Study Results On The Use of Celgene's Thalomid(R) (Thalidomide) As Treatment
For Myelodysplastic Syndromes
Additional Abstracts Report Thalidomide Results in Waldenstrom's
Macroglobulinemia, Acute Myeloid Leukemia, Myelofibrosis, and Castleman's
Disease
SAN FRANCISCO, Dec. 6 /PRNewswire/ -- Celgene Corporation (Nasdaq: 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). 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, 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 in formation, and chronic
myelomonocytic leukemia. According to the American Cancer Society 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; 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) 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. Please feel free to visit the Company's website at
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.
SOURCE Celgene Corporation
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