Dacogen(TM) (Decitabine) Injection Data Presented at American Society of Hematology (ASH) Annual Meeting; Updated Data From Alternative Dosing Regimen Study And Initial Phase 2 AML Results Presented.ATLANTA -- 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) and SuperGen, Inc. (Nasdaq:SUPG SUPG Streamline Upwind Petrov Galerkin ) today provided a summary of the Dacogen(TM) (decitabine) injection presentations made during the American Society of Hematology (ASH) 47th Annual Meeting and Exposition. Dacogen injection was the subject of five oral presentations and 10 poster presentations. Updated results from an alternative dosing study of Dacogen injection in patients with myelodysplastic syndromes (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ) and initial data from a phase 2 trial of Dacogen injection in elderly acute myeloid leukemia myeloid leukemia n. See myelogenous leukemia. (AML AML - A Manufacturing Language ) patients were among the data presented. In addition, MGI PHARMA sponsored a Corporate Friday symposium titled Modulation of 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´ Status: Innovation in the Treatment of Hematological Malignancies, which was chaired by Dr. Jean-Pierre Issa of The University of Texas M.D. Anderson Cancer Center in Houston, TX. "The data presented at ASH continue to support that Dacogen injection may represent a potential new therapeutic option for patients suffering from MDS and we look forward to an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. decision on Dacogen injection for this indication in early 2006," 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. "Additionally, Dacogen injection has shown clinical activity in a broad range of other hematologic malignancies, as both a monotherapy and in combination with other anti-cancer agents. We will continue to investigate Dacogen injection in other indications, as we expand the development program of this important product." Updated Results From Alternative Dosing Study In 96 MDS Patients Interim results of a study designed to compare three dosing regimens for Dacogen injection were presented in a poster session A poster session is the juried presentation of research information by representatives of several research teams at a congress or conference with an academic or professional focus. These are particularly prominent at scientific conferences such as medical congresses. on Sunday, December 11. In this study, patients with intermediate-1, intermediate-2, and high risk MDS were 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. to receive one of three Dacogen regimens every four 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 injection twice per day for five days. Randomization randomization (ranˈ·d  ·m of
patients to each of the three dosing regimens was equal for the first 50
patients enrolled in this study. After the 50th patient was enrolled, a
Bayesian randomization was implemented based on complete response rates,
and all additional study participants were treated using the 5-day 20
mg/m2 intravenous infusion regimen.For 96 evaluable patients, the overall response rate was 47 percent, including a 42 percent complete response rate and a 5 percent partial response rate. In the 65 patients treated with a 20 mg/m2 intravenous Dacogen infusion once per day for five days, the complete response rate was 49 percent. The most frequently-observed adverse events were primarily a result of myelosuppression and included fever (4 percent) and infection (9 percent). These data support the hypothesis that these alternative Dacogen regimens are active in treating MDS patients and may offer dose-scheduling flexibility. A multicenter phase 2 study evaluating the 20 mg/m2 intravenous one hour infusion once per day for five days is currently ongoing, with an enrollment goal of 93 patients with MDS. Initial Phase 2 AML Results Utilizing A 5-Day, One Hour Infusion Regimen Results from a multicenter phase 2 study of Dacogen injection in previously-untreated elderly AML patients were presented in a poster session on Sunday, December 11. Patients in this trial received initial Dacogen injection therapy intravenously at a dose of 15 mg/m2 every 8 hours for 3 days (total dose 135 mg/m2), repeated every six weeks in addition to all-trans retinoic acid retinoic acid /ret·i·no·ic ac·id/ (ret?i-no´ik) an oxidized derivative of retinol, believed to be the form of vitamin A that plays a role in the development and growth of bone and in the maintenance of normal epithelial structures. . Following completion of four courses of initial therapy, patients may then receive maintenance therapy consisting of a one hour infusion of 20 mg/m2 Dacogen injection daily for three days, repeated every eight weeks. The primary endpoint of this study is best response, and secondary endpoints include overall and progression free survival, toxicity and duration of hospitalization. Of the 29 fully evaluable