"The data presentations at ASCO demonstrate our commitment to advancing the discovery of clinical attributes that distinguish each of the oncology products in our portfolio," said Mary Lynne Hedley, Ph.D., Executive Vice President and Chief Scientific Officer of MGI PHARMA. "We look forward to advancing the scientific understanding of our product candidates and the presentation of data at future medical meetings."
Aloxi(R) Injection< and Exchange Commission including its most recently filed Form 10-K and Form 10-Q. MGI PHARMA undertakes no duty to update any of these forward-looking statements.
Robert Stanislaro, 212-850-5657
Study Results on Receptor Interactions of Aloxi Versus Other 5-HT3 Receptor Antagonists
The results of studies characterizing the molecular ligand-receptor interactions of Aloxi and the other 5-HT3 receptor antagonists, ondansetron and granisetron, were reported. Competitive versus allosteric interactions between these agents and the 5-HT(3) receptor were examined in binding experiments using each unlabeled antagonist in competition with ((3)H)-antagonist. Concentrations of ((3)H)-antagonists were representative of the probable concentrations of each antagonist at the receptor site in vivo. Based on a plot of the concentration of unlabeled antagonist needed to observe half maximal binding (IC50) as a function of ((3)H)-antagonist concentration, Aloxi demonstrated dual action suggesting competitive and allosteric interactions with the 5-HT3 receptor. In contrast, ondansetron and granisetron exhibited strictly competitive antagonism. The Aloxi allosteric interaction with the 5-HT3 receptor indicates that it has additional inhibitory potential at the primary receptor binding site compared to the other 5-HT3 receptor antagonists studied.
Study of a Single Day Combination of Aloxi, Dexamethasone and Aprepitant in Patients Receiving Moderately Emetogenic Chemotherapy (MEC) Regimens
The results of a study evaluating the efficacy of Aloxi in combination with dexamethasone and aprepitant given only on Day 1 for the prevention of acute and delayed CINV in patients receiving MEC were presented in a poster session on Saturday, June 2, 2007. Forty-one patients (40 female, 1 male) with solid tumors received a 1-day, 3-drug regimen of intravenous Aloxi 0.25 mg, oral dexamethasone 20 mg and aprepitant 285 mg prior to their first cycle of chemotherapy. Endpoints of the study included complete response (no emesis or rescue medication), no emesis, and no significant nausea (Visual Analogue Score (VAS; 0-100) less than 25) on Day 1, during the delayed period of Days 2-5, and during the overall period of Days 1-5. On Day 1, 100% of patients had no emesis and at least 95% of patients had no emetic episodes in the delayed and overall time periods. A complete response was demonstrated in 75% of patients on Day 1 and in 67% of patients in the delayed time period. Based on VAS, the majority of patients had no significant nausea in the acute, delayed or overall phases. The most commonly observed adverse events were headache and fatigue.
Phase 3 Results of Aloxi in Pediatric Patients
The results of a phase 3, multicenter, randomized, double-blind study to assess the safety, efficacy and pharmacokinetics of single intravenous doses of Aloxi in pediatric patients were presented in a poster session on Sunday, June 3, 2007. Sixty patients (2-17 years of age) were randomized to receive either 3 mcg/kg or 10 mcg/kg with a maximum total dose of 0.25 mg and 0.75mg, respectively, prior to moderately (n=21) or highly (n=39) emetogenic chemotherapy. Twelve additional patients, age 28 days-23 months, were studied in open-label design at the same doses. The majority of patients had received previous chemotherapy. Day 1 complete response (CR: no emetic episodes and no rescue medication) rates of 37.1% (CI, 22.0-55.1%) and 54.1% (CI, 37.1-70.2%) were reported in the 3 mcg/kg (n=35) and 10 mcg/kg (n=37) groups, respectively. The percentage of patients who were emesis-free was numerically higher in the 10 mcg/kg group; however, as with CR, these differences were primarily seen in children less than 2 years. A numerically higher proportion of patients (aged 6-17 years) with no nausea was also observed in the 10 mcg/kg group. Both doses showed a similar time to treatment failure (time to first emetic episode and/or first administration of rescue medication). The pharmacokinetic data show that total body clearance and volume of distribution of Aloxi increased with age-related body weight, as expected. The long half-life (21-37 hours ) of Aloxi in this pediatric population was consistent with that in adults. There were no cardiac safety concerns or serious treatment related adverse events.
