Aloxi(R) Phase 3 Data for Post Operative Nausea and Vomiting (PONV) Presented at the Annual Meeting of the American Society of Anesthesiologists (ASA).Successful Aloxi([R]) Phase 3 Results in PONV PONV Post-Operative Nausea and Vomiting Presented MINNEAPOLIS -- 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), a biopharmaceutical company focused in oncology and acute care, and its partner HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceutical group, today announced the presentation of results of Study PALO-04-07 at the Annual Meeting of the American Society of Anesthesiologists The American Society of Anesthesiologists (ASA) is an association of physicians (primarily anesthesiologists) whose stated goal is to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient. (ASA Asa (ā`sə), in the Bible, king of Judah, son and successor of Abijah. He was a good king, zealous in his extirpation of idols. When Baasha of Israel took Ramah (a few miles N of Jerusalem), Asa bought the help of Benhadad of Damascus and ). PALO-04-07 is 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. , multi-center phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. conducted to evaluate the safety and efficacy of Aloxi([R]) (palonosetron hydrochloride) Injection compared to placebo for the prevention of post-operative 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. (PONV) following elective inpatient gynecologic gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology. or breast surgery. PALO-04-07, along with PALO-04-06, a randomized, multi-center phase 3 clinical trial conducted to evaluate the safety and efficacy of Aloxi compared to placebo for the prevention of PONV following elective outpatient laparoscopic Laparoscopic A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen. Mentioned in: Obstetrical Emergencies abdominal or gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic. laparoscopic surgery, served as the basis of a supplemental New Drug Application that was accepted for filing by the Food and Drug Administration on July 9, 2007. Phase 3 Results of Aloxi in PONV, Study PALO-04-07 (Poster # A52) Results from a randomized, double-blind, multicenter, placebo-controlled phase 3 study designed to assess the incidence, time course, and treatment patterns associated with PONV and post-discharge nausea and vomiting (PDNV) over three days were reported. Female patients (n=544) undergoing elective inpatient gynecological or breast surgery 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. for history of PONV and/or motion sickness and were randomly assigned to receive one of three single intravenous doses of Aloxi (0.025mg, 0.05mg, or 0.075mg) or placebo prior to receiving anesthesia. The results show that the study successfully met the primary efficacy endpoint of CR. Complete response rates for the selected dose of Aloxi 0.075 mg were significantly higher than those for placebo during the 0-24 (56% versus 36%) and 24-72 (70% versus 52%) hour time periods following surgery (p < 0.0166). Occurrences of nausea, as measured by a 4-point categorical scale ("none" to "severe"), were less intense in patients who received Aloxi 0.075 mg compared with patients who received placebo in the 0-6 hour, 6-72 hour, and 0-72 hour intervals. The incidence, pattern, and intensity of adverse events were similar among all treatment groups including placebo, and the most frequently observed side effects were headache and constipation. About Post-Operative Nausea and Vomiting (PONV) Post-operative nausea and vomiting are common consequences of anesthetic and surgical procedures, frequently occurring immediately following the procedure and up to 72 hours post procedure. In the United States, nearly 30 million doses of 5-HT3 receptor antagonists are used annually for the management of PONV. Patients undergoing abdominal, gynecological, ear/nose/throat, or optical procedures are at highest risk for PONV. Additional factors that can increase the risk for PONV include female gender, non-smoking status, prior history of PONV or motion sickness, length of surgery and the use of volatile anesthetics and opioids. If not prevented, PONV can result in delayed discharge from the post-anesthesia care unit (PACU) or ambulatory surgical center facility, hospital re-admissions and increased healthcare costs. About Aloxi([R]) (palonosetron hydrochloride) Injection Aloxi is approved by the U.S. 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. 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 CINV CINV Chemotherapy Induced Nausea and Vomiting caused by moderately emetogenic cancer chemotherapy. The most common adverse reactions related to Aloxi were headache (9%) and constipation (5%). Aloxi 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. Please see the Aloxi package insert, available at www.mgipharma.com and www.aloxi.com, for important additional details. About HELSINN HEALTHCARE HELSINN HEALTHCARE SA, a privately owned pharmaceutical group with headquarters in Switzerland, 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 the company's Web site at www.helsinn.com. 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. 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 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 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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