiated following favorable
results from a previous randomized Phase II trial involving 181 ulcerative
colitis patients. In that trial, MLN0002, derived from an earlier cell
line, was well tolerated and achieved a statistically significant
improvement in clinical remission, the trial's primary endpoint, compared
to placebo. Serious adverse events were mainly related to exacerbations of
underlying ulcerative colitis, which occurred in 15 percent of patients in
the treatment groups, compared to 10 percent in the placebo group. The
results of this trial were published in the June 16, 2005 issue of the New
England Journal of Medicine.
About MLN0002
MLN0002 is a novel monoclonal antibody that selectively binds to alpha
4 beta 7, a T-cell integrin. Its mechanism of action inhibits the migration
of T-cells specifically to the gastrointestinal tract, as demonstrated in
non- clinical studies. Increased gut T-cell trafficking is believed to play
a role
in the pathogenesis of inflammatory bowel diseases (IBD), including
conditions such as ulcerative colitis and Crohn's disease.
MLN0002 is part of a robust pipeline and a component of Millennium's
2007 goals of accelerating several key assets.
About ulcerative colitis
Ulcerative colitis is an IBD, the general name for a group of chronic
disorders that cause inflammation in the gastrointestinal tract. The
disease can be difficult to diagnose because its symptoms are similar to
other intestinal disorders and to another type of IBD called Crohn's
disease.
Ulcerative colitis causes inflammation and sores, called ulcers, in the
lining of the rectum and colon or large intestine. Inflammation in the
colon also causes the colon to empty frequently, causing diarrhea. Other
typical symptoms include lower abdominal pain, rectal irritability and
fecal incontinence.
Annually, ulcerative colitis develops in approximately 24,300 patients
in the U.S. The prevalence in the U.S. is 671,000. Ulcerative colitis can
occur in people of any age, but it usually starts between the ages of 15
and 30, and less frequently between 50 and 70 years of age. It affects men
and women equally and appears to run in families, with reports of up to 20
percent of people with ulcerative colitis having a family member or
relative with ulcerative colitis or Crohn's disease. A higher incidence of
ulcerative colitis is seen in Caucasians and people of Jewish descent.
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:
Kyle Kuvalanka (investors) Jennifer Snyder (media)
(617) 761-4734 (617) 444-1439
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com
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CONTACT:
Investors, Kyle Kuvalanka, +1-617-761-4734,
or Media, Jennifer Snyder, +1-617-444-1439, both of Millennium
Pharmaceuticals, Inc.
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