Millennium Initiates Combination Oncology Trials of MLN341 with Taxotere(R)
Furthers Aggressive Clinical Development Program of Investigational Compound in Solid Tumors in Conjunction with Chemotherapy Agent ?
CAMBRIDGE, Mass., Jan. 7 /PRNewswire/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - news) today announced the initiation of multiple phase I clinical trials of MLN341 (formerly LDP-341, PS-341), in combination with Taxotere® (docetaxel) for Injection Concentrate, Aventis Pharmaceuticals' chemotherapy agent used in the treatment of some breast and lung cancers. The clinical studies are being conducted to assess the safety of MLN341 in combination with the commonly used cancer agent in advanced solid tumors. MLN341, the first investigational drug candidate in a new class of anti-cancer agents, is a small molecule proteasome inhibitor under development by Millennium as a novel potential therapy to treat human malignancies.
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MLN341 is designed to specifically block the proteasome, an enzymatic complex in the cell responsible for breaking down a variety of proteins, including many that regulate cell division. Laboratory studies suggest that by inhibiting the proteasome, MLN341 in cancer cells halts cell division and ultimately causes apoptosis (programmed cell death). While healthy cells appear to be able to recover from the effects of proteasome inhibition, cancer cells seem to be more sensitive to its pro-apoptotic effects. Therefore, proteasome inhibition with MLN341 offers the potential to target cancer cells while sparing healthy ones.
``Millennium's research with MLN341 suggests that proteasome inhibitors, when used alone or in combination with other chemotherapeutic treatments, may offer a novel strategy for the treatment of cancer,'' said Michael Kauffman, M.D. Ph.D., vice president, medicine and MLN341 project leader at Millennium. ``Millennium continues its aggressive MLN341 clinical development program with a variety of phase I and phase II trials underway in solid tumors and hematologic malignancies as both a single agent and in combination. Additionally, we anticipate the start of a phase III trial in multiple myeloma later this year.''
The multi-center trials have been initiated with the Cleveland Clinic and Vanderbilt University Medical Center in prostate cancer and the California Lung Consortium in lung cancer. An additional trial in breast cancer is scheduled to begin in the first quarter at several European sites. The combination trials are open label, dose escalation studies of MLN341 plus Taxotere® in patients with advanced solid tumors. The goal of the studies is to assess the safety and determine the maximum tolerated dose of the MLN341 / Taxotere® combination.
Recent MLN341 News
Millennium presented preliminary findings of an ongoing phase II clinical trial of MLN341 in patients with relapsed and refractory multiple myeloma at the American Society of Hematology (ASH) meeting in December. The study results indicated that MLN341 halted the progression of the disease in most study participants while reducing M protein, a primary marker of cancer severity in many patients. Overall, 85 percent (46 of 54) of the patients eligible for evaluation in the study experienced stabilization of the disease or a reduction in their M protein levels after receiving MLN341 for six weeks. Those receiving the new therapy experienced manageable side effects, including fatigue, diarrhea, decreased platelets and peripheral neuropathy.
In addition, a majority of the patients enrolled in the phase II multiple myeloma study have consented to providing tumor samples for Millennium's pharmacogenomic research. Ongoing analysis of the tumor samples is being conducted to identify drug response markers.
Other Oncology News
Millennium recently initiated a phase I clinical trial of MLN341 in combination with Doxil® (pegylated liposomal doxorubicin) with the University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center. The combination trial is an open label, dose escalation study being conducted to assess the safety of MLN341 in combination with Doxil® in patients with refractory hematologic and solid tumor malignancies.
About Prostate Cancer
According to the American Cancer Society, approximately 189,000 new cases of prostate cancer will be diagnosed in the United States in 2002. Of these new cases, 30,200 will result in death. The five-year survival rate of men with prostate cancer is 100% if the cancer is found before it metastasizes (spreads to another area of the body). The exact cause of prostate cancer is not yet known, however, scientists have identified certain risk factors, including family history of the disease, age, diet and race. The majority (greater than 70%) of prostate cancer patients are more than 65 years old. Early detection is important and it is recommended that men over the age of 50 have a prostate specific antigen (PSA) blood test every year. Coupled with a digital rectal exam, the PSA is a very useful test for determining which men need further evaluation.
About Lung Cancer
According to the American Cancer Society, there will be about 169,400 new cases of lung cancer this year accounting for 13% of all new cancers. The average age of people diagnosed with lung cancer is 60; it does not usually occur in people under the age of 40. Lung cancer is the leading cause of cancer death among both men and women. There will be an estimated 154,900 deaths from lung cancer this year, accounting for 28% of all cancer deaths. The average five-year survival rate for the cancer if it is found before spreading is 48%. However, only 15% of people with lung cancer are diagnosed at this early, localized stage.
About Breast Cancer
According to the American Cancer Society, breast cancer is the most common form of cancer among women with about 203,500 new cases of invasive breast cancer (Stages I-IV) diagnosed in the United States this year. Breast cancer also occurs in men with an estimated 1,500 newly diagnosed cases. There will be an estimated 40,000 deaths from breast cancer this year. Breast cancer is the second leading cause of death in women surpassed only by lung cancer.
Millennium's Oncology Franchise
Millennium has committed to pursuing oncology as a core franchise area, dedicating significant resources and capabilities in the areas of technology, scientific expertise and strategic business development. To this end, Millennium has already produced a deep oncology pipeline that ranges from multiple novel targets to commercialized therapeutic and diagnostic products. Among the most advanced clinical compounds is MLN341, a proteasome inhibitor that is currently is in phase II trials for multiple myeloma and chronic lymphocytic leukemia and entering phase I combination trials for a variety of solid tumors including colon, breast, pancreatic and prostate cancers. Millennium's oncology pipeline also includes an anti-PSMA antibody currently in phase I clinical trials for advanced prostate cancer, guanylyl cyclase C (GC-C), a protein uniquely expressed on the cell surface of colorectal tumors and its related ST ligand and MLN576 (formally XR11576), an oral agent in phase I trials for solid tumors. The CAMPATH® (alemtuzumab) monoclonal antibody, a therapeutic developed from a joint venture of Millennium, is on the market in both the United States and a number of European countries. A Millennium alliance partner and licensee is in the process of developing and commercializing Melastatin(TM), a melastatin detection product developed through our predictive medicine efforts.
Millennium Pharmaceuticals, Inc.
Millennium, a leading biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of breakthrough therapeutic and predictive medicine products, with a goal of delivering personalized medicine. Through the industrialization of this gene-to-patient platform, millennium is also striving to accelerate the process of drug discovery and development. Headquartered in Cambridge, Massachusetts, Millennium currently employs more than 1,500 people.
Taxotere® is a trademark of Aventis Pharmaceuticals, Inc. Doxil® is a registered trademark of ALZA Corporation.
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 Millennium'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; 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.
Editor's Note: This release is available on Millennium's Web site at: www.millennium.com
Contacts:
Gina Brazier (investor)
(617) 551-3611
Steve Sylven (media)
(617) 551-8984
Millennium Pharmaceuticals, Inc.
SOURCE: Millennium Pharmaceuticals, Inc. |
