CAMBRIDGE, Mass., June 12 /PRNewswire/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - news) 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.* (Photo: newscom.com )
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.'... |
