Ημερομηνία: 11/12/2007 6:36:00 πμ Περιοχή: Νέα Υόρκη ΗΠΑ Από: BW
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( BW)(CELGENE-INT'L-SARL)(CELG) REVLIMID(R) (Lenalidomide) in
Combination with Rituximab Demonstrates 70% Overall Response Rate in
Hard to Treat Relapsed/Refractory Mantle Cell Lymphoma
Indications
Business Editors/Health/Medical Writers
SUMMIT, N.J.--(BUSINESS WIRE)--Dec. 10, 2007--Celgene
International Sarl (NASDAQ: CELG) reported that researchers from the
M.D. Anderson Cancer Center in Houston, TX, presented early evidence
of efficacy from a Phase I/II study evaluating lenalidomide with
rituximab for the treatment of relapsed/refractory mantle cell
lymphoma (MCL). The study indicated that 70% of patients achieved
responses with 30% of patients achieving complete responses when given
the combination therapy. The data were presented at the 49th annual
American Society of Hematology (ASH) Meeting and the combination
therapy is further being evaluated by the center as part of the
ongoing Phase II trial.
Study investigators believe that lenalidomide may target the
microenviroment of the MCL cells and enhance the antibody dependent
cell-mediated cytoxicity (ADCC) activity of rituximab. Therefore,
patients in whom rituximab had previously stopped working were able to
achieve responses on the combination therapy. Revlimid's impact on
ADCC is a newly described mechanism of action growing out of these
studies.
The data presented showed that seven out of ten patients achieved
responses including three complete remissions (30%), four partial
remissions (40%), one patient with stable disease, and two patients
with progressive disease. The most common Grade 3/4 adverse events
observed were neutropenia, febrile neutropenia, thrombocytopenia and
myalgia.
"With rituximab cancer patients can develop resistance over time.
Revlimid may enhance the activity against the cancer cells to restore
rituximab's efficacy," said Dr. Wang, M.D. Anderson Cancer Center.
"These promising efficacy and tolerability results warrant additional
studies to further evaluate the benefits."
18 patients were involved in the trial, all of whom had previously
been treated with rituximab, and were given lenalidomide daily for the
first 21 days of a 28 day cycle and rituximab (375 mg/m2) by IV
infusion weekly for four weeks only during the first cycle with the
first dose on Day 1 in Cycle 1. A standard dose escalation was used to
determine that the maximum tolerated dose (MTD) of lenalidomide was 20
mg.
Mantle cell lymphoma (MCL) is a subtype of non-Hodgkin's lymphoma
(NHL). There are approximately 59,000 new cases of NHL diagnosed each
year in the U.S. with MCL cases accounting for approximately 6% of
these diagnoses. MCL is most frequently found in older adults and the
average age of diagnosis is the mid-60s.
About REVLIMID(R)
REVLIMID has obtained Orphan Drug designation in the EU, U.S., and
Australia. REVLIMID is approved for use as an oral treatment in
multiple myeloma in combination with dexamethasone by the European
Medicines Agency (EMEA). REVLIMID is currently approved in the US by
the U.S. Food and Drug Administration (FDA) for multiple myeloma in
combination with dexamethasone for patients who have received at least
one prior therapy. REVLIMID is also approved for treatment of patients
with transfusion-dependent anemia due to low- or intermediate-1-risk
myelodysplastic syndromes (MDS) associated with a deletion 5q
cytogenetic abnormality with or without additional cytogenetic
abnormalities by the FDA.
About Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is one of several subtypes of
non-Hodgkin's lymphoma (NHL) and results from a malignant
transformation of a B lymphocyte in the outer edge of the lymph node
follicles called the mantle zone. The transformed lymphocytes, or
lymphoma cells, grow in an uncontrolled way causing tumors to form in
the lymph nodes leading them to enlarge and the cells can also spread
to other tissues such as the marrow, liver and gastrointestinal tract.
MCL is distinguished from other subtypes of B-cell lymphoma by the
overexpression of cyclin D1, a protein that stimulates cell growth,
which in approximately 85% of cases is caused by a genetic change
involving chromosomes 11 and 14 and may be a result of constant
mutations occurring in many cells, possibly independent of the effects
of an outside, environmental factor.
About Celgene International Sarl
Celgene International Sarl, located in Boudry, Switzerland, is a
wholly owned subsidiary and international headquarters of Celgene
Corporation. Celgene Corporation, headquartered in Summit, New Jersey,
is an integrated global pharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through gene and protein regulation. For more information, please
visit the Company's website at 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 Form 10-K, 10-Q and 8-K reports.
CONTACT: Celgene International
Marie-France Tschudin, +41 32 729 84 30
Director, Strategic Marketing
Europe
OR
Catarina Edfjall, +41 32 729 87 63
Head of Regulatory Affairs
Europe
KEYWORD: TEXAS NEW JERSEY SWITZERLAND INTERNATIONAL AFRICA/MIDDLE
EAST EUROPE
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL MEDICAL PRODUCT
SOURCE: Celgene International Sarl
Copyright Business Wire 2007
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