CAMBRIDGE, Mass., Dec. 8 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced that new data from studies of VELCADE will be featured at the American Society of Hematology (ASH) 48th Annual Meeting in Orlando, Fla., December 9-12, 2006.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"Data continue to show how VELCADE, the only approved product that provides a survival advantage to patients with relapsed multiple myeloma, is showing encouraging results in combination with standard therapies in multiple myeloma and non-Hodgkin's lymphoma," said Deborah Dunsire, M.D., President and CEO, Millennium. "Over 150 abstracts will be presented this week showing some of the highest complete response rates seen to date in the treatment of multiple myeloma in the non-transplant setting."
Highlights from oral and poster presentations of VELCADE include:
Multiple Myeloma: Front Line
(Abstract #56, Sunday 10th December, 4:45 p.m.), Lead Investigator: Jean- Luc Harousseau, M.D., Hospital Hotel-Dieu, Nantes, France
* Preliminary data from a Phase III study of newly diagnosed multiple
myeloma (MM) patients treated with VELCADE plus dexamethasone versus
vincristine, adriamycin and dexamethasone combination therapy (VAD)
(Abstract #796, Tuesday 12th December, 8:45 a.m.), Lead Investigator: Sundar Jagannath, M.D., St. Vincent's Comprehensive Cancer Center, New York, on behalf of the Aptium Oncology Research Network, Los Angeles, California
* Long-term follow-up on a Phase II trial of MM patients treated with
VELCADE alone and in combination with dexamethasone as front-line
therapy
(Abstract #797, Tuesday 12th December, 9:00 a.m.), Lead Investigator: Robert Orlowski, M.D., Ph.D., Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
* VELCADE plus pegylated liposomal doxorubicin as induction therapy for
patients with untreated MM
(Abstract #3093, Monday 11th December, 10:30 a.m.), Lead Investigator: Andrzej Jakubowiak, M.D., Ph.D., University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan
* Preliminary data from a study of VELCADE plus Doxil and dexamethasone in
untreated MM patients, and the efficacy of this regimen following
autologous stem cell transplant
Multiple Myeloma: Relapsed/Refractory
(Abstract #404, Monday 11th December, 11:15 a.m.), Lead Investigator: Robert Orlowski, M.D., Ph.D., Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
* Interim analysis of a Phase III study of VELCADE in combination with
pegylated liposomal doxorubicin compared with VELCADE alone in
relapsed/refractory MM patients
(Abstract #3530, Monday 11th December, 10:30 a.m.), Lead Investigator: Joseph Mikhael, M.D., Princess Margaret Hospital, Toronto, Canada
* Preliminary Phase IIIb data from a study of biweekly VELCADE +/-
dexamethasone in patients with relapsed/ refractory MM, including those
who were heavily pretreated
(Abstract #3529, Monday 11th December, 10:30 a.m.), Lead Investigator: Ruben Niesvizky, M.D., Weill Medical College of Cornell University, New York Presbyterian Hospital, New York
* Analysis of the Phase III APEX and Phase II SUMMIT trials evaluating the
relationship between quality of response to VELCADE and clinical benefit
in relapsed/refractory MM
(Abstract #405, Monday 11th December, 11:30 a.m.), Lead Investigator: Paul Richardson, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts
* Final data from a multicenter Phase I trial of VELCADE in combination
with lenalidomide and dexamethasone in heavily pretreated relapsed MM
patients, including those who had prior treatment with VELCADE,
lenalidomide, thalidomide and stem cell transplant
(Abstract #3537, Monday 11th December, 10:30 a.m.), Lead Investigator: Faith Davies, M.D., Haemato-Oncology Unit, Royal Marsden Hospital, London, England
* Interim data from a retrospective study of VELCADE plus dexamethasone and cyclophosphamide compared to VELCADE alone and VELCADE plus dexamethasone for patients with multiply relapsed MM
(Abstract #3539, Monday 11th December, 10:30 a.m.), Lead Investigator: Asher Chanan-khan, M.D., Roswell Park Cancer Institute, State University of New York at Buffalo, New York
* Final results of a Phase II Study of VELCADE in combination with
pegylated liposomal doxorubicin and thalidomide (VDT) in relapsed MM
patients, targeting the MM cell and its microenvironment
(Abstract #3536, Monday 11th December, 10:30 a.m.), Lead Investigator: Donna Reece, M.D., Princess Margaret Hospital, University Health Network, Toronto, Ontario
* Results from a Phase I/II dose-escalating study of VELCADE plus oral
cyclophosphamide and prednisone for relapsed MM
(Abstract #3541, Monday 11th Dec., 10:30 a.m.), Lead Investigator: Evangelos Terpos, M.D., Dept. of Hematology, General Airforce Hospital, Athens, Greece
* VELCADE in combination with melphalan, dexamethasone and intermittent
thalidomide (VMDT) in relapsed/refractory MM, and impact of the regimen
on markers of bone remodeling
(Abstract #407, Monday 11th December, 12:00 p.m.), Lead Investigator: Antonio Palumbo, M.D., Azienda Ospedaliera San Giovanni Battista, Torino, Italy
* Results of a Phase I/II clinical trial of VELCADE in combination with
melphalan, prednisone and thalidomide (VMPT) for relapsed MM
