MGI PHARMA Summarizes Clinical Data Presented at the 40th Annual Meeting of the American Society of Clinical Oncology.Business Editors/Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--June 8, 2004 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), an oncology-focused biopharmaceutical company today provided a summary of presentations made during the 40th Annual Meeting of the 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 ) in New Orleans, Louisiana. Aloxi(TM) (palonosetron hydrochloride palonosetron hydrochloride Aloxi Pharmacologic class: Selective serotonin subtype 3 (5-HT3) receptor antagonist Therapeutic class: Antiemetic Pregnancy risk category B ) injection for the prevention of chemotherapy induced nausea and vomiting Nausea and Vomiting DefinitionNausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. was the subject of two poster presentations and one published abstract. In addition, one poster presentation and two published abstracts described studies of irofulven in hormone refractory prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. , hepatocellular carcinoma hep·a·to·cel·lu·lar carcinoma n. A carcinoma derived from parenchymal cells of the liver. Also called hepatocarcinoma, malignant hepatoma. , and metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. . Aloxi(TM) Injection Aloxi injection is a selective 5-HT3 receptor antagonist with high receptor binding affinity and an extended 40-hour plasma half-life that was approved by the 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. at a fixed dose of 0.25 mg 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 injection is the only 5-HT3 receptor antagonist to be indicated for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV CINV Chemotherapy Induced Nausea and Vomiting ) caused by moderately emetogenic cancer chemotherapy. Highlights of Aloxi(TM) injection data presented or published at ASCO include: -- A published abstract highlighting interim results of a post-marketing phase 2 study of Aloxi injection in combination with aprepitant. Patients in this study received a single IV dose of Aloxi injection, 125 mg aprepitant, and 12 mg 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 prior to receiving a wide variety of moderate to moderate-high emetogenic chemotherapy. On days two and three following chemotherapy, patients received 80 mg daily of oral aprepitant and 8 mg dexamethasone. Endpoints of the study included complete response, defined as 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 or rescue medication. Of the 39 patients evaluated, a complete response was observed in 90% during the acute (0-24 hour) time period, with 97% of patients experiencing no emetic episodes. For the overall 0-120 hour time period following chemotherapy, 80% of patients had a complete response and 97% of patients had no emetic episodes. In the delayed (24-120 hour) time period, a complete response was observed in 80% of patients, with 97% of patients experiencing no emetic episodes. Consistent with Aloxi injection and/or aprepitant labeling, the most common adverse events observed in this study included diarrhea, fatigue, and constipation. -- A poster describing results of a subset analysis of phase 3 Aloxi injection data in elderly patients was presented on June 8. Data from 165 patients over the age of 65 was pooled from studies 99-03 and 99-04. These patients were treated with Aloxi injection, ondansetron, or dolasetron prior to receiving moderately emetogenic chemotherapy. Endpoints of the studies included complete response rate, defined as no emetic episodes or rescue medication. Analyses show that 71% of elderly patients treated with Aloxi injection had a complete response, compared to 51% of patients treated with ondansetron or dolasetron (p=0.01) in the overall (0 to 120 hours) time period following chemotherapy. In addition, 77% of patients who received Aloxi injection experienced no emetic episodes, compared to 62% of patients who received ondansetron or dolasetron. Adverse events in this elderly population were similar to those observed in patients younger than 65 years of age and included headache and constipation. -- A poster evaluating the carryover effect of Aloxi injection in two phase 3 trials was presented on June 8. Because CINV during the acute (0 to 24 hours) phase is the best predictor of nausea and vomiting in the delayed (24-120 hour) phase, this subanalysis was designed to determine if the efficacy of Aloxi injection in preventing delayed CINV was related to its pharmacologic activity or to a carryover effect. Results demonstrated that patients treated with Aloxi injection had improved prevention of delayed CINV compared to those patients treated with ondansetron or dolasetron, independent of protection from acute CINV. Aloxi injection has a direct pharmacologic effect in the delayed setting. This indicated that prevention of delayed CINV with Aloxi injection is due to direct pharmacologic effect. Irofulven (hydroxymethylacylfulvene) The investigational new drug, Irofulven (hydroxymethylacylfulvene), is the first chemotherapeutic drug candidate in MGI PHARMA's family of proprietary anti-cancer compounds called the acylfulvenes. It is currently being studied in a broad clinical development program designed to evaluate its activity in several types of cancer as both a monotherapy and in combination with other chemotherapeutic drugs. Future marketing of irofulven will be subject to review and approval by the FDA. Highlights of irofulven data disclosed at ASCO include: -- A summary of irofulven data in hormone refractory prostate cancer (HRPC HRPC Hormone-Refractory Prostate Cancer HRPC Hormone-Resistant Prostate Cancer HRPC Hudson River Parks Conservancy HRPC Health Research and Policy Center ) patients published in an abstract at ASCO. Results from two phase 2 monotherapy trials and two phase 1 combination studies demonstrate consistent antitumor an·ti·tu·mor also an·ti·tu·mor·al adj. Counteracting or preventing the formation of malignant tumors; anticancer. Adj. 