MGI PHARMA And HELSINN HEALTHCARE SA Summarize Aloxi Injection Clinical Data Presented at the Multinational Association of Supportive Care in Cancer 16th International Symposium.MIAMI Miami, cities, United States Miami (mīăm`ē, –ə). 1 City (1990 pop. 358,548), seat of Dade co., SE Fla., on Biscayne Bay at the mouth of the Miami River; inc. 1896. -- 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, and HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceutical group, today provided a summary of Aloxi(TM) injection presentations made during the Multinational Association of Supportive Care supportive care, n medical and other interventions that attempt to support and make comfortable rather than to cure. in Cancer (MASCC MASCC Multinational Association of Supportive Care in Cancer ) 16th International Symposium in Miami, Florida. Three poster presentations described the impact of treatment with Aloxi injection on various quality-of-life parameters, the maintenance of efficacy of Aloxi injection in patients weighing more than 90 kilograms, and the pharmacokinetics and safety of repeat doses of Aloxi injection. MGI PHARMA and HELSINN are also sponsoring a symposium titled "Advances in Prevention of Chemotherapy-Induced Nausea & Vomiting - CINV CINV Chemotherapy Induced Nausea and Vomiting " to be held on Saturday, June 26 at 7:00 am ET at Loews Miami Beach Hotel. 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 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. 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) caused by moderately emetogenic cancer chemotherapy. In one poster, the impact of improved control of CINV on various quality-of-life parameters was assessed through subset analyses on results from two phase 3 trials of Aloxi injection (studies 99-03 and 99-04). FLIE (Functional Living Index-Emesis) scores were generated from patient self-assessment questionnaires about the impact of chemotherapy-induced nausea and vomiting on daily activities. These quality-of-life scores were then compared for patients who were treated with Aloxi injection and those who received ondansetron or dolasetron. For both the acute period (day 1) and days 2 through 4 following chemotherapy, FLIE scores indicate that significantly more patients who were treated with Aloxi injection reported no impact on their daily living from nausea and vomiting compared to those patients treated with ondansetron or dolasetron. In a second poster, a subset analysis demonstrated that a fixed 0.25 mg dose of Aloxi injection effectively prevents CINV independent of patient weight. To assess the potential impact of patient weight on complete response rates, data for patients weighing more than 90 kilograms was pooled from two phase 3 trials of Aloxi injection (studies 99-03 and 99-04) and compared to the complete response rates for all patients who received ondansetron or dolasetron. Results of this analysis indicate that the efficacy of Aloxi injection is maintained in patients weighing more than 90 kg. For the overall 0- to 120-hour time period following chemotherapy, a complete response was observed in 66% of patients weighing more than 90 kg and treated with Aloxi injection compared to 42% of all patients who were treated with ondansetron or dolasetron. In the acute phase (0 to 24 hours), 76% of these patients treated with Aloxi injection had a complete response, compared to 61% of all patients who received ondansetron or dolasetron. In the delayed phase (24 to 120 hours), the complete response rate for these patients treated with Aloxi injection was 76%, compared to a 47% complete response rate for all patients who received ondansetron or dolasetron. A third poster described results from a double-blind, 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. , placebo-controlled study that was designed to evaluate the pharmacokinetics and safety of doses of Aloxi injection on three consecutive days. This study demonstrated that three days of consecutive doses of Aloxi injection were well tolerated with predictable plasma concentrations. 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 adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. 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 package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific , available at www.mgipharma.com and www.aloxi.com, for important additional details. MGI licensed the U.S. and Canadian 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 palonosetron hydrochloride Aloxi Pharmacologic class: Selective serotonin subtype 3 (5-HT3) receptor antagonist Therapeutic class: Antiemetic Pregnancy risk category B ) injection, Salagen(R) Tablets (pilocarpine pilocarpine (pīlōkär`pēn), naturally occurring alkaloid obtained from plants of the genus Pilocarpus (family Rutaceae). 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. About HELSINN HEALTHCARE HELSINN HEALTHCARE SA is a privately owned pharmaceutical group with headquarters in Switzerland and is the worldwide licensor of palonosetron. HELSINN's core business is the licensing of pharmaceuticals in therapeutic niche areas. The company's business strategy is to in-license early-stage new chemical entities and complete their development from the performance of pre-clinical/clinical studies and CMC (Common Messaging Calls) A programming interface specified by the XAPIA as the standard messaging API for X.400 and other messaging systems. CMC is intended to provide a common API for applications that want to become mail enabled. 1. development to the attainment of market approvals in strategic markets (U.S. and Europe). HELSINN's products are eventually out-licensed to its marketing partners for distribution. The active pharmaceutical ingredients and the finished dosage forms are manufactured at HELSINN's cGMP facilities and supplied worldwide to its customers. For more information about HELSINN, please visit www.helsinn.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 Form 10-Q See 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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