Multiple Myeloma: Retreatment
(Abstract #3531, Monday 11th December, 10:30 a.m.), Lead Investigator: Therese Conner, Outcomes Research, U.S. Oncology, Houston, Texas
* Efficacy of single-agent VELCADE as retreatment in relapsed MM patients
(Abstract #3532, Monday 11th December, 10:30 a.m.), Lead Investigator: Jeffrey Wolf, M.D., Alta Bates Comprehensive Cancer Center, Berkeley, California
* VELCADE as retreatment in heavily pretreated relapsed MM patients: A
retrospective analysis of the Phase II SUMMIT and CREST and Phase III
APEX studies
Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma (Abstract #2753, Sunday 10th December, 9:00 a.m.), Lead Investigator: Johannes Drach, M.D., Department of Medicine I, Clinical Division of Oncology, Medical University of Vienna, Austria
* Phase II interim results of the study of VELCADE plus rituximab and
dexamethasone in relapsed/refractory mantle cell lymphoma
Follicular and Marginal Zone Lymphoma (Abstract #694, Monday 11th December, 4:15 p.m.), Lead Investigator: Sven De Vos, M.D., Ph.D., UCLA Medical Center, Los Angeles, California
* Final results of a Phase II study with weekly and twice-weekly VELCADE
plus rituximab in relapsed/refractory follicular and marginal zone
lymphomas
B-cell Non-Hodgkin's Lymphoma (Abstract #2759, Sunday 10th December, 9:00 a.m.), Lead Investigator: John Gerecitano, M.D., Memorial Sloan-Kettering Cancer Center, New York, New York
* Final results of a Phase I study of VELCADE plus rituximab,
cyclophosphamide and prednisone (R-CVP) in relapsed/refractory B-cell
non-Hodgkin's Lymphoma
T-Cell Lymphoma (Abstract #2462, Sunday 10th December, 9:00 a.m.), Lead Investigator: Pier Luigi Zinzani, M.D., Unit of Cardiology and Hematology, Institute of Hematology and Medical Oncology, University of Bologna, Bologna, Italy
* Preliminary results of a Phase II study of single-agent VELCADE in
previously treated patients with relapsed peripheral T-cell lymphoma,
unspecified with only skin involvement and cutaneous T-cell lymphomas
About Multiple Myeloma
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 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(1).
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the U.S.(2) The prevalence of NHL is approximately 400,000 patients, 77,000 patients with follicular lymphoma and 10,000 with mantle cell lymphoma. There are approximately 54,000 new cases of NHL diagnosed per year, and 19,000 deaths are attributed to the disease annually(2-5).
Mantle cell lymphoma is an aggressive, rapidly progressive subtype of NHL, and is not curable with standard treatment. Because there is no generally accepted treatment approach and options often are limited, there is a growing need for new therapies. The average life expectancy for a patient with relapsed mantle cell lymphoma is one to two years.
About VELCADE
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 in multiple myeloma. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. will co-promote VELCADE in the U.S. VELCADE also is approved in the European Union after first relapse.
VELCADE(R) (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. VELCADE(R) (bortezomib) for Injection is indicated for the treatment of patients with mantle cell lymphoma 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. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with few or no risk factors for decreased left ventricular ejection fraction. There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome (ARDS) in patients receiving VELCADE. Some of these events have been fatal. A higher proportion of these events have been reported in Japan. There have been rare reports of RPLS in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.
Safety Data: In 1163 patients in MM and MCL studies, the most commonly reported adverse events were asthenic conditions (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy (39%), thrombocytopenia (36%), appetite decreased, including reports of anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%). Twenty percent of patients experienced at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (5%) and neutropenia (3%). Fifty percent of patients reported serious adverse events (SAEs). The most commonly reported SAEs were pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).
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, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. The Company's website is http://www.millennium.com/.
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.
1. American Cancer Society, Overview: Multiple Myeloma, 2005, http://www.cancer.org/
2. Jemal, A. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30.
3. Mantle Cell Lymphoma. 01 June 2006. Lymphoma Information Network. 27 Oct 2006
http://www.lymphomainfo.net/nhl/types/mantle.html
4. Non-Hodgkin's Lymphoma. Onkos Study #52. February 2002;12. Decision Resources, Inc.
5. Data on File
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 444-1439 (617) 761-4734
Editors' Note: This press release is also available under the Media section of the Company's website at: http://www.millennium.com/.
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