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| |  ASCO MEETING: Thalomid Shows Activity In Recurrent Glioblastoma ATLANTA, GA -- May 17, 1999 -- Two teams of researchers investigating the use of Celgene Corp.’s Thalomid(R) (thalidomide) announced that the drug has activity in recurrent glioblastoma multiforme (GBM), and that quality of life measures improved in patients with advanced cancers. These findings were announced this past weekend at two separate presentations as part of the 35th annual meeting of the American Society of Clinical Oncology (ASCO). Jon Glass, MD, from New York University Medical Center, presented phase I/II data on thalidomide used in combination with Paraplatin(R) (carboplatin) to assess the safety and efficacy of this combination therapy in treating patients with recurrent GBM. The study of 71 patients determined the combination of Thalomid and carboplatin to be active in recurrent GBM. Of the 45 patients who were evaluated for efficacy, 27 percent (12) had progressive disease and the rest either had stable disease or tumour regression. The most common side effects reported were constipation and drowsiness. GBM is a highly malignant and usually fatal type of brain tumour that is diagnosed in approximately 9,000 individuals annually. The average survival time following diagnosis is six-to-12 months. Sharon Watanabe, MD, lead investigator at Cross Cancer Institute at the University of Alberta, presented the results of a phase I/II trial with Thalomid. The drug was evaluated in terminal cancer patients using a quality of life instrument. The study measured the intensity of symptoms such as difficulty falling asleep, restedness in the morning, insomnia, nausea, appetite and well-being in 18 patients before and after thalidomide treatment. After 10 days of treatment, all quality of life measures improved by greater than 30 percent. At no time did any patient discontinue thalidomide treatment due to adverse effects. According to The United States Food and Drug Administration clearance to market and sell Thalomid for the treatment of erythema nodosum leprosum (ENL) in leprosy, on July 16, 1998. The drug has been commercially available since October 1, 1998. Recently, Thalomid received orphan drug designation for multiple myeloma and Crohn's disease. 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. The major adverse drug reactions known to be associated with thalidomide treatment include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; and increased HIV-viral load. Related Links: thalidomide, Celgene Corp.
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