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.
Bookmarken
