Anti-inflammatory Compound Advances in Clinic
Source: PR Newswire
CAMBRIDGE, Mass., Feb. 8 /PRNewswire/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that a Phase II clinical trial of LDP-02 for ulcerative colitis is now underway in Canada. LDP-02 is an investigational humanized monoclonal antibody for the treatment of inflammatory bowel diseases (IBD), which includes both ulcerative colitis and Crohn's disease. This multi-center Phase II trial is a randomized, placebo-controlled, double-blind study to determine the safety and effectiveness of LDP-02 in patients with ulcerative colitis.
LDP-02 is currently being evaluated in two additional clinical trials. A Phase I/II clinical trial is underway in the U.S. for ulcerative colitis, and a Phase II trial is ongoing in Canada for the treatment of Crohn's disease. LDP-02 is being developed in collaboration with Genentech, Inc., which holds exclusive worldwide commercialization rights.
"We are encouraged by the initial data of LDP-02 in inflammatory bowel disease (IBD)," said Lee R. Brettman, M.D., senior vice president, medical and regulatory affairs at Millennium. "Based on that data, we are moving forward with this important trial with the long-term goal of providing potential benefit to people who need effective therapeutic options for this chronic and often debilitating disease."
Early last year, Millennium completed a Phase I/II study of LDP-02 for ulcerative colitis in Canada. The results of that trial, which were presented at the annual Digestive Disease Week Conference in San Diego in May 2000, suggested that LDP-02 is well tolerated and the blockade of ?4B7 receptors on circulating lymphocytes was accomplished for several weeks after a single dose of LDP-02.
Inflammatory Bowel Disease
IBD encompasses a group of chronic disorders, including Crohn's disease and ulcerative colitis, that produce inflammation and ulceration in the intestines. A damaging inflammatory response involving the recruitment and activation of leukocytes results in tissue destruction in both disorders. Ulcerative colitis causes bleeding and inflammation of the mucosal lining of the colon and rectum, while Crohn's disease is an inflammation that extends deeper into all layers of the intestinal wall and frequently involves both the small and large intestine. Current drug therapy for serious cases involves several types of therapy which could include steroids and immunosuppressants that broadly suppress the immune response and as a result, carry a risk of infection and adverse side effects.
The Crohn's and Colitis Foundation estimates that up to 1 million Americans have IBD. Although the cause of IBD is unknown, research has shown that the body's inflammatory system contributes to the disease process.
In December 1997, collaboration began with Genentech, Inc. to develop, seek regulatory approval for, and commercialize LDP-02 for the treatment of IBD. Under the terms of the agreement, Genentech receives exclusive worldwide rights to market LDP-02. Millennium is to develop LDP-02 through successful Phase II clinical trials after which Genentech will complete the development of the product. Millennium has the option to share in the Phase III development costs in return for a share of profits on U.S. sales while continuing to receive royalties on non-U.S. sales. Millennium also receives development milestone payments from Genentech. Millennium and Genentech retain separate rights to develop small molecule therapeutics for the treatment of IBD.
Millennium's Inflammation Franchise Area
Inflammation is one of Millennium's three key research and development franchise areas, along with oncology and metabolic disease. The company has a number of inflammation-based targets and compounds in various stages of development that span from discovery research to Phase II 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 1,200 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.
Editor's Note: This release is available on Millennium's website at www.millennium.com.
Contact: Gina Brazier (investor), 617-551-3611 or Lynn Smiledge (media), 617-761-4700 both of Millennium Pharmaceuticals, Inc.