Study Results On the Use of Celgene's Thalomid -Thalidomide- as Treatment for Myelodysplastic Syndromes.Business Editors SAN FRANCISCO--(BUSINESS WIRE)--Dec. 6, 2000 Additional Abstracts Report Thalidomide thalidomide (thəlĭd`əmĭd'), sleep-inducing drug found to produce skeletal defects in developing fetuses. The drug was marketed in Europe, especially in West Germany and Britain, from 1957 to 1961, and was thought to be so safe that Results in Waldenstrom's Macroglobulinemia, Acute Myeloid Leukemia, Myelofibrosis Myelofibrosis Definition Myelofibrosis is a rare disease of the bone marrow in which collagen builds up fibrous scar tissue inside the marrow cavity. , and Castleman's Disease Celgene Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CELG) - Clinical data was presented this week at the 42nd annual meeting of the American Society of Hematology on the use of THALOMID (thalidomide) to treat the bone marrow disorder myelodysplastic syndromes (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ). Researchers from Rush Cancer Institute at Rush-Presbyterian-St. Luke's Medical Center, Medical College of Pennsylvania-Hahnermann University and M.D. Anderson Cancer Center presented four abstracts on thalidomide as treatment for MDS. "Based on these data, suggesting potential activity of THALOMID in MDS, we intend to proceed aggressively with a major Phase III program of THALOMID in treatment of MDS," said Jerome B. Zeldis, M.D., and Ph.D., Chief Medical Officer of Celgene Corporation. Myelodysplastic Syndromes Results Azra Raza, M.D. of the Rush Cancer Institute at Rush-Presbyterian-St. Luke's Medical Center presented results of two studies evaluating the use of THALOMID as a single agent and in combination treatment for patients with MDS. Eighty-three patients who were treated with a starting thalidomide dose of 100 mg/day and escalated according to tolerance to a maximum 400 mg/day. Of the 51 evaluable patients, 41 percent (21 patients) experienced partial response to thalidomide treatment and the 8 patients who were transfusion dependent became completely independent of transfusions. According to Dr. Raza, the median duration of response has not been reached yet, however the longest treated patients have completed one year of thalidomide therapy. Dr. Raza's group also presented data on the use of THALOMID in combination with topotecan, pentoxifylline, ciprofloxacin, dexamethasone dexamethasone /dex·a·meth·a·sone/ (dek?sah-meth´ah-son) a synthetic glucocorticoid used primarily as an antiinflammatory in various conditions, including collagen diseases and allergic states; it is the basis of a screening test in the , or etanercept for patients with low risk MDS. Initial results suggest that the use of thalidomide as part of combination treatment for MDS may cause a reduction of pro-inflammatory cytokines, cell death and angiogenesis. About Myelodysplastic Syndromes MDS are a group of conditions caused by abnormalities of the blood-forming cells in the bone marrow resulting in a shortage of blood cells and, ultimately, low blood counts. The five types of MDS are refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts refractory anemia with excess blasts Hematology A myelodysplastic syndrome of older persons characterized by anemia or pancytopenia and BM hypercellularity Clinical Nonspecific–anemia of gradual onset, fatigue, weakness, exacerbation of underlying heart , refractory anemia with excess blasts in formation, and chronic myelomonocytic leukemia. According to the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, 14,000 new cases of MDS are diagnosed each year in the US, with survival rates ranging from six months to five years for the different types of MDS. Additional Publications Many of the remaining clinical studies presented at the meeting examined thalidomide therapy in patients with Waldenstrom's macroglobulinemia, acute myeloid leukemia, myelofibrosis, and Castleman's disease who had exhausted conventional treatment options. Safety Notice 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(TM)) distribution program may prescribe or dispense THALOMID(R) (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 hypotension or low blood pressure Condition in which blood pressure is abnormally low. It may result from reduced blood volume (e.g., from heavy bleeding or plasma loss after severe burns) or increased blood-vessel capacity (e.g., in syncope). ; 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(R) (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) clearance on July 16, 1998 for the acute treatment of cutaneous cutaneous /cu·ta·ne·ous/ (ku-ta´ne-us) pertaining to the skin. cu·ta·ne·ous adj. Of, relating to, or affecting the skin. Cutaneous Pertaining to the skin. manifestations of moderate to severe erythema nodosum leprosum erythema nodosum le·pro·sum n. An acute lepromatous reaction with generalized systemic involvement characterized by the formation of painful deep nodules on the face, thighs, and arms, usually seen in undiagnosed, untreated, or neglected cases of leprosy. (ENL Noun 1. ENL - an inflammatory complication of leprosy that results in painful skin lesions on the arms and legs and face erythema nodosum leprosum Hansen's disease, leprosy - chronic granulomatous communicable disease occurring in tropical and subtropical ) 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 neuritis (n  rī`tĭs, ny . 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. Please feel free to visit the Company's website at http://www.celgene.com. This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports. |
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