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| |  Thalidomide Reduces Multiple Myeloma Progression MIAMI, FL -- Dec. 8, 1998 -- Researchers investigating Celgene Corp.’s Thalomid™ (thalidomide) in the treatment of multiple myeloma -- one of the most deadly forms of cancer -- reported that 34 percent of patients undergoing therapy experienced a reduction in tumour burden. The study further concluded that some patients experienced more than a 75 percent reduction in tumour growth, including three who approached a near complete response. In total, 89 patients participated in the trial, all of whom had exhausted conventional forms of therapy, including chemotherapy and bone marrow transplantation. The data were presented yesterday at the 40th annual meeting of the American Society of Hematology by Seema Singhal, M.D., of the Myeloma and Transplantation Research Center (MTRC), the Arkansas Cancer Research Center (ACRC). Dr. Singhal said all study participants had end state refractory (non-responsive) multiple myeloma and that each had previously relapsed following treatments with other therapeutic modalities, including 75 who had one and 56 who had two prior transplants. These recent findings are consistent with results of an earlier analysis of 26 patients which determined that over half of all patients with advanced disease developed either stable disease or improvement with thalidomide therapy. Current clinical trials at MTRC, under the leadership of Dr. Bart Barlogie, address the usefulness of adding thalidomide to primary induction therapy for newly-diagnosed patients with myeloma, followed by tandem transplant and consolidation therapy. "We are extremely pleased with the efficacy of thalidomide in these patients that had failed all other therapies," said Dr. Bart Barlogie, the principal investigator on the thalidomide projects. "Thalidomide was also effective in patients with high grade myeloma, including those who had chromosome 13 deletion, which is usually refractory to high-dose chemotherapy and transplantation." Dr. Barlogie added preliminary results indicate that the combination of thalidomide with chemotherapy appears to be effective in treating plasma cell leukemia and fulminant multiple myeloma. According to the Leukemia Society of America, 13,800 new cases of multiple myeloma will be reported this year, resulting in approximately 11,300 deaths. Multiple myeloma is a malignant cancer of the plasma cells, which are a type of white blood cell found in many tissues of the body, but mainly in the bone marrow. As the cancer grows it destroys normal bone tissue, causing pain and crowding out normal blood cell production. Studies are continuing at the ACRC to evaluate the potential role of thalidomide in the treatment of multiple myeloma. While researchers have not identified the mechanism by which thalidomide treats multiple myeloma, they suspect several possibilities, including the possibility that thalidomide suppresses tumour necrosis factor-a production, and that it increases the body's production of interleukin 10. Dr. Barlogie also suspects that thalidomide works through anti-angiogenesis, by preventing the growth of vessels that aliment the malignant cells, especially since myeloma is associated with increased blood vessel formation in the bone marrow. "Additional studies are beginning at the MTRC, to evaluate the role of thalidomide in the treatment of AL amyloidosis and Waldenstrom macroglobulinemia [a cancer closely related to multiple myeloma]," he said. Thalidomide can cause severe birth defects or death to an unborn baby if taken during pregnancy. The drug should never be used by women who are pregnant or who could become pregnant while taking the drug. Adverse experiences are similar to those previously reported and include nerve damage that may be permanent, drowsiness/somnolence, dizziness/orthostatic hypotension, neutropenia and hypersensitivity reactions. Related Links: Thalomid, Celgene Corp.
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