Dacogen -Decitabine- for Injection Data Presented at American Society of Hematology -ASH- Annual Meeting.SAN DIEGO -- MGI MGI Mouse Genome Informatics MGI Modular Gateway Interface MGI McKinsey Global Institute MGI Military Geographic Information MGI Marine Geological Institute MGI Policy on the Management of Government Information (Canada) PHARMA, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (Nasdaq:MOGN): -- Final Phase 3 data in MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there presented -- Activity in other hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. cancers reported MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG SUPG Streamline Upwind Petrov Galerkin ) today provided a summary of the Dacogen(TM) (decitabine) for Injection presentations made during the American Society of Hematology (ASH) 46th Annual Meeting and Exposition. Dacogen injection was the subject of four oral presentations, five poster presentations, and two published abstracts at the meeting. Final results of a Phase 3 study of Dacogen injection in patients with myelodysplastic syndrome (MDS) and of a trial of three different dosing regimens for Dacogen injection were among the data presented, in addition to data from clinical studies in acute myelogenous leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. (AML AML - A Manufacturing Language ) 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 (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. ). Final Phase 3 Data Demonstrates Activity in MDS Final results of 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. , double blind, Phase 3 study of Dacogen injection were presented in an oral presentation on Sunday, December 5. The co-primary endpoints of this study were overall response rate (as defined by International Working Group (IWG IWG International Working Group IWG Interagency Working Group IWG Informal Working Group IWG Implementation Working Group IWG International Working Group on Women and Sport IWG Interoperability Working Group IWG Interface Working Group ) criteria) and time to AML progression or death. Patients in this study were randomized to receive Dacogen injection plus supportive care or supportive care alone. Dacogen injection was administered intravenously over three hours at a dose of 15 mg/m2 every eight hours for three consecutive days. Secondary endpoints included duration of response, cytogenetic cytogenetic /cy·to·ge·net·ic/ (-je-net´ik) 1. pertaining to chromosomes. 2. pertaining to cytogenetics. cytogenetic pertaining to or originating from the origin and development of the cell. response rate, transfusion requirements, quality of life, survival, and safety. The overall response rate (complete responses plus partial responses) for patients treated with Dacogen injection, inclusive of independent and blinded review, was 17% with a median response duration of 266 days, compared to 0% in the supportive care arm (p less than 0.001). For all patients in the Dacogen arm, median time to progression or death was 340 days vs. 219 days for patients who received only supportive care. The response rates for patients classified as high risk, intermediate-2, or intermediate-1 were 13%, 21% and 14%, respectively. All patients who responded to Dacogen treatment were transfusion independent and had higher quality of life scores for several parameters, including improvement of global health status, physical functioning, fatigue, and dyspnea. The primary toxicity associated with Dacogen treatment was myelosuppression, including neutropenia Neutropenia Definition Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria. , thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. , and anemia. "Dacogen injection demonstrated significant activity in the treatment of MDS patients," stated Dr. Jean-Pierre Issa of the University of Texas MD Anderson Cancer Center. "Patients who responded to Dacogen therapy showed sustained improvements in several aspects of physical health, including transfusion independence, and quality of life measures such as physical functioning and fatigue." Three-Arm Study Demonstrates Activity of Several Dosing Options in MDS Interim results of a study designed to compare three different dosing regimens for Dacogen injection were presented in a poster session on Saturday, December 4. MDS patients in this study were randomized to receive one of three Dacogen regimens every four to six weeks: 1) a 20 mg/m2 intravenous one hour infusion once per day for five days; 2) a 10 mg/m2 one hour intravenous infusion once per day for 10 days; or 3) a 10 mg/m2 subcutaneous dose of Dacogen injection twice per day for five days. Of the 51 evaluable patients, the overall response rate was 43%; including a 35% complete response rate and an 8% partial response rate by IWG criteria. In the 21 patients treated with a 20 mg/m2 intravenous Dacogen infusion once per day for five days, the complete response rate was 48%. For those patients who received a 10 mg/m2 one hour intravenous Dacogen infusion once per day for 10 days, the complete response rate was 24%. The complete response rate for patients who were treated with a 10 mg/m2 subcutaneous dose of Dacogen injection twice per day for five days was 28%. Adverse events were primarily a result of myelosuppression and included fever (7%) and infection (12%). These data support the hypothesis that these alternative Dacogen regimens are active in treating MDS patients and may offer dose scheduling flexibility. MDS Re-Dosing Study Describes Dacogen Activity Following Relapse Interim results from a re-dosing study were presented in a poster session on Saturday, December 4 and included data from 22 MDS patients who responded to Dacogen therapy (12 CRs, 6 PRs, and 4 HIs) and were later re-treated with Dacogen injection after MDS relapse. Re-treatment of these patients began a median of 11 months after their last course of Dacogen therapy. During retreatment, patients received a median of 3 courses of Dacogen therapy which resulted in a 45% overall response rate. Additional Clinical Activity Observed in CML Preliminary results of a Phase 2 study of Dacogen injection in Gleevec(R) (imatinib) refractory or intolerant patients with CML were presented on Monday, December 6. Dacogen injection was administered to 35 patients intravenously at a dose of 15 mg/m2 once per day, five days per week for two weeks. The overall hematologic response rate was 65%, including 12 patients who had complete hematologic responses, 7 who had hematologic responses, and 4 who experienced hematologic improvement. The overall cytogenetic response