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|VELCADE® (bortezomib) for Injection Phase II Clinical Trial Initiated in Lung Cancer|
|Company-sponsored trial in patients with either brochioloalveolar carcinoma
(BAC) or adenocarcinoma with BAC features reinforces commitment to strategic
CAMBRIDGE, Mass., April 25, 2005 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced, in collaboration with Johnson & Johnson Pharmaceutical Research & Development, LLC, the initiation of PEAK (Prospective Evaluation of bortezomib in Adenocarcinoma with bronchioalveolar features as a Keystone of therapy). This is a multicenter phase II clinical trial of VELCADE in patients with either advanced BAC or adenocarcinoma with BAC features that have progressed on or after receiving one to two lines of chemotherapy, one of which must have been an epidermal growth factor receptor tyrosine kinase inhibitor (EGRF TKI). The open-label study will assess efficacy in terms of tumor response rate measured by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
"Millennium, and our partner Johnson and Johnson, are committed to investigating VELCADE as a therapy for lung cancer and this trial is an integral component of our global development plan," said David Schenkein, M.D., senior vice president, clinical research, Millennium. "In reviewing previous VELCADE experiences, we saw several dramatic single-agent responses in patients with BAC and we are eager to explore the potential of VELCADE so that we may be able to offer new options for patients in need."
VELCADE is approved in the U.S. for the treatment of patients who have received at least one prior therapy. Millennium and Johnson & Johnson continue to investigate VELCADE globally in phase I, II and III clinical trials in both hematologic and solid tumors, including frontline MM, non-Hodgkin's lymphoma and lung, prostate and ovarian cancers.
Patients with BAC or adenocarcinoma with BAC features comprise a 30,000- patient group representing approximately 20% of the overall non-small cell lung population. These patients tend to have a unique histology and have typically responded poorly to cytotoxic drugs used for non-small cell lung cancer. Data suggest that the incidence of BAC is increasing, notably in younger non-smoking women. Despite reports of prolonged survival, BAC remains incurable with the vast majority of patients dying of respiratory failure or pneumonia within five years of diagnosis.
About VELCADE® (bortezomib) for Injection
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.
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 1.3 mg/m2 dose in the phase III APEX 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%) and anorexia and appetite decreased (34%). 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 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. VELCADE is approved in more than 40 countries worldwide including the U.S., European Union members, and a number of countries within Latin America and South-East Asia such as Argentina, China, Korea, Singapore and Thailand.
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, a novel cancer product, co- promotes INTEGRILIN® (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, Millennium is seeking to develop breakthrough products.
This press release contains "forward-looking statements," including statements about the Company's discovery 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® (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.