Dacogen(R) for Injection
Study of Response to Dacogen in Older Patients Diagnosed with Acute Myelogenous Leukemia (AML)
The impact of Dacogen on the survival of older patients with AML was presented in a poster discussion on Monday, June 4, 2007. A total of 33 patients meeting the WHO definition of AML ( greater than or equal to 20% bone marrow blasts) who had been treated with Dacogen as front-line therapy on either the randomized Phase 3 study in patients with myelodysplastic syndromes, or on two consecutive studies of Dacogen, alone or in combination with valproic acid were evaluated retrospectively. Response to therapy was assessed by the International Working Group criteria. In the 33 patients treated with intravenous Dacogen (100-150 mg/m2/course), an overall response rate ranging from 50-57% was observed across the three clinical trials with complete and partial response rates of 24% and 6%, respectively, and hematologic improvement and marrow complete response rates of 15% and 6%, respectively. The median survival for the Dacogen treated patients was 12.6 months, the median duration of response was 8.8 months, and 1- and 2-year survival rates were 51% and 26%, respectively. Regardless of blast percentage, cytogenetics, or age, responses were observed in all risk groups. Additionally, the survival of the Dacogen treated group compared favorably to that of 330 patients with AML (over 60 years of age) given standard induction therapy containing cytarabine and treated in the same time-period. Non-hematologic adverse events included myocardial infarction, dyspnea, hyperbilirubinemia, dehydration, syncope, headache, and hypokalemia.
Phase 1 Study of Dacogen in Patients with Relapsed or Refractory Acute Lymphocytic Leukemia (ALL)
Interim results of two consecutive phase 1 st udies designed to evaluate the dose, toxicity, biologic response, and preliminary clinical response of Dacogen alone and in combination with hyperCVAD, in patients with relapsed/refractory ALL were presented on Saturday, June 2, 2007. Patients were treated with intravenous Dacogen administered daily for five days every other week (starting at 100 mg/m2 per course) with 7 of 13 patients subsequently retreated with Dacogen (starting at 25 mg/m2 per course) and given hyperCVAD every three to four weeks. Both agents were started on Day 1. Two patients had complete bone marrow response on Dacogen alone with one of these patients also having a complete response except for platelets (CRp) with subsequent hyperCVAD therapy. Two additional patients who also received combination therapy had a complete response (CR). One of the responding patients received a successful allogeneic stem cell transplant. Correlative studies on patient peripheral blood samples demonstrated hypomethylation and hematological control. No significant Grade 3 or Grade 4 drug related non-hematological toxicities were observed.
Retrospective Data on the Overall Survival of Patients with Glioblastoma Treated with Gliadel Wafer Implantation as Part of Multimodal Therapy
The results of a retrospective analysis to assess the survival of patients treated with rotational multi-agent chemotherapy compared to those who received chemotherapy together with Gliadel Wafer were presented in a poster discussion on Monday June 4, 2007. Eighty-five patients with primary glioblastoma multiforme received surgery with (n=36) or without (n=49) Gliadel implantation followed by radiotherapy and concurrent temozolomide (TMZ) plus one year of adjuvant rotational multi-agent chemotherapy (lomustine (CCNU), TMZ, and irinotecan), consisting of two cycles of each agent. After a median follow-up of 132 weeks, the group that received Gliadel had an extended median survival of 89.4 weeks (95% CI, 65.1- (Infinity)) compared to 72.7 weeks (95% CI, 57.7-84.3) for patients who did not receive Gliadel. One- and 2- year survival rates were also increased with the addition of Gliadel (81% vs. 67% and 44% vs. 27%, respectively). A Cox proportional hazards model accounting for the effects of the Recursive Partitioning Analysis (RPA) class was performed, and the effect of Gliadel treatment on survival was found to approach significance (p less than 0.055). Adverse events were similar in patients treated with or without Gliadel and included thrombocytopenia, leukopenia, seizures, fatigue, and gastrointestinal.
