Dacogen(R) (Decitabine) for Injection Data Presented at the American Society of Hematology (ASH) 49th Annual Meeting and Exposit
10 Dezembro 2007 - 9:26PM
Business Wire
MGI PHARMA, INC. (NASDAQ:MOGN), a biopharmaceutical company focused
in oncology and acute care, today provided a summary of the
Dacogen� (decitabine) for Injection presentations made during the
American Society of Hematology (ASH) 49th Annual Meeting and
Exposition. Dacogen was the subject of five oral presentations, 11
poster presentations, and four publications. A survival analysis of
the five-day outpatient regimen of Dacogen in patients with
myelodysplastic syndromes (MDS) and preliminary results from a
multicenter, phase 2 study evaluating the five-day regimen of
Dacogen in patients with de novo or secondary MDS were among the
data presented. Data from a phase 2 trial evaluating Dacogen in
older patients with acute myelogenous leukemia (AML) were also
presented at the conference. �We are very pleased with the results
of the Dacogen clinical trials presented at the 2007 ASH Annual
Meeting,� said Mary Lynne Hedley, Ph.D., Executive Vice President
and Chief Scientific Officer. �The data demonstrate the activity of
the Dacogen 5 day dosing regimen when utilized either in patients
with MDS or in elderly patients with AML. We continue to evaluate
Dacogen in a broad development program, which includes clinical
studies in patients with MDS, AML, other hematological malignancies
and solid tumors�. Survival and Efficacy of Decitabine in
Myelodysplastic Syndromes, Analysis of the 5-Day IV Dosing Regimen
(Abstract # 115) Results from a single center, phase 2, three arm
adaptive randomization study evaluating Dacogen in 115 patients
with higher risk MDS have been described recently (Kantarjian et
al, Cancer 2007;109:265-273). Seventy percent of the patients in
the study were 60 years of age or older, 27% presented with
secondary MDS, and 51% had received prior therapies. The results of
this trial have been described in the context of a pooled data set
from all three treatment arms. This presentation provided an update
of efficacy and toxicity endpoints specific to 93 patients treated
with the 5-day Dacogen dosing schedule. Dacogen was administered at
20 mg/m2 intravenously over one hour once daily for five days
repeated at four-week intervals. Fifty-four patients were
categorized according to the International Prognostic Scoring
System (IPSS) with 24%, 50%, and 26% scored as High risk,
Intermediate-2, and Intermediate-1, respectively. Patients treated
with Dacogen demonstrated a median survival time of twenty months,
with one and two-year survival rates of 61% and 41%, respectively.
Overall complete response rates (CR) were seen in 39% of patients
(International Working Group 2006 criteria). The responses were
prompt (median time 2.3 months) and CR�s were durable (median of 14
months). The median number of cycles was more than eight. The side
effect profile for the five-day dosing regimen was consistent with
what has been previously reported. �This study enrolled a
difficult-to-treat patient population, including those who had
received prior therapies and those who had secondary MDS�, said Dr.
Hagop Kantarjian, Chairman and Professor, Leukemia Department,
University of Texas M.D. Anderson Cancer Center. �These data,
particularly the rapid time to response and survival benefit, are
impressive�. Preliminary Results of a Phase II Study of Decitabine
Administered Daily for 5 Days Every 4 Weeks to Adults with
Myelodysplastic Syndrome (Abstract # 1450) This presentation
provided preliminary results from a multi-center, open label,
single arm phase 2 study of Dacogen in 99 patients with de novo or
secondary MDS. Dacogen was administered at 20 mg/m2 intravenously
over one hour once daily for five days repeated at four-week
intervals. The primary study endpoint was clinical response.
Secondary endpoints included evaluation of hematologic improvement,
cytogenetic response, overall survival, time to acute myeloid
leukemia progression or death, transfusion requirements, and
toxicity. An overall complete response rate of 32% (International
Working Group 2006 criteria) was achieved with the outpatient
administration of Dacogen, confirming previously reported response
rates in the outpatient setting. Additionally, 82% of those
patients who improved demonstrated a response by cycle 2. Median
survival at the time of data analysis was 19.4 months, and over
half the patients continue to be followed for survival. The
one-year survival rate for patients treated with Dacogen was 66%.
