Dacogen(TM) (Decitabine) for Injection Data Presented at the American Society of Hematology (ASH) 48th Annual Meeting and Exposition.
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MGI Policy on the Management of Government Information (Canada) PHARMA, INC. (Nasdaq:MOGN), a biopharmaceutical company focused in oncology and acute care, today provided a summary of the Dacogen[TM] (decitabine) for Injection presentations made during the American Society of Hematology (ASH) 48th Annual Meeting and Exposition. Dacogen was the subject of two oral presentations, 10 poster presentations, and four publications. Preliminary results from a phase 2 study of Dacogen in elderly patients with acute myeloid leukemia (AML AML - A Manufacturing Language ) and a retrospective survival analysis of Dacogen-treated patients with chronic myelomoncytic leukemia (CMML CMML Chronic Myelomonocytic Leukemia
CMML Continuous Media Markup Language
CMML Civilian Manpower Management Letter ) were among the data presented. In addition, MGI PHARMA sponsored a corporate symposium on Friday, December 8 titled The Therapeutic Potential of Epigenetics in MDS MDS,
n See temporomandibular pain-dysfunction syndrome.
MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there and AML, which was chaired by Dr. Jean-Pierre Issa of The University of Texas M.D. Anderson Cancer Center in Houston, Texas.
"We are extremely pleased to have 16 abstracts describing the activity of Dacogen at the 2006 ASH Annual Meeting," said Mary Lynne Hedley, Ph.D., Executive Vice President and Chief Scientific Officer of MGI PHARMA. "We continue to believe that Dacogen may have activity in a variety of malignancies, and are currently evaluating it in a broad development program including clinical studies in patients with MDS, AML, CML 1. CML - A query language.
["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986].
2. CML - Concurrent ML. , and solid tumors."
Phase 2 Data Demonstrate Activity of Dacogen in Older Patients with AML (Abstract 1984)
Because elderly patients with AML are often considered to be at high risk of mortality after receiving standard induction therapy, additional approaches to managing this patient population may offer improved outcomes. A multicenter phase 2 trial of Dacogen is being conducted in elderly patients diagnosed with de novo or secondary AML or AML transformed from MDS with poor or intermediate risk cytogenetics cytogenetics /cy·to·ge·net·ics/ (-je-net´iks) the branch of genetics devoted to cellular constituents concerned in heredity, i.e. chromosomes. . The primary endpoint of the trial is complete morphologic response rate (CR). Secondary endpoints included overall, relapse free and event free survival, other measures of response, and safety. Patients in this study received Dacogen at a dose of 20 mg/m2 intravenously for one hour daily for five consecutive days, repeated every four weeks. Preliminary efficacy results from 28 evaluable patients indicate an overall response rate of 29% (n=8), including two CRs, two complete cytogenetic cytogenetic /cy·to·ge·net·ic/ (-je-net´ik)
1. pertaining to chromosomes.
2. pertaining to cytogenetics.
pertaining to or originating from the origin and development of the cell. responses (CRc), and four patients with morphologic complete response and incomplete blood count recovery (CRi). The median time to first response was three treatment cycles. The most common adverse events in this study possibly related to Dacogen were myelosuppression, fatigue, nausea, asthenia, dyspnea, diarrhea, and pneumonia. In addition to this phase 2 study, MGI PHARMA is conducting a multicenter, phase 3 trial of Dacogen in elderly AML patients.
Survival Benefit with Dacogen vs. Intensive Chemotherapy in Patients with High Risk MDS (Abstract 2652)
Although intensive chemotherapy can result in responses in patients with high risk MDS, it is also associated with considerable morbidity and mortality Morbidity and Mortality can refer to:
Decitabine Induces Responses in Patients with MDS after Failure of Azacitidine Therapy (Abstract 518)
A phase 2 study was conducted to evaluate Dacogen in patients with MDS who have failed three or more courses of azacitidine treatment or who experienced severe azacitidine-related toxicity. Dacogen was administered to 14 patients at a dose of 20 mg/m2 intravenously for one hour daily for five consecutive days, repeated every four weeks. Responses were evaluated after at least three courses, unless disease progression occurred. Courses were repeated regardless of myelosuppression as long as MDS persisted in the bone marrow and no severe life threatening complications occurred. Among the 14 patients, three (21%) experienced a CR, one (7%) had a complete bone marrow response, five (36%) experienced disease stabilization, four had disease progression, and one died. The median number of courses required to achieve a response was three, with a median survival of six months. Grade three and four toxicities included fatigue, abdominal distention dis·ten·tion or dis·ten·sion
The act of distending or the state of being distended.
n a state of dilation. , syncope syncope
Effect of temporary impairment of blood circulation to a part of the body. It is often used as a synonym for fainting, which is loss of consciousness due to inadequate blood flow to the brain. and hypokalemia Hypokalemia Definition
Hypokalemia is a condition of below normal levels of potassium in the blood serum. Potassium, a necessary electrolyte, facilitates nerve impulse conduction and the contraction of skeletal and smooth muscles, including the heart. .
