MGI PHARMA UNVEILS DACOGEN (DECITABINE) FOR INJECTION.MGI PHARMA, INC. (Nasdaq: MOGN), Minneapolis, has announced that Dacogen(tm) (decitabine) for Injection is now commercially available in the United States. Dacogen was approved by the U.S Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) on May 2, 2006 for the treatment of patients with myelodysplastic syndromes (MDS MDS,
n See temporomandibular pain-dysfunction syndrome.
MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ) 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) groups.
"In line with our strategy, MGI PHARMA continues to expand its presence in oncology and acute care. The introduction of Dacogen is a significant step in our penetration of these markets and in our path to generating $1 billion in total revenue by 2010. In addition to Dacogen, MGI PHARMA markets Aloxi and Gliadel, and has five ongoing pivotal programs to drive future growth," said Lonnie Moulder, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of MGI PHARMA. "With our field commercial organization now trained, we look forward to discussing the availability of Dacogen with the hematologists and oncologists who treat patients with MDS."
Results from a phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of Dacogen demonstrated an overall response rate of 21% in Dacogen-treated patients considered evaluable for response, defined as those patients with pathologically confirmed MDS at baseline who received at least 2 cycles of treatment, compared to 0% in the supportive care arm. All patients who responded to Dacogen treatment became or remained transfusion independent during the time of the response. It is recommended that patients be treated with Dacogen for a minimum of four cycles, and treatment may continue as long as the patient continues to benefit.
Important Safety Information
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%). Visit http://www.mgipharma.com for full prescribing information.
Ongoing Clinical Studies
MGI PHARMA is currently conducting a phase 3 pivotal trial to evaluate Dacogen in patients with AML AML - A Manufacturing Language . Additional phase 2 studies are also underway to evaluate alternative dosing regimens for Dacogen in patients with MDS, 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 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. . A phase 3 European Organization for Research and Treatment of Cancer- (EORTC-) sponsored study of Dacogen in patients with MDS is ongoing in Europe.
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(tm) (Decitabine)For Injection
Dacogen is a hypomethylating agent that is believed to exert its antineoplastic antineoplastic /an·ti·neo·plas·tic/ (-ne?o-plas´tik)
1. inhibiting or preventing development of neoplasms; checking maturation and proliferation of malignant cells.
2. an agent that so acts. effects by incorporation into DNA and inhibition of an enzyme called DNA methyltransferase. Methylation methylation,
n a phase-II detoxification pathway in the liver; methyl groups combine with toxins to rid the body of various substances.
(meth´ is a process in which methyl (CH3) groups are added to DNA, resulting in the inactivation of genes that are critical for control of cellular differentiation and proliferation. Abnormal methylation, which silences certain genes, is associated with the development of many types of tumors. Dacogen-induced hypomethylation in neoplastic cells may restore normal function to genes that are critical for the control of cellular differentiation and proliferation. In rapidly dividing cells, the cytotoxicity of Dacogen may also be attributed to the formation of covalent co·va·lent
Of or relating to a chemical bond characterized by one or more pairs of shared electrons. adducts between DNA methyltransferase and decitabine incorporated into DNA. Non-proliferating cells are relatively insensitive to Dacogen.
About MGI PHARMA
MGI PHARMA, INC. is an oncology- and acute care-focused biopharmaceutical company that acquires, researches, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA has a portfolio of proprietary pharmaceuticals, and intends to become a leading biopharmaceutical company. 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, visit http://www.mgipharma.com or http://www.dacogen.com or call 212/332-4381.