MGI PHARMA Announces Publication of Phase 3 Data for Saforis(TM) (glutamine) Powder in UpTec(TM) for Oral Suspension in Cancer.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, today announced publication of 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. , double-blind, placebo-controlled phase 3 trial of Saforis[TM] (glutamine glutamine (gl  `təmēn), organic compound, one of the 20 amino acids commonly found in animal proteins. ) Powder in UpTec[TM] for Oral Suspension in the journal Cancer. Results of this study, which were first presented at 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 OncologyASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) 2004 Annual Meeting, indicate that treatment with Saforis significantly reduced the incidence of severe oral mucositis when compared to placebo. Saforis is an investigational therapy for the treatment and prevention of oral mucositis in patients receiving mucotoxic cancer therapy. Results of this phase 3 study formed the foundation for the Saforis New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ). MGI PHARMA received an approvable letter for Saforis from the U.S. Food and Drug Administration (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. ) in October 2006. Based on the FDA's request for an additional phase 3 trial, the Company is currently evaluating options to maximize the value of Saforis. The pivotal phase 3 trial of Saforis was conducted in 326 patients with breast cancer who were receiving anthracycline-based chemotherapy regimens. Patients in this trial were randomized to receive Saforis or placebo during their first chemotherapy cycle. After their first treatment cycle was complete, study participants were then crossed over to receive the alternate treatment alternate treatment, n the contract provisions that authorize the insurance carrier to determine the amount of benefits payable, giving consideration to alternate procedures, services, or courses of treatment that may be performed to accomplish the during their next cycle of chemotherapy. The primary endpoint of this trial, defined as a reduction in incidence and severity of oral mucositis, was met. Data from this study indicate that the incidence of World Health Organization (WHO) Grade 2 or higher oral mucositis was significantly reduced in Saforis-treated patients compared to patients who received placebo (38.7 percent versus 49.7 percent; p=0.026). Among those patients that experienced oral mucositis in this study, the incidence of severe oral mucositis (WHO Grade 3 or higher) was significantly lower in the Saforis arm compared with the placebo arm (1.2 percent versus 6.7 percent; p=0.005). Overall, the data indicated that the safety profile of Saforis was comparable with that of placebo. The most frequently-observed adverse events considered possibly or probably related to the study drug were nausea and dry mouth. No patient experienced a serious adverse event while receiving Saforis. About Oral Mucositis Oral mucositis, a common side effect of mucotoxic cancer therapy, is characterized by painful ulcerations Ulcerations Breaks in skin or mucous membranes that are often accompanied by loss of tissue on the surface. Mentioned in: Hypersplenism , redness and swelling in the mouth, which can cause difficulty swallowing and eating. It is estimated that approximately 35% of patients undergoing mucotoxic cancer therapy develop significant oral mucositis, which equates to more than 200,000 patients per year. In addition to being difficult for patients to manage, oral mucositis can interfere with a patient's ability to continue their cancer therapy and may lead to an increased risk of infection. It is also associated with higher healthcare expenses as a result of frequent opioid analgesics Analgesics, Opioid Definition Opioid analgesics, also known as narcotic analgesics, are pain relievers that act on the central nervous system. Like all narcotics, they may become habit-forming if used over long periods. used to manage mucositis-related pain, emergency room visits due to complications from oral mucositis and prolonged hospital stays. About Saforis[TM] (glutamine) Powder in UpTec[TM] For Oral Suspension Saforis[TM] (glutamine) Powder in UpTec[TM] for Oral Suspension is a product candidate for the prevention and treatment of oral mucositis that occurs as a result of mucotoxic cancer therapy. Saforis has not been approved for marketing by the U.S. FDA or any other regulatory agency regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. . An oral formulation of glutamine delivered via MGI PHARMA's proprietary UpTec[TM] system, Saforis is designed to deliver high concentrations of glutamine into damaged oral mucosa in order to prevent damage from mucotoxic cancer therapies and to promote healing. Although glutamine is the most abundant amino acid amino acid (əmē`nō), any one of a class of simple organic compounds containing carbon, hydrogen, oxygen, nitrogen, and in certain cases sulfur. These compounds are the building blocks of proteins. in human plasma, the availability of and demand for glutamine becomes critical when oral mucosa has been injured as a result of chemotherapy or radiation. By directly exposing the oral mucosa to increased concentrations of this important amino acid, Saforis may prevent damage to and promote healing of the lining of the mouth. 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 palonosetron hydrochloride Aloxi Pharmacologic class: Selective serotonin subtype 3 (5-HT3) receptor antagonist Therapeutic class: Antiemetic Pregnancy risk category B ) Injection, Dacogen[TM] (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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