1. activity of irofulven alone and in combination with other chemotherapeutic drugs in HRPC. In a phase 2 monotherapy trial using the every other week dosing schedule of irofulven, of 56 evaluable patients, 1 patient had a complete response, 8 patients had a partial response, and 17 patients had stable disease by 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. assessment. Of 9 patients with HRPC enrolled in a combination phase 1 study with cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic. cis·plat·in n. , 1 had a complete response, 2 had partial responses, and 1 had stable disease. In the phase 1 capecitabine combination study, of 7 patients with HRPC, 1 patient had a complete response and 2 have had stable disease. A phase 2 combination program designed to evaluate the activity of irofulven in combination with capecitabine and a platinum agent in HRPC patients who have failed docetaxel-containing regimens is currently ongoing. -- Results from a phase 2 trial designed to assess the efficacy and safety of irofulven using the every other week dosing schedule in patients with unresectable hepatocellular carcinoma were presented on June 5. Patients enrolled in this study had measurable hepatocellular carcinoma that could not be removed surgically, and had been treated with no more than one chemotherapy regimen prior to enrollment. Of the 44 evaluable patients, two patients have ongoing partial responses with tumor marker reductions lasting more than 6 months, 18 patients had stable disease, and 24 patients had progressive disease. Of those patients with stable disease, 13 had a time to disease progression greater than four months. The most common adverse events observed in this study were 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 nausea. -- Data from a phase 2 study of irofulven plus CPT-11 in metastatic colorectal cancer patients who had previously failed oxaliplatin/5FU based therapy published as an abstract at ASCO. Of the 18 evaluable patients, three patients had a partial response and five had stable disease. The most frequently observed grade 3 and 4 toxicities 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. , febrile febrile /feb·rile/ (feb´ril) pertaining to or characterized by fever. feb·rile adj. Of, relating to, or characterized by fever; feverish. neutropenia, thrombocytopenia, and diarrhea. Below is the list of abstracts published at the 2004 ASCO annual meeting: Palonosetron plus aprepitant and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting after emetogenic chemotherapy; abstract #8262 Palonosetron vs. ondansetron/dolasetron in preventing chemotherapy-induced nausea and vomiting in elderly patients: combined results from two phase 3 trials; abstract #8049; poster #11 Prevention of delayed nausea and vomiting: Carryover effect analysis of pooled data from two phase 3 studies of palonosetron; abstract #8051; poster #13 Clinical activity of irofulven in hormone refractory prostate cancer; abstract #4766 Phase 2 trial of every two weeks dosing of irofulven in patients with unresectable hepatocellular carcinoma: preliminary results; abstract #4083; poster #T9 Phase 2 trial of irofulven and CPT-11 in metastatic colorectal cancer patients failing oxaliplatin 5FU based chemotherapy; abstract #3713 Oral pilocarpine pilocarpine (pīlōkär`pēn), naturally occurring alkaloid obtained from plants of the genus Pilocarpus (family Rutaceae). to treat vaginal xerosis xerosis /xe·ro·sis/ (ze-ro´sis) abnormal dryness, as of the eye, skin, or mouth.xerot´ic xerosis generalisa´ta associated with chemotherapy-induced amenorrhea amenorrhea (āmĕn'ərē`a, əmĕn'–), cessation of menstruation. Primary amenorrhea is a delay in or a failure to start menstruation; secondary amenorrhea is an unexpected stop to the menstrual cycle. in pre-menopausal women; abstract #8099 About Aloxi(TM) Injection Aloxi injection was approved by the FDA on July 25, 2003 at a fixed dose of 0.25 mg 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 injection 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. Adverse reactions observed in the pivotal trials were similar in frequency, intensity, and duration with Aloxi injection as with the active comparator comparator Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies. agents, ondansetron and dolasetron. The most common adverse reactions related to the study drug at a dose of 0.25 mg were headache (9%) and constipation (5%). Aloxi injection is contraindicated in patients known to have hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to the drug or any of its components. The effect of Aloxi injection on ECG ECG electrocardiogram. ECG abbr. 1. electrocardiogram 2. electrocardiograph ECG Also called an electrocardiogram, it records the electrical activity of the heart. parameters was comparable to ondansetron and dolasetron in clinical trials; it should be administered with caution in patients who have or may develop prolongation of cardiac conduction intervals. Please see the Aloxi injection package insert, available at www.mgipharma.com and www.aloxi.com, for important additional details. MGI licensed the U.S. and Canada rights for Aloxi injection from Helsinn Healthcare SA of Lugano, Switzerland. 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(TM) (palonosetron hydrochloride) injection, Salagen(R) Tablets (pilocarpine hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. ) and Hexalen(R) (altretamine) capsules in the United States. The Company directly markets its products in the U.S. and collaborates with partners in 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 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 Company'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'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 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 Company's filings with the Securities and Exchange Commission including its most recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements to conform them to actual results. |
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