-my MLNM buy at $41 last week is going down as a real beaut.
Millennium Initiates Phase II Clinical Trial of LDP-977 in Asthma
Anti-inflammatory Compound Advances in Clinic
CAMBRIDGE, Mass., Jun 12, 2001 /PRNewswire via COMTEX/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM chart, msgs) today announced that a Phase II clinical trial has been initiated with LDP-977, an orally active investigational drug. LDP-977 is a second generation compound in the class of allergy and asthma therapies known as 5-Lipoxygenase inhibitors, with activity that blocks the production of leukotrienes, major mediators of the inflammatory response.
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The multi-center Phase II trial is a randomized, placebo-controlled, double-blind, parallel group, dose-finding study to evaluate the safety and effectiveness of LDP-977 in adult patients with chronic asthma. The study will be conducted at 30 sites and is designed to include 320 patients. Pharmacogenomic information derived from the clinical studies will be examined in hopes of revealing the genetic controls for response or resistance to asthma therapy.
Millennium has entered into an agreement with Taisho Pharmaceutical Co., Ltd. regarding the development, marketing and sale of LDP-977 in Europe and Asia.
Three Phase I trials and one Phase I/II trial have been conducted with LDP-977 in healthy volunteers and asthmatic adults to date. "We are moving forward with the Phase II trial because we are encouraged by the initial study results of LDP-977 in asthma," said Lee R. Brettman, M.D., senior vice president, clinical development and regulatory affairs at Millennium. "Patients with asthma need additional effective therapies for this chronic, debilitating and sometimes life-threatening disease. LDP-977 is being studied as an option for these patients."
William Busse, M.D., University of Wisconsin-Madison Medical School/Allergy, Asthma Clinical Research Unit, assisted with the study protocol design and is a lead investigator in the LDP-977 trial. "Anti- leukotriene agents such as LDP-977 represent potentially promising new alternatives in the treatment of asthma," said Dr. Busse. "LDP-977 acts early in the leukotriene production pathway to block the production of both LTB4 and the cysteinyl leukotrienes, LTC4, D4 and E4."
Asthma
Asthma is a chronic disease characterized by airway inflammation and bronchoconstriction (narrowing of the airways). Those affected with the disease experience asthmatic episodes when their airways become inflamed and they have difficulty breathing. According to the U.S. Centers for Disease Control and Prevention, the number of asthma sufferers has more than doubled from 6.7 million in 1980 to 17.3 million in 1998. Asthma results in more than 5,000 deaths annually. The Asthma and Allergy Foundation of America reports that many asthma-related deaths and hospitalizations are preventable when asthma is properly managed.
Taisho Collaboration
In January 2000, collaboration began with Taisho Pharmaceutical Co., Ltd., to develop, seek regulatory approval for, and commercialize LDP-977 for the treatment of chronic asthma. Under the terms of the agreement, Taisho holds an exclusive license to LDP-977 in Japan, Asia and Europe while Millennium retains rights for the rest of the world, including North America. In exchange, Taisho funds all of the research and development expenses of the compound in Japan and Asia, and two-thirds of the expenses in the United States and Europe. Quarterly payments began in the first quarter of 2000.
Millennium's Inflammation Franchise Area
Millennium's approach to personalized medicine is demonstrated through the development of a portfolio of breakthrough products comprised of both therapeutic (small molecule and antibody) and predictive programs. Inflammation, oncology and metabolic disease comprise Millennium's three key research and development franchises. The company has a number of inflammation-based targets and compounds in various stages of development that span from discovery research to advanced clinical trials. These programs include small molecules, monoclonal antibodies and proteins to potentially treat a broad spectrum of chronic inflammatory diseases such as inflammatory bowel disease, asthma, and multiple sclerosis, as well as acute inflammatory conditions such as stroke.
Millennium, a leading biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of breakthrough therapeutic and predictive medicine products, with a goal of delivering personalized medicine. Through the industrialization of this gene-to-patient platform, Millennium is also striving to accelerate the process of drug discovery and development. Headquartered in Cambridge, Mass., Millennium currently employs more than 1,400 people.
This press release contains "forward-looking statements," including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. Various risks may cause Millennium's actual results to differ materially, including: adverse results in our drug discovery and clinical development processes; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; 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 we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise |
