INSULIN INHALER TESTS NEARING A FINAL PHASE GIANT LEAP FOR MANNKIND.Byline: Eugene Tong Staff Writer VALENCIA - Local biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. firm MannKind Corp. has completed the second-phase trial for its experimental insulin inhalation system and will begin the final studies for federal approval by year's end. The Valencia company said this week it recently met with the U.S. Food and Drug Administration officials to discuss plans for taking the Technosphere Insulin System into Phase 3 trials. Insulin for diabetics is usually injected by needle and, in some cases, by a new pump system. But the technology under development allows delivery through an inhaler inhaler /in·hal·er/ (in-hal´er) 1. an apparatus for administering vapor or volatilized medications by inhalation. 2. ventilator (2). in·hal·er n. . ``The discussions focused on our plans for pivotal Phase 3 clinical development, which is expected to include two years of safety data from a subset of trial patients with type 1 and with type 2 diabetes type 2 diabetes n. See diabetes mellitus. at the time of submission of a new drug application,'' Dr. Wendell Cheatham, company vice president and chief medical officer, said in a statement. MannKind completed Phase 2 trials in October. The study, which lasted two years, examined the treatment's effectiveness. Results are slated to be released in the coming weeks. Phase 1 trials examined general safety issues and began in the late 1990s. Officials plan to begin phase 3 studies in Europe by year's end, and in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. by mid-2005. The company's insulin therapy consists of a proprietary dry powder Dry Powder A slang term for cash reserves kept on hand to cover future obligations. Notes: For example, if a venture capitalist expects bad times in the IPO markets you might hear him say something like, "we want to keep enough dry powder around to keep funding our insulin formula that is inhaled in·hale v. in·haled, in·hal·ing, in·hales v.tr. 1. To draw (air or smoke, for example) into the lungs by breathing; inspire. 2. into the deep lung using an inhaler. The company claims their system's unique procedure and convenience holds potential change for current diabetes treatment paradigm. Eugene Tong, (661) 257-5253 eugene.tong(at)dailynews.com |
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