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Celgene Corporation (CELG)
Celgene drug exceeds expectations.
Celgene shares soared early this morning after the company reported positive data for its blood cancer drug Revlimid. Celgene said on Monday that late-stage trials of its blood cancer drug Revlimid in combination with a standard chemotherapy significantly extended the remission time.
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The Revlimid Phase III trials included patients with relapsed or refractory multiple myeloma. Patients were randomized to receive Revlimid plus dexamethasone or dexamethasone alone. The trials enrolled 705 patients and are being conducted in 97 sites internationally, including: U.S., Europe and Australia. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria. The company said in a release that preliminary results showed the drugs achieved an acceptable safety level.
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Celgene's Revlimid is part of a new class of drugs used to treat hematology and oncology conditions. Multiple myeloma is a cancer of the blood in which malignant plasma cells are overproduced in bone marrow. The company said it plans to unblind the studies and allow all patients in the studies access to the drug, Revlimid. Celgene has begun discussions with the Food and Drug Administration and international regulatory authorities regarding the submission of this data for potential approval.
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Revlimid is a follow-on drug to Celgene's existing drug Thalomid. Thalomid, which began life as thalidomide, a treatment for morning sickness that achieved notoriety for causing birth defects, is approved to treat leprosy but most of its sales come from the treatment of multiple myeloma, a blood cancer. Celgene shares jumped $4.95, to $32.98, a gain of 16.8 percent, after the company reported the Phase III results on Revlimid. An independent committee monitoring the drug's results made the findings from the study. Celgene's shares, which were among the most actively traded shares rose more than 16 percent to $33.52 in early trading on Nasdaq.
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Profile |
A Delaware Corporation incorporated in 1986, is an independent biopharmaceutical company engaged primarily in the discovery, development and commercialization of orally administered, small molecule drugs for the treatment of cancer and immunological diseases.
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