BLUE BELL, PA June 30, 2003 - InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced the initiation of patient screening in the Company's Phase IV study using Visicol® tablets as a laxative in patients with constipation. Visicol® tablets are currently marketed in the United States for cleansing of the bowel prior to colonoscopy in adults. The study will be a randomized dose ranging trial in approximately 40 patients with either chronic functional constipation or constipation-predominant Irritable Bowel Syndrome (IBS). Patients will be treated for up to 28 days. Data from the study are expected in the fourth quarter of 2003.
The Company has previously completed a study comparing the laxative effects of Visicol® and Miralax® in healthy volunteers, where the laxative effects of Visicol® were significantly greater and more prompt than the effects of Miralax®, the most widely prescribed drug for constipation. Additionally, effects on electrolytes were comparable at the end of the study.
In the current study, we expect to learn the appropriate dosing regimen for Visicol® in a broad range of constipated patients, as well as the safety of continued dosing over 4 weeks, said Martin Rose, M.D., J.D., Executive Vice President for Research and Development at InKine. 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 annually. Sodium phosphate solution and other marketed colon cleansing products are used as laxatives at lower doses. It is highly likely Visicol will also prove to be an effective laxative at a lower dose, further commented Robert F. Apple, Chief Operating and Financial Officer.
About InKine Pharmaceutical
InKine Pharmaceutical Company, Inc. is a publicly traded biopharmaceutical company focused on the diagnosis and treatment of cancer and autoimmune diseases. The Company's development strategy is to acquire late-stage drug candidates with short time lines to commercialization. The Company's first product, Visicol is the first and only tablet purgative preparation indicated for bowel cleansing prior to colonoscopy. InKine's second product, IBStat, is a novel oral hysocyamine spray for the treatment of Irritable Bowel Syndrome (IBS) and spasm of the colon. Additionally, the Company is developing other clinical compounds such as Colirest, which is in clinical trials for the treatment of Crohn's disease and completed Phase II trials for the treatment of ulcerative colitis. For further information, please visit InKine on their web site http://www.inkine.com.
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