CAMBRIDGE, Mass., Nov. 3 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced the initiation of a multicenter phase I study of MLN8054, a novel and highly selective Aurora kinase inhibitor, in patients with advanced malignancies. MLN8054, an orally administered small molecule, was discovered and is being developed by Millennium scientists. It was advanced from concept to clinic in less than four years. This first clinical study will assess safety, determine the maximum tolerated dose, and evaluate preliminary activity across a variety of cancers.
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“Aurora kinases have been implicated in the development and growth of cancer and represent an exciting new group of oncology therapeutic targets,” said Joseph Bolen, Ph.D., senior vice president, research and drug discovery, Millennium. “MLN8054 selectively inhibits the cancer-promoting Aurora kinase. Preclinical studies indicated significant therapeutic potential and showed that MLN8054 distributes widely throughout the body and has activity across a range of tumors.”
The phase I study is expected to enroll approximately 30 patients with advanced solid tumors, including lymphomas. MLN8054 will be given orally and the dose will be escalated in cohorts of patients as tolerability is demonstrated at the given dose level. The primary endpoint is to determine dose-limiting toxicities and maximum tolerated dose. Secondary endpoints of the study will include pharmacokinetics, pharmacodynamics, and preliminary assessment of anti-tumor activity. Exploratory analysis will also include the evaluation of specific molecular biomarkers.
“This program demonstrates the focus and capability of our discovery and development teams and further validates our research focus on critical pathways,” said David Schenkein, M.D., senior vice president, clinical development, Millennium. “The outcomes of this trial will help us determine the future clinical development program of this promising product candidate, including the specific indications to pursue and at what dose.”
About MLN8054
MLN8054 is a novel small molecule Aurora A kinase inhibitor discovered and developed by scientists at Millennium for the treatment of human cancers. Aurora kinases are required for cells to proceed through mitosis (cell division) and are over-expressed in a variety of cancers and therefore represent an attractive group of oncology therapeutic targets. In preclinical studies, MLN8054 demonstrated specificity and potency against its target Aurora kinase and also demonstrated broad activity both in vitro and in vivo at doses that were well tolerated. MLN8054 is administered as an oral agent, distributes widely throughout the body, and displays pharmacokinetics favorable for chronic dosing.
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE(R) (bortezomib) for Injection, a novel cancer product, and has a robust clinical development pipeline of product candidates. The Company’s research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized drug discovery platform, Millennium is seeking to develop breakthrough products.
Editor’s Note: This release is available on the Media section of the Millennium website at http://www.millennium.com
This press release contains “forward-looking statements,” including statements about the Company’s discovery 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.
Contacts: Theresa McNeely (media) Kyle Kuvalanka (investors) (617) 679-7405 (617) 761-4734
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CONTACT: Theresa McNeely, +1-617-679-7405, or Kyle Kuvalanka,+1-617-761-4734, both of Millennium Pharmaceuticals, Inc.
Web site: http://www.millennium.com//
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