Healthcare Industry News: Janssen
News Release - July 16, 2007
Millennium Initiates Phase III Trial to Determine the Optimal VELCADE(R) (Bortezomib) for Injection Based Therapy in Newly Diagnosed Multiple Myeloma PatientsU.S.-based trial builds on previously presented data demonstrating some of the highest reported complete remission and survival rates
CAMBRIDGE, Mass., July 16 (HSMN NewsFeed) -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM ) today announced the initiation of a randomized, multi-center, Company-sponsored Phase III trial to determine the most effective VELCADE based combination therapy with approved agents for the treatment of newly diagnosed multiple myeloma (MM) patients, ineligible for stem cell transplantation. The trial, named UPFRONT and conducted primarily at community physician networks nationwide, will compare three VELCADE based therapies. VELCADE, currently the market leader in relapsed MM, is being developed for registration in front-line MM based on strong survival data seen in earlier clinical trials.
"VELCADE has delivered some of the highest complete remission and survival rates, rarely seen with the exception of high-dose therapy and stem cell transplantation," said Ruben Niesvizky, M.D., New York Presbyterian Hospital and Weill-Cornell Medical Center, and the UPFRONT Principal Investigator. "Our goal with the UPFRONT trial is to further evaluate VELCADE in combination with standards of care and identify the optimal combination that will potentially extend survival in newly diagnosed multiple myeloma patients."
The UPFRONT (Untreated Patients receiving therapy For multiple myeloma in a Randomized trial Of three novel regimens for patients Not intending to receive Transplant therapy) trial will evaluate the safety and efficacy of VELCADE and dexamethasone (VD); VELCADE, thalidomide and dexamethasone (VTD); and VELCADE, melphalan and prednisone (VMP). The primary endpoint of the trial is progression-free survival with secondary endpoints including duration of response, overall survival and overall safety / tolerability. Target enrollment for the trial is up to 500 patients and participants will remain in the trial on treatment for up to one year.
UPFRONT has a unique, adaptive design, providing the flexibility to modify the therapies (following an interim analysis) should a new standard of care be established in the marketplace. The adaptive design will help ensure that the most effective treatment options are evaluated in the most efficient way.
For more information about VELCADE clinical trials including this trial, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (835-2233). Additional information can also be found at www.velcade.com.
About Multiple Myeloma
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 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.
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. is co-promoting 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 and many other countries worldwide, 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%) in single-agent VELCADE, 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%).
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 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® (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.
Source: Millennium Pharmaceuticals
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