CAMBRIDGE, Mass., May 29 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced that new clinical data for VELCADE in hematological and solid tumors will be featured at the 43rd American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 1-4, 2007.
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“VELCADE is the market-leading therapy with unsurpassed single-agent efficacy for previously treated multiple myeloma and mantle cell lymphoma patients,” said Deborah Dunsire, M.D., President and Chief Executive Officer, Millennium. “With over 35 VELCADE abstracts featured at ASCO, data will demonstrate that combining the power of VELCADE with other active agents increases time to disease progression and improves survival. These clinical trial results are expected to further strengthen the role of VELCADE in its approved indications and provide exciting new evidence for the potential of VELCADE in additional disease settings.”
Previously Treated Multiple Myeloma
Data are expected to further support the role of VELCADE as the foundation of combination therapy with both established and emerging therapies. Clinical trial results will include time to disease progression and survival updates. Data also will be featured on subcutaneous administration. This formulation is being evaluated as a new and convenient administration option for patients and physicians without compromising the efficacy and well-characterized safety profile of VELCADE. Abstract highlights include:
-- Effect of the Combination of Pegylated Liposomal Doxorubicin And Bortezomib on Time to Progression (TTP) and Overall Survival of Patients with Relapsed/Refractory Multiple Myeloma Compared with Bortezomib Alone * Lead investigator: Jean-Luc Harousseau, M.D., University Hospital Hotel-Dieu * Abstract #8002; Clinical Science Symposium: Monday 4th June, 8:00 a.m. -- Impact of Prior Thalidomide Therapy on the Efficacy of Pegylated Liposomal Doxorubicin and Bortezomib in Relapsed/Refractory Multiple Myeloma * Lead investigator: Pieter Sonneveld, University Hospital Rotterdam-Dijkzigt * Abstract: #8023; Oral presentation: Sunday 3rd June, 3:00 p.m. -- Tanespimycin and Bortezomib in Multiple Myeloma: Pharmacology, Safety and Activity in Relapsed/Refractory Patients * Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer Institute * Abstract #3532; Poster session: Saturday 2nd June, 2:00 p.m.; Discussion: Saturday 2nd June, 5:00 p.m. -- Prospective Comparison of Subcutaneous to Intravenous Administration of Bortezomib in Patients with Multiple Myeloma: Pharmacokinetics, Efficacy and Toxicity * Lead investigator: Philippe Moreau, M.D., Hospital Hotel-Dieu * Abstract #8046; Poster session: Monday 4th June, 2:00 p.m.; Discussion: Monday 4th June, 5:00 p.m.
Front-Line Multiple Myeloma
Previously presented data have shown that VELCADE based combinations produce very high complete and near complete response rates in both transplant and non-transplant settings. Data presented at this conference are expected to support the emerging evidence that this benefit may lead to substantial improvement in time to progression and survival for patients with newly diagnosed multiple myeloma. Abstract highlights include:
-- Phase II Study of Total Therapy 3 (TT3) with Added Bortezomib for Multiple Myeloma * Lead investigator: Bart Barlogie, M.D., Ph.D., University of Arkansas for Medical Sciences * Abstract #8020; Oral presentation: Sunday 3rd June, 2:00 p.m. -- Final Results of a Phase II PETHEMA Trial of Alternating Bortezomib and Dexamethasone as Induction Regimen Prior to Autologous Stem Cell Transplantation (ASCT) in Younger Patients with Multiple Myeloma (MM): Efficacy and Clinical Implications of Tumor Response * Lead investigator: Laura Rosinol, M.D., Hospital Clinic, University of Barcelona * Abstract #8024; Oral presentation: Sunday 3rd June, 3:15 p.m. -- Bortezomib Prior to and as Maintenance Therapy After Autologous Stem Cell Transplant in Multiple Myeloma: Long-Term Follow-Up of a Phase II Study * Lead investigator: Sagun Goyal, M.D., Washington University School of Medicine * Abstract #8044; Poster session: Monday 4th June, 2:00 p.m.; Discussion: Monday 4th June, 5:00 p.m.
