ATLANTA, Dec. 13 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced results from studies exploring VELCADE alone, or in combination with other commonly used agents, for previously untreated multiple myeloma. Overall response rates as high as 92 percent, with complete response rates as high as 30 percent were achieved. These results were presented in independent oral presentations at the 47th Annual Meeting of the American Society of Hematology (ASH) being held December 10-13, 2005, in Atlanta, GA. Overall response rates of 95 percent have been previously reported with VELCADE based therapy in this setting(1).
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"These are among the best overall response and complete response rates seen to date for the treatment of newly-diagnosed multiple myeloma patients," said Robert Tepper, M.D., president, research & development, Millennium. "Multiple VELCADE based regimens with consistently high complete response rates provide evidence to support VELCADE as the backbone of therapy."
VELCADE Combination with Melphalan and Prednisone (abstract #786)
A phase I/II trial led by Dr. M. Victoria Mateos, M.D., of the Grupo Espanol de Multiple Myeloma in Spain, and Professor J. San Miguel, M.D., of the Hematology Department at the University of Salamanca in Spain and conducted within the Spanish Myeloma Group (GEM/PETHEMA), evaluated the safety and efficacy of VELCADE plus melphalan and prednisone (V-MP) in previously untreated multiple myeloma patients 65 years of age and older. These patients were not eligible for transplant therapy. The phase II portion of the study with 53 evaluable patients demonstrated:
"With only one cycle of V-MP, we have achieved a higher response rate than in our historical controls with six cycles of conventional MP. After a median of 5 cycles of the V-MP regimen, the response rates in elderly, newly- diagnosed multiple myeloma patients are similar to those achieved with transplantation, long considered to be one of the best treatment options for young patients," said Dr. San Miguel.
VELCADE Alone and In Combination with Dexamethasone (abstract #783)
In an update of a phase II trial conducted by Sundar Jagannath, M.D., of St. Vincent's Comprehensive Cancer Center in New York, data on VELCADE alone and in combination with dexamethasone in patients with previously untreated, symptomatic multiple myeloma was presented. Results from 48 evaluable patients included:
A retrospective study, led by Michael Wang, M.D., of the University of Texas M.D. Anderson Cancer Center in Houston, evaluated the safety and activity of VELCADE in combination with thalidomide and dexamethasone in previously untreated multiple myeloma patients followed by autologous stem cell transplant. Data from 35 evaluable patients showed:
MM is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 45,000 to 50,000 individuals have MM and over 15,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually(3).
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, cardiac disorders, gastrointestinal adverse events, thrombocytopenia 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%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%), anorexia and appetite decreased (34%), parasthesia (27%), dysesthesia (27%), anemia and headache (26%), and cough (21%). Fourteen percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%), and hypercalcemia (2%). A total of 144 patients on VELCADE (44%) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea and pneumonia (4%), and vomiting (3%).
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 more than 60 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).
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE(R) (bortezomib) for Injection, 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.
This press release contains "forward-looking statements," including statements about the Company's growth 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 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.
Editor's Note: Abstracts can be accessed on the ASH website at http://www.hematology.org/ and were published in the November 16, 2005 issue of BLOOD, the journal of the American Society of Hematology.
Also, this release is available under the Media section on the Company's website at http://www.millennium.com/.
CONTACT: Theresa McNeely (media), +1-617-679-7405, or Kyle Kuvalanka (investors), +1-617-761-4734, both for Millennium Pharmaceuticals
Web site: http://www.millennium.com/ http://www.hematology.org/
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