Efficacy of Dacogen in the Treatment of Patients with Chronic Myelomonocytic Leukemia (CMML) (Abstracts 2652 and 2655)
Two poster presentations focused on the efficacy of Dacogen in treating patients with CMML. In a phase 2 study, a total of 19 patients with CMML received infusions of Dacogen at a dose of 20 mg/m2 for one hour daily for five consecutive days or two alternative schedules of 100 mg/m2 per course, repeated every four weeks. Response was evaluated by the modified International Working Group (IWG) criteria. Of the 19 patients, 11 (58%) had a complete response and two (11%) experienced hematologic hematological, hematologic
pertaining to or emanating from blood cells.
total and differential white cell counts, hematocrit estimation, erythrocyte count. improvement. Among six patients who responded to Dacogen and had pretreatment pretreatment,
n the protocols required before beginning therapy, usually of a diagnostic nature; before treatment.
n See predetermination. chromosomal abnormalities, one had a complete cytogenetic response and two had partial cytogenetic responses (greater than 50% reduction of cytogenetic abnormalities). The median survival was 19 months. The most frequently observed adverse events included nausea, vomiting, bone aches, liver dysfunction, bleeding, fatigue, and diarrhea.
A retrospective review of 28 patients with CMML who received Dacogen in previously-conducted phase 2 and phase 3 studies was performed to evaluate the complete response, partial remission, and hematologic improvement rates. In two single arm phase 2 studies and in a randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. , multicenter phase 3 study, patients received Dacogen intravenously at a dose of 15 mg/m2 every eight hours for three consecutive days, repeated every six weeks. In this CMML population, the overall response rate (ORR) was 25%, including a 14% complete response rate and an 11% partial response rate. In addition, 11% of patients experienced hematologic improvement. Adverse events included myelosuppression, nausea or vomiting, pneumonia (one fungal), epistaxis epistaxis /ep·i·stax·is/ (-stak´sis) nosebleed; hemorrhage from the nose, usually due to rupture of small vessels overlying the anterior part of the cartilaginous nasal septum.
n. , diarrhea, and thrombocytopenia Thrombocytopenia Definition
Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. .
Below is the list of all Dacogen abstracts presented at the 2006 ASH annual meeting:
Abstract Number: 518
Decitabine Induces Responses in Patients with Myelodysplastic Syndrome (MDS) after Failure of Azacitidine Therapy. Session Type: Oral Session
Abstract Number: 556
Decitabine Targets the Erythroid erythroid /er·y·throid/ (er´i-throid)
1. of a red color; reddish.
2. pertaining to the cells of the erythrocytic series.
1. Progenitor/Precursor Subpopulations for the Y-Globin Gene Demethylation in Baboon. Session Type: Oral Session
Abstract Number: 1582
Exportin 4, a Potential Amplifier of TGF-B Signaling, Is Increased in Primary Baboon Bone Marrow Erythroblasts Following Decitabine Treatment
Abstract Number: 1584
Differences in the Pattern of Histone histone (hĭs`tōn), any of a class of protein molecules found in the chromosomes of eukaryotic cells. They complex with the DNA (see nucleic acid) and pack the DNA into tight masses of chromatin, which have the structure of coiled coils, much H3 (K4) and (K27) Methylation methylation,
n a phase-II detoxification pathway in the liver; methyl groups combine with toxins to rid the body of various substances.
(meth´ throughout the -Globin Gene Locus in Baboon Fetal Liver and Adult Bone Marrow Erythroblasts Pre- and Post-Decitabine Treatment
Abstract Number: 1590
Recapitulation of the Fetal Pattern of Expression of the I and V-Globin Genes in Cultured Baboon CD34+ Bone Marrow Cells
Abstract Number: 1984
Phase II Study of Low-Dose Decitabine for the Front-Line Treatment of Older Patients with Acute Myeloid Leukemia (AML)
Abstract Number: 1965
Effect of Failure To Respond to Targeted Therapy on Response to Cytotoxic Therapy in Pts Age 60 with Newly-Diagnosed AML
Abstract Number: 2223
Decitabine and Vitamin D3 Differentially Increase C-Jun, PU.1, and Sp1 Hematopoietic hematopoietic /he·ma·to·poi·et·ic/ (-poi-et´ik)
1. pertaining to hematopoiesis.
