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| |  ASCO: Thalidomide Promising in a Variety of Cancers NEW ORLEANS, LA -- May 24, 2000 -- Teams of researchers investigating the use of Thalomid® (thalidomide) announced study results in patients suffering from several types of hematological and solid tumor cancers. These findings were announced as parts of individual oral, poster and published presentations at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO). Multiple Myeloma "These results in multiple myeloma are consistent with clinical results we have observed previously with the drug, as well as with clinical findings of other investigators," said Dr. Barlogie. "We are now conducting additional studies to further define the most appropriate thalidomide treatment regimens to treat this serious disease, be it as a single agent or in combination with other drugs." The study's most commonly reported adverse events were constipation, weakness, somnolence and tingling/numbness. These toxicities were found to be dose-related, allowing 90 percent of the patients to tolerate thalidomide treatment of 400 mg/day. In addition to the single agent study, Dr. Barlogie discussed an ongoing investigation of thalidomide as part of several combination therapy regimens for multiple myeloma patients. According to Dr. Barlogie, more than 300 patients have been enrolled in these clinical investigations intended to determine the most effective treatment program for this disease. Myeloma And Waldenstrom's Macroglobulinemia Adverse events witnessed during this investigation included grades 1-3+ reversible neurotoxicity including peripheral and/or autonomic neuropathy, drowsiness and possible thrombosis. In some patients, these toxicities required dose reduction. There are approximately 14,000 new cases of multiple myeloma diagnosed in the United States each year, making it the second most common blood cancer. Incurable with conventional chemotherapy, 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. Waldenstrom's macroglobulinemia, a disease related to myeloma, results in the overgrowth of lymphoplasmacyctic cells. These cells cause the excessive production of an antibody called IgM, resulting in hyperviscosity of the blood. Classified as a low-grade type of lymphoma, Waldenstrom's macroglobulinemia can include symptoms such as enlarged lymph nodes or spleen, fatigue, headaches, weight loss, a tendency to bleed easily, visual problems, confusion, dizziness, and loss of coordination. Renal Cell Carcinomas According to Dr. Minor, the results of this study suggest that Thalomid should be evaluated in further well-controlled multicenter studies. Somnolence and constipation were the study's most widely reported adverse events. Some patients also developed either arterial or venous thrombi or impaired wound healing, but according to investigators, these events may have been unrelated to thalidomide. Additional Presentations "Celgene is very pleased by the breadth of thalidomide research presented at this meeting. We will encourage and support the continued investigation of this exciting drug, particularly as it expands into the areas of combination therapies as well as less debilitated patient populations," said Jerome B. Zeldis, M.D., Ph.D., vice president of medical affairs and chief medical officer, Celgene Corporation. To this end, Celgene held an investigators meeting during ASCO where plans for the clinical development of Thalomid in colorectal cancer, renal cell carcinoma, melanoma and prostate cancer were discussed. Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by a pregnant woman can cause severe birth defects or death to an unborn baby. To minimize this risk, only prescribers and pharmacies registered with the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.™) distribution program may prescribe or dispense Thalomid (thalidomide). Other adverse drug reactions known to be associated with thalidomide therapy include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; hypersensitivity reactions; and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with Thalomid. Thalomid (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of cutaneous manifestation recurrences. Thalomid is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis. Celgene Corporation, headquartered in Warren, New Jersey, is an independent biopharmaceutical company engaged in the discovery, development and commercialization of small molecule drugs for cancer and immunological diseases. Related Links: Thalomid (thalidomide) and Celgene Corporation.
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