Millennium Initiates Phase II Clinical Trial with VELCADE(TM) (Bortezomib) for Injection in Patients with Relapsed or Refractory Mantle Cell Lymphoma
Wednesday July 2, 8:00 am ET
-- Company-sponsored trial reinforces commitment to develop VELCADE across a broad range of hematological and solid tumor cancers --
# CAMBRIDGE, Mass., July 2 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced the initiation of a multicenter phase II clinical trial of VELCADE in patients with relapsed or refractory mantle cell lymphoma. The single-arm, open-label, three-stage study will assess time to progression, response rate, duration of response and overall survival in patients with relapsed or progressive mantle cell lymphoma following one or two prior chemotherapeutic regimens.(Logo: NewsCom: newscom.com )
"This trial is a high priority at Millennium because new therapies are urgently needed for this type of lymphoma," said Barry Greene, general manager, oncology at Millennium. "Preclinical and clinical studies that were recently presented at the American Society for Clinical Oncology (ASCO) meeting provided encouraging data that contributed to our decision to move forward with a phase II trial for mantle cell lymphoma."
The clinical trial is being conducted at multiple sites in North America and U.K., and will enroll approximately 152 patients with relapsed or refractory mantle cell lymphoma who have received one or two prior lines of therapy. Response rates will be analyzed at two interim points to determine the utility of the study.
"Following the recent launch of VELCADE in multiple myeloma, Millennium continues to be committed to strategically and expeditiously developing VELCADE in other malignancies," added Greene. "This trial is an integral part of a broad development program for VELCADE in non-Hodgkin's lymphoma."
VELCADE and proteasome inhibition represent a completely new approach to treating cancer. The development of this product is based on the Company's deep understanding of cancer disease pathways and the effect of proteasome inhibition on those pathways. The proteasome is an enzyme complex that exists in all cells and plays an important role in degrading proteins that control the cell cycle and cellular processes. By blocking the proteasome, VELCADE disrupts numerous biologic pathways, including those related to the growth and survival of cancer cells.
About Mantle Cell Lymphoma
Mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma, accounts for approximately six percent of all lymphomas. This form of lymphoma is characterized by small to medium sized cells and is often widespread when diagnosed and typically involves the lymph nodes, bone marrow and spleen. Only one fifth of patients survive more than five years following diagnosis.
About VELCADE(TM) (bortezomib) for Injection
VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma -- a cancer of the blood. Millennium received approval from the U.S. Food and Drug Administration on May 13, 2003 to market VELCADE 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 an improvement in survival.
VELCADE(TM) (bortezomib) for Injection has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
In 228 patients who were treated with VELCADE(TM) (bortezomib) for Injection in two phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (65 percent), nausea (64 percent), diarrhea (51 percent), appetite decreased (including anorexia) (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade four toxicity, with the most common toxicity being thrombocytopenia (three percent) and neutropenia (three percent). A total of 113 (50 percent) of the 228 patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pyrexia (seven percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5 percent), dehydration (5 percent) and nausea (4 percent).
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 headquartered in Cambridge, Mass., co-promotes INTEGRILIN® (eptifibatide) Injection, a market-leading cardiovascular product, markets VELCADE(TM) (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 four disease areas: cardiovascular, oncology, inflammation and metabolic. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized technology platform, Millennium is seeking to develop breakthrough personalized medicine products.
This press release contains "forward-looking statements," including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. Various risks may cause the Company's actual results to differ materially, including: adverse results in our drug discovery and clinical development processes; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the commercial success of INTEGRILIN® (eptifibatide) Injection and VELCADE(TM) (bortezomib) for Injection; 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 we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim 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: www.millennium.com.
Contacts:
Kelly Lindenboom (media) Gina Price Nugent (investor)
(617) 679-7405 (617) 551-3611
Source: Millennium Pharmaceuticals, Inc. |
