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Millennium Initiates Phase II Clinical Trial in Patients With Multiple Sclerosis

Posted on: Monday, 11 July 2005, 09:00 CDT

CAMBRIDGE, Mass., July 11 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced the initiation of a multicenter phase II clinical trial of MLN1202 in approximately 40 patients with relapsing-remitting multiple sclerosis (MS), the most common form of the disease. MLN1202, a novel humanized monoclonal antibody, is designed to block CCR2 chemokine receptors and prevent the infiltration of immune cells into inflammatory sites. The CCR2 chemokine pathway is believed to play a central role in a number of inflammatory conditions, including MS.

(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )

This proof-of-concept study will assess the safety and tolerability of the molecule and determine the effect of MLN1202 on disease activity by magnetic resonance imaging (MRI). Study participants will receive multiple doses of MLN1202 in two dosing regimens over the course of four months. The study will be conducted at sites in Canada and Europe.

"MLN1202 is designed to specifically target the CCR2 receptors found primarily on monocytes and macrophages -- versus all leukocytes -- which may be beneficial in lowering the risk of systemic immune suppression," said Nancy Simonian, M.D., senior vice president, clinical, regulatory and medical affairs, Millennium. "MS remains a significant area of unmet medical need and we are hopeful that the novel mechanism of action of MLN1202 could provide patients with a new treatment option."

About MLN1202

MLN1202 specifically targets CCR2 chemokine receptors found on the surface of a specific subset of leukocyte: macrophages and monocytes. A number of published preclinical studies suggest that chemokine receptors -- such as CCR2 -- play an important role in the inflammatory response, particularly the trafficking of monocytes and macrophages in both normal and pathological states. The expression of these chemokines and their receptors is increased during the acute phase of MS in humans as well as in animal models of MS. As a result, chemokines have become an emerging focus for research into novel therapeutics for MS.

Currently, Millennium is evaluating MLN1202 in a multi-center phase II clinical trial involving approximately 30 patients with rheumatoid arthritis. The first three cohorts have been fully enrolled and MLN1202 appears to be well tolerated with favorable pharmacokinetic and pharmacodynamic profiles. A fourth cohort has been added with data anticipated in 2006. Additional studies of MLN1202 are planned in atherosclerosis and scleroderma.

For more information about MLN1202 clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at (800) 589-9005 or +1 (617) 551-2972.

About Multiple Sclerosis (MS)

MS is characterized pathologically by the destruction of myelin sheath tissue, which surround nerve fibers in the central nervous system. It is believed that this tissue damage in the brain and spinal cord of MS patients is caused by an inflammatory response.

More than two million people worldwide are estimated to suffer from multiple sclerosis, which is the leading cause of neurological disability in young adults.(1) MS is the most common inflammatory and neurodegenerative disorder of the central nervous system, including the brain, spinal cord and optic nerves.(2) It is usually diagnosed between age 20 and 40 and is twice as common in women as men.(1)

MS can have a significant impact on patients' social activities, employment and overall quality of life. MS typically presents in relapsing forms. Relapsing-remitting MS is the most common form of the disease. These patients suffer acute attacks (relapses) of neurological dysfunction followed by complete or incomplete remission in function. Over time, the majority of patients develop progressive neurological disability. Patients can experience symptoms ranging from fatigue, tingling, numbness and blurred vision to poor muscle control with partial or complete paralysis, speech or mental impairment.

About Millennium

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE(R) (bortezomib) for Injection, a novel cancer product, co-promotes INTEGRILIN(R) (eptifibatide) Injection, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, 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.

References

(1) Multiple Sclerosis International Federation ( http://www.msif.org/en/ms_the_disease/quick_facts.html ).

(2) Multiple Sclerosis International Federation ( http://www.msif.org/en/ms_the_disease/index.html ).

(3) Multiple Sclerosis International Federation ( http://www.msif.org/en/ms_the_disease/types_of_ms.html ).

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 growth and 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(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.

Contact: Theresa McNeely (media) Kyle Kuvalanka (investors) (617) 679-7405 (617) 761-4734

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk,photodesk@prnewswire.com

Millennium Pharmaceuticals, Inc.

CONTACT: Media: Theresa McNeely, +1-617-679-7405; or Investors: KyleKuvalanka, +1-617-761-4734, both for Millennium Pharmaceuticals

Web site: http://www.millennium.com/http://www.msif.org/en/ms_the_disease/quick_facts.htmlhttp://www.msif.org/en/ms_the_disease/index.htmlhttp://www.msif.org/en/ms_the_disease/types_of_ms.html

Company News On-Call: http://www.prnewswire.com/comp/114562.html

Source: PRNewswire-FirstCall

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