- Data presented at ASCO showed MLN8054 activity -
- Second-generation Aurora A kinase inhibitor advances to Phase I trial in
advanced-stage cancer patients -
CHICAGO, June 3 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals,
Inc. (Nasdaq: MLNM) today announced two important advancements in its
Aurora A kinase program. Preliminary results from a Phase I study of
MLN8054, a first- in-class, orally-administered, small molecule to the
Aurora A kinase, were presented at the 43rd Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago. In addition, the Company
initiated a new Phase I clinical program for MLN8237, a second-generation
Aurora A kinase inhibitor.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
Inhibition of the Aurora A kinase represents a novel approach to
treating cancer. Aurora A kinases are required for cancer cells to divide
and create tumors. In preclinical models, the inhibition of Aurora A
kinases has been shown to stop the proliferation of the cells and reduce
tumor growth. Aurora A kinases have been shown to be over-expressed in a
variety of cancers.
"The preliminary results from the MLN8054 Phase I study validate the
potential of our product candidates in this exciting area," said Nancy
Simonian, M.D., Chief Medical Officer, Millennium. "Building on our early
experience with MLN8054 and our enhanced understanding of the biology and
chemistry of the Aurora A kinase, we have engineered MLN8237, with
expectations for even better efficacy and tolerability."
MLN8054
Phase I Clinical Trial of MLN8054, a Selective Inhibitor of Aurora A
Kinase (Abstract #3577)
Data were presented on 49 patients with advanced-stage malignancies,
including colorectal and non-small cell lung cancers and sarcoma, from an
ongoing Phase I trial. Preliminary findings and next steps included:
-- Once-daily oral administration was well tolerated at seven days, at
which point steady-state exposure of the drug was achieved
-- The only drug-limiting toxicity was predicted, off-target somnolence,
which was successfully managed with a four-times-daily dosing regimen
and the addition of methylphenidate; dose escalation continues
-- In terms of clinical response, six patients maintained stable disease
for longer than eight months, even though a maximum tolerated dose has
not yet been identified
-- In skin biopsies taken from patients with higher blood concentrations
of MLN8054, early evidence of Aurora A kinase inhibition was observed
- In particular, analysis of biopsies showed that skin cells showed
evidence of mitotic arrest, which is indicative of Aurora A
kinase inhibition
-- When a dose is established for the four-times-daily dosing, treatment
duration will be extended to 14 days to evaluate the effect of
prolonged exposure to the drug
The study is being conducted to determine the dose-limiting toxicities
and maximum tolerated dose of MLN8054 in advanced-stage cancer patients.
Pharmacokinetics are also being measured through serial blood samples.
Pharmacodynamics are being measured through serial skin biopsies to assess
inhibition of Aurora A kinase.
MLN8237
Based on the early clinical experience with MLN8054, Millennium
engineered a second-generation Aurora A kinase inhibitor, MLN8237. The
Company recently initiated a Phase I trial for this new molecule. The
open-label, dose- escalation study will enroll advanced-stage cancer
patients and is designed to determine safety and maximum tolerated dose of
this new product candidate. The Company will develop both Aurora A kinase
inhibitors simultaneously to determine which one could be brought forward
to pivotal trials. The Company typically develops second-generation
molecules as part of its small molecule strategy.
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(R) (bortezomib) for Injection 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.
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 448-0281 (857) 498-0818
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com
Photo Notes: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 for Millennium
Pharmaceuticals, Inc.
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