2. an agent that promotes hematopoiesis.
1. pertaining to or affecting the formation of blood cells. Transcription Factors To Induce Monocytic Differentiation
Abstract Number: 2322
Hypomethylation Induction and Molecular Response after Decitabine Therapy in Chronic Myelomonocytic Leukemia (CMML)
Abstract Number: 2652
Survival Benefit with Decitabine Compared to Historical Experience with Intensive Chemotherapy in Patients with Higher Risk Myelodysplastic Syndrome (MDS)
Abstract Number: 2655
Decitabine Induces High Response Rates in Patients with Chronic Myelomonocytic Leukemia (CMML)
Abstract Number: 2676
Efficacy of Decitabine in the Treatment of Patients with Chronic Myelomonocytic Leukemia (CMML)
Abstract Number: 4923
Phase II Study of Decitabine in Myelofibrosis Myelofibrosis Definition
Myelofibrosis is a rare disease of the bone marrow in which collagen builds up fibrous scar tissue inside the marrow cavity. with Myeloid Metaplasia
Abstract Number: 5257
Non-Intensive AML/MDS Treatment with Low-Dose Decitabine Prior to Reduced-Intensity Conditioning (RIC) and Allogeneic Blood Stem Cell Transplantation Stem Cell Transplantation Definition
Stem cells are basic human cells that reproduce (replicate) easily, providing a continuous source of new, sometimes different types of cells. of Older Patients
Abstract Number: 4573
Hemoglobin F Induction Is Frequent during Low-Dose 5-aza-2-Deoxycytidine Treatment of Older AML/MDS Patients
Abstract Number: 4303
Hydroxyurea hydroxyurea /hy·droxy·urea/ (-u-re´ah) an antineoplastic that inhibits a step in DNA synthesis, used in treatment of chronic granulocytic leukemia, some carcinomas, malignant melanoma, and polycythemia vera. with Azacitidine or Decitabine in Combination Is Antagonistic on DNA Methylation Inhibition
About Dacogen[TM] (Decitabine) For Injection
Dacogen[TM] (decitabine) for Injection was approved by the U.S. Food and Drug Administration on May 2 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 Hematology A myelodysplastic syndrome of older persons characterized by anemia or pancytopenia and BM hypercellularity Clinical Nonspecific–anemia of gradual onset, fatigue, weakness, exacerbation of underlying heart , refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2 and High-Risk International Prognostic Scoring System prognostic scoring system Any scoring to help predict outcome(s) and identify Pts and clinical situations in which the potential value of intensive care is low, while the burden of therapy is high, providing a numerical prediction of mortality. (IPSS IPSS International Prostate Symptom Score
IPSS Instituição Particular de Solidariedade Social (Portugese: Private Social Solidarity Institution)
IPSS International Prognostic Scoring System
IPSS Inferior Petrosal Sinus Sampling ) groups. 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 2 months afterwards. The most commonly occurring adverse reactions with Dacogen include neutropenia (90%), thrombocytopenia (89%), anemia (82%), pyrexia pyrexia /py·rex·ia/ (pi-rek´se-ah) pl. pyrex´iae fever.pyrex´ial
py·rex (53%), fatigue (48%), nausea (42%), cough (40%), petechiae Petechiae
Tiny purple or red spots on the skin associated with endocarditis, resulting from hemorrhages under the skin's surface.
Mentioned in: Endocarditis, Hantavirus Infections, Hemorrhagic Fevers, Idiopathic Thrombocytopenic Purpura
(39%), constipation (35%), and diarrhea (34%). Please visit www.mgipharma.com for full prescribing information.
MGI PHARMA is currently conducting a phase 3 pivotal trial to evaluate Dacogen in patients with acute myeloid leukemia, or AML. Additional phase 2 studies are also underway to evaluate alternative dosing regimens for Dacogen in patients with MDS and in patients with AML and chronic myelogenous leukemia Chronic myelogenous leukemia (CML)
Also called chronic myelocytic leukemia, malignant disorder that involves abnormal accumulation of white cells in the marrow and bloodstream.
Mentioned in: Bone Marrow Transplantation , or CML. A phase 3 EORTC-sponsored study of Dacogen in patients with MDS is ongoing in Europe.
About MGI PHARMA, INC.
MGI PHARMA, INC. is an oncology and acute care focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi[R] (palonosetron hydrochloride) Injection, Dacogen[TM] (decitabine) for Injection, and Gliadel[R] 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 the Companies' 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 to successfully introduce Dacogen for Injection into the marketplace; acceptance by physicians and patients of the product; and Dacogen for Injection competing successfully with other therapies for MDS; and other risks and uncertainties detailed from time to time in the Companies' 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 to conform them to actual results.