The safety profile of this dosing regimen was consistent with what
has been previously reported. Continued Low-Dose Decitabine (DAC)
Is an Active First-Line Treatment in All Cytogenetic Subgroups of
Older AML Patients: Results of the FR00331 Multicenter Phase II
Study (Abstract # 300) This large phase 2 multi-center trial
accessed low-dose Dacogen as a therapeutic option for AML patients
older than 60 years of age and ineligible for induction
chemotherapy. The primary endpoint of the trial was overall
response rate, defined as complete remission (CR), partial
remission (PR), or an antileukeumic effect (ALE), defined as
greater than 25% bone marrow blast reduction. Secondary endpoints
included overall survival (OS) and toxicity. Low-dose Dacogen was
administered intravenously at a dosage of 135 mg/m2 over 72 hours,
repeated every six weeks for up to four courses. All-trans retinoic
acid (ATRA, 45 mg/m2 for twenty eight days), was permitted during
the second course in patients with acute leukemia or stable disease
(SD). Maintenance with Dacogen at 20 mg/m2 intravenously
administered over one hour for three days every 6-8 weeks on an
outpatient basis was offered to patients who had completed all four
Dacogen courses. Results of 155 patients demonstrate an overall
response rate of 54%. Stable disease was seen in an additional 24%
of patients. Median overall survival from start of treatment was
5.5 months and the one-year survival rate in this poor risk group
was 26%. Below is the list of all Dacogen abstracts presented at
the 2007 ASH meeting. Oral Presentations Abstract #115 Survival and
Efficacy of Decitabine in Myelodysplastic Syndromes (MDS), Analysis
of the 5-Day IV Dosing Regimen. Abstract #300 Continued Low-Dose
Decitabine (DAC) Is an Active First-line Treatment in All
Cytogenetic Subgroups of Older AML Patients: Results of the FR00331
Multicenter Phase II Study Abstract #62 Generation of Treg-Like
Cells from CD4+CD25- T Cells via Epigenetic Modification Using a
Demethylating Agent Decitabine Abstract #571 Fetal Hemoglobin
Induction in Baboons (P. Anubis) Following Administration of a
Novel Decitabine Dinucleotide (S110) Compound Abstract #718
MicroRNA (miRNA)-29b Targets DNMT3A and B and Induces Re-Expression
of the Hypermethylated ESR1 and p15 Genes in Acute Myeloid Leukemia
(AML) Posters Abstract #1450 Preliminary Results of a Phase II
Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to
Adults with Myelodysplastic Syndrome (MDS) Abstract #897 Phase I
Study of Suberoylanilide Hydroxamic Acid (SAHA) and Decitabine in
Patients with Relapsed, Refractory or Poor Prognosis Leukemia
Abstract #908 A Phase I Clinical Trial of Two Sequence-Specific
Schedules of Decitabine and Vorinostat in Patients with Acute
Myeloid Leukemia (AML) Abstract #1468 Outcome of Allogeneic Stem
Cell Transplantation after Hypomethylating Therapy with
2'-Deoxy-5-Azacytidine for Patients with Myelodysplastic Syndrome
Abstract #987 Epigenetic Repression of the Adaptor Molecule LAT2 by
the Leukemic Fusion Protein AML1/ETO Abstract #1448 Use of
Post-Treatment Clinical Data to Predict Response to Decitabine
Abstract #1768 Expression of �Globin is Reactivated by a Novel
Mechanism in Baboon CD34+ Erythroid Progenitor Cell Cultures
Abstract #1769 Targeting MBD2 Increase -Globin Expression in a
CID-Dependent Human -YAC Murine Fetal Bone Marrow Cell Line
Abstract #2826 Phase I Study of 5-aza-2'-Deoxycitidine, alone or in
Combination with Hyper-DVAD, in Relapsed or Refractory Acute
Lymphocytic Leukemia (ALL) Abstract #2858 Benefit of
Anti-Infectious Prophylaxis in Patients with Acute Myeloid Leukemia
or High-Risk Myelodysplastic Syndrome Receiving Frontline Targeted
Therapy Abstract #2859 Randomized Study of Decitabine versus
Observation or Continued Cytotoxic Chemotherapy in Patients with
intermediate and Poor Risk Acute Myeloid Leukemia in First or
Subsequent Complete Remission Publication Only Abstract #3792
Decitabine Improves Clinical Outcomes in Severely Ill Sickle Cell
Disease patients Who Have Exhausted Standard of Care Options
Abstract #4150 Decreased Expression of the Histone
Methyltransferase SUV39H1 in AML Cells Abstract #4382 Salvage
Therapy with Standard Dose Cytarabine is Appropriate for Patients
with Acute Myelogenous Leukemia Refractory to Front-Line Therapy
with Hypomethylating Agents. Abstract #4387 Combination
Methyltransferase and Histone Deacetylase Inhibition in Elderly
