New Data on VELCADE(R) (bortezomib) for Injection to be Presented at Upcoming American Society of Hematology Meeting
-- VELCADE Featured in More Than 50 Abstracts --
CAMBRIDGE, Mass., Dec. 1 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq:MLNM) today announced that data from studies involving VELCADE data will be featured at the 46th Annual Meeting of the American Society of Hematology in San Diego, Calif., December 4-7, 2004.
Highlights of data from several clinical trials with VELCADE to be presented at the meeting include:
* Results of several ongoing phase II studies investigating VELCADE alone
or in combination as a frontline treatment in untreated multiple myeloma
patients:
-- VELCADE alone and in combination with dexamethasone;
-- VELCADE, dexamethasone and doxorubicin; and
-- VELCADE and melphalan and prednisone.
* Final data from the APEX phase III, multi-center trial comparing VELCADE
to high-dose dexamethasone in time to progression, response rates,
duration of response and survival.
* Updates from ongoing studies in which VELCADE is being used as a single
agent for the treatment of certain types of non-Hodgkin's lymphoma
including:
-- A multi-center, phase II study of VELCADE in non-Hodgkin's lymphoma,
including follicular lymphoma and mantle cell lymphoma;
-- A phase II trial of VELCADE in mantle cell lymphoma for patients who
were previously untreated or had received up to two prior
chemotherapy regimens; and
-- A phase II study of VELCADE for patients with relapsed and refractory
non-Hodgkin's lymphoma.
Abstracts can be accessed on the ASH website at hematology.org and were published in the November 16, 2004 issue of BLOOD, the journal of the American Society of Hematology.
Millennium and Johnson & Johnson Pharmaceutical Research and Development, L.L.C., continue to investigate VELCADE globally in both hematologic and solid tumors and currently have approximately 80 ongoing clinical trials.
VELCADE is currently approved in the United States, 27 European Union states, Argentina, Israel, and South Korea. VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan.
About VELCADE(R) (bortezomib) for Injection
VELCADE is approved for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in survival. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, orthostatic hypotension, congestive heart failure, gastrointestinal adverse events, thrombocytopenia, and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 228 patients who were treated with VELCADE 1.3 mg/m2/dose in phase II studies, the most commonly reported adverse events were asthenic conditions (65%), nausea (64%), diarrhea (51%), decreased appetite including anorexia (43%), constipation (43%), thrombocytopenia (43%), peripheral neuropathy (37%), pyrexia (36%), vomiting (36%), and anemia (32%). Fourteen percent of patients experienced at least one episode of Grade 4 toxicity, with the most common toxicities being thrombocytopenia (3%) and neutropenia (3%). A total of 113 (50%) of the 228 patients experienced Serious Adverse Events (SAEs) during studies. The most commonly reported SAEs included pyrexia (7%), pneumonia (7%), diarrhea (6%), vomiting (5%), dehydration (5%), and nausea (4%).
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE.
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, co- promotes INTEGRILIN(R) (eptifibatide) Injection, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, and inflammation. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized drug discovery platform, the Company is seeking to develop breakthrough products.
Editor's Note: This release is available under the Media section on the Company's website at millennium.com.
Contacts:
Adriana Jenkins (media) Gina Nugent (investor)
(617) 761-6996 (617) 551-3611
SOURCE Millennium Pharmaceuticals, Inc.
CO: Millennium Pharmaceuticals, Inc.; American Society of Hematology
ST: California, Massachusetts
SU: TDS
Web site: millennium.com
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12/01/2004 08:02 EST |
