CAMBRIDGE, Mass., May 26 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced that additional data from studies of VELCADE will be featured at the American Society of Clinical Oncology (ASCO) 42nd Annual Meeting in Atlanta, GA, June 2-6, 2006.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO ) Highlights from oral presentations of VELCADE include:
Multiple Myeloma (Abstract 7504, Sunday 4th June, 10:00-10:15am), Lead Investigator: Paul Richardson, M.D., The Dana-Farber Cancer Institute
* Efficacy of single-agent VELCADE in newly-diagnosed multiple myeloma:
Results of a Phase II multicenter study
Multiple Myeloma (Abstract 7519, Monday 5th June, 10:00-10:15am), Lead Investigator: Bart Barlogie, M.D., Myeloma Institute for Research and Therapy at the University of Arkansas for Medical Sciences
* Incorporating VELCADE into up-front therapy for multiple myeloma with
tandem transplants
Non-Small Cell Lung Cancer (Abstract 7017, Sunday 4th June, 3:30-3:45pm), Lead Investigator: Angela Davies, M.D., University of California Davis Cancer Center
* Results from a Phase II study of VELCADE in combination with a standard front-line regimen in advanced non-small cell lung cancer, conducted by the Southwest Oncology Group (SWOG)
Non-Hodgkin's Lymphoma (Abstract 7512, Sunday 4th June, 10:45-11:00am), Lead Investigator: Andre Goy, M.D., The Cancer Center at Hackensack University Medical Center
* Final Phase II data from the PINNACLE study of single-agent VELCADE in the treatment of relapsed or refractory mantle cell lymphoma Other Abstract Highlights on VELCADE Include: Multiple Myeloma
(Abstract 2032, Sunday 4th June, 2:00-6:00pm), Lead Investigator: Daniel Mulkerin, M.D., University of Wisconsin Department of Medicine
* A dose-escalating and pharmacologic study of VELCADE in multiple myeloma
patients with impaired renal function
(Abstract 17539, publication only), Lead Investigator: Mark Druck, M.D., Combined Hematology Oncology Practice of New Jersey, Jersey City
* Phase IV trial of VELCADE for retreatment of multiple myeloma patients
following an initial response to VELCADE
(Abstract 7546, Monday 5th June, 2:00-6:00pm), Lead Investigator: Dan Vogl, M.D., University of Pennsylvania School of Medicine
* Analysis of the impact of prior autologous stem cell transplant in relapsed/refractory multiple myeloma patients receiving VELCADE or dexamethasone
(Abstract 7548, Monday 5th June, 2:00-6:00pm), Lead Investigator: Shachar Peles, M.D., Washington University School of Medicine, St. Louis, MO
* Results from a prospective study of the effects of once weekly VELCADE on markers of bone metabolism in multiple myeloma patients Waldenstrom's Macroglubulinemia
(Abstract 7543, Monday 5th June, 2:00-6:00pm), Lead Investigator: Christine Chen, M.D., University Health Network, Princess Margaret Hospital, Toronto ON
* Final results of a Phase II study of VELCADE in previously untreated and treated Waldenstrom's macroglobulinemia About VELCADE
VELCADE is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 331 patients who were treated with VELCADE in a Phase III study, the most commonly reported adverse events were asthenic conditions (61 percent), diarrhea (57 percent), nausea (57 percent), constipation (42 percent), peripheral neuropathy (36 percent), vomiting (35 percent), pyrexia (35 percent), thrombocytopenia (35 percent), psychiatric disorders (35 percent), anorexia and appetite decreased (34 percent), parasthesia (27 percent), dysesthesia (27 percent), anemia and headache (26 percent), and cough (21 percent). Fourteen percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4 percent), neutropenia (2 percent), and hypercalcemia (2 percent). A total of 144 patients on VELCADE (44 percent) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6 percent), diarrhea (5 percent), dyspnea, pneumonia (4 percent), and vomiting (3 percent).
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. VELCADE is approved in 66 countries worldwide. VELCADE is also approved in the European Union as a second-line treatment.
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, 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. The Company's website is http://www.millennium.com.
Editor's Note: This release is available on the Media section of the Millennium website at http://www.millennium.com.
Contacts:
Theresa McNeely (media) Kyle Kuvalanka (investor) (617) 679-7405 (617) 761-4734
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk photodesk@prnewswire.comMillennium Pharmaceuticals, Inc.CONTACT: Theresa McNeely (media), +1-617-679-7405, or Kyle Kuvalanka(investor), +1-617-761-4734, both of Millennium Pharmaceuticals, Inc.
Web site: http://www.millennium.com//
Company News On-Call: http://www.prnewswire.com/comp/114562.html/