Non-Hodgkin’s Lymphoma (NHL)
Building on the recent approval of VELCADE in patients with previously treated mantle cell lymphoma, a form of NHL with one of the worst prognoses, data also will be featured on newly diagnosed patients and on patients with other subsets of NHL. For the first time, clinical trial results will be featured for VELCADE based combinations in diffuse large B-cell lymphoma, the most prevalent form of NHL. Abstract highlights include:
-- A Feasibility Study of VcR-CVAD with Maintenance Rituximab for Untreated Mantle Cell Lymphoma * Lead investigator: Brad Kahl, M.D., University of Wisconsin for Eastern Cooperative Oncology Group * Abstract #8062; Poster session: Saturday 2nd June, 8:00 a.m. -- Efficacy and Toxicity of Two Schedules of R-CHOP plus Bortezomib in Front-Line B Lymphoma Patients: A Randomized Phase II Trial from the Groupe d’Etude des Lymphomes de l’Adulte * Lead investigator: Nicolas Mounier, M.D., Ph.D., Hopital Saint Louis * Abstract #8010; Oral presentation: Sunday 3rd June, 10:00 a.m. -- CHOP-R + Bortezomib as Initial Therapy for Diffuse Large B-Cell Lymphoma * Lead investigator: John Leonard, M.D., Weill Medical College of Cornell University for Cancer & Leukemia Group B * Abstract #8031; Poster session: Monday 4th June, 2:00 p.m.; Discussion: Monday 4th June, 5:00 p.m.
Solid Tumors and Additional Hematological Cancers
Data are expected to show the potential for VELCADE in combination with other active agents in patients with solid tumors including colorectal cancer and glioma. In addition, VELCADE will be featured in Waldenstrom’s macroglobulinemia and amyloidosis, which are disease areas with a high unmet medical need. Abstract highlights include:
-- A Phase I Study of Vorinostat in Combination with Bortezomib in Refractory Solid Tumors * Lead investigator: William Schelman, M.D., Ph.D., University of Wisconsin Hospital and Clinics * Abstract #3573; Poster session: Sunday 3rd June, 8:00 a.m. -- A Phase I Study of Bortezomib in Combination with 5FU/LV Plus Oxaliplatin in Patients with Advanced Colorectal Cancer: EORTC 16029 * Lead investigator: Denis Lacombe, M.D., MSc, European Organisation for Research and Treatment of Cancer * Abstract #4090; Poster session: Monday 4th June, 8:00 a.m. -- A Phase I Trial Using the Proteasome Inhibitor Bortezomib and Concurrent Temazolomide and Radiotherapy for High Grade Gliomas * Lead investigator: Adam Dicker, M.D., Ph.D., Thomas Jefferson University * Abstract #2061; Poster session: Monday 4th June, 1:00 p.m.; Discussion: Monday 4th June, 1:00 p.m. -- Phase I/II Study of Bortezomib in Subjects with Systemic AL-Amyloidosis * Lead investigator: Donna Reece, M.D., Princess Margaret Hospital * Abstract #8050; Poster session: Monday 4th June, 2:00 p.m.; Discussion: Monday 4th June, 5:00 p.m.
About Multiple Myeloma (MM)
Multiple myeloma 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 close to 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and more than 45,000 deaths annually.
About Non-Hodgkin’s Lymphoma (NHL) and Mantle Cell Lymphoma (MCL)
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. The prevalence of NHL in the U.S. is approximately 400,000 patients, including approximately 200,000 patients with diffuse large B-cell lymphoma, 100,000 patients with follicular and marginal zone lymphoma and 10,000 with MCL. There are approximately 54,000 new cases of NHL diagnosed in the U.S. per year, and 19,000 deaths are attributed to the disease annually.
MCL is an aggressive, rapidly progressive subtype of NHL, and is not curable with standard treatment. The median life expectancy for a patient with MCL following first relapse 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. 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 is approved in more than 80 countries worldwide.
In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. VELCADE 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. In the European Union, VELCADE is approved for patients with multiple myeloma after first relapse.
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 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 multiple myeloma and mantle cell lymphoma studies, the most commonly reported adverse events were asthenic conditions (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy (39%), thrombocytopenia (36%), appetite decrease, including reports of anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%). Twenty percent of patients reported 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. The most commonly reported serious adverse events 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. Millennium’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. Millennium’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.
Editors’ Note: This press release is also available under the Media section of the Company’s website at: http://www.millennium.com.
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors) (617) 444-1439 (617) 761-4734
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CONTACT: Media, Jennifer Snyder, +1-617-444-1439, or Investors, KyleKuvalanka, +1-617-761-4734, both of Millennium Pharmaceuticals, Inc.
Web site: http://www.millennium.com/
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