Patients with Secondary Acute Myelogenous Leukemia Abstract #4597
Good Response to Decitabine in an Elderly patient with MDS
(Refractory Anemia with Excess Blasts RAEB-2) after Failure of
Azacitidine About MDS Myelodysplastic syndromes, or MDS, are a
group of diseases of the bone marrow characterized by the
production of poorly functioning and immature blood cells. People
with MDS may experience a variety of symptoms and complications,
including anemia, bleeding, infection, fatigue and weakness. Those
patients with high-risk MDS may experience bone marrow failure,
which may lead to death from bleeding and infection. Over time, MDS
can progress to acute leukemia, or AML. The Aplastic Anemia and MDS
International Foundation currently estimates that up to 30,000 new
cases of MDS are diagnosed annually in the United States. About
Dacogen� (decitabine) For Injection Dacogen� (decitabine) for
Injection was approved by the U.S. Food and Drug Administration on
May 2, 2006 and is indicated for treatment of patients with
myelodysplastic syndromes (MDS) including previously treated and
untreated, de novo and secondary MDS of all French-American-British
(FAB) subtypes (refractory anemia, refractory anemia with ringed
sideroblasts, refractory anemia with excess blasts, refractory
anemia with excess blasts in transformation, and chronic
myelomonocytic leukemia), and Intermediate-1, Intermediate-2 and
High-Risk International Prognostic Scoring System (IPSS) groups.
The recommended Dacogen dose is 15 mg/m2 administered by continuous
intravenous infusion over three hours repeated every eight hours
for three days. Dacogen may cause fetal harm when administered to a
pregnant woman. Women of childbearing potential should be advised
to avoid becoming pregnant while using Dacogen. Men should be
advised not to father a child while receiving treatment with
Dacogen and for two months afterwards. The most commonly occurring
adverse reactions with Dacogen include neutropenia (90%),
thrombocytopenia (89%), anemia (82%), pyrexia (53%), fatigue (48%),
nausea (42%), cough (40%), petechiae (39%), constipation (35%), and
diarrhea (34%). Please visit www.mgipharma.com or www.dacogen.com
for full prescribing information. About MGI PHARMA MGI PHARMA, INC.
is a biopharmaceutical company focused in oncology and acute care
that acquires, researches, develops, and commercializes proprietary
products that address the unmet needs of patients. MGI PHARMA
markets Aloxi� (palonosetron hydrochloride) Injection, Dacogen�
(decitabine) for Injection, and Gliadel� Wafer (polifeprosan 20
with carmustine implant) in the United States. The Company directly
markets its products in the U.S. and collaborates with partners to
reach international markets. For more information about MGI PHARMA,
please visit www.mgipharma.com. This news release contains certain
�forward-looking� statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements are
typically preceded by words such as �believes,� �expects,�
�anticipates,� �intends,� �will,� �may,� �should,� or similar
expressions. These forward-looking statements are not guarantees of
MGI PHARMA�s future performance and involve a number of risks and
uncertainties that may cause actual results to differ materially
from the results discussed in these statements. Factors that might
cause MGI PHARMA's results to differ materially from those
expressed or implied by such forward-looking statements include,
but are not limited to, the ability of MGI PHARMA�s product
candidates to be proven safe and effective in humans, to receive
marketing authorization from regulatory authorities, and to
ultimately compete successfully with other therapies; continued
sales of MGI PHARMA�s marketed products; development or acquisition
of additional products; reliance on contract manufacturing; changes
in strategic alliances; continued access to capital; ability of MGI
PHARMA to successfully complete the integration of Guilford with
its existing operations; the risk that the perceived advantages of
the Guilford transaction may not be achieved; and other risks and
uncertainties detailed from time to time in MGI PHARMA�s filings
with the Securities and Exchange Commission including its most
recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to
update any of these forward-looking statements.
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