InKine Initiates Dosing of Subjects in Laxative Study of Visicol Tablets.Business Editors BLUE BELL, Pa.--(BUSINESS WIRE)--March 13, 2003 InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced that the first 10 patients began treatment yesterday in the Company's post-marketing study of the use of Visicol tablets (sodium phosphate) as a laxative laxative, drug or other substance used to stimulate the action of the intestines in eliminating waste from the body. The term laxative usually refers to a mild-acting substance; substances of increasingly drastic action are known as cathartics, purgatives, . Visicol tablets are currently marketed in the US for cleansing of the bowel prior to colonoscopy in adults. The study, which is being performed in adult, healthy volunteers, 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. , open label trial that will investigate the safety and laxative effects of two low dose regimens of Visicol tablets compared to Miralax(R), a marketed prescription laxative. Subjects will be treated for one week and study results are expected in the second quarter of 2003. The constipation marketplace represents a potentially large extension of Visicol's utility, with over two million patients seeking treatment each year yielding over 3.5 million prescriptions. "Sodium phosphate solution and other marketed colon cleansing products are used as laxatives Laxatives Definition Laxatives are products that promote bowel movements. Purpose Laxatives are used to treat constipation—the passage of small amounts of hard, dry stools, usually fewer than three times a week. at lower doses," said Martin Rose, M.D., J.D., InKine's Executive Vice President for Research and Development. "It is highly likely that Visicol will also prove to be an effective laxative. This study will give us information on the safety of two low doses of Visicol tablets given daily for one week. In addition, we will be focusing on the dose response and the time course of laxative effects with Visicol. The comparison with Miralax will be important, because the labeling for Miralax indicates that it may take two to four days to produce a bowel movement." About InKine Pharmaceutical InKine Pharmaceutical Company, Inc. is a publicly traded biopharmaceutical company focused on the diagnosis and treatment of cancer and autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . The Company's development strategy is to acquire late-stage drug candidates with short time lines to commercialization. The Company's first product, Visicol(TM) is the first and only tablet purgative purgative /pur·ga·tive/ (purg´it-iv) cathartic (1, 2). pur·ga·tive n. An agent used for purging the bowels. adj. Tending to cause evacuation of the bowels. preparation indicated for bowel cleansing prior to colonoscopy. InKine's second product, IBStat(TM), is a novel oral hysocyamine spray for the treatment of Irritable Bowel Syndrome irritable bowel syndrome (IBS), condition characterized by frequently alternating constipation and diarrhea in the absence of any disease process. It is usually accompanied by abdominal pain, especially in the lower left quadrant, bloating, and flatulence. (IBS IBS Irritable bowel syndrome, see there ) and spasm of the colon. Additionally, the Company is developing other clinical compounds such as Colirest(TM), which is in clinical trials for the treatment of Crohn's disease
The treatment of Crohn's disease is sequential: to treat acute disease, and then to maintain remission. Treatment initially involves the use of medications to treat any infection and to reduce inflammation. and completed Phase II trials for the treatment of ulcerative colitis This article concerns the treatment of ulcerative colitis, a form of inflammatory bowel disease (IBD). Ulcerative colitis is a form of colitis, a disease of the intestine, specifically the large intestine or colon, that includes characteristic ulcers, or open sores, in the colon. . For further information, please visit InKine on their web site http://www.inkine.com In addition to historical facts or statement of current condition, this press release may contain forward-looking statements. Forward-looking statements provide InKine's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings projections, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. InKine's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties such as those set forth in its reports on Form 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, InKine does not intend (and it is not obligated ob·li·gate tr.v. ob·li·gat·ed, ob·li·gat·ing, ob·li·gates 1. To bind, compel, or constrain by a social, legal, or moral tie. See Synonyms at force. 2. To cause to be grateful or indebted; oblige. ) to update publicly any forward-looking statements. This discussion is permitted by 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. |
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