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MGI PHARMA Summarizes Data Presented at the 2007 American Society of Clinical Oncology (ASCO) Annual Meeting.


--Dacogen([R]) Activity in Older Patients with AML AML - A Manufacturing Language  and in Refractory ALL Patients Presented--

--Differentiation of the molecular interaction of Aloxi([R]) with the 5-HT3 Receptor Reported--

--Results of a Survival Analysis of Glioblastoma glioblastoma /glio·blas·to·ma/ (gli?o-blas-to´mah) any malignant astrocytoma.

glioblastoma multifor´me
 Patients Treated with Multimodal Therapy, including Gliadel([R] )Described--

--Survival Analysis of Irofulven in Second-Line HRPC HRPC Hormone-Refractory Prostate Cancer
HRPC Hormone-Resistant Prostate Cancer
HRPC Hudson River Parks Conservancy
HRPC Health Research and Policy Center
 Patients Presented--

CHICAGO -- MGI PHARMA, INC. (Nasdaq:MOGN), a biopharmaceutical company focused in oncology and acute care, today provided highlights of data presentations made during the 2007 American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas.  (ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company
) Annual Meeting. Dacogen([R]) (decitabine) for Injection was the subject of five posters including the presentation of efficacy data in older patients with 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) and activity observed in patients with refractory acute lymphocytic leukemia acute lymphocytic leukemia
n.
See acute lymphoblastic leukemia.


acute lymphocytic leukemia Acute lymphoblastic leukemia, ALL A malignant lymphoproliferative process that commonly affects children and young adults
 (ALL). Gliadel([R]) Wafer (polifeprosan 20 with carmustine implant) was the subject of two posters with one detailing the impact of multimodal therapy that included Gliadel implantation, followed by treatment with radiation and concurrent temozolomide plus rotational chemotherapy, on survival in patients with primary glioblastoma. A poster discussion provided updated response and survival data from 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.
 phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study.  of Irofulven (MGI 114; hydroxymethylacylfulvene) in hormone refractory prostate cancer (HRPC) patients who failed docetaxel treatment. In addition to two posters, Aloxi([R]) (palonosetron hydrochloride) Injection was the subject of a published abstract describing study results that differentiate the molecular interaction of Aloxi with the 5-HT3 receptor. These data provide new insight into the receptor binding mechanisms that may explain the enhanced protection from chemotherapy-induced nausea and vomiting Nausea and Vomiting Definition

Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth.
 (CINV CINV Chemotherapy Induced Nausea and Vomiting ) observed with Aloxi in clinical trials.

"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

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 allosteric /al·lo·ster·ic/ (al?o-ster´ik) pertaining to allostery.

allosteric

pertaining to an effect on the biological function of a protein, produced by a compound not directly involved in that function (an allosteric
 interactions between these agents and the 5-HT3 receptor were examined in binding experiments using each unlabeled antagonist in competition with [3H]-antagonist. Concentrations of [3H]-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 [3H]-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 dexamethasone /dex·a·meth·a·sone/ (dek?sah-meth´ah-son) a synthetic glucocorticoid used primarily as an antiinflammatory in various conditions, including collagen diseases and allergic states; it is the basis of a screening test in the  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 emesis /em·e·sis/ (em´e-sis) vomiting.

em·e·sis
n. pl. em·e·ses
The act or process of vomiting.


Emesis
The medical term for vomiting.
 or rescue medication), no emesis, and no significant nausea (Visual Analogue Score (VAS; 0-100) <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 emetic (əmĕt`ĭk), substance that produces vomiting. Direct, or gastric, emetics, which act directly on the stomach, include syrup of ipecac, sulfate of zinc or copper, alum, ammonium carbonate, mustard in water, or copious quantities of  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 < 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 pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 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 hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 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 cytogenetics /cy·to·ge·net·ics/ (-je-net´iks) the branch of genetics devoted to cellular constituents concerned in heredity, i.e. chromosomes. , 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 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.
, headache, 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.
.

Phase 1 Study of Dacogen in Patients with Relapsed or Refractory Acute Lymphocytic Leukemia (ALL)

Interim results of two consecutive phase 1 studies 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 hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 control. No significant Grade 3 or Grade 4 drug related non-hematological toxicities were observed.

Gliadel([R]) Wafer

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 CCNU lomustine.

CCNU

see lomustine.

CCNU Cyclonexyl-chloroethyl-nitrosourea, lomustine Oncology A chemotherapeutic used in adjuvant therapy of high-grade astrocytomas, also used in NHL, melanoma, myeloma, GI CAs Adverse
), 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-[?]) 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<0.055). Adverse events were similar in patients treated with or without Gliadel and included thrombocytopenia Thrombocytopenia Definition

Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets.
, leukopenia leukopenia /leu·ko·pe·nia/ (-pe´ne-ah) reduction of the number of leukocytes in the blood below about 5000 per cubic mm.leukope´nic

basophilic leukopenia  basophilopenia.
, seizures, fatigue, and gastrointestinal.

Irofulven

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 prednisone (prĕd`nĭsōn): see corticosteroid drug.  +- 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 stratified /strat·i·fied/ (strat´i-fid) formed or arranged in layers.

strat·i·fied
adj.
Arranged in the form of layers or strata.
 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 (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce.  response was noted in 22% of patients receiving irofulven + capecitabine + prednisone 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 MDS,
n See temporomandibular pain-dysfunction syndrome.

MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there
: 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 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 # 9565

"Decitabine (DAC See D/A converter and discretionary access control.

DAC - Digital to Analog Converter
) in combination with doxorubicin (DOX) and cyclophosphamide cyclophosphamide /cy·clo·phos·pha·mide/ (-fos´fah-mid) a cytotoxic alkylating agent of the nitrogen mustard group; used as an antineoplastic, as an immunosuppressant to prevent transplant rejection, and to treat some diseases  (CTX) in relapsed neuroblastoma Neuroblastoma Definition

Neuroblastoma is a type of cancer that usually originates either in the tissues of the adrenal gland or in the ganglia of the abdomen or in the ganglia of the nervous system.
 (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"

Abstract #34157

"A retrospective safety and efficacy analysis of combination therapy for GBM GBM 1 Glioblastoma multiforme, see there 2. Glomerular basement membrane  using temozolomide, external beam radiation (EBRT EBRT External Beam Radiation Therapy ), 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 the 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 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. 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 pyrexia /py·rex·ia/ (pi-rek´se-ah) pl. pyrex´iae   fever.pyrex´ial

py·rex·i·a
n.
See fever.



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 or www.dacogen.com for full prescribing information.

About Gliadel([R]) Wafer

Gliadel is a biodegradable wafer containing the chemotherapy agent carmustine, or BCNU BCNU - Be seein' you. , 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 Craniotomy Definition

Surgical removal of part of the skull to expose the brain.
Purpose

A craniotomy is the most commonly performed surgery for brain tumor removal.
) without Gliadel, 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.

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 MGI PHARMA's 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 continue to increase sales of its marketed products, the ability to successfully commercialize Saforis[TM] / the ability for MGI PHARMA to respond to the FDA's approvable letter, the successful completion of clinical trials for the Company's other product candidates, and other risks and uncertainties detailed from time to time in MGI PHARMA's filings with the Securities 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.
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