Some very nice looking early results from MLNM here in refractory MM:
Monday December 10, 2:01 pm Eastern Time
Press Release
SOURCE: Millennium Pharmaceuticals, Inc.
New Phase II Data on Millennium's Proteasome Inhibitor Holds Promise For Patients With Refractory Multiple Myeloma
--Investigational compound shown to stop the progression of disease in patients whose disease has progressed on multiple prior therapies--
CAMBRIDGE, Mass., Dec. 10 /PRNewswire/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - news) announced today preliminary findings of an ongoing phase II clinical trial of its investigational drug LDP-341 (formerly known as PS-341) in patients with multiple myeloma who have failed to respond to other treatments. The study results, announced at the annual meeting of the American Society for Hematology in Orlando, FL, showed that LDP-341 halted the progression of the disease in almost all study participants while reducing a primary marker of cancer severity in a significant number of patients. In addition, those receiving the new therapy experienced manageable side effects.
(Photo: newscom.com )
``While considerable progress has been made in the battle against multiple myeloma, thousands of patients still die each year and no established cure is available,'' said lead study author Paul G. Richardson, M.D., from Dana-Farber Cancer Institute in Boston, MA. ``These study results mark an important step in finding a treatment for extremely ill patients with multiple myeloma whose disease has progressed on therapies such as combination or high dose chemotherapy, steroids and thalidomide. In the study, LDP-341 has been shown in this study to stabilize these patients while avoiding many of the more toxic and debilitating side effects common with standard treatments.''
LDP-341 is designed to specifically block proteasomes, which are enzymes 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, LDP-341 in cancer cells halts cell division, and ultimately causes programmed cell death (also known as apoptosis). 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 LDP-341 offers the potential to target cancer cells while sparing healthy ones.
Study findings
LDP-341 -- the first proteasome inhibitor to enter clinical trials -- has been evaluated in over 150 patients with relapsed and refractory multiple myeloma, a cancer of the plasma cell (a type of white blood cell responsible for producing infection-fighting antibodies) in the bone marrow. Among the patients included in the study presented today, there was an average of five prior therapies for their cancer, including 70 percent who previously received thalidomide and 53 percent who had prior stem cell transplantation or other high dose therapy.
Preliminary safety results were presented based on 93 patients and preliminary efficacy results were presented based on 54 patients who had completed a minimum of two cycles of therapy. The majority of patients receiving LDP-341 experienced a reduction or stabilization in their M protein, a substance in the blood that physicians use to determine the severity of multiple myeloma. Specifically, 40 percent of patients (22 out of 54) had at least a 50-percent reduction in their M protein levels after just two cycles of therapy, while 11 percent (six out of 54) had at least a 90-percent reduction. In addition, LDP-341 completely halted the progression of the disease in an additional 33 percent of patients (18 out of 54). Notably, one patient who had undergone 14 unsuccessful therapies had M protein levels that completely disappeared after treatment with LDP-341. Overall, 85 percent of patients (46 of 54) in the study experienced stabilization of the disease or a reduction in their M protein levels after receiving LDP-341 for six weeks.
Side effects with LDP-341 were manageable and included fatigue, diarrhea, decreased platelets, and peripheral neuropathy. There was no hair loss or apparent increase in infection risk as often is seen with patients on chemotherapy. Only 9 percent of patients in the study discontinued due to adverse events.
``Given the refractory nature of the multiple myeloma in the treated patients -- the fact they had undergone multiple prior therapies -- and most had complications associated with their disease and previous treatments, the observations concerning the relative tolerability of LDP-341 were particularly welcome,'' added Dr. Richardson.
``These findings demonstrate that LDP-341 is a novel investigational therapy that could provide hope to many seriously ill cancer patients,'' said Millennium CEO Mark Levin. ``LDP-341 is the cornerstone of Millennium's oncology franchise, that, along with key development programs including J591 for prostate cancer and GCC, an exciting preclinical molecule for colon cancer, will allow us to build a premier oncology pipeline through a combination of internally-derived, in-licensed and acquired products and capabilities.''
About multiple myeloma
Multiple myeloma is a cancer of the blood in which white blood cells called plasma cells, normally responsible for the production of antibodies (proteins that fight infection and disease), are overproduced in the bone marrow -- the tissue inside the bone that manufactures all blood cells. The proliferation of these abnormal plasma cells, known as myeloma cells, causes decreased production of normal red and white blood cells, and of normal disease-fighting antibodies, as well as the growth of tumors that spread to ``multiple'' sites - hence the term multiple myeloma. The decreased white blood cell production damages the immune system while the myeloma tumors cause bone destruction that manifests as pain and fractures.
Multiple myeloma is the second most common cancer of the blood and represents about 1 percent of all cancers and 2 percent of all cancer deaths. Although the disease is predominantly a cancer of the elderly (the peak age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. About 11,200 Americans (5,800 men and 5,400 women) are expected to die of multiple myeloma this year. The average survival time of those diagnosed with multiple myeloma is about 2 to 5 years. The disease is about twice as common in males as females. Among African Americans, multiple myeloma is one of the top 10 leading causes of cancer death. |