Results of a Randomized Phase 2 Trial of Irofulven in Hormone Refractory Prostate Cancer (HRPC) Patients who Failed First-line Docetaxel Treatment
Updated results of a randomized, 3-arm phase 2 study of irofulven + prednisone +/- capecitabine compared to mitoxantrone + prednisone in patients with HRPC were presented in a poster discussion on Saturday, June 2, 2007. A total of 137 patients with documented resistance to first-line treatment with docetaxel were stratified by presence or absence of disease related pain at study entry and assigned to treatment in a 2:2:1 manner (i.e. 4/5 patients received an irofulven-containing regimen). Although the study was not designed for a statistical comparison of survival, there was a consistent trend toward increased survival in the irofulven arms vs. mitoxantrone over the entire study period and through last follow-up. The observed median overall survival was 10.6 months for patients treated with irofulven + prednisone, 9.4 months for irofulven + capecitabine + prednisone, and 7.3 months for mitoxantrone + prednisone. Similarly, patients with disease-related pain at baseline receiving irofulven + prednisone had a median survival of 8 months vs. 5.5 months for those patients receiving mitoxantrone + prednisone. PSA response was noted in 22% of patients receiving irofulven + capecitabine + predn isone and in 10% of patients treated with irofulven + prednisone. No PSA responses were observed following treatment with mitoxantrone + prednisone. Treatment related toxicity including Grade 3-4 myelosuppression was manageable in all 3 arms. These results support further study of irofulven in this setting.
Additional Abstracts Presented at the 2007 ASCO Annual Meeting
Abstract # 7080
"Changing the treatment paradigm for patients with MDS: how the development of therapeutics influences population-based care in community oncology - the Georgia Cancer Specialists Outcomes Database experience"
Abstract # 7088
"Phase II trial of decitabine in myelofibrosis with myeloid metaplasia"
Abstract # 9565
"Decitabine (DAC) in combination with doxorubicin (DOX) and cyclophosphamide (CTX) in relapsed neuroblastoma (NBL): A Children's Oncology Group Study"
Abstract # 2036
"Phase II trial of Gliadel plus O6-benzylguanine (O6-BG) for patients with recurrent glioblastoma multiforme"
"A retrospective safety and efficacy analysis of combination therapy for GBM using temozolomide, external beam radiation (EBRT), and Gliadel Wafers"
About Aloxi(R) Injection
Aloxi is approved for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Aloxi is the first and only 5-HT3 receptor antagonist to be indicated for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) caused by moderately emetogenic cancer chemotherapy. In clinical trials, the most common adverse reactions related to Aloxi were headache (9%) and constipation (5%). Aloxi is contraindicated in patients known to have hypersensitivity to the drug or any of its components. Please see t he Aloxi package insert, available at www.mgipharma.com and www.aloxi.com, for important additional details.
About Dacogen(R) For Injection
Dacogen is approved by the U.S Food and Drug Administration for the 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. 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. In clinical trials, the most commonly occurring adverse reactions included 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 Gliadel(R) Wafer
Gliadel is a biodegradable wafer containing the chemotherapy agent carmustine, or BCNU, and is indicated in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. Gliadel is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery. As a Gliadel Wafer dissolves, BCNU is delivered directly to the site once occupied by the tumor. Side effects that have been reported in patients receiving Gliadel include seizures, intracranial infections, abnormal wound healing, and brain edema (swelling). Although these events may result as a consequence of brain surgery (craniotomy) without Gliade l, they may occur more frequently when Gliadel is used. In clinical studies, the most common side effects that occurred more often in patients receiving Gliadel than in patients receiving placebo, included pain and abnormal wound healing. Please visit www.gliadel.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(R) (palonosetron hydrochloride) Injection, Dacogen(R) (decitabine) for Injection and Gliadel(R) Wafer (polifeprosan 20 with carmustine implant) in the United States. MGI PHARMA directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information, please visit www.mgipharma.com.
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successfully commercialize Saforis(TM) / the ability for MGI PHARMA
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