patients, 14 percent experienced a complete response, 17 percent had a partial response, and 10 percent had stable disease. The median overall survival from the start of therapy was 7.5 months. Adverse events included 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. , fever, infection, and pancytopenia pancytopenia /pan·cy·to·pe·nia/ (-sit-ah-pe´ne-ah) abnormal depression of all the cellular elements of the blood. pan·cy·to·pe·ni·a n. . These interim results suggest that Dacogen injection may be tolerated and may show activity in elderly patients with AML. This study is currently ongoing with an enrollment goal of at least 60 patients. Analysis of Phase 2 & 3 Data Indicate That Prolonged Therapy Optimizes Efficacy An analysis of response rates from four trials of Dacogen injection in MDS patients was presented in a poster session on Sunday, December 11. One pivotal phase 3 trial and three supportive phase 2 trials were conducted to assess the safety and efficacy of Dacogen injection plus supportive care supportive care, n medical and other interventions that attempt to support and make comfortable rather than to cure. compared to supportive care alone in patients with MDS. In the phase 2 studies, patients received a median of four cycles of Dacogen injection therapy, compared to the phase 3 study, in which patients received a median of three cycles of therapy. Across these four studies, responses were observed in MDS patients from all 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 and FAB subgroups. In the two phase 2 studies, in which responses were centrally reviewed, overall response rate was 26 percent in each trial. The overall response rate (ORR) observed in the phase 3 study (D-0007) was 17 percent as assessed by 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, compared to 0 percent for patients that received supportive care alone. The primary toxicity associated with Dacogen injection treatment in these trials was myelosuppression, including neutropenia, 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. Because Dacogen injection impacts DNA methylation patterns, DNA synthesis and subsequent demethylation are required for its activity. Analysis of ORR results and median durations of therapy for these studies suggest that prolonged therapy with Dacogen injection may optimize response rates for MDS patients. Phase 2 Data Demonstrate Activity in Combination with Imatinib in 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. Patients Data from a phase 2 study of Dacogen injection in combination with imatinib in patients with 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) were presented in a poster session on Saturday, December 10. To be eligible for this study, patients who had previously been treated with imatinib must have clinical evidence of imatinib failure. Patients enrolled in this trial were treated with Dacogen injection 15 mg/m2 intravenously for five days per week for two consecutive weeks, repeated every six weeks, plus 600 mg oral imatinib daily. A total of 20 patients received at least 2 cycles of treatment and were evaluated for response. For these 20 patients, the overall hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. response rate was 44 percent, including a 33 percent complete hematologic response rate and an 11 percent partial hematologic response rate. The median duration of response was 13 weeks. The most frequently observed grade 3 and 4 toxicities associated with this study included neutropenia, infection, CNS See Continuous net settlement. CNS See continuous net settlement (CNS). bleed and GI bleed. These data demonstrate that the combination of Dacogen injection plus imatinib may be an active regimen for patients with CML, including those who have previously been treated with imatinib. Below is the list of all Dacogen injection abstracts presented at the 2005 ASH annual meeting: Oral Presentations ------------------ Abstract Number: 371 Hypomethylation Therapy of Decitabine in Patients with Myelodysplastic Syndromes (MDS) Induces Apoptosis and Reduces Proliferation. Session Type: Oral Session Monday, December 12, 2005, 12:00 PM Abstract Number: 495 Decitabine: Where Is the Target? Session Type: Oral Session Monday, December 12, 2005, 2:00 PM Abstract Number: 525 Subdomains of the Baboon (P. anubis) Beta-Globin Gene Cluster Are Differentially Sensitive to Dacogen Treatment. Session Type: Oral Session Monday, December 12, 2005, 2:00 PM Abstract Number: 408 Final Results of a Phase I/II Study of the Combination of the Hypomethylating Agent 5-aza-2'-Deoxycytidine (DAC) and the Histone Deacetylase Inhibitor Valproic Acid (VPA) in Patients with Leukemia. Session Type: Oral Session Monday, December 12, 2005, 2:45 PM Abstract Number: 790 CpG Island Methylation Is a Poor Prognostic Factors in Myelodysplastic Syndrome Patients and Is Reversed by Decitabine Therapy-Results of a Phase III Randomized Study. Session Type: Oral Session