MGI PHARMA Announces the Presentation of Salagen Tablets Data By RTOG At 2001 ASTRO Meeting.Business Editors & Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--Nov. 6, 2001 Pilocarpine pilocarpine (pīlōkär`pēn), naturally occurring alkaloid obtained from plants of the genus Pilocarpus (family Rutaceae). improved salivary flow salivary flow, n the amount of saliva naturally produced by the salivary glands. Saliva production is increased by the presence of food or irritating substances, such as vomit, in the oral cavity. when used during radiation therapy for head and neck cancer patients 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) today announced that the Radiation Therapy Oncology Group (RTOG RTOG Radiation Therapy Oncology Group RTOG Round Table of Goodness (diecast toy car collecting club) ) presented final results on data regarding the Company's Salagen(R) Tablets product at this year's American Society for Therapeutic Radiology and Oncology (ASTRO) meeting held in San Francisco on November 4-8, 2001. The resulting data were discussed by Dr. Charles W. Scarantino, lead investigator of the RTOG study on Salagen Tablets, in his presentation entitled: "A Phase 3 study on the concurrent use of pilocarpine to reduce hyposalivation and mucositis associated with radiation therapy in head an neck cancer patients - final results of RTOG 97-09." Study Data The RTOG presented data showing that use of 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. ), MGI's approved product to treat the symptoms of radiation-induced dry mouth, gave a statistically significant improvement of salivary flow versus placebo in head and neck cancer patients receiving curative radiation therapy. This Phase 3 trial, with 244 eligible patients, showed the pilocarpine group, who received active drug during radiation therapy and up to six months post therapy, had significantly better salivary flow than did the placebo group at end of radiation therapy, and at three-month and six-month follow-up visits. Based on these findings, RTOG concluded that these results provide new support for the use of Salagen Tablets during radiation treatment. One of the main side effects Side effects Effects of a proposed project on other parts of the firm. of radiation therapy for head and neck cancer patients is dry mouth, a condition that can be permanent, according to Dr. Scarantino, a radiation oncologist radiation oncologist Radiation therapist A radiologist specialized in using radioactive substances and x-rays to treat tumors and CA; an oncologist who uses various formats of radiation to manage CA Salary ± $200K. See Oncologist. with the Rex Healthcare Center, Raleigh, NC, and Southeastern Cancer Control Consortium. "We are quite pleased with the results of the study in that by taking pilocarpine three or four times a day in pill form, salivary flow was better than taking placebo," said Dr. Scarantino. "These were just the results we were hoping for and we believe we can now build on this study in the future. These clinical results are of real importance to cancer patients." Dr. Scarantino said that although the drug had a real impact on dry mouth symptoms, it did not have an effect on mucositis, another side-effect of radiation treatment for head and neck cancer. Mucositis is a painful condition associated with inflammation of the mucous membrane mucous membrane n. A membrane lining all body passages that communicate with the exterior, such as the respiratory, genitourinary, and alimentary tracts, and having cells and associated glands that secrete mucus. Also called mucosa. . About Salagen(R) Tablets MGI developed and markets Salagen Tablets for the treatment of chronic dry mouth symptoms associated with head and neck cancer patients treated with radiation, and with Sjogren's syndrome patients. MGI has marketed Salagen Tablets in the United States for the cancer-related indication since 1994 and the Sjogren's syndrome indication since 1998. Salagen Tablets are the first and only prescription medication approved in the United States for treating dry mouth symptoms associated with both of these patient populations. Chronic dry mouth can be a potentially painful and debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction condition. Salagen Tablets stimulate the exocrine glands, including the salivary glands, to increase their moisture-producing activity. When head and neck cancer patients receive radiation treatment, this therapy often damages the salivary glands and their ability to produce moisture. Salagen Tablets can stimulate the glands to generate more moisture. Salagen Tablets do not work for everyone and are contraindicated when uncontrolled asthma is present and when miosis miosis /mi·o·sis/ (mi-o´sis) contraction of the pupil. mi·o·sis or my·o·sis n. pl. mi·o··ses 1. is undesirable. When used for radiation-induced xerostomia xerostomia /xe·ro·sto·mia/ (zer?o-sto´me-ah) dryness of the mouth due to salivary gland dysfunction. xe·ro·sto·mi·a n. , the most common side effect is sweating. Although less frequent, in some people, headache, flushing, and frequent urination urination Process of excreting urine from the bladder (see urinary system). Nerve centres in the spinal cord, brain stem, and cerebral cortex control it through involuntary and voluntary muscles. The need to void is felt when the bladder holds 3. can also occur. When used for Sjogren's syndrome, the most common side effect is sweating, and in some people, chills, flushing, and frequent urination can occur. About RTOG The Radiation Therapy Oncology Group (RTOG) is a federally funded cancer clinical trials cooperative group, which carries out multi-disciplinary research nationwide. It is a major clinical research component of the American College of Radiology The American College of Radiology (ACR), founded in 1923, is a non-profit professional medical organization composed of diagnostic radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians, and medical physicists. . About MGI PHARMA MGI PHARMA, Inc. is an oncology-focused pharmaceutical company that acquires, develops and commercializes proprietary products that address unmet cancer patient needs. MGI is building a balanced product portfolio of proprietary pharmaceuticals, and intends to become a leader in oncology. The Company focuses its sales efforts solely in the United States and collaborates with other pharmaceutical or biotechnology companies for its products in international markets. For more information about MGI, please visit the Company's Web site at 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 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 in Exhibit 99 to 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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