13.06.2008 15:49:00
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VIDAZA(R) Continues to Show Significant Overall Survival Benefit When Compared with Conventional Care Regimens Across the EU
Celgene International Sàrl (Nasdaq:CELG)
today announced that data showed VIDAZA (azacitidine) provides a
significant overall survival benefit for patients with higher-risk
myelodysplastic syndromes (MDS) regardless of whether patients were
treated with low-dose Ara-C or best supportive care in the control arm.
In aggregate, the survival benefit for VIDAZA across all countries was
24.4 months versus 15.3 months (hazard ratio 0.36) (95% Cl: 0.20-0.65) [p=0.0006])
compared to the other treatment arms. The data were presented at the 13th
Congress of the European Hematology Association (EHA) in Copenhagen,
Denmark.
VIDAZA was compared with low-dose Ara-C in the UK and France, and
compared with best supportive care in Germany, Italy, Sweden, Greece,
Spain and the Netherlands. In both groups, VIDAZA consistently showed an
overall survival benefit. VIDAZA is a novel epigenetic therapy that may
restore normal expression to genes critical for cell differentiation and
proliferation.
"These data reinforce VIDAZA’s
role and the importance of this epigenetic drug in the treatment
paradigm for higher-risk MDS patients,” said
Professor Valeria Santini, hematologist and lead investigator of the
trial, University of Florence. "These results
continue to show that VIDAZA can provide a significant overall survival
benefit regardless of which regimen is used for comparison.”
The results from this trial are consistent with the data from the large,
international, multi-center Phase III trial AZA-001, recently presented
at the American Society of Clinical Oncology (ASCO) Annual Meeting,
which demonstrated that VIDAZA was the first drug to significantly
prolong overall survival in higher-risk MDS patients.
The most commonly occurring major adverse events for patients receiving
VIDAZA are thrombocytopenia (69.7%), neutropenia (65.7%) and anemia
(51.4%).
About VIDAZA
In May 2004, VIDAZA became the first drug approved in the United States
by the FDA for the treatment of patients with Myelodysplastic Syndromes
(MDS). VIDAZA was approved for IV administration in January 2007. The
FDA approved VIDAZA, the first in a new class of drugs called
demethylation agents, for treatment of all five MDS subtypes, which
include both low-risk and high-risk patients. These subtypes include:
refractory anemia (RA) or refractory anemia with ringed sideroblasts
(RARS) if accompanied by neutropenia or thrombocytopenia or requiring
transfusions; refractory anemia with excess blasts (RAEB), refractory
anemia with excess blasts in transformation (RAEB-T), and chronic
myelomonocytic leukemia (CMMoL). The VIDAZA marketing authorization as a
potential treatment for patients with higher-risk MDS is currently under
review by the EMEA.
VIDZA is an epigenetic agent, which may restore normal expression to
genes critical for cell differentiation and proliferation. The cytotoxic
effects of VIDAZA cause the death of rapidly dividing cells, including
cancer cells that are no longer responsive to normal growth control
mechanisms. Non-proliferating cells are relatively insensitive to
VIDAZA. VIDAZA is believed to exert its antineoplastic effects by
causing hypomethylation of DNA and direct cytotoxicity on abnormal
hematopoietic cells in the bone marrow. The concentration of VIDAZA
required for maximum inhibition of DNA methylation in vitro does not
cause major suppression of DNA synthesis. Hypomethylation may restore
normal function to genes that are critical for differentiation and
proliferation.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of hematologic malignancies
that affect approximately 300,000 people worldwide. Myelodysplastic
syndromes occur when blood cells remain in an immature or "blast”
stage within the bone marrow and never develop into mature cells capable
of performing their necessary functions. Eventually, the bone marrow may
be filled with blast cells suppressing normal cell development.
According to the American Cancer Society, 10,000 to 20,000 new cases of
MDS are diagnosed each year in the United States, with median survival
rates ranging from approximately six months to six years for the
different classifications of MDS. MDS patients must often rely on blood
transfusions to manage symptoms of anemia and fatigue and may develop
life-threatening iron overload and/or toxicity from frequent
transfusions, thus underscoring the critical need for new therapies
targeting the cause of the condition rather than simply managing its
symptoms.
About Celgene International Sárl
Celgene International Sárl, 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. Abstract #0236
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