Tuesday, December 13, 2005, 8:45 AM Poster Presentations -------------------- Abstract Number: 1092 Outcome of Salvage Therapy in Patients (pts) with Chronic Myeloid Leukemia (CML) Who Failed Imatinib after Developing BCR-ABL Kinase Mutation. Session Type: Poster Session 250-I Saturday, December 10, 2005, 9:15 AM Abstract Number: 1099 Phase II Study of Decitabine in Combination with Imatinib Mesylate in Patients with Accelerated (AP) or Blastic Phase (BP) of Chronic Myeloid Leukemia (CML). Session Type: Poster Session 257-I Saturday, December 10, 2005, 9:15 AM Abstract Number: 1854 A Phase I Pharmacokinetic Trial of Decitabine Administered as a 3-Hour Infusion to Patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS). Sunday, December 11, 2005, 9:15 AM Abstract Number: 2534 Myelodysplastic Syndromes (MDS): An International Practice and Treatment Survey. Session Type: Poster Session 738-II Sunday, December 11, 2005, 9:15 AM Abstract Number: 1852 Continued Low-Dose Decitabine (DAC) Is an Active First-Line Treatment of Older AML Patients: First Results of a Multicenter Phase II Study. Session Type: Poster Session 56-II Sunday, December 11, 2005, 9:15 AM Abstract Number: 2522 Decitabine Low-Dose Schedule (100 mg/m2/Course) in Myelodysplastic Syndrome (MDS). Comparison of 3 Different Dose Schedules. Session Type: Poster Session 726-II Sunday, December 11, 2005, 9:15 AM Abstract Number: 2515 Response Rates of Phase 2 and Phase 3 Trials of Decitabine (DAC) in Patients with Myelodysplastic Syndromes (MDS). Session Type: Poster Session 719-II Sunday, December 11, 2005, 9:15 AM Abstract Number: 1861 Phase I Study of Low Dose Decitabine in Patients with Acute Myeloid Leukemia (AML): Pharmacokinetics (PK), Pharmacodynamics (PD), and Clinical Activity. Session Type: Poster Session 65-II Sunday, December 11, 2005, 9:15 AM Abstract Number: 2516 Decitabine, a Potential Targeted Therapeutic for Juvenile Myelomonocytic Leukemia. Session Type: Poster Session 720-II Sunday, December 11, 2005, 9:15 AM Abstract Number: 3440 Demethylation Profiling of CD34-Positive Hematopoietic Cells in Patients with Myelodysplastic Syndromes. Session Type: Poster Session 691-III Monday, December 12, 2005, 10:30 AM About Dacogen(TM) (Decitabine) Injection Dacogen injection is a product candidate that belongs to a class of drugs called hypomethylating agents that is currently being evaluated in a broad clinical development program in patients with MDS, AML, CML, and solid tumors. Dacogen injection 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. The Dacogen injection 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 ) is under review by the FDA for the MDS indication. A phase 3 EORTC-sponsored trial is currently ongoing in Europe to evaluate Dacogen injection in patients with MDS. MGI PHARMA is conducting a pivotal program to evaluate Dacogen injection in patients with AML. Additional clinical studies are also underway in patients with MDS to evaluate alternative dosing regimens for Dacogen injection. 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 blood disorders, n.pl hematologic dyscrasias that affect the component cells and plasma elements of the blood. They are generally divided into two broad groups: those in which an increase in bulk occurs (e.g. . SuperGen's product portfolio includes Orathecin(TM) (rubitecan) capsules, an investigational drug being evaluated for the treatment of pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. ; Nipent(R) (pentostatin for injection), approved for the treatment of hairy-cell leukemia; 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. , for use in the therapy of disseminated adenocarcinoma adenocarcinoma: see neoplasm. of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as a palliative treatment palliative treatment n. Treatment to alleviate symptoms without curing the disease. Palliative treatment A type treatment that does not provide a cure, but eases the symptoms. Mentioned in: Laparoscopy when other modalities have failed; and SurfaceSafe(R) cleaner. For more information about SuperGen, please visit http://www.supergen.com. 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 markets Aloxi(R) (palonosetron hydrochloride palonosetron hydrochloride Aloxi Pharmacologic class: Selective serotonin subtype 3 (5-HT3) receptor antagonist Therapeutic class: Antiemetic Pregnancy risk category B ) 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 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 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's and SuperGen'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 and SuperGen's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; and other risks and uncertainties detailed from time to time in the Companies' filings with the Securities and Exchange Commission including their most recently filed Forms 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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