rate, including both major and minor responses, was 46%. The most common grade 3 and 4 toxicities were related to myelosuppression. "In addition to showing activity in patients with MDS, Dacogen injection has shown clinical activity in a broad range of other hematologic malignancies, including AML and CML and certain solid tumors," said Lonnie Moulder moul·der v. Chiefly British Variant of molder. moulder or US molder Verb to crumble or cause to crumble, as through decay: , 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. "We look forward to beginning a Phase 3 trial of Dacogen injection in AML in early 2005." Below is the list of all Dacogen injection abstracts presented at the 2004 ASH annual meeting: Oral Presentations ------------------ Abstract Number: 67 First Report of the Phase III North American Trial of Decitabine in Advanced Myelodysplastic Syndrome (MDS). Sunday, December 5, 2004, 4:30 PM Abstract Number: 263 Results of a Phase I/II Study of the Combination of 5-aza-2'-deoxycytidine (DAC) and Valproic Acid (VPA) in Patients (pts) with Leukemia. Monday, December 6, 2004, 11:00 AM Abstract Number: 378 The Effect of Decitabine on Covalent Histone Modifications of Chromatin Associated with Globin Gene Promoters in the Baboon (P. anubis). Monday, December 6, 2004, 11:00 AM Abstract Number: 204 Identification of Putative New Tumor Suppressor Genes in Highly Purified CD34+ Bone Marrow Cells from Patients with Myelodysplastic Syndromes. Monday, December 6, 2004, 7:30 AM Poster Presentations -------------------- Abstract Number: 1437 Decitabine Low-Dose Schedule (100 mg/m2/course) in Myelodysplastic Syndrome (MDS). Comparison of 3 Different Dose Schedules. Saturday, December 4, 2004, 6:00 PM Abstract Number: 2956 Hypomethylation Dynamics Following Decitabine Therapy in Chronic Myelogenous Leukemia. Monday, December 6, 2004, 5:30 PM Abstract Number: 1447 Re-Treatment with Low-Dose 5-Aza-2'-Deoxycytidine (Decitabine) Results in Second Remissions of Previously Responsive MDS Patients. Saturday, December 4, 2004, 6:00 PM Abstract Number: 1165 AML1/ETO Expresssion in Myeloid Leukemia Cells Is Associated with Enhanced Growth-Inhibitory and P15/INK4b Demethylating Effects of 5-aza-2'-deoxycytidine. Saturday, December 4, 2004, 6:00 PM Abstract Number: 1166 5'-AZA-2'-Deoxycytidine Induces p21/WAF Expression by Demethylation of p73 Leading to p53-Independent Apoptosis in Myeloid Leukemia. Saturday, December 4, 2004, 6:00 PM Publication Only ---------------- Abstract Number: 4528 Decitabine-Induced Differentiation Syndrome in a Patient with Acute Myeloid Leukemia: A Case Report. Abstract Number: 4707 Effect of 5-Aza-2'-Deoxycytidine in High-Risk Myelodysplasia Cells In Vitro. About Dacogen Injection Dacogen injection is an investigational drug that belongs to a class of drugs called hypomethylating agents, with a unique mechanism of action. Methylation methylation, n a phase-II detoxification pathway in the liver; methyl groups combine with toxins to rid the body of various substances. methylation (meth´ is a process in which methyl (CH3) groups are added to DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. to inactivate in·ac·ti·vate v. 1. To render nonfunctional. 2. To make quiescent. in·ac  ti·va or "silence" genes. It is not approved
for marketing in the U.S. or by other regulatory agencies in their
respective countries; therefore, safety and efficacy have not yet been
established in any patient population. In clinical trials, Dacogen
injection has been shown to have a broad spectrum of activity in several
hematological malignancies as well as solid tumors.The new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Dacogen injection was submitted to the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. during the fourth quarter of 2004. The Marketing Authorization Application (MAA MAA abbr. macroaggregated albumin ) for Dacogen injection has been accepted for review by the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ). About MDS MDS is a cancer of the bone marrow that is often fatal. Some cases of MDS progress to leukemia. According to the Aplastic Anemia and MDS International Foundation (http://aamds.org/), 20,000 to 30,000 new cases of MDS are diagnosed annually in the United States. The number of new cases diagnosed each year is increasing. The average life expectancy for patients diagnosed with MDS is 6 months to 5 years, depending on the severity of the disease. About SuperGen Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapies for solid tumors, hematological malignancies and blood disorders. SuperGen's product portfolio includes Orathecin(TM) (rubitecan) capsules, an investigational drug intended for the treatment of pancreatic cancer; Nipent(R) (pentostatin for injection); Mitomycin mitomycin /mi·to·my·cin/ (mi?to-mi´sin) 1. any of a group of antitumor antibiotics (e.g., mitomycin A, B, C) produced by Streptomyces caespitosus. 2. mitomycin C; used as a palliative antineoplastic. ; and SurfaceSafe(R) cleaner. For more information about SuperGen, please visit www.SuperGen.com. About MGI PHARMA MGI PHARMA, INC. is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients. MGI PHARMA has a portfolio of proprietary pharmaceuticals, and intends to become a leader in oncology. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) injection, Kadian(R) (sustained release morphine sulfate) capsules, Salagen(R) Tablets (pilocarpine pilocarpine (pīlōkär`pēn), naturally occurring alkaloid obtained from plants of the genus Pilocarpus (family Rutaceae). hydrochloride) and Hexalen(R) (altretamine) capsules 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. Gleevec(R) is a trademark of Novartis Pharmaceuticals Corporation. 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 or SuperGen'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 either Company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, whether Dacogen injection will be approved in a timely manner, if at all; whether the drug if approved will be successfully commercialized; continued sales of MGI PHARMA's or SuperGen's other marketed products; development or acquisition of additional products; reliance on contract manufacturing and third party supply; changes in strategic alliances; and other risks and uncertainties detailed from time to time in either Company's filings with the Securities and Exchange Commission, including their most recently filed Form 10-Q or 10-K. MGI PHARMA and SuperGen undertake no duty to update any of these forward-looking statements to conform them to actual results. |
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